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Pharmaceutical Quality Symposium 2021 Part 1 with Keynote Addresses

Janet Woodcock, M.D., Director of Food and Drugs, and Michael Kopcha, PhD, RPh; Director of the Office of Pharmaceutical Quality (OPQ), welcome attendees to the “Pharmaceutical Quality Symposium 2021: Innovations in a Changing World” and deliver their keynote addresses.

Additional presenters, from OPQ (unless otherwise noted), and presentations include:

Regulation of Pharmaceutical Quality in the U.S.
Lucinda Buhse, PhD

Policy Updates on Pharmaceutical Quality
Laurie Graham

FDA’s Facility Oversight
Stelios Tsinontides, PhD
Nancy Rolli, Office of Regulatory Affairs

Q&A Panel (Includes all above presenters)
For slides and additional information:
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Upcoming Training –
SBIA Listserv –
SBIA 2021 Playlist –
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SBIA Training Resources –
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Email –
Phone – (301) 796-6707 I (866) 405-5367

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