2023 Report on Scientific Conferences With Expenses Over $30,000

Section 3074 of 21st Century Cures Act requires the FDA to report on scientific conferences hosted, sponsored, co-sponsored, or attendance at non-Federal Scientific Meetings with FDA expenses in excess of $30,000. The following outlines the total expenses for each scientific meeting together with other pertinent information including how the conference advanced the mission of the agency, a description of the conference activities. Section 3074 requires additional information of compelling circumstances for the costs exceeding $150,000.

2023 Annual Report

1. FDA23 Center of Excellence on Compounding for Outsourcing Facilities Conference

Applicable Conference Type:   FDA Hosted/Sponsored/Co-Sponsored
Conference Location:   Virtual
Conference Start Date:   09/12/2023
Conference End Date:   09/13/2023

Total FDA cost of the conference: $520,945
Total number of individuals whose travel expenses were paid by the FDA: N/A

Explanation of how conference advanced the mission of FDA:

The Center of Excellence on Compounding for Outsourcing Facilities Conference was designed to help the outsourcing facility industry meet its intended function, so the FDA engaged in a number of initiatives during the conference to address challenges and support advancement. These included the development and provision of practical and virtual training, as well as in-depth research to better understand barriers that impede growth and potential solutions.

General description of the scientific conference activities:

The Center of Excellence on Compounding for Outsourcing Facilities Conference was a year-end conference for outsourcing facility staff to engage the sector on issues related to outsourcing facilities and drug production as well as educate the sector on relevant policy matters and FDA oversight approaches. The purpose of this conferences was to educate outsourcing facility members on relevant policy matters and FDA oversight approaches regarding outsourcing facilities and drug production. The execution of a two-day year-end conference enabled engagement and information sharing between FDA and Outsourcing Facilities to directly support FDA’s goals of ensuring the sector can provide products of reliable quality, as well as effective implementation of federal law on drug compounding overall.

Explanation/description of circumstances for conference exceeding $150,000:

The information disseminated during the Center of Excellence on Compounding for Outsourcing Facilities Conference to the participants was critical to the mission of the FDA related to drug compounding. Although compounded drugs can serve an important medical need for certain patients when an approved drug is not medically appropriate, they also can present a risk to patients. Compounded drugs are not FDA-approved. Therefore, they do not undergo premarket review by FDA for safety, effectiveness, and quality. The Drug Quality and Security Act of 2013 created “outsourcing facilities” – a new industry sector of drug compounders held to higher quality standards to protect patient health. Outsourcing facilities are intended to offer a more reliable supply of compounded drugs needed by hospitals, clinics, and other providers.

2. FDA23 International Association for Food Protection Annual Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Toronto, Canada
Conference Start Date:   07/16/2023
Conference End Date:   07/19/2023

Total FDA cost of the conference: $417,309
Total number of individuals whose travel expenses were paid by the FDA: 105

Explanation of how conference advanced the mission of FDA:

Attending the International Association for Food Protection conference provided in-depth discussions and analyses on a wide variety of timely topics by bringing together experts from the federal government, industry, the private bar, non-profit, patient and consumer advocates, consulting organizations, and academia. Attendees were able to hear FDA’s strategic priorities directly from the FDA Commissioner, Chief Counsel, Center Directors, and other key leaders within the Agency. Attendees were also able to learn about the current Top Cases in Food Protection as well as different viewpoints and advance understanding.

General description of the scientific conference activities:

The International Association for Food Protection conference is a highly recognized, international scientific meeting hosting the top professionals in the food safety space. This annual meeting was attended by more than 3,600 of the top industry, academic and governmental food safety professionals from six continents. This renowned event owes its reputation and success to the quantity, quality, and diversity of each year's program; the quality and relevance of exhibits sharing the latest in available technologies; leading experts speaking on a variety of timely topics; and special recognition of outstanding professionals and students for their contributions in the food safety field. Attendees learned information on current and emerging food safety issues, the latest science, innovative solutions to new and recurring problems, and the opportunity to network with thousands of food safety professionals from around the globe.

Explanation/description of circumstances for conference exceeding $150,000:

It was important for FDA attendees to attend the 2023 International Association for Food Protection Annual Meeting because the conference offered education and training on emerging food safety issues, the latest science, obtained the most late-breaking information on antimicrobial resistance in foodborne pathogens, innovative solutions to new and recurring problems, and the opportunity to network with thousands of food safety professionals from around the globe and facets of the FDA-regulated industry. This conference was the premier conference for the community and all industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies. The information attendees received from this conference was critical to FDA’s evaluation of antimicrobials and other alternative compounds for microbial food safety, ensuring that human and animal foods are properly evaluated for hazards to human and animal health. Also, some participants presented mission critical data to peers, and one chaired a professional development group (PDG) meeting and made a presentation on a current microbial animal food safety project. Attendees learned up-to-date knowledge on detection, antimicrobial resistance, epidemiology, genomics, metagenomics, and public health. The International Association of Food Protection is an international conference focused entirely on food safety including innovative products, antimicrobial resistance mechanisms, and ensuring the safety of animal derived food products. It is one of the 2 largest and most well-respected conferences held annually and includes targeted interactions with industry, academics, and international regulatory participants. Attendance at this conference was critical to exchanging scientific/regulatory information between FDA, and its regulatory counterparts, international standard-setting organizations, and industry.

3. FDA23 Society of Toxicology Conference

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Nashville, Tennessee
Conference Start Date:   03/19/2023
Conference End Date:   03/23/2023

Total FDA cost of the conference: $282,171
Total number of individuals whose travel expenses were paid by the FDA: 177

Explanation of how conference advanced the mission of FDA:

The Society of Toxicology (SOT) Annual Meeting is the largest gathering of toxicologists in the world and benefits the FDA by allowing scientists to present their data and develop ideas for future projects, which will benefit the Agency. This sharing of research and technology methods with others to educate and protect the public health allowed scientists to stay current in the latest advances in the assessment of toxicities associated with FDA regulated products.

General description of the scientific conference activities:

The Society of Toxicology (SOT) conference benefited the FDA by allowing scientist to develop ideas for future projects that will be beneficial to FDA, sharing of up-to-date research and technology methods with others to educate and protect the public health. Attending the conference provided attendees with current scientific advancements in the field of toxicology and safety assessment. Attendance at this meeting also provided the opportunities to interact with clinical and academic science professionals from across the globe to gain a national and international perspective into the latest advances in toxicology, to stay on top of state-of-the-art concepts, tools, and techniques in toxicology.

Explanation/description of circumstances for conference exceeding $150,000:

The Society of Toxicology (SOT) is committed to creating a safer and healthier world by advancing the science of toxicology. Toxicology is the branch of science concerned with the nature, effects, and detection of poisons. The Society promotes the acquisition and utilization of knowledge in toxicology, aids in the protection of public health, and facilitates disciplines. SOT's definition of toxicology is 'the study of the adverse effects of chemical, physical or biological agents on living organisms and the ecosystem, including the prevention and amelioration of such adverse effects.’ We live in an ecosystem where technology and science evolve quickly. New problems and threats, like the COVID-19 pandemic, continually emerge. Societal needs, perspectives, and values change, as do the needs of our employees. Attending the SOT Conference aided FDA in continuing to develop an organization that is prepared for innovations in technology and unanticipated national health challenges, while engaging with and continuing to serve the American public. This conference was mission critical as attendance will allow staff to meet with industry and academia to discuss innovative technologies and to discuss the clinical data requirements for future device submissions. Attendees were also able to discuss the Center programs that can benefit IDE protocol design for devices that address unmet medical needs. This meeting aided in the professional development in the areas of toxicology, risk assessment, and biocompatibility that are used to assess safety concerns relevant to medical devices as well as allowed FDA attendees to obtain training to understand advances in the field to support FDA review work and the agency’s mission. In addition to giving a presentation during one of the conference symposiums, FDA staff attended the SOT conference to stay informed about findings in the field. Sessions relevant to FDA work included discussions on: i) humanized preclinical models for CAR T cells, ii) approaches for immunotoxicity testing, iii) methods to measure adverse pulmonary endpoints, and iv) methods to predict and measure the hepatotoxic potential of therapeutic agents.

4. FDA23 Drug Information Association Global Annual Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Boston, Massachusetts
Conference Start Date:   06/25/2023
Conference End Date:   06/29/2023

Total FDA cost of the conference: $140,659
Total number of individuals whose travel expenses were paid by the FDA: 56

Explanation of how conference advanced the mission of FDA:

Participation at the Drug Information Association Global conference was mission critical to FDA's strategic priorities, including Clinical Evaluations to Improve Patient outcomes. The DIA Annual Conference supported FDA’s mission by providing numerous training and discussion sessions that helped the attendee develop a deeper and more nuanced understanding of the scientific and legal issues present in advisory committee meetings to form more precise and timely legal determinations. This conference was a unique forum that brought together regulatory and scientific experts to share ideas and problem solve regulatory, scientific, medical, and ethical issues facing the public industry as well as FDA.

General description of the scientific conference activities:

The DIA 2023 Global Annual Meeting invites industry, regulatory government, academics, and patients to network, problem-solve, and discuss global and local challenges facing the life sciences community. Hosted in Boston, DIA 2023 will amplify different perspectives while highlighting expertise across the globe to reimagine current processes that better enhance health and well-being. This conference allowed attendees to participate in technical and informational sessions with FDA's international partners. This year’s conference included discussions and updates from speakers on these priorities as well as efforts to improve implementation of diversity, equity, and inclusion (DEI) in clinical trials, the impact of artificial intelligence (AI) on regulatory submissions and review, and efforts to continue to create access to innovative therapies across FDA.

5. FDA23 United States Public Health Service Symposium

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Tulsa, Oklahoma
Conference Start Date:   05/08/2023
Conference End Date:   05/11/2023

Total FDA cost of the conference: $138,896
Total number of individuals whose travel expenses were paid by the FDA: 103

Explanation of how conference advanced the mission of FDA:

The United States Public Health Service Commissioned Corps, also referred to as the Commissioned Corps of the United States Public Health Service, is the federal uniformed service of the U.S. Public Health Service and one of the eight uniformed services of the United States. They work on the front lines of public health. Their medical, health and engineering professionals fight disease, conduct research, and care for patients in underserved communities across the nation and throughout the world. They serve in agencies across the government as physicians, nurses, dentists, veterinarians, scientists, engineers, and other professionals. The United States Public Health Service Commissioned Officers Foundation for the Advancement of Public Health hosted the Symposium. Attending the U.S. Public Health Service Education and Training Symposium was an excellent means of obtaining continuing education credits across a variety of disciplines. Attendance enabled FDA Commissioned Corps officers to take the required course work to keep them to keep current with current practices and technology and to remain proficient in the various agency programs to which they are assigned. Attending this conference was mission critical as it supported the FDA’s mission with emphasis on promoting public health. Reviewers must have had updated knowledge and training to enable management to make fully informed approval and disapproval decisions regarding medical device applications. This training was a unique opportunity for professional development and networking since the conference is the only annual, in-person conference for PHS Commissioned Corps officers. The United States Public Health Service Symposium was also mission critical because the conference offered PHS employees the chance to learn advances in the fields of health care and public health, as well as to facilitate improvements in public health through collaboration and to maintain licensure and professional competency, officers must take continuing education coursework each year. This enabled them to keep current with state-of-the-art practices and technology and to remain proficient in the various agency programs to which they are assigned.

