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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.
View FDA Archive for past meetings and materials: 2011-2015; 2016-2020.
Upcoming Workshops, Meetings & Conferences
2024 Workshops, Meetings & Conferences
- Workshop for the Identification and Standardization of Methods for Assessing Gene Therapy Product Activity and Comparability and the Evaluation of T-Cell Therapies
November 16, 2023 – November 17, 2023 - Warrior Families: Advancing Regenerative Medicine Through Science
October 5, 2023 - OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products
August 30, 2023 - OTP Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls – June 2023
June 8, 2023 - RDEA Pilot Program 2023 Public Workshop
June 7 – 8, 2023 - Regulatory Education for Industry (REdI) Annual Conference 2023
June 5 – 9, 2023 - Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products
April 27, 2023 - Recombinant Protein-Based COVID-19 Vaccines Workshop
April 27, 2023 - OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – April 2023
April 25, 2023 - Clinical Trials: The Patient Experience
APRIL 13, 2023 - Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards
April 4, 2023 – November 7, 2023 - Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation; Public Workshop
March 30, 2023 - FDA CBER Office of Therapeutic Products (OTP) Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) Workshop
March 14, 2023 - OTAT Town Hall: Clinical Development of Gene Therapy Products for Rare Diseases
February 7, 2023
- 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 - 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
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Content current as of:
09/17/2024
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Regulated Product(s)
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