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
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: https://www.fda.gov/drugs/news-events-human-drugs/pharmaceutical-quality-symposium-2021-innovations-changing-world-10262021-10272021
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 – https://www.fda.gov/cdersbia
SBIA Listserv – https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2021 Playlist – https://youtube.com/playlist?list=PLey4Qe-UxcxYS1MaTusSgyifQDqdeepyD
SBIA LinkedIn – https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources – https://www.fda.gov/cdersbialearn
Twitter – https://twitter.com/FDA_Drug_Info
Email – CDERSBIA@fda.hhs.gov
Phone – (301) 796-6707 I (866) 405-5367