Workshops, Meetings & Conferences (Biologics)
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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
- FDA Roundtable: Strengthening the Supply Chain for Blood Manufacturing
September 29, 2026 - FDA Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics
September 23, 2026 - Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma
May 12, 2026 - Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
May 19 - 20, 2026 - Advancing Pediatric Cell and Gene Therapy Clinical Trials: Scientific, Ethical, Regulatory, and Practical Considerations
April 9, 2026
- FDA CBER OTP Public Listening Meeting: Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies
September 18, 2025 - FDA Public Meeting: Onshoring Manufacturing of Drugs and Biological Products
September 30, 2025 - OTP Town Hall: Gene Therapy Manufacturing CMC and Facility Readiness for BLAs and Post-licensure Changes
October 22, 2025 - Approval of New Patch Tests for the Diagnosis of Allergic Contact Dermatitis; Public Workshop
October 23, 2025
- Meeting 2: Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases
December 4, 2024 - Live Biotherapeutic Products to Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants
October 25, 2024 - Meeting 1: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases
September 20, 2024 - 2024 Center for Biologics Evaluation and Research (CBER) Science Symposium
September 16 - 18, 2024 - Developing Vaccines for Fungal Diseases: Coccidioidomycosis/Valley Fever
August 13-14, 2024 - OTP Town Hall: CMC Readiness for Gene Therapy BLAs
June 4, 2024 - Biomarker-driven Drug Development for Allergic Diseases and Asthma; Public Workshop
February 22, 2024 - WCBP Symposium 2024
January 23 - 25, 2024
- 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 - Information for Practitioners - FDA’s Regulatory Oversight of Regenerative Medicine Products
November 17, 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
- 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
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The latest information from the Center for Biologics Evaluation and Research.