General description of the scientific conference activities:

The U.S. Public Health Service (USPHS) Scientific and Training Symposium served as the premiere meeting for all USPHS Commissioned Officers. This event was the only annual meeting dedicated exclusively to the work of the USPHS Commissioned Corps officers, where officers and USPHS leadership come together to discuss solutions to the Nation's pressing public health issues. Attendance helped strengthen the nation's public health and emergency response capability, promoting esprit de corps, while strengthening relationships that will further the mission and objectives of public health agencies. Attendance at this symposium helped officers maintain professional licensure and competencies in public health. Attendance allowed officers to remain current with state of the art in public health and clinical practices and technology. This enabled officer proficiency in a variety of assigned programs that support the FDA's mission of protecting public health and supporting ORA Strategic Priority of developing a diverse, highly capable, high-performing and adaptable workforce. Failure to attend conferences like this could result in the lapse of required licenses and result in ORA having fewer employees available to conduct regulatory activities in support of ORA strategic goal of protecting the public against violations associated with FDA-regulated products.

6. FDA23 Small Business Regulatory Education for Industry Annual Conference

Applicable Conference Type:   FDA Hosted/Sponsored/Co-Sponsored
Conference Location:   Virtual
Conference Start Date:   06/05/2023
Conference End Date:   06/09/2023

Total FDA cost of the conference: $134,555
Total number of individuals whose travel expenses were paid by the FDA: N/A

Explanation of how conference advanced the mission of FDA:

The Small Business Regulatory Education for Industry Annual Conference was a major program element for the CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM) of the FDA. This meeting allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. It also allowed FDA to share targeted regulatory information to attendees. This in turn will assist in sponsors submitting more complete application to the FDA, which should ultimately reduce the review time. Attendees also participated at REdI to present on FDA's regulatory requirements to legally study and market drugs, medical devices, and biologics in the United States.

General description of the scientific conference activities:

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance’s (SBIA’s) mission is to promote productive interaction by assisting regulated domestic and international small pharmaceutical business and industry seeking timely and accurate information relating to development and regulation of human drug products. The SBIA outreach activities include hosting events (such as this one) in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic and device industries. The Small Business Regulatory Education for Industry Annual Conference helped empower small businesses in their interactions with FDA and aided those businesses in the development of more complete submissions and first-cycle drug approvals.

7. FDA23 International Council on Harmonization International Pharmaceutical Regulators Program

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Incheon, Republic of Korea
Conference Start Date:   11/15/2022
Conference End Date:   11/16/2022

Total FDA cost of the conference: $125,517
Total number of individuals whose travel expenses were paid by the FDA: 28

Explanation of how conference advanced the mission of FDA:

Participating in the International Council on Harmonization Bi-Annual Meeting was critical to advancing development of an international drug regulation standard on Stability of pharmaceutical products. The US leads the ICH Q1/Q5C expert working group developing this harmonized international guideline, and FDA attendees’ expertise was essential to the success of this effort. ICH responds to the increasingly global face of drug development, and its mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource efficient manner.

General description of the scientific conference activities:

The International Council for Harmonization Bi-Annual meeting was unique in bringing together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. This meeting assisted in progressing the development of internationally harmonized guidelines in the areas of Safety, Efficacy, Quality, and Multidisciplinary topics. The meeting also advanced regulatory harmonization of technical standards as well as regulatory reliance and convergence of standards and processes.

8. FDA23 Small Business Regulatory Education for Industry Advancing Generics Forum

Applicable Conference Type:   FDA Hosted/Sponsored/Co-Sponsored
Conference Location:   Virtual
Conference Start Date:   09/01/2023
Conference End Date:   09/02/2023

Total FDA cost of the conference: $108,595
Total number of individuals whose travel expenses were paid by the FDA: N/A

Explanation of how conference advanced the mission of FDA:

The Small Business Regulatory Education for Industry Advancing Generics Forum was a major program element for the CDER Small Business and Industry Assistance (CDER SBIA) program within the FDA. This meeting allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. It also allowed FDA to share targeted regulatory information to attendees. This in turn will assist in sponsors submitting more complete application to the FDA, which should ultimately reduce the review time. The purpose of this science-focused workshop was to communicate to the generic industry how FDA research outcomes guide and facilitate complex generic drug product development. FDA linked GDUFA science and research on complex drug products to product-specific guidance development, discuss pre-ANDA meetings and review, and examine various areas of complex product science.

General description of the scientific conference activities:

9. FDA23 Small Business Regulatory Education for Industry Generic Drugs Forums

Applicable Conference Type:   FDA Hosted/Sponsored/Co-Sponsored
Conference Location:   Virtual
Conference Start Date:   04/12/2023
Conference End Date:   04/13/2023

Total FDA cost of the conference: $108,595
Total number of individuals whose travel expenses were paid by the FDA: N/A

Explanation of how conference advanced the mission of FDA:

The Small Business Regulatory Education for Industry Generic Drugs Forums were major program elements for the CDER Small Business and Industry Assistance (CDER SBIA) program within the FDA. This meeting allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. It also allowed FDA to share targeted regulatory information to attendees. This in turn will assist in sponsors submitting more complete application to the FDA, which should ultimately reduce the review time. This meeting was also invaluable assistance to both CDER and SBIA staff, as it served as a reference | training material to help direct them in producing relevant material responsive to their audience's inquiries and needs.

General description of the scientific conference activities:

The Generic Drugs Forum (GDF) was an annual, two-day virtual event that offered attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. The goal of the forum was to provide information to aid potential and current applicants by offering practical advice and taking a deep dive into the Abbreviated New Drug Application (ANDA) assessment process. This year’s theme was Celebrating 10 Years of GDF, and presentations were focused on hot topics such as GDUFA III updates, information and technology, and complex generics. The purpose of the meeting was to educate the small business generic pharmaceutical industry on key elements associated with the generic drug development continuum.

10. FDA23 Association of Official Analytical Chemists International Annual Meeting and Exposition

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   New Orleans, Louisiana
Conference Start Date:   08/25/2023
Conference End Date:   08/30/2023

Total FDA cost of the conference: $108,123
Total number of individuals whose travel expenses were paid by the FDA: 38

Explanation of how conference advanced the mission of FDA:

Association of Official Analytical Collaboration (AOAC) conference advanced food safety, food integrity, and public health, by bringing together members, organizations, and experts dedicated to developing and validating standards, methods, and technologies of global relevance. This global scientific event provided unparalleled professional development, networking, and collaboration opportunities. FDA's attendance at this meeting was critical to advance the FDA scientific review process of animal feed ingredients for ensuring safe animal food.

General description of the scientific conference activities:

The Association of Official Analytical Collaboration (AOAC) conference provided an in depth understanding in standard methods of analysis that ensure the safety and integrity of foods and other products is critical for CVM’s scientific reviews on animal feed ingredients. This in turn facilitated FDA’s mission on safeguarding human and animal health. Attending the AOAC meeting was important as it provided opportunities to learn new trends, standards, and methods, develop professional expertise, and networking in methods-based science. Businesses were able to meet scientific and regulatory experts and become community leaders. Scientists were also able to build professional expertise and share best practices as well as regulators were able to leverage stakeholder collaboration to improve compliance and public safety.

11. FDA23 American Society Quality World Conference for Quality & Improvement

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Philadelphia, Pennsylvania
Conference Start Date:   05/07/2023
Conference End Date:   05/10/2023

Total FDA cost of the conference: $107,857
Total number of individuals whose travel expenses were paid by the FDA: 45

Explanation of how conference advanced the mission of FDA:

The American Society Quality World Conference for Quality & Improvement brought together thousands of professionals representing manufacturing, consulting, health care, government, education, aerospace, and more for learning that will produce long-term gains in an organization’s quality mission. From emerging quality practitioners to experienced professionals, the WCQI 2023 offered meaningful networking, education, and product discovery to help individuals and organizations pursue excellence through quality. Attending this conference contributed to FDA's mission of protecting the public heath, specifically ORAs Strategic Plan, GOAL 1: Foster and diverse, highly capable, high-performing, and adaptable workforce, specifically Objective 1.2: Train and develop our workforce to meet future advances and challenges. Attending assisted FDA in meeting the outcome of the strategic goals of a diverse, highly capable, high-performing, and adaptable workforce that executes FDA's mission to meet future needs.

General description of the scientific conference activities:

The American Society Quality World Conference for Quality & Improvement explored the symbiotic relationship between human and scientific aspects of quality management. Attendance allowed employees to gain new knowledge from quality practitioners conducting training sessions and workshops and new insights about what has changed in quality management. The educational theme for this conference was to reinforce the essentials— curriculum includes total quality management, continuous improvement, ISO standards, data integration—and embrace emerging, universal concepts including culture, diversity and ESG (environmental, social, and governance). At WCQI 2023, attendees learned how quality processes and methodologies bolster their organizations’ response to risks like supply chain, economic pressures, and global volatility, and help spark a culture of excellence and a sustainable, strong foundation for success.

12. FDA23 Biennial Meeting of the Conference for Food Protection

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Houston, Texas
Conference Start Date:   04/24/2023
Conference End Date:   04/28/2023

Total FDA cost of the conference: $106,531
Total number of individuals whose travel expenses were paid by the FDA: 42

Explanation of how conference advanced the mission of FDA:

Active participation by FDA personnel in the Biennial Meeting of the Conference for Food Protection was vital to the success of the Conference and the Agency's mission to ensure the safety of the food supply. FDA presence facilitated more effective engagement in all the sessions and allowed attendees to work together with all constituents involved in the food industry as well as to develop and implement policies and recommendations to strengthen and enhance the overall safety of food for everyone. Attending advanced the mission of the agency as the conference provided information about current microbiological and toxicological aspects of food safety, emerging problems of food safety, and existing FDA recommendations and regulations.

