Michael Kopcha, PhD, RPh; Director of the Office of Pharmaceutical Quality (OPQ), delivers his closing remarks to the “Pharmaceutical Quality Symposium 2021: Innovations in a Changing World”. Includes responses to audience in a question-and-answer panel.
Additional presenters, from OPQ (unless otherwise noted), and presentations include:
FDA's Advanced Manufacturing Product Development Science Program
Thomas O’Connor, PhD
Extramural Advanced Manufacturing Product Development Science: Continuus
Ernie Penachio, Continuus Pharmaceuticals
Industry Development of Advanced Manufacturing: On Demand Pharmaceuticals
John Lewin, PharmD, MBA; On Demand Pharmaceuticals Inc.
Q&A Panel (Includes all above presenters)
For slides and additional information: [ Ссылка ]
--------------------
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 ]
SBIA 2021 Playlist - [ Ссылка ]
SBIA LinkedIn - [ Ссылка ]
SBIA Training Resources - [ Ссылка ]
Twitter - [ Ссылка ]
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
