2022 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.
2022 Annual Report
1. FDA22 Center of Excellence on Compounding for Outsourcing Facilities 2022
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Virtual
Conference Start Date: 09/13/2022
Conference End Date: 09/14/2022
Total FDA cost of the conference: $376,249
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
This conference (Center of Excellence on Compounding for Outsourcing Facilities 2022) allowed FDA/CDER’s Office of Compliance, as well as other offices in CDER (such as the Office of Pharmaceutical Quality), and other Centers at the FDA (such as the Office of Regulatory Affairs) to work together to advance FDA’s public health mission 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.
General description of the scientific conference activities:
This conference is a two-day year-end conference for outsourcing facility staff that engaged the sector on issues related to outsourcing facilities and drug production as well as educated the sector on relevant policy matters and FDA oversight approaches. Content topics included key and recent policies related to compounding issued by FDA; CGMP for outsourcing facilities; process design and use of automation technology by outsourcing facilities; FDA inspectional process for outsourcing facilities; interactions with FDA during and after inspections, including responses to FDA Form 483s and warning letters; and pre-operational meetings with FDA. The details gathered from training sessions and interviews with outsourcing facilities, state regulators, and other stakeholders were used to solidify the conference agenda and format.
Explanation/description of circumstances for conference exceeding $150,000:
The cost estimate provided was based on the contractor's proposal in August of 2020. The contractor, in coordination with CDER and OC, identified the conference goals, identified potential topics that support those goals, created the conference agenda, identified potential speakers for each session, extended invitations to the identified compounding stakeholders, coordinated conference logistics, facilitated and executed the conference, and provided a summary of attendee feedback as well as recommendations for possible topics for future conferences.
2. FDA22 International Association of Food Protection Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Pittsburgh, Pennsylvania
Conference Start Date: 07/31/2022
Conference End Date: 08/03/2022
Total FDA cost of the conference: $259,414
Total number of individuals whose travel expenses were paid by the FDA: 126
Explanation of how conference advanced the mission of FDA:
Attendance at the International Association of Food Protection Annual Meeting was mission critical and supported the FDA/ORA goals in this area of expertise (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. Goal 3: Protect the public against violations associated with FDA-regulated products. Goal 4: Partnerships of ORA's Strategic Plan: Advance toward an integrated public health system. Specifically, objective 4.3: Increase mutual acceptance and reliance on regulatory and public health partner work, data and action and objectives 3.1 Support a culture of safety and quality in regulated industry and 3.4: Lead the collective response to violations of applicable laws and regulations.). The impact of not attending would have caused FDA to not meet these strategic goals of fostering a highly capable, high-performing workforce capable of engaging within the integrated food safety community and fostering partnerships with local, tribal, and federal partners and further mutual reliance in action with a collective FDA presence with State regulators and FDA employees. The conference provided food professional safety worldwide with a forum to exchange information on protecting the supply. The International Association for Food Protection annual meeting was focused on the scientific developments in food safety, and food safety is integral to FDA’s mission. Attending the conference advanced the mission of the agency so that scientists would ensure that antibiotics approved for use in food animal agriculture have no or limited effect on human health. The attendees learned about the latest developments in food microbiology and foodborne disease epidemiology as they relate to antimicrobial resistant foodborne bacteria. The purpose of the International Association for Food Protection (IAFP) is a professional organization dedicated to promoting professional development and excellence in all areas of food research and regulatory issues. As the premier food safety and quality conference in the United States, the annual IAFP conference offered the leading forum for emerging ideas and empirical results in health economics research related to food issues, which is the basis for the economic analysis of FDA regulations and policies. The sessions, symposiums, and papers presented at this conference covered the economics of all manner of food products regulated by FDA. The FDA benefited from the enhanced technical and scientific knowledge that the attendees to this conference gained. The immediate benefits will be to food regulation development through enhanced regulatory impact analyses. Both presenters and participants also benefited from in-person attendance, which allowed for more direct feedback and additional discussion as well as networking with other attendees on FDA-related topics.
General description of the scientific conference activities:
Each year the International Association for Food Protection (IAFP) hosts an Annual Meeting, providing attendees with 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. Held in various locations throughout North America, this meeting has grown over the years to become the leading food safety conference worldwide. Attendees gained an understanding of the latest in food safety and antimicrobial resistance mechanisms and detection methods. This meeting helped in providing findings to current research and technology in microbiology, antimicrobial resistance, food safety, innovative solutions to new and recurring problems, and the opportunity to network with thousands of food safety professionals from around the globe. Topics at this conference included: Food Hygiene and Sanitation, International Food Protection, Control of Foodborne Illness, Food Safety Assessment, Audit and Inspection, HACCP Utilization and Food Safety Systems, Meat and Poultry Safety and Quality, Food Chemical Hazards and Food Allergy, Pre Harvest Food Safety, Retail and Foodservice, Food Defense, Sanitary Procedures, Animal and Pet Food Safety, Beverages and Acid/Acidified Foods, Dairy Quality and Safety, Food Fraud, Food Law, Fruit and Vegetable Safety and Quality, Seafood Safety and Quality, Viral and Parasitic Foodborne Disease, Applied Laboratory Methods, Developing Food Safety Professionals, Diversity, Equality and Inclusion, Food Packaging, Food Safety Culture, Food Safety Education, Microbial Modeling and Risk Analysis, Sanitary Equipment and Facility Design, and Water Safety and Quality. (IAFP) represents a broad range of members with a singular focus- protecting the global food supply. Within the conference, one found educators, government officials, microbiologists, food industry executives, and quality control professionals, who are involved in all aspects of growing, storing, transporting, processing, and preparing all types of foods.