General description of the scientific conference activities:

The Biennial Meeting of the Conference for Food Protection brought together representatives from the food industry, government, academia, and consumer organizations to identify and address emerging problems of food safety and to formulate recommendations. This year’s conference offered an opportunity to work collaboratively with fellow food safety professionals to help influence model laws and regulations. Participants learned more about these topics, which impacted FDA's mission to protect and promote public health. The conference sought to balance the interest of regulatory and industry while providing an open forum for the consideration of ideas from any source as well as to help identify and address problems in the production, processing, packaging distribution, sale, and service of foods. Attending this conference allowed for the experience and knowledge to be acquired that in turn benefited professional development.

13. FDA23 American Association for Cancer Research Annual Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Orlando, Florida
Conference Start Date:   04/14/2023
Conference End Date:   04/19/2023

Total FDA cost of the conference: $104,213
Total number of individuals whose travel expenses were paid by the FDA: 36

Explanation of how conference advanced the mission of FDA:

Attending the American Association for Cancer Research Annual conference provided a unique opportunity to meet regulatory representatives from many firms in one location. This enabled attendees to meet face to face with submission authors that FDA regularly interacts with and establish beneficial rapport. In addition, attending this meeting served to further enhance attendees scientific and clinical knowledge as well as to better inform our review of cutting-edge devices. There were critical discussions on clinical applications of recent current edge in vitro diagnostic devices that have the potential to advance cancer diagnostics and treatment.

General description of the scientific conference activities:

The American Association for Cancer Research Annual Meeting was the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gathered to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR Annual Meeting highlighted the work of the best minds in cancer research from institutions all over the world.

14. FDA23 Association for Food and Drug Officials 127th Annual Educational Conference

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Norfolk, Virginia
Conference Start Date:   06/11/2023
Conference End Date:   06/14/2023

Total FDA cost of the conference: $102,870
Total number of individuals whose travel expenses were paid by the FDA: 43

Explanation of how conference advanced the mission of FDA:

Attendance at this educational conference, the Association for Food and Drug Officials 127th Annual Educational Conference, promoted public health by supporting the agency’s mission of helping safe and effective products reach the market as well as helping the public obtain accurate, science-based information to improve public health. It provided an opportunity for in-depth workshops and trainings on a wide array of food safety issues and the chance to meet more specialists and professionals in the industry to improve experience and understanding on the complexities in the space. The AFDO conference partnered with different regional AFDO affiliates to present this learning experience in a different geographic area annually. During the conference, the AFDO AEC was the center of the food safety world for professionals from government, states, academia, consumer groups, and manufacturing. Attending this annual meeting allowed FDA to build partnerships between top industry executives, academic, and governmental food safety professionals, which is critical to advancing public health.

General description of the scientific conference activities:

The 127th Association of Food and Drug Officials (AFDO) Annual Educational Conference is held annually to provide information on current and emerging food, agriculture, and drug topics impacting health and safety and to build consensus among the states on regulatory approaches to address them. Representatives from government, industry, states, and the public were invited to participate, and this conference presented a valuable opportunity to liaise with industry officials and stay informed on critical topics impacting our regulatory mission. The AFDO conference partnered with different regional AFDO affiliates to present this learning experience in a different geographic area annually. Subject matter experts convened for the education conference ready and willing to share their knowledge. There were dozens of national and international experts on more than 40 topics in the food manufacturing, food retail, produce, cannabis, and body art.

15. FDA23 American Society of Gene and Cell Therapy Annual Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Los Angeles, California
Conference Start Date:   05/16/2023
Conference End Date:   05/20/2023

Total FDA cost of the conference: $102,862
Total number of individuals whose travel expenses were paid by the FDA: 21

Explanation of how conference advanced the mission of FDA:

The American Society of Gene and Cell Therapy Annual meeting experiences were designed to provide the full, comprehensive educational experience our members and attendees expect from the ASGCT Annual Meeting. There were plenary lectures, oral abstract presentations, scientific symposia, education sessions, the virtual poster hall, and select industry-sponsored sessions. The in-person attendees were able to gain knowledge in the field of gene and cell therapy. This conference was beneficial for all FDA attendees to support the Agency mission. This allowed FDA to have a better understanding of the industry and our international counterparts to expedite the availability of gene therapy.

General description of the scientific conference activities:

The American Society of Gene and Cell Therapy Annual meeting is the leading American conference focusing solely on gene and cell therapy. It provided an international forum where the latest gene and cell therapy developments are presented and critically discussed. Attendance was critical for FDA staff to stay abreast of the most recent developments related to the products of animal biotechnology, with applicability to the attendees’ responsibilities related to scientific/policy development and review. Attending the conference allowed attendees to understand scientific advancements in genome editing technologies and gene/cell therapies and their biomedical and agricultural applications. In addition, the attendees engaged with other federal agencies, industry representatives and academic researchers.

16. FDA23 63rd American Society of Hematology Annual Meeting and Exposition

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   New Orleans, Louisiana
Conference Start Date:   12/10/2022
Conference End Date:   12/13/2022

Total FDA cost of the conference: $94,958
Total number of individuals whose travel expenses were paid by the FDA: 27

Explanation of how conference advanced the mission of FDA:

The American Society of Hematology Annual Meeting and Exposition conference helped to maintain critical functional competencies, and it was necessary for attendance to gather information and learn of any new and emerging issues that may be on the rise in the Oncology community. This allowed FDA to continue to meet its mission of creating a unified and collaborative scientific environment to advance the development and regulation of oncology products for patients with cancer including blood diseases. FDA also sends a representative each year to this annual conference, who is an expert on Blood Diseases and impacts on Cancer. This was mission critical because ASH is the world's largest professional society serving both clinicians and scientists around the world, who are working to conquer blood diseases.

General description of the scientific conference activities:

The American Society of Hematology leads the world in promoting and supporting clinical and scientific hematology research in malignant, and non-malignant hematology. The American Society of Hematology Annual Meeting and Exposition conference was the premier national event for hematology professionals in academia, clinical practice, industry, and advocacy. The American Society of Hematology (ASH) Annual Meeting and Exposition brought together healthcare providers, scientists, advocates, industry, and other professionals dedicated to better outcomes for people with hematological conditions. This 4-day conference consisted of top-notch medical education, cutting-edge science, networking with colleagues from all over the world, and the latest in hematological treatments and diagnostic tools from nearly 300 exhibitors.

17. FDA23 Small Business Regulatory Education for Industry Clinical Investigator Training Course

Applicable Conference Type:   FDA Hosted/Sponsored/Co-Sponsored
Conference Location:   Virtual
Conference Start Date:   12/01/2022
Conference End Date:   12/01/2022

Total FDA cost of the conference: $87,199
Total number of individuals whose travel expenses were paid by the FDA: N/A

Explanation of how conference advanced the mission of FDA:

The Small Business Regulatory Education for Industry Clinical Investigator Training Course allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. This forum also allowed FDA to share FDA expectation of the roles and responsibilities of the clinical investigator with respect to data obtained and used in clinical trials to support FDA drug application approvals, clinical trial design, and outcomes. This meeting also was of invaluable assistance to both CDER and SBIA staff, as it will serve as reference | training material to help direct them in producing relevant material responsive to their audience's inquiries and needs.

General description of the scientific conference activities:

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance’s (SBIA’s) mission is to promote productive interaction by assisting regulated domestic and international small pharmaceutical business and industry seeking timely and accurate information relating to development and regulation of human drug products. The SBIA outreach activities include hosting events (such as this one) in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic and device industries. The Small Business Regulatory Education for Industry Clinical Investigator Training Course was dedicated to assisting industry/academia with the roles and responsibilities of the clinical investigator with respect to data obtained and used in clinical trials to support FDA drug application approvals.

18. FDA23 Small Business Regulatory Education for Industry Electronic Drug Reg and Listing Forum

Applicable Conference Type:   FDA Hosted/Sponsored/Co-Sponsored
Conference Location:   Virtual
Conference Start Date:   09/28/2023
Conference End Date:   09/28/2023

Total FDA cost of the conference: $87,199
Total number of individuals whose travel expenses were paid by the FDA: N/A

Explanation of how conference advanced the mission of FDA:

The Small Business Regulatory Education for Industry Electronic Drug Reg and Listing Forum was a major program element for the CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). This meeting allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. This forum also allowed FDA to share targeted regulatory information and updates. This in turn assisted regulatory affairs professionals working on registration and listing or who submit Structured Product Labeling (SPL) to FDA to submit more efficient and complete data to the FDA. This meeting was also of invaluable assistance to both CDER and SBIA staff, as it will serve as reference training material to help direct them in producing relevant material responsive to their audience's inquiries and needs.

General description of the scientific conference activities:

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance’s (SBIA’s) mission is to promote productive interaction by assisting regulated domestic and international small pharmaceutical business and industry seeking timely and accurate information relating to development and regulation of human drug products. The SBIA outreach activities include hosting events (such as this one) in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic and device industries. This conference was dedicated to assisting industry with creating complete and accurate registration and listing submissions.

19. FDA23 Small Business Regulatory Education for Industry Drug Master File Workshop

Applicable Conference Type:   FDA Hosted/Sponsored/Co-Sponsored
Conference Location:   Virtual
Conference Start Date:   11/30/2022
Conference End Date:   11/30/2022

Total FDA cost of the conference: $87,199
Total number of individuals whose travel expenses were paid by the FDA: N/A

Explanation of how conference advanced the mission of FDA:

The Small Business Regulatory Education for Industry Drug Master File Workshop was a major program element for the CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). This meeting allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. It also allowed FDA to share expectations of upcoming legislation with reference to Generic Drug User Fee Amendments of October 2022. This meeting was of invaluable assistance to both CDER and SBIA staff, as it will serve as reference training material to help direct them in producing relevant material responsive to their audience's inquiries.

General description of the scientific conference activities:

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance’s (SBIA’s) mission is to promote productive interaction by assisting regulated domestic and international small pharmaceutical business and industry seeking timely and accurate information relating to development and regulation of human drug products. The SBIA outreach activities include hosting events (such as this one) in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic and device industries. The Small Business Regulatory Education for Industry Drug Master File Workshop was designed to host a virtual 1-day conference dedicated to assisting industry with the drug master files (DMF) requirements as reflected in the upcoming Generic Drug User Fee Amendments (GDUFA)III.

20. FDA23 Small Business Regulatory Education for Industry Pharmaceutical Quality Symposium

Applicable Conference Type:   FDA Hosted/Sponsored/Co-Sponsored
Conference Location:   Virtual
Conference Start Date:   10/01/2022
Conference End Date:   10/01/2022

Total FDA cost of the conference: $87,199
Total number of individuals whose travel expenses were paid by the FDA: N/A

Explanation of how conference advanced the mission of FDA:

The Small Business Regulatory Education for Industry Pharmaceutical Quality Symposium was a major program element for the CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). This meeting allowed FDA to hear directly from small business owners and industry at large about their questions/concerns of the FDA regulatory procedures. This forum also allowed FDA to share regulatory and scientific perspectives specific to the submission, review and approval of applications based on data derived from nanotechnology.

