OTP Events, Meetings, and Workshops

The Office of Therapeutic Products (OTP) hosts a variety of events to share information about OTP-regulated products and bring together important stakeholders to discuss the development and advancement of these products. Learn more about our various event series, register for our upcoming events, or find information about previous events.

Learn More About Our Events

RegenMedEd Series

The RegenMedEd series brings together important stakeholders and FDA staff to discuss foundational information about regenerative medicine therapies, such as gene and cell therapy products, and explore opportunities for patients, caregivers, and advocates to engage with FDA to help advance product development. Recent topics include gene therapy clinical trials, the importance of natural history studies, and regenerative medicine 101. 

OTP Virtual Town Hall Series

The OTP Virtual Town Halls aim to engage with product development stakeholders and researchers. These town halls have a question-and-answer format with the goal of providing regulatory information to stakeholders to help advance development of OTP-regulated products. 

Additional Workshops, Meetings, and Events

In addition to our event series, OTP also hosts a number of other meetings and workshops throughout the year. Most of these events are held virtually and are free and open to the public.

Past Events

Looking for information about previous events? Use the chart below to find more information about our past events, as well as recordings and other event materials.

Date	Title	Series
06/04/24	OTP Town Hall: CMC Readiness for Gene Therapy BLAs	OTP Virtual Town Hall
03/07/24	FDA CBER Webinar: Considerations for the Development of CAR T Cell Products	N/A
02/29/24	FDA CBER Webinar: Human Gene Therapy Products Incorporating Human Genome Editing	N/A
10/05/23	Warrior Families: Advancing Regenerative Medicine Through Science	RegenMedEd
08/30/23	OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products	OTP Virtual Town Halls
06/08/23	OTP Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls – June 2023	OTP Virtual Town Hall
04/27/23	Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products	N/A
04/25/23	OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – April 2023	OTP Virtual Town Hall
04/13/23	Clinical Trials: The Patient Experience	RegenMedEd
03/30/23	Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation; Public Workshop	N/A
03/14/23	FDA CBER Office of Therapeutic Products (OTP) Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) Workshop	N/A
02/07/23	OTAT Town Hall: Clinical Development of Gene Therapy Products for Rare Diseases	OTP Virtual Town Hall
12/16/22	Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products	N/A
12/07/22	OTAT Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls	OTP Virtual Town Hall
11/17/22	Information for Practitioners - FDA’s Regulatory Oversight of Regenerative Medicine Products	N/A
11/15/22	FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products	N/A
10/27/22	Natural History Studies to Support Regenerative Medicine: A How-To Webinar	RegenMedEd
09/29/22	OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls	OTP Virtual Town Hall
05/24/22	Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates	RegenMedEd
03/09/22	RegenMedEd Webinar: The Critical Role of Patients in Advancing Gene Therapy Treatments for Rare Diseases	RegenMedEd
11/16/21	Regenerative Medicine 101 Webinar: Information for Patients, Caregivers & Advocates	RegenMedEd
05/06/21	Patient Engagement & Regenerative Medicine: An FDA CBER Workshop for Patient Advocates	RegenMedEd

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