FDA discusses pharmaceutical quality and new innovations in regulatory science. Includes responses to audience in a question-and-answer panel.
Presenters, from OPQ, and presentations include:
Integrated Quality Assessment (IQA): Aligned Teams
Don Henry
Knowledge-Aided Assessment and Structured Application (KASA): Part 1
Ee-Sunn “Joanne” Chia, PhD
Knowledge-Aided Assessment and Structured Application (KASA): Part 2
Joel Welch, PhD
Quality Surveillance Dashboard (QSD)
Alex Viehmann
Q&A Panel (Includes all above presenters)
For slides and additional information: [ Ссылка ]
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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 - [ Ссылка ]
SBIA Listserv - [ Ссылка ]
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SBIA Training Resources - [ Ссылка ]
Twitter - [ Ссылка ]
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