General description of the scientific conference activities:

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance’s (SBIA’s) mission is to promote productive interaction by assisting regulated domestic and international small pharmaceutical business and industry seeking timely and accurate information relating to development and regulation of human drug products. The SBIA outreach activities include hosting events (such as this one) in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic and device industries. At the Small Business Regulatory Education for Industry Pharmaceutical Quality Symposium, FDA employees presented on FDA's regulatory requirements on specific aspects of the science nanotechnology as relevant to new drug applications. This virtual event will be offered for 1 day.

21. FDA23 American College of Toxicology Annual Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Denver, Colorado
Conference Start Date:   11/13/2022
Conference End Date:   11/16/2022

Total FDA cost of the conference: $86,576
Total number of individuals whose travel expenses were paid by the FDA: 34

Explanation of how conference advanced the mission of FDA:

The American College of Toxicology is a global community of professional scientists representing the pharmaceutical and biotech industries, regulatory agencies, contract research organizations, academia, and consulting firms. The mission of the College is to educate, lead, and serve scientists by promoting an exchange of information and perspectives on safety assessment and new developments related to applied toxicology. The American College of Toxicology Annual Meeting was the heart of ACT, bringing together a community of toxicologists at small venues conducive to idea exchange, professional networking, and continuing education. There were first-rate Scientific Sessions that were member-driven, pharma-focused (though not pharma exclusive), and organized to maximize learning opportunities.

General description of the scientific conference activities:

The 43rd American College of Toxicology Annual Meeting included a wide-ranging scientific program and educational courses, with distinguished plenary speakers, the popular Poster Session, an Awards Ceremony, and several professional networking events. The ACT Expo Live! and the ACT Annual Meeting Support program provided companies with a unique environment—toxicologists, industry consultants, and other professionals in one location with networking and marketing opportunities at every turn. Finally, the conferences assisted in making professional connections and gaining valuable exposure for those attending.

22. FDA23 American Association of Pharmaceutical Scientists PHARMSCI 360

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Boston, Massachusetts
Conference Start Date:   10/16/2022
Conference End Date:   10/19/2022

Total FDA cost of the conference: $85,957
Total number of individuals whose travel expenses were paid by the FDA: 42

Explanation of how conference advanced the mission of FDA:

The American Association of Pharmaceutical Scientists PHARMSCI 360 conference covered microbiological scopes in regulatory medical products, which is critical to FDA mission. The conference provided an excellent opportunity for interaction between scientists from pharmaceutical industry and FDA. Attendance to this conference enhanced the interaction and understanding between pharmaceutical industry and the regulatory agency. Since veterinary medicine is a poorly represented component of the pharmaceutical sciences, it was essential that FDA be present, so that this information could be incorporated into the work FDA does as well as ensure that our own concerns and challenges are adequately addressed within the context of this evolving scientific area.

General description of the scientific conference activities:

The American Association of Pharmaceutical Scientists PHARMSCI 360 conference 360 combined all the energy of a large scientific conference with the intimacy of a small niche meeting. It featured six tracks, five of which are split equally between chemical and biomolecule drug programming. These tracks encompassed many areas making the biggest headlines today. The state-of-the-art technologies in manufacturing, modeling, and pharmacokinetic research was showcased, discussed, and debated at this meeting and workshops covering all aspects of the pharmaceutical science. Networking with experts in the field provided new opportunities for growing insights and solutions for current regulatory challenges.

23. FDA23 American Society of Microbiology MICROBE National Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Houston, Texas
Conference Start Date:   06/15/2023
Conference End Date:   06/19/2023

Total FDA cost of the conference: $84,402
Total number of individuals whose travel expenses were paid by the FDA: 44

Explanation of how conference advanced the mission of FDA:

Attending the American Society of Microbiology MICROBE National Meeting advanced the mission of the agency as the ASM Microbe meeting provided an outstanding venue to learn current developments in multiple tracks of microbiological sciences. It also offered a great opportunity to network with top scientists working in academia, government, and industry from many countries. The knowledge gained was used in current research program to improve animal food safety and prevent the development and dissemination of antimicrobial resistance among zoonotic bacteria throughout the food chain. As reviewers of medical devices, including catheters and flexible endoscopes, it was critical that attendees learn of emerging pathogenic microbes and new technologies intended to prevent device-associated infections. The knowledge that attendees gained from attending this conference will enable them to understand the impact of device design and usage on the infection potential of devices that are reviewed.

General description of the scientific conference activities:

The American Society of Microbiology MICROBE National conference was the largest gathering of microbiologists in the world and the only meeting in the field that explores the full scope of microbiology - from basic science to translational and clinical application. The AMS Microbe 2023 provided unparalleled learning and networking opportunities that can’t be found elsewhere. It offered all the high-quality programming of the General Meeting and ICAAC. It also provided targeted trans-disciplinary sessions, a special profession of microbiology track, topic-based networking opportunities and track-specific areas. The ASM Microbe meeting was the premier microbiology conference in the world, combining basic science with infectious disease science and clinical microbiology. Attendees learned the latest-breaking science on infectious diseases, including device-associated infections.

24. FDA23 American Society of Clinical Oncology Annual Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Chicago, Illinois
Conference Start Date:   06/02/2023
Conference End Date:   06/06/2023

Total FDA cost of the conference: $78,557
Total number of individuals whose travel expenses were paid by the FDA: 21

Explanation of how conference advanced the mission of FDA:

The American Society of Clinical Oncology Annual Meeting was mission critical because it covered enhancing patient care through the education of the members of oncology teams. The ASCO provided oncologists with the training, tools, and data they need to perform their day-to-day work in the field of cancer research. The oncology community gained in-person relationship-building opportunities and online discussions with thought leaders, industry experts, and peers. The in-person attendees were able to gain knowledge in the field of oncology. This conference was beneficial for all FDA attendees to support the Agency mission.

General description of the scientific conference activities:

The American Society of Clinical Oncology Annual Meeting was one of the principle oncology meetings held each year that included the latest data in oncology and recent results for clinical trials including new treatment regimens for both targeted and non-targeted therapies. A large proportion of the medical devices reviewed by FDA were companion diagnostics used to identify patients being considered for targeted therapies. Therefore, attendance at this meeting was critical to aid in the understanding of the current clinical research which may eventually be submitted as a CDx for approval in conjunction with a new or existing therapeutic that has been submitted for review. The ASCO’s primary concern for this meeting was to gain knowledge in Cutting-edge research more than 2,500 abstract presentations, a diverse lineup of ASCO Voices that will showcase a variety of personal narratives and perspectives from the oncology community that illustrate the compassionate side of cancer care, practice-changing science, state-of-the-art tools, standards, and models for quality care and career resources and mentorship opportunities.

25. FDA23 Shrimp Summit

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Ho Chi Minh City, Vietnam
Conference Start Date:   07/24/2023
Conference End Date:   07/26/2023

Total FDA cost of the conference: $75,821
Total number of individuals whose travel expenses were paid by the FDA: 4

Explanation of how conference advanced the mission of FDA:

The 2023 Shrimp Summit convened the global seafood value chain to address the critical challenges facing shrimp-farming in Asia and across the globe, from stagnant production to growers’ livelihoods, with a cross-topic focus on sustainability and climate change. Asia constitutes two-thirds of global shrimp production, but growth in Vietnam, China, India, Thailand, and Indonesia is leveling off or contracting. Meanwhile, Ecuador is projected to represent the majority of the world’s 7% growth in shrimp production in 2023. By sharing expertise, developing a common understanding of issues, and working toward consensus solutions, the 2023 Shrimp Summit fostered discussions where new paradigms are expected to emerge through productivity, improved livelihoods, and achievement of a higher level of sustainability, especially regarding climate change.

General description of the scientific conference activities:

Concerning the shrimp summit, CFSAN (in coordination with the Government of Indonesia) conducted training programs in Good Aquaculture Practices and FDA Import Operations. This training was part of continuing effort to establish a Regulatory Agreement for aquaculture shrimp between the FDA and the Ministry of Marine Affairs and Fisheries Government of Indonesia. This activity was part of the Congressional Shrimp Mandate Section 787 and the funds associated with those activities. The shrimp summit conference was an opportunity for the international aquaculture community of industry leaders market analyst academic researchers and government officials to present their work exchange ideas and develop a vision for the future. There were critical discussions and contribution to solutions that will position global shrimp farming for long-term growth.

26. FDA23 Gartner IT Symposium/Xpo 2022

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Orlando, Florida
Conference Start Date:   10/17/2022
Conference End Date:   10/20/2022

Total FDA cost of the conference: $71,726
Total number of individuals whose travel expenses were paid by the FDA: 13

Explanation of how conference advanced the mission of FDA:

Attendance at the Gartner IT Symposium/Xpo symposium allowed attendees to explore technology, insights, and trends shaping the future of IT and business, including accelerating digital business, the future of work, data, analytics and artificial intelligence, and cybersecurity. They gained invaluable insight and ideas in the areas of IT modernization and innovation that are necessary to support the FDA mission. Attendance also allowed insight into new perspectives, which can be incorporated into digital transformation solutions that impact offices across FDA. This conference provided the opportunity to meet with peers and discuss the technological landscape of the future.

General description of the scientific conference activities:

It is imperative that its leaders know and keep up with technological trends and changes. Attendance to the Gartner IT Symposium/Xpo symposium ensured FDA's Information Technology division maintained knowledge of trends, changes, and other information, helping the Center maintain its technological variance in the Agency. At this conference, attendees were allowed to discover never-before-seen research through the Signature Series sessions, attend inspiring guest keynote presentations, gain new experiences and share best practices when you join exclusive CIO Experience sessions, hone your negotiating skills at a Contract Negotiation Clinic, walk through IT Xpo to explore emerging technologies from leading solution providers to help you accelerate your technology decisions, interact with a Gartner expert in one-on-one meetings to get expert guidance on your biggest challenges, and share experiences and gain valuable lessons through workshops, roundtables and facilitated networking sessions.

27. FDA23 AdvaMed The MedTech Conference

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Boston, Massachusetts
Conference Start Date:   10/24/2022
Conference End Date:   10/26/2022

Total FDA cost of the conference: $68,742
Total number of individuals whose travel expenses were paid by the FDA: 33

Explanation of how conference advanced the mission of FDA:

Attendance at the AdvaMed MedTech Conference was mission critical because it provided updates and guidance on the latest regulatory guidelines affecting the healthcare industry. It was one of the most important annual regulatory conferences. It brought together key stakeholders that work to innovate medical devices through new regulatory submissions. Attendance at this conference benefited FDA by providing a summary of CDRH leadership highlights from the past year and what is forthcoming in 2022/2023. This was consistent with the Center's strategic efforts focused on scientific, yet efficient, product evaluation. FDA heard from leading experts and authorities in the Medical Device field.

