Electronic Submission of Safety Reports - Ready for Primetime скачать в хорошем качестве

Electronic Submission of Safety Reports - Ready for Primetime

In the first half of this FDA Drug Topics webinar, Mr. Sarajan De will discuss how the FDA will require reporting of IND and postmarket safety reports to be submitted in the ICH E2B(R3) format to FAERS via the Electronic Submission Gateway or the Safety Reporting Portal. He will also identify the updated requirements since the last publication that are key for postmarket, IND, and IND-exempt BA/BE safety reporting. He will then describe the implementation status and progress of premarket and postmarket safety reports in E2B (R3) format and then Explain how to prepare for the electronic exchange of safety reports. 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