Explanation/description of circumstances for conference exceeding $150,000:
A high level of attendance at FDA22 International Association of Food Protection (IAFP) Annual Meeting was mission critical because the conference offered education and training in the field of Food Safety. This conference was the most significant conference for the food safety community. The IAFP covered all industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities in the U.S. and globally, including drugs, medical devices, food, dietary supplements, cosmetics, veterinary, and tobacco products. This annual conference addressed complex legal, regulatory, compliance, and policy issues in all facets of Food Safety of the FDA-regulated industry. It 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 challenges and strategies in the food safety management systems. The discussions presented at this conference on the safety of our food supply were particularly relevant to FDA. The attendees were able to discuss the benefits of food safety and public health. This conference was beneficial for all FDA attendees.
3. FDA22 Small Business Regulatory Education for Industry Annual Conference
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Virtual
Conference Start Date: 06/06/2022
Conference End Date: 06/10/2022
Total FDA cost of the conference: $131,243
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
This meeting (FDA22 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). 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 to attendees. This in turn assisted in sponsors submitting more complete application to the FDA, which should ultimately reduce the review time. This meeting was of invaluable assistance to the SBIA staff to help direct them in producing relevant material. This conference was deemed mission critical y FDA because participants learned directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course was designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities. Featuring the respective FDA Center Directors from CDER, CBER, and CDRH, this conference also took a look ahead at FDA’s future activities in the fight against COVID-19 and beyond. An emergency use authorization, or EUA, is a regulatory pathway that allows FDA to help strengthen the nation’s public health protections by facilitating the availability and use of medical countermeasures needed during public health emergencies. Under this pathway, FDA may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.
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. SBIA outreach activities includes hosting events in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic and device industries. CDER SBIA helps empower small businesses in their interactions with FDA and aids those businesses in the development of more complete submissions and first-cycle drug approvals. FDA employees participated at REdI to present on FDA's regulatory requirements to legally study and market drugs, medical devices, and biologics in the United States. This meeting was designed for one-on-one interaction and also offered a virtual on-line format to promote the accessibility of valuable knowledge and expand the number of global attendees. This SBIA event targeted small pharmaceutical/devices/biologics businesses, and in fact, was widely attended by all levels of industry including small, medium, and large pharma. CDER SBIA in the Division of Drug Information (DDI) in CDER’s Office of Communications, hosted this virtual event with different areas of focus.
4. FDA22 Society of Toxicology Annual Meeting and ToxExpo
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Diego, California
Conference Start Date: 03/27/2022
Conference End Date: 03/31/2022
Total FDA cost of the conference: $130,128
Total number of individuals whose travel expenses were paid by the FDA: 4
Explanation of how conference advanced the mission of FDA:
The Society of Toxicology (SOT) annual event featured a broad range of scientific sessions and a thematic program that provided participants with a unique opportunity to deepen their knowledge in topical areas and interact with leaders in their respective disciplines. If the FDA did not attend this conference, it would have missed the opportunity to learn first-hand the latest information and research pertaining to toxicology and its application to the mission of FDA. This conference benefited the FDA by allowing scientists to network with clinical academic science professionals from across the nation to develop ideas for future ideas, while collaborating and sharing up-to-date research with colleagues in the latest technology advances in toxicities, for medical devices, new materials, and a combination of devices to assist in review/memos/consults on new devices that incorporate these materials into toxicological analysis. Also, attendance helped increase the current knowledge and understanding of regulations and analytical science in the area of food safety and frauds. FDA’s strategic priorities to promote better informed decisions about the use of FDA-regulated products as defined in FDASIA and 21st Century Cures was advanced at this conference. Many organizations are not aware of FDA regulated products as well as FDA as a resource of information in the treating or controlling of chronic illnesses, which is why it was essential in attending this conference. Finally, this conference was a unique opportunity for others to obtain FDA safety and health information, being that FDA is responsible for protecting public health by assuring the safety and efficacy of FDA regulated products. One of FDA's 21st Century Cures Act Initiative is about Clinical Trials, and this research is critical for ensuring FDA regulated products are safe and effective.
General description of the scientific conference activities:
The Society of Toxicology (SOT) annual meeting was the largest meeting of its kind. This annual event and its scientific program included plenary lectures and other featured sessions, symposium, workshops, roundtable discussions, informational sessions, and a regional interest session as well as platform/poster sessions, all on the topic of toxicology. Those attending this conference received information on current scientific advancements in the field of toxicology and safety assessment. Also, attendees were allowed the opportunity to interact with clinical and academic science professionals (building new relationships and strengthening existing ones) from across the nation 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.
The Society of Toxicology (SOT) is the largest society representing scientists from industry, academia, and government in the field of toxicology, including many who work in the field of tobacco product toxicity. The scientific virtual seminars were directly applicable to FDA job duties and reached/disseminated FDA messages and materials to a diverse group of audiences (such as scientific academia, medical associations, state, and local tobacco control, minority organizations, and public health groups). FDA was able to connect with over 6,000 interested and qualified attendees in the toxicology field.
5. FDA22 Small Business Regulatory Education for Industry Prescription Drug Labeling Forum
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Virtual
Conference Start Date: 08/17/2022
Conference End Date: 08/18/2022
Total FDA cost of the conference: $106,027
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
This meeting (Small Business Regulatory Education for Industry Prescription Drug Labeling Forum) allowed FDA to hear directly from manufacturers and regulators. It also allowed FDA to share targeted regulatory information to attendees, which in turn will assist in sponsors submitting more complete application to the FDA. Ultimately, this will reduce the review time. This SBIA event targeted small pharmaceutical/devices/biologics businesses, and in fact, was widely attended by all levels of industry including small, medium, and large pharma.