General description of the scientific conference activities:

The AdvaMed MedTech Conference covered important regulatory topics. The topics discussed were regarding patient input, clinical trial design, and ways to innovate device research through quantitively or methodological innovation were critical to understand as they directly impact current and future work at FDA. This event served as the incubator for the ideas, partnerships and innovations that lead to a healthier world. Face-to-face conversations, quality programming focused on today’s hot topics (like global regulatory convergence efforts and increased M&A activity), and the best networking in the business were all a part of this conference. It was the most prestigious gathering of MedTech leaders. Attendees were allowed to get the latest updates with more than 100 sessions that bring different perspectives to light, an understanding of how physicians view value-based care as well as how policymakers are approaching cybersecurity and trade considerations, and a know how concerning scientists and their thinking about different applications for AI.

28. FDA23 Association of American Feed Control Officials Midyear Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   San Antonio, Texas
Conference Start Date:   01/17/2023
Conference End Date:   01/19/2023

Total FDA cost of the conference: $65,882
Total number of individuals whose travel expenses were paid by the FDA: 36

Explanation of how conference advanced the mission of FDA:

Attending the Association of American Feed Control Officials Midyear Meeting contributed to FDA's mission of protecting the public heath, specifically ORAs Strategic Plan Goal 1: Foster a diverse, highly capable, high-performing, and adaptable workforce; Objective 1.2: Train and develop our workforce to meet future advances and challenges; and Goal 4: Partnerships: Advance toward an integrated public health system; specifically 4.3: Increase mutual acceptance and reliance on regulatory and public health partner work, data, and action. Attending this conference allowed FDA to meet these strategic goals of training and developing of the workforce and to engage within the integrated food safety community and foster partnerships with local, tribal, and federal partners as well as to foster further mutual reliance in action with a collective FDA presence with State regulators and FDA employees. Greater than 70% of FDA field work ensures the safety of animal food and is done by our state partners, who are all members of AAFCO. We have several regulations and initiatives that are being launched, including Food Safety Modernization Act, Veterinary Feed Directive and animal feed labelling. Attending the meeting advanced the mission of the agency, as state partners would be unable to implement, monitor, and inspect for compliance within FDA regulations without the knowledge and skills being presented by FDA employees. The Burden of compliance and enforcements would fall to FDA's limited resources likely leading to preventable distribution of adulterated animal food products.

General description of the scientific conference activities:

At the Association of American Feed Control Officials Midyear Meeting, attendees learned about current feed issues, Feed & Feed Ingredient Manufacturing, Inspection & Sampling, Ingredient Definitions, Laboratory Methods, presentations on Working Better Together, and Enforcement Issues. The Association of American Feed Control Officials (AAFCO) Midyear Meeting was a 3-day meeting, which allowed communication and collaboration with State partners to advance the efforts of the Animal Feed Regulatory Program Standards (AFRPS) and Preventive Controls Cooperative Agreement. Topics of discussion during this meeting were as follows: a nationally integrated feed safety system; developing and maintaining best practices; and enhancing human and animal food safety. In addition, the Cooperative Agreement provides funding for laboratories that support animal feed programs and are pursuing or expanding accreditation under the international standard ISO/IEC 17025.

29. FDA23 American Academy of Dermatology Annual Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   New Orleans, Louisiana
Conference Start Date:   03/17/2023
Conference End Date:   03/21/2023

Total FDA cost of the conference: $60,106.44
Total number of individuals whose travel expenses were paid by the FDA: 15

Explanation of how conference advanced the mission of FDA:

The panel sessions and presentations at the American Academy of Dermatology Annual Meeting was directly relevant to FDA employees' work as reviewers of dermatological devices, including wound dressings and dermal fillers. The content presented at the conference included sessions about the state of the art in clinical dermatology practice as well as educational sessions about different topics in dermatology.

General description of the scientific conference activities:

The American Academy of Dermatology Annual Meeting offered an opportunity to network and engage with the dermatology community, which assisted in FDA regulatory oversight to ensure device safety and effectiveness, as well as promotion of innovation and technology advancement. At this conference, attendees learned about the diagnosis and medical, surgical, and cosmetic treatment of the skin, hair, and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair, and nails.

30. FDA23 Joint Statistical Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Toronto, Canada
Conference Start Date:   08/05/2023
Conference End Date:   08/10/2023

Total FDA cost of the conference: $53,875.23
Total number of individuals whose travel expenses were paid by the FDA: 22

Explanation of how conference advanced the mission of FDA:

Attendance at the Joint Statistical Meeting benefited the medical device user fee agreement (MDUFA)/prescription drug user fee agreement (PDUFA) guidance development as well as training related to new MDUFA commitments. Speakers from the industry, academia, and FDA were invited to discuss the use of PROs in regulatory science and statistical methods on PRO data analysis. Attendance advanced the mission of the agency as it is critical that FDA keep abreast of current issues in the application of statistics to regulatory science as well as research science. This conference was designed to communicate with leaders in the areas of statistics from academia, industry, and regulatory sections, and it was an effective meeting to gather current information and interact with these experts. The JSM statistics forum addressed statistical challenges in drug development and was critical to FDA biostatisticians staying current on statistical issue in regulatory science in fulfillment of FDA's mission.

General description of the scientific conference activities:

Th Joint Statistical Meeting was the largest gathering of statisticians and data scientists held in North America. It was also one of the broadest statistical meetings with topics ranging from applications to methodology and theory. This was a unique opportunity to present on and learn about emerging topics of importance to FDA review and industry interest. In addition, it allowed FDA attendees to discuss topics related to guidance commitments with a broad audience as well as it allowed for training and discussion on unique topics relevant to regulatory decision making. Attendance at this conference connected FDA with other statisticians/data scientists/operational research analysts in the world to stay on the cutting edge of the techniques and practices in resource capacity planning.

31. FDA23 Pittcon Conference and Exposition

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Philadelphia, Pennsylvania
Conference Start Date:   03/18/2023
Conference End Date:   03/22/2023

Total FDA cost of the conference: $53,666
Total number of individuals whose travel expenses were paid by the FDA: 26

Explanation of how conference advanced the mission of FDA:

The purpose of the Pittcon Conference and Exposition was to inform and teach new methodologies, and improve technical skills related to analytical instrumentation that is used in the FDA Labs. By attending PITTCON, FDA scientists were able to network and establish rapport with scientists and develop new ideas to improve laboratory methods. This conference also provided attendees with an opportunity to meet with scientists to exchange ideas and analytical methods which is critical to the future of the FDA Labs and the FDA. This conference supported the FDA's mission by keeping analysts informed and up to date on current laboratory methods performed that protect the public health. If FDA was not able to attend this conference, scientists would have missed the opportunity to learn about state-of-the-art practices and network with fellow scientists.

General description of the scientific conference activities:

The Pittcon Conference and Exposition is an annual conference on laboratory science providing latest advances in analytical chemistry research and instrumentation development. The conference provided plenary lectures and poster presentations by experts in the areas of analytical chemistry both from academia and industry. Pittcon provided technical sessions and exposition involving current analytical methods and instruments used to analyze drug substances and drug products, which directly applies to my review work.

32. FDA23 Food and Drug Law Institute Annual Conference

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Washington, District of Columbia
Conference Start Date:   05/17/2023
Conference End Date:   05/18/2023

Total FDA cost of the conference: $98,998
Total number of individuals whose travel expenses were paid by the FDA: 99

Explanation of how conference advanced the mission of FDA:

The Food and Drug Law Institute (FDLI) Annual Conference advanced the mission of FDA by providing topics which covered a range of legal and regulatory issues that are encountered every day at FDA and there focusing on the high-level impact of current challenges in the healthcare space. This conference was for key stakeholders in the healthcare and medical device space, all of which is incorporated in the FDLI Annual Conference. There were opportunities to network with key stakeholders both within government and outside, many of whom we are either in direct or indirect contact with through our daily job duties. It is vital to stay up to date on current issues, challenges, and current thinking.

General description of the scientific conference activities:

The FDLI Annual Conference was the premier conference for the food and drug law community. The annual conference addressed complex legal, regulatory, compliance and policy issues in all facets of the FDA-regulated industry. There were in-depth discussions and analyses on a wide variety of topics by bringing together experts from the federal government, industry, the private bar, non-profit, patient and consumer advocates, consulting organizations, and academia. There were over 30 breakout sessions available for selections covering the latest in legal, regulatory, compliance, policy, marketing and related issues. Attendees learned from more than 100 well-known officials and experts and heard about the top cases in Food & Drug Law. They also had the opportunity to network and build relationships with seasoned legal, regulatory, compliance, policy and government officials.

33. FDA23 Pharmaceutical Inspection Co-Operation Scheme Seminar

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Dublin, Ireland
Conference Start Date:   10/05/2022
Conference End Date:   10/07/2022

Total FDA cost of the conference: $53,139
Total number of individuals whose travel expenses were paid by the FDA: 14

Explanation of how conference advanced the mission of FDA:

The Pharmaceutical Inspection Co-Operation Scheme Seminar advanced the mission of FDA by enabling FDA reliance on other capable drug inspectorates to ensure global oversight of pharmaceutical manufacturing and quality management to support patient access to safe and effective medicines. The Pharmaceutical Quality System Committee Meeting and PIC/S Seminar on Inspection is the international organization of pharmaceutical regulatory inspectorates that aimed to harmonize inspection procedures worldwide by developing common standards in the field of GMP and by providing training to Inspectors.

General description of the scientific conference activities:

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It was open to any Authority having a comparable GMP inspection system. PIC/S is presently comprised of 54 Participating Authorities coming from all over the world (Europe, Africa, America, Asia and Australasia). The seminar focused on a particular aspect of GMP with the aim of providing training and harmonization in the field covered. Annual PIC/S training Seminars were open to Inspectors from PIC/S Participating Authorities and other interested Medicine Regulatory Authorities.

34. FDA23 Society of Photographic Instrumentation Engineers Medical Imaging

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   San Diego, California
Conference Start Date:   02/19/2023
Conference End Date:   02/23/2023

Total FDA cost of the conference: $52,358
Total number of individuals whose travel expenses were paid by the FDA: 19

Explanation of how conference advanced the mission of FDA:

The Society of Photographic Instrumentation Engineers Medical Imaging advanced the mission of FDA by providing the opportunity for FDA to interact and learn about the latest medical imaging devices under development and to better understand the challenges in terms of evaluation methodologies while representing the Agency and its current thinking in terms of regulatory evaluations for devices in the areas of digital pathology, the use of virtual clinical trials, and new applications of Artificial Intelligence.

