The Office of Study Integrity and Surveillance (OSIS) ensures that data supporting regulatory decisions are reliable by conducting and directing inspections of bioavailability/bioequivalence (BA/BE) and non-clinical Good Laboratory Practice (GLP) studies ) studies submitted to the FDA. This webinar described the mission and vision of OSIS, discussed the basic elements necessary for a bioanalytical laboratory to successfully undergo an FDA inspection, and provided an overview of compliance programs related to inspections of facilities that adhere to GLP, Animal Rule ( AR), Conducting In Vivo Clinical BA/BE and in vivo Analytical BA/BE Studies.

Timestamps

00:51 – Office of Study Integrity and Surveillance (OSIS): Mission and vision

15:46 – Overview of the Collaboration, Risk Assessment and Surveillance Team (CREST) site selection model

23:09 – Analytical inspections for bioavailability/bioequivalence studies

34:53 – Q&A panel

53:42 – Clinical inspections for bioavailability/bioequivalence studies

01:11:55 – Good Laboratory Practice (GLP)

01:34:06 – Q&A panel

01:53:22 – Discussion panel

Speakers | Panelists:

Tahseen Mirza, PhD
Deputy Director for Regulatory Affairs
Office of Study Integrity and Surveillance (OSIS)
Office of Translational Sciences (OTS)
Center for Drug Evaluation and Research (CDER) | FDA

Gabriel Davila, DVM
Biologist
OSIS | OTS | CDER | FDA

Li-Hong (Paul) Yes, PhD
Interdisciplinary scientist
Division of New Drug Study Integrity (DNDSI)
OSIS | OTS | CDER | FDA

Clint Mitchell, PhD
Head of Pharmacokinetics
OSIS | OTS | CDER | FDA

Monica Javidnia, PhD
Staffmate
Generic Drug Studies Integrity Department (DGDSI)
OSIS | OTS | CDER | FDA

Mark Seaton, PhD, DABT
Senior Pharmacokinetics
DNDSI | OSIS | OTS | CDER | FDA

Seongeun (Julia) Cho, PhD
Division Director
DGDSI | OSIS | OTS | CDER | FDA

Kimberley Benson, PhD
Deputy department director
DGDSI | OSIS | OTS | CDER | FDA

Arindam Dasgupta, PhD
Deputy department director
DNDSI | OSIS | OTS | CDER | FDA

Charles Bonapace, PharmD
Division Director
DNDSI | OSIS | OTS | CDER | FDA

Read more at: https://www.fda.gov/drugs/news-events-human-drugs/osis-workshop-cder-bioavailabilitybioequivalence-study-sites-and-inspections-good-laboratory

———————–

FDA CDER's Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human pharmaceuticals and clinical research.

Upcoming training – https://www.fda.gov/cdersbia
SBIA Listserv – https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist – https://www.youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn – https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources – https://www.fda.gov/cdersbialearn
Twitter – https://twitter.com/FDA_Drug_Info
Email – [email protected]
Phone – (301) 796-6707 I (866) 405-5367

Please take the opportunity to connect and share this video with your friends and family if you find it useful.