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.
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).
- Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products
December 16, 2022
- FDA Clinical Investigator Training Course (CITC) 2022
December 7 - 8, 2022
- OTAT Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls
December 7, 2022
2022 Workshops, Meetings & Conferences
- FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement
November 14 - 16, 2022
- FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products
November 15, 2022
- Natural History Studies to Support Regenerative Medicine: A How-To Webinar
October 27, 2022
- FDA NanoDay Symposium 2022
October 11, 2022
- OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls
September 29, 2022
- 2022 Center for Biologics Evaluation and Research (CBER) Science Symposium
September 20-22, 2022
- Regulatory Education for Industry (REdI) Annual Conference 2022
June 6 - 10, 2022
- 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
- Science and Regulation of Bacteriophage Therapy Workshop
August 30 - September 1, 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
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
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