General description of the scientific conference activities:

Medical Imaging was the meeting where information was shared about image processing, physics, computer-aided diagnosis, perception, image-guided procedures, biomedical applications, ultrasound, informatics, radiology, digital pathology, and more. This meeting was the internationally recognized forum for reporting state-of-the-art research and development in medical imaging. The event focused on the latest innovations found in underlying fundamental scientific principles, technology developments, scientific evaluation, and clinical application. The symposium covered the full range of medical imaging modalities focusing on image acquisition, display, processing, analysis, perception, decision support, and informatics.

35. FDA23 American Chemical Society Fall

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   San Francisco, California
Conference Start Date:   08/13/2023
Conference End Date:   08/17/2023

Total FDA cost of the conference: $51,943
Total number of individuals whose travel expenses were paid by the FDA: 15

Explanation of how conference advanced the mission of FDA:

The American Chemical Society (ACS) National Meeting and Exhibition advanced the mission of FDA by offering advanced materials, technologies, systems & processes, and other recent advances in chemistry to be presented. This provided opportunities to interact with chemical scientists from around the world, and to gain first-hand knowledge and recent advances in science related to drug product manufacturing. The conference also advanced the mission of FDA by providing attendees the opportunity to network and collaborate with peers from organizations, institutions, non-profits, and academia and the opportunity to learn about the latest in Chemistry research innovations.

General description of the scientific conference activities:

The ACS Fall National Meeting and Exposition was an annual 5-day event where chemistry professionals met to share ideas and advance scientific and technical knowledge. With nearly 157,000 members, the American Chemical Society (ACS) was the world’s largest scientific society and one of the world’s leading sources of authoritative scientific information. A nonprofit organization, chartered by Congress, ACS was at the forefront of the evolving worldwide chemistry enterprise and the premier professional home for chemists, chemical engineers and related professions around the globe.

36. FDA23 North American Chemical Residue Workshop

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Fort Lauderdale, Florida
Conference Start Date:   07/23/2023
Conference End Date:   07/26/2023

Total FDA cost of the conference: $51,930
Total number of individuals whose travel expenses were paid by the FDA: 22

Explanation of how conference advanced the mission of FDA:

The North American Chemical Residue Workshop advanced the mission of FDA by providing information for bench chemists, technical scientists, laboratory managers, quality managers, and anyone else involved in pesticide residue or environmental contaminant residue analyses. Attendees gained valuable information on the methodologies and analytical tools used in residue level analyses of pesticides, veterinary drugs and environmental contaminants; met others who are doing the very same things, and to establish valuable contacts with many experts; learn about regulatory issues effecting chemical residue work; and view vendor exhibits and see the latest in instrumentation. Participation in scientific conferences and meetings was a critical tool for increasing our scientist’s knowledge and skills while keeping them up to date in their fields of expertise. The information provided at these meetings is invaluable to FDA to safeguard public health and is an important part of staff professional development. FDA staff received the opportunity to build technical and professional skills the Agency requires and to successfully use the resources that ORA management has given them.

General description of the scientific conference activities:

The North American Chemical Residue Workshop (NACRW) conducted an annual meeting for scientists particularly interested in trace level analysis of pesticides, veterinary drug residues, and other chemicals in food, animal feed, and environmental samples. The purpose was to provide training, develop and improve technical knowledge, facilitate development and distribution of new analysis methods and techniques, and to establish networking to promote professional cooperation between scientists of these interests. This meeting was expected to have approximately 300 to 350 attendees representing government, academia, and industries.

37. FDA23 Interstate Shellfish Sanitation Conference

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Baton Rouge, Louisiana
Conference Start Date:   03/18/2023
Conference End Date:   03/23/2023

Total FDA cost of the conference: $50,359
Total number of individuals whose travel expenses were paid by the FDA: 19

Explanation of how conference advanced the mission of FDA:

The Interstate Shellfish Sanitation Conference advanced the mission of FDA by helping protect public health in the deliberations and adoption of changes to the Model Ordinance. Attendance and participation at this national conference fosters and promoted the molluscan shellfish sanitation program and FDA personnel fulfilled the following roles and responsibilities at the conference. FDA staff served as agency spokespersons on proposals submitted to the Conference for deliberation. They served as FDA Representatives to the working committees and Task Forces that deliberated the proposals. The staff served as technical resources for state regulatory and industry officials who would deliberate the proposals. FDA staff actively participate in the committees that have been charged by the Task Forces to deliberate the proposals. They served as recorders and assisted to ensure the successful execution of the Conference. They participated in FDA nightly meetings to provide updates on all committee and Task Force activities conducted throughout the day and they attend State and Regional caucus meetings when invited by state agencies to provide technical assistance during discussion of proposals.

General description of the scientific conference activities:

The National Shellfish Sanitation Program was the Federal/State cooperative program for the sanitary control of bivalve molluscan shellfish produced and sold for human consumption. The Interstate Shellfish Sanitation Conference Biennial Meeting was the forum for federal and state regulatory agencies and the shellfish industry to deliberate changes to the National Shellfish Sanitation Program Model Ordinance which includes the guidelines for ensuring that shellfish produced in States in compliance with the guidelines are safe and sanitary.

38. FDA23 39th International Conference on Pharmacoepidemiology & Therapeutic Risk Management

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Halifax, Canada
Conference Start Date:   08/23/2023
Conference End Date:   08/27/2023

Total FDA cost of the conference: $50,356
Total number of individuals whose travel expenses were paid by the FDA: 11

Explanation of how conference advanced the mission of FDA:

The 39th International Conference on Pharmacoepidemiology & Therapeutic Risk Management advanced the mission of FDA by promoting an international non-profit organization dedicated to advancing the health of the public by providing a global forum for the exchange of scientific information and for the development of policy, education, and advocacy for the field of pharmacoepidemiology, including pharmacovigilance, drug utilization research, outcomes research, comparative effectiveness research, and therapeutic risk management. ISPE states its 2,200 members are from various foreign countries and represent the multiple scientific disciplines involved in studying drugs and other therapeutic products.

General description of the scientific conference activities:

The 39th International Conference on Pharmacoepidemiology & Therapeutic Risk Management was an international conference dedicated to advancing the health of the public by providing a global forum for the open exchange of scientific information and for the development of policy, education, and advocacy for the field of pharmacoepidemiology, including such areas as pharmacovigilance, drug utilization research, comparative effectiveness review, and therapeutic risk management.

39. FDA23 Heart Rhythm Society Scientific Sessions

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   New Orleans, Louisiana
Conference Start Date:   05/19/2023
Conference End Date:   05/21/2023

Total FDA cost of the conference: $48,367
Total number of individuals whose travel expenses were paid by the FDA: 17

Explanation of how conference advanced the mission of FDA:

The Heart Rhythm Society Scientific Sessions directly advanced the mission of FDA by covering relevant device and clinical trial information for devices that cardiovascular team routinely reviews. Conference attendance provided information about recent developments in clinical cardiac pacing and electrophysiology that is important for completion of clinically relevant animal study reviews.

General description of the scientific conference activities:

The Heart Rhythm Society Scientific Sessions was the premier scientific meeting for the discussion of major advances in cardiovascular science & healthcare. Attending the Annual Scientific Sessions benefitted employees' skills and experience as premarket lead reviewers. HRS focused on the most recent developments in technology for implantable electrophysiology devices and offered an opportunity to stay up to date on these advancements.

40. FDA23 Institute of Food Technology Food Improved by Research, Science and Technology Conference

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Chicago, Illinois
Conference Start Date:   07/16/2023
Conference End Date:   07/19/2023

Total FDA cost of the conference: $48,335
Total number of individuals whose travel expenses were paid by the FDA: 20

Explanation of how conference advanced the mission of FDA:

The Institute of Food Technology (IFT) Food Improved by Research, Science and Technology Conference advanced the mission of FDA by providing a good opportunity for leadership to attend an international meeting related to the mission and progressive thinking for food security and learn contemporary views on these topics and learn about innovative solutions to food security. IF FDA staff were unable to attend this meeting, they would have missed the opportunity to network and collaborate with peers from organizations, institutions, non-profits, and academia.

General description of the scientific conference activities:

The IFT Food Improved by Research, Science and Technology Conference covered areas pertinent to food safety and security such as technology and innovation, sustainability and climate impact, health and nutrition and education. The attendees moderated a scientific & technical forum discussion titled 'What Do All Professions Within the Science of Food Need to Know About Traceability and FSMA Section 204 Implications.

41. FDA23 American Academy of Orthopedic Surgeons Annual Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Las Vegas, Nevada
Conference Start Date:   03/07/2023
Conference End Date:   03/11/2023

Total FDA cost of the conference: $48,294
Total number of individuals whose travel expenses were paid by the FDA: 21

Explanation of how conference advanced the mission of FDA:

The American Academy of Orthopedic Surgeons Annual Meeting advanced the mission of FDA by benefiting FDA employees with the most updated innovations for orthopedic medical devices, preparing for the possible incoming submissions and discovering possible marketing violation issues (e.g., inappropriate labeling/marketing materials). The meeting also provided required CME for maintenance of board certified, licensed medical professionals.

General description of the scientific conference activities:

The American Academy of Orthopedic Surgeons Annual Meeting gathers professional and provided the employees an opportunity to gain firsthand knowledge on emerging and current trends for treatments regarding device related treatment of the spinal column and its related neurological structures. There was also an in-person view of sponsor's marketing efforts of regulated orthopedic devices. The specialty day session presented orthopedic specific subspecialty training (e.g. Hip and Knee Arthroplasty CME led by AAHKS (American Association of Hip and Knee Surgeons).

42. FDA23 American Public Health Association Annual Meeting & Expo

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Boston, Massachusetts
Conference Start Date:   11/06/2022
Conference End Date:   11/09/2022

Total FDA cost of the conference: $47,439
Total number of individuals whose travel expenses were paid by the FDA: 27

Explanation of how conference advanced the mission of FDA:

Attendance to the American Public Health Association Annual (APHA) Meeting & Expo advanced the FDA mission by allowing attendees to engage in workshops led by experts from around the country. They received accurate, science-based information needed to maintain, improve, and protect the public's health. This meeting offered ample educational opportunities to grow both professionally and personally. The attendees were exposed to current public health issues that are applied in their daily work at the FDA.

General description of the scientific conference activities:

The APHA Annual Meeting and Expo provided high-quality, science-based education, engaging networking opportunities, and cutting-edge resources to thousands of public health professionals from across the nation. The American Public Health Association annual meeting allowed professional to interact with key Federal partners and NGOs involved in tobacco use prevention that support FDA's efforts to reduce the harms caused by tobacco use. The conference also provided the opportunity for attendees to discuss emerging and important issues in public health which can better inform the work attendees are doing in their professional careers. The Expo is the largest and most influential yearly gathering of public health professionals, bringing 15,000 members of the public health community together to experience robust scientific programming, poster sessions and more.