General description of the scientific conference activities:
In the Small Business Regulatory Education for Industry Prescription Drug Labeling Forum, FDA employees collaborated with the National Institutes of Health (NIH), Unites States Pharmacopoeia (USP), and others to present on FDA's regulatory requirements as related to these stakeholders with a proposed emphasis on strengthening global regulatory capacity for the review of new priority medicines for treatment of TB. This meeting was an inroad 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) in that it ushered in a new collaboration with NIH and USP. 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. SBIA outreach activities includes hosting events in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic and device industries. CDER SBIA 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.
6. Small Business Regulatory Education for Industry Pharmaceutical Quality Symposium
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Virtual
Conference Start Date: 10/01/2021
Conference End Date: 10/02/2021
Total FDA cost of the conference: $106,027
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
This meeting 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 concerning their questions/concerns about the FDA regulatory procedures. Also this forum allowed FDA to share targeted regulatory information to attendees. This in turn assisted in sponsors submitting more complete applications to the FDA, which ultimately reduced the review time.
General description of the scientific conference activities:
FDA employees presented on FDA's regulatory requirements on a specific aspect of the drug development continuum: Pharmaceutical Quality. 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. SBIA’s outreach activities included hosting events in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic and device industries. CDER SBIA helps empower small businesses in their interactions with FDA and aids those businesses in the development of more complete submissions and first-cycle drug approvals. This meeting was designed for to offer a virtual on-line format to promote the accessibility of valuable knowledge and expand the number of global attendees. Also, this meeting assisted in targeting small pharmaceutical/devices/biologics businesses and was widely attended by all levels of industry including small, medium, and large pharma.
7. FDA22 Small Business Regulatory Education for Industry Innovative Generic Drug Development Forum
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Virtual
Conference Start Date: 09/22/2022
Conference End Date: 09/22/2022
Total FDA cost of the conference: $106,027
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
This meeting (Small Business Regulatory Education for Industry Innovative Generic Drug Development 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). It also allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. In this forum, FDA shared targeted regulatory information to attendees. This in turn assisted in sponsors submitting more complete application to the FDA, which ultimately will reduce the review time.
General description of the scientific conference activities:
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, discussed pre-ANDA meetings and review, and examined various areas of complex product science.
8. FDA22 Small Business Regulatory Education for Industry Generic Drugs Forum
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Virtual
Conference Start Date: 04/01/2022
Conference End Date: 04/02/2022
Total FDA cost of the conference: $91,000
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
This meeting (Small Business Regulatory Education for Industry Generic Drugs 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). It also allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. In this forum, FDA shared targeted regulatory information to attendees. This in turn assisted in sponsors submitting more complete application to the FDA, which ultimately will reduce the review time. 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.
General description of the scientific conference activities:
The purpose of the Small Business Regulatory Education for Industry Generic Drugs Forum was to educate the small business generic pharmaceutical industry on key elements associated with the generic drug development continuum. SBIA outreach activities, like this one, include hosting events in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic and device industries. CDER SBIA 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.
9. FDA22 Small Business Regulatory Education for Industry Good Clinical Practice Forum
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Virtual
Conference Start Date: 07/19/2022
Conference End Date: 07/20/2022
Total FDA cost of the conference: $91,000
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
This meeting (Small Business Regulatory Education for Industry Good Clinical Practice 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). It also allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. In this forum, FDA shared targeted regulatory information to attendees. This in turn assisted in sponsors submitting more complete application to the FDA, which ultimately will reduce the review time. 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.
General description of the scientific conference activities:
During the Small Business Regulatory Education for Industry Good Clinical Practice Forum, FDA employees presented on FDA's regulatory requirements on a specific aspect of the drug development continuum: Good Clinical Practice. SBIA outreach activities, like this one, include hosting events in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic and device industries. CDER SBIA 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.
10. FDA22 Association of Food and Drug Official Educational Conference
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Glendale, Arizona
Conference Start Date: 06/11/2022
Conference End Date: 06/15/2022
Total FDA cost of the conference: $87,434
Total number of individuals whose travel expenses were paid by the FDA: 45
Explanation of how conference advanced the mission of FDA:
FDA attendance at this educational conference promoted public health by supporting the agency’s mission of helping safe and effective products reach the market, and helping the public obtain accurate, science-based information to improve public health. FDA representation at the conference was mission critical by representing FDA on food safety modernization activities and human food safety-related matters with external stakeholders. Engagement with these stakeholders accomplished the program goals of building an integrated national food safety system. This conference brought together subject matter experts from across the food safety industry, which allowed for increased collaboration and offered an opportunity to present to key stakeholders on the latest initiatives for the New Era of Smarter Food Safety. Also FDA attendance at this conference was mission critical by supporting Goal 3 (Protect the public against violations associated with FDA-regulated products) and Goal 4 (Partnerships of ORA's Strategic Plan: Advance toward an integrated public health system). Specifically, attendance supported objective 4.3: Increase mutual acceptance and reliance on regulatory and public health partner work, data and action and objectives 3.1 Support a culture of safety and quality in regulated industry and 3.4: Lead the collective response to violations of applicable laws and regulations. The impact of not attending would not have allowed FDA to meet these strategic goals to engage within the integrated food safety community, foster partnerships with local, tribal, and federal partners, and further mutual reliance in action with a collective FDA presence with State regulators and FDA employees.
