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FDA's Center for Biologics Evaluation and Research (CBER) sponsors or co-sponsors meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties. Minutes, transcripts, summaries and/or presentations for CBER sponsored or co-sponsored meetings and workshops are made available as soon after the meeting as possible.

Presentations are in chronological order, with the most recent event at the top of the list. Most will be removed after one year. If you want to keep the slides for future reference, they may be downloaded and saved. Slides that have been removed from the web site may be requested by submitting a written request to FDA's Freedom of Information staff.

Workshops, Meetings & Conferences prior to 2016 are available on FDA Archive.

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Upcoming Workshops, Meetings & Conferences

The following are upcoming workshops, meetings, and conferences sponsored or co-sponsored by the Center for Biologics Evaluation and Research (CBER).

• Regulatory Education for Industry (REdI) Annual Conference 2022
  June 6 - 10, 2022

2022 Workshops, Meetings & Conferences

• Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates
  May 24, 2022
• RegenMedEd Webinar: The Critical Role of Patients in Advancing Gene Therapy Treatments for Rare Diseases
  March 9, 2022

2021 Workshops, Meetings & Conferences

• Regenerative Medicine 101 Webinar: Information for Patients, Caregivers & Advocates
  November 16, 2021
• Regulatory Education for Industry (REdI) Annual Conference 2021
  July 19 - 23, 2021
• Model Informed Drug Development Approaches for Immunogenicity Assessments
  June 9, 2021
• Patient Engagement & Regenerative Medicine: An FDA CBER Workshop for Patient Advocates
  May 6, 2021

2020 Workshops, Meetings & Conferences

• Considerations for the Use of Real-World Evidence to Assess the Effectiveness of Preventive Vaccines
  September 17 - 18, 2020
• Summary of FDA & EMA Global Regulators Meeting on Data Requirements Supporting First-in-Human Clinical Trials with SARS-CoV-2 Vaccines
  March 18, 2020
• 23rd US-Japan Cellular and Gene Therapy Conference
  March 12, 2020, 8:30 a.m. - 5:00 p.m.
• Facilitating End-to-End Development of Individualized Therapeutics
  March 3, 2020

2019 Workshops, Meetings & Conferences

• Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies
  November 4, 2019
• Identification and Use of Biomarkers to Advance Development of Preventive Vaccines; Public Workshop
  September 16 - 17, 2019
• Developing Alpha-1 Antitrypsin Therapeutics; Public Workshop
  September 16, 2019, 8 am - 5 pm
• Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review; Public Workshop
  July 15, 2019, from 8 a.m. – 5 p.m. and July 16, 2019, from 9 a.m. – 1 p.m.
• Compute Objects: Tools for Communicating NGS Data and Analysis; Public Workshop 
  May 14, 2019, from 9:00 a.m. – 5:00 p.m.
• 22nd US-Japan Cellular and Gene Therapy Conference
  March 7, 2019, 8:30 a.m. – 5:00 p.m.

2018 Workshops, Meetings & Conferences

• Quantitation of AAV-Based Gene Therapy Products
  December 7, 2018, 9 a.m. – 4:00 p.m.
• Pathogen Reduction Technologies for Blood Safety; Public Workshop
  November 29-30, 2018
• FDA Oncology Center of Excellence - Society for Immunotherapy of Cancer Public Workshop: Immune-modified Response Criteria in Cancer Immunotherapy Clinical Trials
  November 8, 2018, 2 p.m. – 6 p.m.
• CBER Secure Email Policy Takes Effect October 1, 2018
  September 26, 2018
• Science and Regulation of Live Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases in Humans
  September 17, 2018, 9 a.m. – 5:30 p.m.
• 2018 Center for Biologics Evaluation and Research Science Symposium
  June 25 and 26, 2018, from 9 a.m. – 3 p.m.
• 21st US-Japan Cellular and Gene Therapy Conference
  March 1, 2018
• Biologics Effectiveness and Safety (BEST) Sentinel Initiative Industry Day
  February 12, 2018, from 1 p.m. – 5 p.m.

2017 Workshops, Meetings & Conferences

• Immune Globulin Potency in the 21st Century; Public Workshop
  November 8, 2017, from 8 a.m. – 5 p.m., and on November 9, from 8:30 a.m. – 12:00 p.m.
• Public Meeting on Patient-Focused Drug Development for Hereditary Angioedema
  September 25, 2017
• Public Symposium: IXA-FDA Symposium on Regulatory Expectations for Xenotransplantation Products
  September 20, 2017
• Bacteriophage Therapy: Scientific and Regulatory Issues Public Workshop
  July 10-11, 2017
• Public Workshop for Emerging Tick-Borne Diseases and Blood Safety
  April 6, 2017
• The 20th US-Japan Cellular and Gene Therapy Conference
  March 9, 2017
• Public Workshop: Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products
  February 8 - 9, 2017

2016 Workshops, Meetings & Conferences

• Public Workshop: Pre-Clinical Evaluation of Red Blood Cells for Transfusion
  October 6 – 7, 2016
• Public Hearing; Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products
  September 12 – 13, 2016
• Public Workshop: Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval
  September 8, 2016
• The 19th US-Japan Cellular and Gene Therapy Conference
  March 10, 2016