43. FDA23 71st American Society for Mass Spectrometry Conference on Mass Spectrometry and Allied Topics

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Houston, Texas
Conference Start Date:   06/03/2023
Conference End Date:   06/08/2023

Total FDA cost of the conference: $47,030
Total number of individuals whose travel expenses were paid by the FDA: 19

Explanation of how conference advanced the mission of FDA:

The 71st American Society for Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics advanced the mission of FDA by helping FDA staff maintain information based on the state of the art in this important analytical technique. The conference was an excellent opportunity to learn the latest research innovations in food and analytical Chemistry and network directly with experts. Attendance also allowed employees to learn new technology development in the field of chemical characterization of medical devices, specifically mass spectrometry.

General description of the scientific conference activities:

The American Society for Mass Spectrometry (ASMS) was formed in 1969 to promote and disseminate knowledge of mass spectrometry and allied topics. Membership includes over 8,500 scientists involved in research and development. Members come from academia, industry and government laboratories. Their interests included advancement of techniques and instrumentation in mass spectrometry, as well as fundamental research in chemistry, geology, forensics, biological sciences and physics. ASMS sponsored the Annual Conference on Mass Spectrometry and Allied Topics that was attended by more than 6,500 scientists. Approximately 3,000 papers were presented as posters and talks.

44. FDA23 Global Harmonization Working Party Annual Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Riyadh, Saudi Arabia
Conference Start Date:   02/13/2023
Conference End Date:   02/16/2023

Total FDA cost of the conference: $45,775
Total number of individuals whose travel expenses were paid by the FDA: 5

Explanation of how conference advanced the mission of FDA:

The Global Harmonization Working Party Annual Meeting advanced the mission of FDA by allowing attendees to strategically engage, leverage partnerships and promote medical device convergence in Africa, Asia and the Middle East. Each participant provided U.S. regulatory updates and disseminate information related to FDA programmatic activities. In addition, each delegation member participated in a separate bilateral meeting with Saudi Arabia’s Food and Drug Authority (SFDA) to learn more about their medical device landscape, how SFDA engages with other countries in the region and to encourage greater participation in other harmonization forums.

General description of the scientific conference activities:

The Global Harmonization Working Party Annual Meeting was part of a non-profit organization. Its goals were to study and recommend ways to harmonize medical device regulations and to work in coordination with international stakeholders such as WHO, OECD, International Medical Devices Regulators Forum (IMDRF), and Global Alliances such as : GS1, Asia Pacific Medical Technology Association (APACMed), Global Medical Devices Nomenclature Agency (GMDN Agency) , Global Medical Technology Alliance (GMTA), Global Diagnostic Imaging, Healthcare IT, and Radiation Therapy Trade Association (DITTA) and Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector (IACRC),aimed at establishing harmonized requirements, procedures and standards.

45. FDA23 MedCon Conference

Applicable Conference Type:   FDA Hosted/Sponsored/Co-Sponsored
Conference Location:   Columbus, Ohio
Conference Start Date:   04/24/2023
Conference End Date:   04/27/2023

Total FDA cost of the conference: $45,664
Total number of individuals whose travel expenses were paid by the FDA: 31

Explanation of how conference advanced the mission of FDA:

The MedCon Conference advanced the mission of FDA by providing knowledge exchange, and collaboration between FDA and medical device regulated industry. The conference reaches out to the industry that FDA regulates and updated attendees on new requirements, policies and issues with medical devices that will help CSOs perform more efficient inspections. they receive information on new requirements and policy that will assist them in performing medical device inspections.3. FDA attendees will also receive information on new requirements and policy that will assist them in performing medical device inspections.

General description of the scientific conference activities:

For more than 13 years, MedCon has united the healthcare products industry to work for a better tomorrow for our patients. With a distinct focus on important issues that increase speed to market and product quality through innovation, the event brought together medical device regulators and industry experts from around the world for content-rich conference sessions that included uncommon collaboration, deep dialogue, and sharing. MedCon 2023 was hosted by the AFDO/RAPS Healthcare Products Collaborative and co-sponsored by Food and Drug Administration of the U.S. Department of Health and Human Services.

46. FDA23 International Council for Harmonisation Summer Assembly Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Vancouver, Canada
Conference Start Date:   06/10/2023
Conference End Date:   06/13/2023

Total FDA cost of the conference: $44,414
Total number of individuals whose travel expenses were paid by the FDA: 12

Explanation of how conference advanced the mission of FDA:

The International Council for Harmonisation Summer Assembly Meeting advanced the mission of FDA by providing expert groups that addressed a range of critical topics including drug safety, efficacy, quality and electronic standards. Attendees learned to promote and protect the public health through development of an internationally harmonized Common Technical Document guideline. These meetings helped maintain the information required for position within FDA and helped advanced regulatory harmonization of technical standards and regulatory reliance and convergence of standards and processes.

General description of the scientific conference activities:

The International Council for Harmonisation Summer Assembly Meeting was unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH's mission was to achieve greater harmonisation worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. Harmonisation was achieved through the development of ICH Guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side. Key to the success of the process was the commitment of the ICH regulators to implement the final Guidelines.

47. FDA23 American Academy of Allergy Asthma and Immunology Annual Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   San Antonio, Texas
Conference Start Date:   02/24/2023
Conference End Date:   02/27/2023

Total FDA cost of the conference: $44,241
Total number of individuals whose travel expenses were paid by the FDA: 17

Explanation of how conference advanced the mission of FDA:

The American Academy of Allergy Asthma and Immunology (AAAAI) annual meeting advanced the mission if FDA by introducing attendees to essential knowledge regarding allergen immunotherapy for environmental and food allergies as well as diagnostic testing such as skin prick testing, intradermal, and patch systems to diagnose environmental, food, and venom allergies as well as contact dermatitis. Food allergy is now a serious and life-threatening disorder of particular interest to public health with treatments in development. It was crucial that FDA engaged with other research colleagues and maintain a level or knowledge and preparedness to serve the public with our review of these therapies and diagnostics.

General description of the scientific conference activities:

The American Academy of Allergy Asthma and Immunology (AAAAI) annual meeting is a premier national clinical conference that is regularly attended by FDA allergist medical officers. Attendees learned about the advancement of the knowledge and practice of allergy, asthma and immunology for optimal patient care and gained knowledge on the latest research findings amongst the experts in the field of allergy, asthma, and immunology in order to advance their regulatory contribution within FDA.

48. FDA23 Society for Nuclear Medicine and Molecular Imaging Annual Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Chicago, Illinois
Conference Start Date:   06/24/2023
Conference End Date:   06/27/2023

Total FDA cost of the conference: $42,721
Total number of individuals whose travel expenses were paid by the FDA: 11

Explanation of how conference advanced the mission of FDA:

The Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting advanced the mission of FDA by providing attendees the opportunity to learn the latest research findings in the areas of AI and nuclear imaging which are directly aligned with FDA’s regulatory science programs and the FDA's regulatory mission. The meeting also provided leadership and guidance to industry on statistical, computational, and mathematical aspects of FDA's programs.

General description of the scientific conference activities:

The SNMMI Annual Meeting promoted the science, technology and practical application of nuclear medicine and molecular imaging. The SNMMI Annual Meeting strives to be a leader in unifying, advancing and optimizing molecular imaging, with an ultimate goal of improving human health. With 18,000 members worldwide, SNMMI Annual Meeting represented nuclear and molecular imaging professionals, all of whom were committed to the advancement of the field. The premier educational, scientific, research, and networking event in nuclear medicine and molecular imaging, the SNMMI Annual Meeting provided physicians, technologists, pharmacists, laboratory professionals, and scientists with an in-depth view of the latest research and development in the field as well as providing insights into practical applications for the clinic.

49. FDA23 Association of American Feed Control Officials Annual Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Baltimore, Maryland
Conference Start Date:   07/31/2023
Conference End Date:   08/02/2023

Total FDA cost of the conference: $40,639
Total number of individuals whose travel expenses were paid by the FDA: 26

Explanation of how conference advanced the mission of FDA:

The Association of American Feed Control Officials Annual Meeting advanced the mission of FDA by supporting FDAs Strategic Plan that fosters a diverse, highly capable, high-performing, and adaptable workforce. The AAFCO provided training and development pertaining to the workforce to meet future advances and challenges and to advance toward an integrated public health system; specifically. The meeting also increased mutual acceptance and reliance on regulatory and public health partner work, data and action.

General description of the scientific conference activities:

AAFCO is a membership association of local, state, and federal agencies charged with regulating the sale and distribution of animal feeds and animal drug remedies. They are the people behind animal feed and pet food and feature a process for defining ingredients in animal feed and pet food; a forum where state, federal and industry can develop a uniform language that states may adopt for reference in laws; and hold specialized trainings for both members and industry. This meeting featured sessions on current issues; advancing human and animal health safety; ingredient definitions; feed labeling; laboratory methods; feed and feed manufacturing; and inspection and sampling.

50. FDA23 National Environmental Health Association Annual Education Conference (NEHA AEC)

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   New Orleans, Louisiana
Conference Start Date:   07/31/2023
Conference End Date:   08/03/2023

Total FDA cost of the conference: $40,244
Total number of individuals whose travel expenses were paid by the FDA: 18

Explanation of how conference advanced the mission of FDA:

The National Environmental Health Association Annual Education Conference (NEHA) advanced the mission of FDA by providing food safety training in retail and manufactured foods. Specific focus was on process monitoring and verification activities used in the implementation of Human and Animal Food Preventive Controls and associated management components. Retail and manufactured food safety training knowledge that was gained will be used for FDA course maintenance. Educational materials presented at this conference offers critical activities under the Food Safety and Modernization Act.

General description of the scientific conference activities:

The NEHA Annual Education Conference supports the advancement of environmental health professionals for the purpose of providing a healthful environment for all. In addition to maintaining high standards of practice and testing for its credentialing programs, NEHA provided training and resources for continuing education through courses and textbooks, hosting an annual conference, fostering networking and career growth, and publishing the peer-reviewed Journal of Environmental Health. NEHA’s agenda included presentations, learning labs, and specific trainings related to the FDA Model Food Code, the National Retail Food Regulatory Program Standards, Self-Assessments and Verification Audits, Risk Factor Studies and foodborne disease.