General description of the scientific conference activities:
The Association of Food and Drug Officials (AFDO) is a regulatory organization that connects food and medical-products safety stakeholders and impacts the regulatory environment by shaping sound, science-based rules, law, regulations, and sharing best practices that protect public health. By developing a broad base of support for new approaches, AFDO has become a recognized voice in determining the rules and shape of the regulatory playing field of the future. The consensus that AFDO develops is key to advancing uniform laws, regulations, and guidelines that result in more efficient regulation and less confusion among industry in the marketplace. AFDO develops support for its positions by interfacing with high-level regulatory officials, industry representatives, trade associations, and consumer organizations. This continues to have a significant impact on regulations at the federal, state, and local level. The Association of Food and Drug Officials (AFDO) education conference was the center of the food and medical product safety world for five days for professionals from government, states, academia, consumer groups, and manufacturing. Subject matter experts convened for the annual education conference willing to share their knowledge. Dozens of national and international experts were available on more than 40 topics in the food safety and medical products arena. AFDO also hosted pre-conference in-depth workshops and training opportunities on a broad number of topics adjacent to the annual conference. Also, there was a special first-time attendees’ session and communications that helped newcomers make the most of their conference experience.
11. FDA22 Small Business Regulatory Education for Industry Electronic Drug Registration and Listing Forum
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Virtual
Conference Start Date: 10/01/2021
Conference End Date: 10/01/2021
Total FDA cost of the conference: $85,243
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
This meeting is 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). It allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. Also, it 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.
General description of the scientific conference activities:
This was a FDA hosted conference dedicated to assisting industry with creating complete and accurate registration and listing submissions. 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. SBIA outreach activities include hosting events in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic and device industries. In this conference, CDER SBIA 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. This conference was designed to promote the accessibility of valuable knowledge and expand the number of global attendees. This event allowed SBIA to target small pharmaceutical/devices/biologics businesses, but in fact, are widely attended by all levels of industry including small, medium, and large pharma.
12. FDA22 American Society for Gene and Cell Therapy Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Virtual
Conference Start Date: 05/16/2022
Conference End Date: 05/19/2022
Total FDA cost of the conference: $77,550
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
Attending this conference of American Society for Gene and Cell Therapy was to the advancement of the FDA mission because members of the Division of Animal Bioengineering and Cellular Therapies, along with other crucial members of the Office of New Animal Drug Evaluation, as well as the Office of Surveillance and Compliance, are charged with reviewing applications using gene- and cell-based products, with the goal of protecting public and animal health and promoting the development of innovative products. This conference also allowed attendees to update their knowledge and specific experience efficiently and effectively in the field of science and technology related with gene therapy products in order to improve CMC review duties. Attending this conference supported the FDA Mission to protect the public health by assuring the safety and security of biological products. Lack of attendance would have not supported the cooperative educational structure established by the FDA, nor would it have allowed attendees to stay informed on the latest developments and information in the field of gene therapies.
General description of the scientific conference activities:
American Society for Gene and Cell Therapy annual meeting provided an international forum where the latest gene and cell therapy developments are presented and critically discussed. Attendance was critical for FDA/CVM 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. It also 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. The purpose of this conference was for people in the field to learn from the latest scientific research, stay up to date on new technologies, and make career-advancing connections with peers. The education of the industry and other regulatory counterparts for uniform understanding of laws and regulations was indeed furthered at this event as well as the exchange of scientific ideas and dialogue was enabled with regulators that form the basis of evolving regulatory practices in the development of these diverse and innovative products. Finally, attendees were able to review many devices that are used with gene therapies for hemophilia as well as were able to listen to presentations about this topic with regards to safety risks to gene therapies.
13. FDA22 American Society for Clinical Pharmacology and Therapeutics Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Virtual
Conference Start Date: 03/16/2022
Conference End Date: 03/18/2022
Total FDA cost of the conference: $72,370
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
The American Society for Clinical Pharmacology and Therapeutics Annual Meeting (ASCPT) advanced the mission of FDA by providing access to the latest advancements in clinical pharmacology translational science and dozens of scientific sessions on ground-breaking research including ASCPT’s popular State of the Art lectures, poster presentations, panels and more. This conference also met the mission of FDA and by providing learning opportunities to better process generic drug applications which protects and promotes public health.
General description of the scientific conference activities:
The ASCPT Annual Meeting attendees received updates and knowledge on Network & Community experience that assisted in their duties within FDA. Topics from the meeting also included innovative tools in clinical pharmacology that model-informed drug development and advanced the attendees pharmacokinetic pharmacodynamic (PKPD) knowledge on the latest drug developments.
14. FDA22 American Society of Hematology Annual Meeting and Exposition
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Virtual
Conference Start Date: 12/11/2021
Conference End Date: 12/14/2021
Total FDA cost of the conference: $60,835
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
Attending the American Society of Hematology Annual Meeting and Exposition conference advanced the mission of the FDA by assisting in the prioritization of research within the hematology field. It also helped to identify key emerging and transformative areas of research that will launch the field into the next generation of therapies for hematologic conditions. The American Society of Hematology Annual Meeting and Exhibition provided an invaluable educational experience and the opportunity to review thousands of scientific abstracts highlighting updates in the hottest topics in hematology. Also, it allowed FDA to network with the top minds in the field and a global community of more than 25,000 hematology professionals from every subspecialty. Being that this was the premier national event for hematology professionals in academia, clinical practice, industry, and advocacy, this meeting brought together healthcare providers, scientists, advocates, industry, and other professionals dedicated to better outcomes for people with hematological conditions. FDA most definitely gained supporting clinical and scientific hematology research through the meeting’s many innovative programs to help meet FDA mission.
