OSIS Workshop: CDER BA/BE Study Sites and Inspections of Good Laboratory Practice

The Office of Study Integrity and Surveillance (OSIS) ensures data supporting regulatory decisions are reliable by conducting and directing inspections of Bioavailability/Bioequivalence (BA/BE) and nonclinical Good Laboratory Practice (GLP) studies submitted to FDA. This webinar described the Mission and Vision of OSIS, discussed the basic elements needed for a bioanalytical lab to successfully undergo an FDA inspection, and provided an overview of compliance programs dealing with inspections of facilities that perform GLP, Animal Rule (AR), 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 – Collaboration, Risk Evaluation, and Surveillance Team (CREST) Site Selection Model Overview

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
Associate 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) Yeh, PhD
Interdisciplinary Scientist
Division of New Drug Study Integrity (DNDSI)
OSIS | OTS | CDER | FDA

Clint Mitchell, PhD
Lead Pharmacokineticist
OSIS | OTS | CDER | FDA

Monica Javidnia, PhD
Staff Fellow
Division of Generic Drug Study Integrity (DGDSI)
OSIS | OTS | CDER | FDA

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

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

Kimberley Benson, PhD
Deputy Division Director
DGDSI | OSIS | OTS | CDER | FDA

Arindam Dasgupta, PhD
Deputy Division Director
DNDSI | OSIS | OTS | CDER | FDA

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

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

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