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FDA Regulatory Education for Industry (REdI) Annual Conference
June 6 @ 8:00 am - June 10 @ 5:00 pm
Learn directly from the FDA’s regulatory experts in medical product centers:
drugs, devices, and biologics. This free course is designed to provide
participants with a strong, basic foundation in the FDA’s regulatory
requirements, and also create awareness of current activities.
Drugs, Devices, and Biologics Center Tracks
Topics By Conference Track:
The Drugs Track (June 6-7) will focus on several key components of the PDUFA VII goals. It will identify new processes and enhancements to existing practices of the human drug review program, including new approaches to increase efficiencies and expand communication and feedback. Subject matter experts will provide cutting edge insights and perspectives on how these goals will be implemented at the practical level.
The Devices Track (June 8-9) will provide an introduction to the device regulatory framework, and useful insights into the development of a high-quality marketing submission. It will also discuss key program updates across the device total product lifecycle to allow audiences to be current on important device regulatory policies.
The Biologics Track (June 9-10) will focus on the development of advanced therapies, including cellular and tissue-based products, gene therapies, and xenotransplantation products. Speakers will present updates on various regulatory aspects of cellular and gene therapy product development along with new topics related to the regulation of xenotransplantation products and post-marketing safety signal evaluation and risk mitigation for approved advanced therapies.