General description of the scientific conference activities:
The American Society of Hematology (ASH) leads the world in promoting and supporting clinical and scientific hematology research in malignant and non-malignant hematology. The purpose of the American Society of Hematology Annual Meeting and Exposition was to receive scientific education on real-world use of emerging immunotherapies; the interplay between immunology, hematology, and coagulation in infectious disease (e.g. COVID-19); and to discover the newest advances in hematology. The mission of this conference was to further the understanding, diagnosis, treatment, and prevention of disorders affecting the blood, bone marrow, and the immunologic, hemostatic, and vascular systems, by promoting research, clinical care, education, training, and advocacy in hematology.
15. FDA22 Association of American Food Control Official Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: St. Louis, Missouri
Conference Start Date: 08/04/2022
Conference End Date: 08/06/2022
Total FDA cost of the conference: $59,644
Total number of individuals whose travel expenses were paid by the FDA: 34
Explanation of how conference advanced the mission of FDA:
The Association of American Food Control Official (AAFCO) annual meeting featured sessions on current issues, such as: advancing human and animal health safety; ingredient definitions; feed labeling; laboratory methods; feed and feed manufacturing; and inspection and sampling. Attendance at this meeting was mission critical and supported the FDA mission by supporting ORA’s Strategic Plan, specifically; 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). The impact of not attending would have been that we would not meet these strategic goals of training and developing our workforce as well as to engage within the integrated food safety community and foster partnerships with local, tribal and federal partners and further mutual reliance in action with a collective FDA presence with State regulators and FDA employees. Finally, greater than 70% of FDA field work to ensure the safety of animal food is done by our state partners, who are all members of AAFCO. CVM has several regulations and initiatives that are being launched in this area, including Food Safety Modernization Act, Veterinary Feed Directive and animal feed labelling. Attending the meeting advanced the mission of the agency as state partners, otherwise, 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:
The Association of American Food Control Official (AAFCO) is a key regulatory partner to ensure the safety of animal feed. Members of AAFCO are state animal feed regulatory officials that are responsible for ensuring safe feed in their state under contract and cooperative agreements perform inspections and feed analysis on behalf of FDA. FDA is a member of AAFCO. Partnership with AAFCO is a critical part of FDA mission and the Partnership for Food Protection (PFP) to ensure a safe animal food supply and that edible products for humans are safe. The AAFCO Feed Administrations Seminar is held yearly and provides a forum for feed safety officials at FDA and the state to meet to discuss critical issues facing the feed regulators. 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.
16. FDA22 Regulatory Affairs Professionals Society 2022 Convergence
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Phoenix, Arizona
Conference Start Date: 09/11/2022
Conference End Date: 09/13/2022
Total FDA cost of the conference: $57,859
Total number of individuals whose travel expenses were paid by the FDA: 41
Explanation of how conference advanced the mission of FDA:
FDA contains advisors, device subject matter experts, and trainers that need to stay abreast of current industry best practices. The Regulatory Affairs Professionals Society (RAPS) 2022 Convergence conference provided a comprehensive review of emerging medical device practices that will help FDA attendees become a more effective in this area. It is mission critical that the agency attended this conference to further the education of industry and staff for a uniform understanding of the laws and regulations as well as to allow for the engagement of both industry and government involved in the regulatory profession. The discussions and presentations in this conference provided a unique opportunity to view the regulatory environment from the perspective of industry, academia, and others who interact with FDA as well as to learn how these stakeholders plan and execute their regulatory strategies. Also, this meeting was beneficial to the attendees who serve as regulatory affair professionals in their jobs, and this event allowed them to learn best methods and practices and allow them to share them with their team at FDA. Finally, FDA’s Latin America office believed that it was critical for our staff to participate in-person, in order to benefit from the global discussions on the state of regulatory affairs post-pandemic in order to guide our office strategic priorities moving forward. Furthermore, several key regulatory partners in the Latin America region participated at this conference, and it was essential for the Latin America Office to attend this conference and take advantage of this opportunity to meet in-person with these key stakeholders. In-person meetings are a critical way of doing business in Latin America; hence, it was critical for FDA to continue these engagements with the regulatory stakeholders and build connections through this event to develop strong collaborations and make progress related to key FDA priorities in the Latin America region.
General description of the scientific conference activities:
The Regulatory Affairs Professionals Society (RAPS) 2022 Convergence annual conference provided the opportunity to further expand regulatory knowledge beyond FDA employees' immediate subject area. The RAPS conference incorporated regulatory professionals specializing in devices, drugs, and biologics from across the globe. The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics, and nutritional products, deeming this conference highly important. Attending this conference helped attendees in regulatory profession education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities, and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. Many FDA Pharma staff have received and benefited from these regulatory affairs certifications over the years. The annual RAPS Convergence is the largest annual gathering of regulatory professionals, regulators, scientists, and innovators from around the world as well as the only US event that is exclusively dedicated to the regulatory profession. The conference allowed attendees to engage with peers in the field, interact with other regulatory experts and top health authorities, listen to and exchange experiences, celebrate the successes and victories with others in the regulatory
profession, and connect to the latest innovations from solution providers via video chat and virtual booths.
