Electronic Submission of Safety Reports - Ready for Primetime
Published 2024-05-16
In the second half, Jung Lee will give brief overview of the generic drug pharmacovigilance and cover the bioavailability, BA, and bioequivalence, BE, study safety reporting requirements and focus on the electronic safety reporting from BA BE studies.
Chapters:
00:00 - Welcome and Opening Remarks
03:25 - Saranjan De Presentation
27:08 - Jung Lee Presentation
43:25 - Questions and Answers