FDA provides an overview of postmarketing drug safety inspections and points to consider. Topics include an overview of PADE laws and regulations, written procedures, business relationships and agreements, and electronic reporting of individual case safety reports.
Speakers from the FDA’s PADE Compliance Team include: Kelle Simms, Diana Bruce, Namita Kothary, Richard Abate. Suranjan De, from CDER’s Office of Surveillance and Epidemiology also presents.
Learn more at www.fda.gov/Dr...
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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 and free continuing education credits: www.fda.gov/cd...
CDER SBIA 2020 Playlist: • 2020 CDER Small Busine...
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Training resources: www.fda.gov/cd...
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CDER small business e-mail update subscription: updates.fda.go...
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
12 апр 2020