17. FDA22 American Society of Clinical Oncology Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Chicago, Illinois
Conference Start Date: 06/03/2022
Conference End Date: 06/07/2022
Total FDA cost of the conference: $53,030
Total number of individuals whose travel expenses were paid by the FDA: 15
Explanation of how conference advanced the mission of FDA:
The American Society of Clinical Oncology Annual Meeting (ASCO) advanced the mission of FDA by covering enhanced patient care through educating members of oncology teams. ASCO hoped to contribute and advance the field by providing oncologists with the training, tools, and data they needed.
General description of the scientific conference activities:
The ASCO Conference covered Medical, Health, Breast Cancer, Oncology, Cancer, Medical Oncology, Cancer Treatment, Immunotherapy, Colorectal Cancer, Skin Cancer, Cancer Prevention, Melanoma, Pediatric Oncology, Gynecologic Cancer and Tumor Biology. The guides contained space for patients to record the specifics of their individual diagnosis and treatment plan. With the number of cancer patients projected to grow dramatically in the years ahead in the United States and worldwide, everything possible must be done to ensure that we are well-positioned to deliver the care they will need. Yet, anticipating and preparing for the future is an absolute necessity for the oncology field. ASCO International supports the professional development of early career oncologists from all over the world.
18. FDA22 American Association for Cancer Research Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Virtual
Conference Start Date: 04/08/2022
Conference End Date: 04/13/2022
Total FDA cost of the conference: $51,000
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
The American Association for Cancer Research Annual Meeting (AACR) advanced the mission of FDA by highlighting the work of the best minds in cancer research from institutions all over the world. FDA attendees were able to obtain training to understand advances in the field of neurology to support FDA review work. The AACR Annual Meeting highlighted the work of the best minds in cancer research from institutions all over the world, which helped the FDA mission.
General description of the scientific conference activities:
The AACR Annual Meeting was the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather 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 purpose for attending the conference was to expand and enrich the scientific knowledge behind tobacco-related tumorigenesis and broaden the scientific horizons with novel insights around the tobacco-related cancer research. It contributed to the attendees’ professional growth as a regulatory reviewer and provided them with the proper tools to better assess the potential public health risks associated with tobacco and ENDS consumption and, consequently, may potentially affect positively the Agency’s functionality.
19. FDA22 38th International Society for Pharmacoepidemiology Annual Conference
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Copenhagen, Denmark
Conference Start Date: 08/24/2022
Conference End Date: 08/28/2022
Total FDA cost of the conference: $48,147
Total number of individuals whose travel expenses were paid by the FDA: 7
Explanation of how conference advanced the mission of FDA:
The 38th International Society for Pharmacoepidemiology Annual Conference (ISPE) advanced the mission of FDA by providing the public with information to promote the safe and appropriate use of biological products and by advancing the appropriate use of real-world data for patient-centric regulatory purposes.
General description of the scientific conference activities:
The ISPE Annual Conference to brought together international members by providing a global forum for the open exchange of scientific information and for the development of policy, education, and advocacy for the real-world data community. The conference was also committed to providing an unbiased scientific forum to the views of all parties with interests in drug development, drug delivery, drug use, drug costs, and drug effects. Which provided attendees the ability to interact with others 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.
20. FDA22 American College of Toxicology 42nd Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Virtual
Conference Start Date: 11/10/2021
Conference End Date: 11/19/2021
Total FDA cost of the conference: $47,485
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
Attendance at the American College of Toxicology (ACT) 42nd annual meeting advanced the mission of the FDA in obtaining vital information on the current methodologies used in the risk assessment of industrial chemical, pesticides, and herbicides. Scientists with skills in risk assessment in toxicology are needed to ensure that FDA has the most up-to-date information when developing new policies and approving new feed ingredients. Also, toxicologists at FDA (in the Technical Additives Team specifically) review animal food additive petitions, GRAS substances, and ingredient definitions by conducting risk assessment for hazards in a diverse range of animal food substances. So attending this conference was vital to gain the necessary knowledge on the current advances in the field of toxicology and risk assessment in order to ensure the safety of animal food ingredients.
General description of the scientific conference activities:
The American College of Toxicology is a global community of industry, government, and academic professionals renowned for its ability to educate, lead, and serve scientists related to applied toxicology in a welcoming and collegial environment, such as the American College of Toxicology (ACT) 42nd Annual Meeting. This conference allowed the exchange of information and perspectives as well as brought together a community of toxicologists in an environment conducive to these exchanges of ideas, professional networking, and continuing education. It included a wide-ranging scientific program with distinguished plenary speakers, the popular poster viewing session, Talking Tox webinars (exhibitor-hosted webinars), and professional networking events. Finally, the ACT annual meeting contained first-rate Scientific Sessions that were member driven, pharma focused (but not pharma exclusive), and organized to maximize learning opportunities.
21. FDA22 International Forum on Process Analytical Chemistry Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: North Bethesda, Maryland
Conference Start Date: 06/12/2022
Conference End Date: 06/15/2022
Total FDA cost of the conference: $46,180
Total number of individuals whose travel expenses were paid by the FDA: 2
Explanation of how conference advanced the mission of FDA:
The FDA22 International Forum on Process Analytical Chemistry Annual Meeting (IFPAC) advanced the mission of FDA by keeping the agency abreast of the most current advances and by including multiple tracks in Biotechnology, where representatives from the FDA, USP, NIST, industry leaders, academia, and research institutions from across the globe attended to discuss upcoming challenges.
General description of the scientific conference activities:
The IFPAC Annual Meeting Scientific Board consists of a scientific board of industry, regulatory, and academic leaders that collaborated to create a comprehensive program that addressed important mainstay topics, as well as the latest trends, technologies, and applications. The meeting also brought together experienced professionals and the next generation of leaders to share in discussions, giving input and getting ideas for the future well-being of the industry.