51. FDA23 American Pharmacists Association Annual Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Phoenix, Arizona
Conference Start Date:   03/24/2023
Conference End Date:   03/27/2023

Total FDA cost of the conference: $38,206
Total number of individuals whose travel expenses were paid by the FDA: 11

Explanation of how conference advanced the mission of FDA:

The American Pharmacists Association Annual Meeting advanced the mission of FDA by providing attendees updates on pharmacy law and disease states as related to the mission of providing access to safe, effective medical devices. Attendees were given the opportunity to grow professionally and make an impact to the current pharmaceutical challenges both in manufacturing and quality drugs given to the American Public.

General description of the scientific conference activities:

The American Pharmacists Association Annual Meeting empowered attendees to showcase leadership in patient care, bridging healthcare gaps and made a lasting impact. Attendees connected with pharmacists from all practice settings and experience levels to learn, connect, and create change. Whether you're a seasoned pharmacist or just starting your career, the American Pharmacists Association Annual Meeting was tailor-made for those interested. Attendees also had access to engaging educational sessions, thought-provoking discussions, and networking opportunities that could set the stage for your next big breakthrough.

52. FDA23 American Society for Microbiology Conference on Rapid Applied Microbial

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Baltimore, Maryland
Conference Start Date:   10/16/2022
Conference End Date:   10/19/2022

Total FDA cost of the conference: $37,539
Total number of individuals whose travel expenses were paid by the FDA: 17

Explanation of how conference advanced the mission of FDA:

The American Society for Microbiology Conference on Rapid Applied Microbial advanced the mission of FDA by providing current developments in genomics, metagenomics, and bioinformatics. The meeting also advanced the mission by updating attendees about the most recent advances in NGS and bioinformatics research and allowing attendees to engage with leaders in the field to inform management of his current regulatory science portfolio.

General description of the scientific conference activities:

The American Society for Microbiology (ASM) Conference on Rapid Applied Microbial Next-Generation Sequencing and Bioinformatic Pipelines explored the full scope of microbiology - from basic science to translational and clinical application. The ASM Conference on Rapid Applied Microbial Next-Generation Sequencing and Bioinformatic Pipelines provided unparalleled learning and networking opportunities that couldn’t be found elsewhere. It also provided topic-based networking opportunities and track-specific areas such as genomic sequencing - an indispensable tool for clinical reference diagnostics, public health surveillance outbreak detection and response.

53. FDA23 Global Coalition for Regulatory Science Research

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Parma, Italy
Conference Start Date:   9/27/2023
Conference End Date:   9/28/2023

Total FDA cost of the conference: $37,258
Total number of individuals whose travel expenses were paid by the FDA: 11

Explanation of how conference advanced the mission of FDA:

The Global Coalition for Regulatory Science Research conference advanced the mission of FDA by providing a platform where regulators, policy makers, and bench scientists from various countries can exchange views on how to develop, apply, and implement innovative methodologies into regulatory assessments in their respective countries, as well as harmonizing strategy via global collaboration. It also advanced the mission by keeping FDA aware of any new or influential findings and that Agency needs are represented throughout method development.

General description of the scientific conference activities:

The Global Coalition for Regulatory Science Research conference was an international conference for discussion of innovative technologies and partnerships to enhance translation of basic science into regulatory applications within the global context. The conference also provided an opportunity for scientists from government, industry, and academic research communities to objectively assess the utility of emerging technologies (such as nanotechnology, imaging, -omics for translational science, personalized medicine, medical product safety and food safety) for addressing regulatory research questions and to discuss the best way to translate these technologies into real-world applications.

54. FDA23 American Society of Cataract and Refractive Surgery Annual Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   San Diego, California
Conference Start Date:   05/05/2023
Conference End Date:   05/08/2023

Total FDA cost of the conference: $35,114
Total number of individuals whose travel expenses were paid by the FDA: 8

Explanation of how conference advanced the mission of FDA:

The American Society of Cataract and Refractive Surgery Annual Meeting advanced the mission of FDA by making conference attendees aware of the TAP program and helping FDA staff with implementation of TAP. The meeting also advanced the mission by providing updates on rapid development as well as widespread patient access to safe, effective, high-quality medical devices of public health importance and the TAP program and learning from conference attendees helped FDA staff with implementation of TAP through the Medical Device User Fee Act V.

General description of the scientific conference activities:

The American Society of Cataract and Refractive Surgery Annual Meeting has been at the forefront of anterior segment surgery and has established itself as a trusted resource for cataract, refractive, cornea, and glaucoma surgeons. For more than 40 years, ASCRS has been committed to advancing the art and science of ophthalmic surgery as a primary source for the latest clinical information, published research, and regulatory updates affecting anterior segment surgeons and the patients they serve.

55. FDA23 International Society on Thrombosis and Haemostasis Congress

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Montreal, Canada
Conference Start Date:   06/24/2023
Conference End Date:   06/28/2023

Total FDA cost of the conference: $35,041
Total number of individuals whose travel expenses were paid by the FDA: 11

Explanation of how conference advanced the mission of FDA:

The International Society on Thrombosis and Haemostasis Congress Great advanced the mission of FDA by providing FDA attendees the opportunity to learn professional network and to learn from global experts that shared ground-breaking research which can be very beneficial to the public health. This conference also advanced the mission by generating and facilitating the overall research progress. The program was aimed to facilitate regulation and generation of more efficient products with blood coagulation factor VIII (FVIII) to improve the treatment of Hemophilia. This meeting was beneficial for the development both as a scientist and regulatory reviewer.

General description of the scientific conference activities:

The International Society on Thrombosis and Haemostasis Congress conference allowed attendees to experience the latest science in thrombosis and hemostasis, interacted with the global hematology experts and advanced your knowledge and career. The ISTH conference also provided an opportunity to learn from global hematology experts about latest science in the areas of thrombosis and hemostasis, which are pertinent to research and regulatory work.

56. FDA23 Institute for Health Care Fraud Prevention Annual Training Conference

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Orlando, Florida
Conference Start Date:   11/15/2022
Conference End Date:   11/18/2022

Total FDA cost of the conference: $34,967
Total number of individuals whose travel expenses were paid by the FDA: 15

Explanation of how conference advanced the mission of FDA:

The Institute for Health Care Fraud Prevention Annual Training Conference advanced the mission of FDA by fostering the creation of partnerships with other law enforcement agencies in the arena of health care fraud. Attendance also allowed existing partnerships to grow and for the PFP to expand on communication and case development for the existing successful program.

General description of the scientific conference activities:

The Institute for Health Care Fraud Prevention Annual Training Conference was designed to detect, investigate, and prosecute health care fraud-related schemes involving pharmaceutical and biologic products and medical devices. The PFP focused on fraudulent marketing schemes, clinical trial fraud, application fraud, and flagrant manufacturing-related violations involving prescription drugs, compounded drugs, biologics, and/or medical devices. The training included topics such as pharmaceutical fraud schemes, law enforcement and pharmaceutical fraud round table discussions, health care fraud updates, and case studies.

57. FDA23 American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Lab Expo

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Anaheim, California
Conference Start Date:   07/23/2023
Conference End Date:   07/27/2023

Total FDA cost of the conference: $34,713
Total number of individuals whose travel expenses were paid by the FDA: 10

Explanation of how conference advanced the mission of FDA:

The American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Lab Expo advanced the mission of FDA by providing attendees with an exceptional opportunity to hear vital research and learn about important new developments in laboratory medicine. The meeting also required attendees to become familiar with industry standards in verification and validation of a medical devices. This knowledge helped in reviewing the future premarket applications that will be received by FDA.

General description of the scientific conference activities:

The American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Lab Expo offered more than 200 educational sessions that covered subjects ranging from personalized medicine and infectious diseases to point of care and laboratory-developed tests; and enabled attendees to design an educational experience that met their needs to stay ahead of changes in the field. Attendees also learned about cutting edge diagnostic technology and more than 200 new products and had an opportunity to connect with global experts in clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of breaking science in laboratory medicine.

58. FDA23 Association for Research in Vision and Ophthalmology

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   New Orleans, Louisiana
Conference Start Date:   04/23/2023
Conference End Date:   04/27/2023

Total FDA cost of the conference: $32,994
Total number of individuals whose travel expenses were paid by the FDA: 12

Explanation of how conference advanced the mission of FDA:

The Association for Research in Vision and Ophthalmology advanced the mission of FDA by keeping attendees abreast of the latest developments in basic and clinical visual science, visual testing methods, ophthalmic optics, and ophthalmic devices that either assess or affect visual function. Attendance ensured that FDA remained ahead in the ophthalmic field with the latest developments and breakthroughs.

General description of the scientific conference activities:

The Association for Research in Vision and Ophthalmology meeting was the premier worldwide forum for basic and clinically applied research in visual science and ophthalmology, including research on ophthalmic devices. The meeting also improved knowledge of gene and cell therapy in the area of Ophthalmology in support of OTAT product review and policy development activities.

59. FDA23 Parenteral Drug Association (PDA) Annual Conference in Bengaluru

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Bengaluru, India
Conference Start Date:   02/20/2023
Conference End Date:   02/22/2023

Total FDA cost of the conference: $32,986
Total number of individuals whose travel expenses were paid by the FDA: 5

Explanation of how conference advanced the mission of FDA:

The Parenteral Drug Association (PDA) Annual Conference fulfilled the agency goals to participate and educate external stakeholders on programs deemed of high importance to FDA and HHS as well as to participate in research and/or science-based activities deemed of high importance to HHS and provided technical assistance in support of FDA and CDER strategic goals with our global stakeholders.

General description of the scientific conference activities:

The Parenteral Drug Association (PDA) Annual Conference in Bengaluru was a two-day event to discuss and update the industry with the current technology & industry advancement. They provided an informative, lively panel discussion on crucial considerations that will ensure that you are aware of industry best practices from some of our best industry experts.

60. FDA23 International Society for Cell and Gene Therapy Annual Meeting

Applicable Conference Type:   Non-FDA Conference Attended by FDA
Conference Location:   Paris, France
Conference Start Date:   05/31/2023
Conference End Date:   06/03/2023

Total FDA cost of the conference: $31,047
Total number of individuals whose travel expenses were paid by the FDA: 4

Explanation of how conference advanced the mission of FDA:

Attendance to the International Society for Cell and Gene Therapy Annual Meeting advanced the mission of FDA by regulating stem cell-based products for animal use. Since stem cells are manufactured in large quantities out of their natural environment, they can become ineffective, dangerous and produce adverse reactions. In response to this challenge, FDA developed laboratory techniques that will enable the agency to carefully evaluate and characterize these products in order to reliably predict whether they will be safe and effective.

General description of the scientific conference activities:

Since stem cells are manufactured in large quantities out of their natural environment, they can become ineffective, dangerous and produce adverse reactions. In response to this challenge, FDA is developing laboratory techniques that will enable the agency to carefully evaluate and characterize these products to reliably predict whether they will be safe and effective. While attending the conference FDA was able to exchange knowledge with our stakeholders and the community.