22. FDA22 National Environmental Health Association Annual Conference
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Spokane, Washington
Conference Start Date: 06/28/2022
Conference End Date: 07/01/2022
Total FDA cost of the conference: $44,069
Total number of individuals whose travel expenses were paid by the FDA: 17
Explanation of how conference advanced the mission of FDA:
National Environmental Health Association Annual Conference attendance gave attendees unparalleled exposure to local voices of agencies, industries, and government, and they were able to learn from these unique perspectives and contribute towards the advancement of the environmental health profession. Attendees were able to choose from over 200 educational sessions in the follow subject areas: Healthy Communities, General Environmental Health, Emergency Preparedness, Climate & Health, Workforce & Leadership, Water Quality, Food Safety, Infectious & Vectorborne Diseases, and Data & Technology. Also, attendance supported FDA/ORAs Strategic Plan (specifically 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. The impact of not attending would have caused FDA to not meet these strategic goals of fostering a highly capable, high-performing workforce, capable of engaging within the integrated environmental health community, and fostering partnerships with local, tribal and federal partners.
General description of the scientific conference activities:
The National Environmental Health Association (NEHA) 2022 Annual Educational Conference allowed attendees to receive public health training and certificate maintenance, learn new skills in educational sessions, and participate in networking opportunities. This conference was the nexus for environmental health training, education, networking, and advancement. Environmental health professionals from around the globe (including FDA) came together to learn and discuss current and emerging environmental health topics and issues.
23. FDA22 Well Characterized Biotechnology Products 25th Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Virtual
Conference Start Date: 01/25/2022
Conference End Date: 01/27/2022
Total FDA cost of the conference: $40,130
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
The Well Characterized Biotechnology Products 25th Annual Meeting (WCBP) advanced the FDA mission by addressing the analytical development/regulatory interface for biotechnology derived health intervention products by providing participants with an excellent opportunity to meet, network and participate in exchanging knowledge for mutual education with other colleagues in analytical development/regulatory interface for biotechnology-derived health intervention products.
General description of the scientific conference activities:
The WCBP 25th Annual Meeting gave an insight on the current topics and issues that are under discussion within the pharmaceutical and biotech industry and that gave attendees the opportunity to bridge between industry, academia, and regulatory agencies. The interactive format of the Symposium proved to be an effective means of benchmarking strategies and clarifying expectations among the regulatory and technical experts. The WCBP Symposium series is the pre-eminent conference addressing the analytical development/regulatory interface for biotechnology derived health intervention products. As a participant, you will have an excellent opportunity to meet, network and participate in exchanging knowledge for mutual education with other colleagues in analytical development/regulatory interface for biotechnology-derived health intervention products.
24. FDA22 Joint Statistical Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Washington, District of Columbia
Conference Start Date: 08/06/2022
Conference End Date: 08/11/2022
Total FDA cost of the conference: $38,144
Total number of individuals whose travel expenses were paid by the FDA: 17
Explanation of how conference advanced the mission of FDA:
The Joint Statistical Meeting benefited the FDA mission by offering opportunities for collaboration and expanded the agencies knowledge in statistical application. The meeting gave FDA the opportunity to present on and learn about emerging topics pertaining to industry interest and regulatory decision making.
General description of the scientific conference activities:
The Joint Statistical Meeting is one of the largest statistical events in the world that covered a broad array of topics, which included statistical applications to methodology and theory to the expanding boundaries of statistics. Attendees were given a better understanding in turning knowledge into practice and leveraging data for data-informed resource planning and operational management support capabilities.
25. FDA22 American Academy of Ophthalmology Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Chicago, Illinois
Conference Start Date: 09/30/2022
Conference End Date: 10/03/2022
Total FDA cost of the conference: $32,815
Total number of individuals whose travel expenses were paid by the FDA: 4
Explanation of how conference advanced the mission of FDA:
This conference advanced the mission of FDA by providing insight into the development of eye diseases that could have a direct impact on regulatory review of ophthalmic devices. It also provided attendees/participants access to scientists who are involved in this cutting-edge research, which can facilitate discussions about how vision science can further develop to improve patient’s vision.
General description of the scientific conference activities:
Conference attendees interacted with other science experts in the field of ophthalmology, consumers, users, and manufacturers of regulated products. FDA speakers conducted courses in FDA regulation. The American Academy of Ophthalmology’s mission is to advance the lifelong learning and professional interests of ophthalmologists to ensure that the public can obtain the best possible eye care.
26. FDA22 Commercializing Continuous Processing in Pharm Summit
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Virtual
Conference Start Date: 03/22/2022
Conference End Date: 03/25/2022
Total FDA cost of the conference: $31,921
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
The Joint Statistical Meeting benefited the FDA mission by offering opportunities for collaboration and expanded the agencies knowledge in statistical application. The meeting gave FDA the opportunity to present on and learn about emerging topics pertaining to industry interest and regulatory decision making.
General description of the scientific conference activities:
The Joint Statistical Meeting is one of the largest statistical events in the world that covered a broad array of topics, which included statistical applications to methodology and theory to the expanding boundaries of statistics. Attendees were given a better understanding in turning knowledge into practice and leveraging data for data-informed resource planning and operational management support capabilities.
27. FDA22 American Academy of Ophthalmology Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: New Orleans, Louisiana
Conference Start Date: 11/12/2021
Conference End Date: 11/15/2021
Total FDA cost of the conference: $31,425
Total number of individuals whose travel expenses were paid by the FDA: 1
Explanation of how conference advanced the mission of FDA:
This conference (American Academy of Ophthalmology Annual Meeting) advanced the mission of FDA by providing insight into the development of eye diseases that could have a direct impact on regulatory review of ophthalmic devices. It also provided attendees/participants access to scientists who are involved in this cutting-edge research, which can facilitate discussions about how vision science can further develop to improve patient’s vision.
General description of the scientific conference activities:
The American Academy of Ophthalmology Annual Meeting exposed attendees to cutting-edge technological advances in ophthalmic devices and allowed networking with innovators, academicians, and industry, improving their awareness of and promoting innovation of devices in the treatment of eye conditions. CDRH management requires reviewers to have updated knowledge and training to enable management to make fully informed approval and disapproval decisions regarding medical device applications. CDRH, therefore, benefited when the reviewers have up-to-date knowledge and training. The American Academy of Ophthalmology is the world’s largest association of eye physicians and surgeons. The AAO empowers lives by setting the standards for ophthalmic education and advocating for patients and the public as well as to ensure the delivery of the highest-quality eye care.
28. FDA22 Association of Official Agricultural Chemist Conference
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Scottsdale, Arizona
Conference Start Date: 08/26/2022
Conference End Date: 09/01/2022
Total FDA cost of the conference: $31,349
Total number of individuals whose travel expenses were paid by the FDA: 13
Explanation of how conference advanced the mission of FDA:
The Association of Official Analytical Chemists (AOAC) Annual Meeting advanced the mission of FDA by facilitating training, sharing knowledge, offering workshops, providing experts to meet from around the country, and by spreading information and resources that could assist both professionally and in personal growth. Also, the meeting provided the opportunity to network and collaborate with peers from organizations, institutions, non-profits, and academia and to learn about innovations in analytical methods, which assisted attendees in meeting the mission at FDA.
General description of the scientific conference activities:
The Association of Official Analytical Chemists (AOAC) Annual Meeting is a forum for finding appropriate science-based solutions through the development of microbiological and chemical standards. AOAC standards are used globally to promote and to facilitate public health and safety. AOAC develops analytical methods for a broad spectrum of safety interests including foods and beverages, dietary supplements, infant formula, feeds, fertilizers, soil and water, veterinary drugs, pharmaceuticals and more. AOAC's extensive membership, volunteer base and industry partners are made up of government agencies, academic international organizations, laboratories, contract research organizations, rapid assay developers, high technology providers, and instrument manufacturers. AOAC's primary activity is the development of globally accepted standards.
29. FDA22 3D Printing in Hospitals: Very Low Risk Applications and Implementing Quality Management
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Virtual
Conference Start Date: 03/16/2022
Conference End Date: 03/17/2022
Total FDA cost of the conference: $30,386
Total number of individuals whose travel expenses were paid by the FDA: N/A
Explanation of how conference advanced the mission of FDA:
The 3D Printing in Hospitals: Very Low Risk Applications and Implementing Quality Management conference advanced the mission of FDA by having Quality Management Systems in place, to evaluate safe use of 3D printers in Veterans Hospitals, and to expand the Quality Management Systems currently implemented in Veteran Administration Hospitals.
General description of the scientific conference activities:
This public workshop was a joint collaboration with the Veteran Health Administration’s Office to share efforts to bring 3D Printing to their hospitals within FDA’s conceptual framework. 3D printing at the point of care may serve an important public health purpose and may provide for rapid and agile production of devices, including but not limited to patient-matched devices and anatomical models for surgical planning. Veteran Health Administration’s Office of Advanced Manufacturing has worked diligently to evaluate how to safely 3D print devices at Veteran Health Administration hospitals, and how it’s successfully implemented a quality management system per 21 CFR part 820 for 3D printing medical devices in three hospitals, with plans to implement in more hospitals in the future. The FDA speakers shared their perspectives and lessons learned. Also, speakers from other hospitals, professional societies, and medical device manufacturers shared their experiences. Each session concluded with a group discussion and provided opportunity for the speakers to address audience questions. This workshop helped inform the public on 3D printing at hospitals by sharing the VHA’s experiences, hearing from others in the field, and having an open dialogue with relevant stakeholders.
30. FDA22 75th Tobacco Science Research Conference
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: New Orleans, Louisiana
Conference Start Date: 09/11/2022
Conference End Date: 09/14/2022
Total FDA cost of the conference: $30,353
Total number of individuals whose travel expenses were paid by the FDA: 37
Explanation of how conference advanced the mission of FDA:
Attendance to the 75th Tobacco Science Research Conference advanced the mission of FDA by helping staff understand and evaluate the tobacco testing methods that industry uses for its products. New methodology was presented due to the recent release of the deeming that gave FDA jurisdiction over more types of tobacco products. The conference provided an interdisciplinary platform for researchers, academics, government employees, and the many others working across disciplines in the field of nicotine and tobacco research. Also, it provided an understanding of how they are expanding their current analytical methods to include the newly regulated tobacco products.
General description of the scientific conference activities:
The Tobacco Science Research Conference (TSRC) brought together leading academic scientists and research scholars to exchange and share experiences and research results on tobacco science research. It covered manufacturing and laboratory testing of many types of tobacco products and nicotine delivery devices, as well as trends on the regulation of Harmful or Potentially Harm Compounds (HPHC) in finished products. It also provided an opportunity to engage academia, tobacco control, and key stakeholders as well as expanded the knowledge of current evidence and perspectives on tobacco products.