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  4. OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice - 06/13/2024
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Workshop | Virtual

Event Title
OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice
June 13, 2024

Date:
June 13, 2024
Time:
8:50 a.m. - 11:25 a.m. ET

Topic & Presentations

Speakers

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

 

Office of Study Integrity and Surveillance (OSIS): Mission and Vision

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

Collaboration, Risk Evaluation, and Surveillance Team (CREST) Site Selection Model Overview

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

Analytical Inspections for Bioavailability/Bioequivalence Studies

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

Q&A Panel

Tahseen Mirza, Gabriel Davila,

And

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

Clinical Inspections for Bioavailability/Bioequivalence Studies

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

Good Laboratory Practice (GLP)

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

Q&A Panel

Mark Seaton

And

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

Discussion Panel

Tahseen Mirza, Seongeun (Julia) Cho,

And

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

Agenda

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ABOUT THIS EVENT

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. FDA experts will:

  • Describe the Mission and Vision of OSIS.
  • Discuss the basic elements needed for a bioanalytical lab to successfully undergo an FDA inspection.
  • Provide 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.
  • Engage attendees to work through case studies representative of the above programs.

INTENDED AUDIENCE

  • Regulatory affairs professionals who submit INDs, NDAs, BLAs and ANDAs that include bioanalytical study data.
  • Regulatory affairs professionals who are involved in GLP-regulated nonclinical laboratory studies and Animal Rule studies data.
  • Researchers involved in regulated bioanalysis.
  • Sponsors planning studies involving bioanalysis.
  • Industry professionals associated analytical laboratories that involve bioanalysis.

TOPICS COVERED

  • Expectations during BA/BE Inspections – Immunogenicity, Clinical, Clinical Endpoints and Analytical Clinical Programs.
  • Overview of Good Laboratory Practice (GLP) /Animal Rule (AR) Compliance Programs and inspections.
  • Understanding of OSIS BA/BE Program that includes BA Studies 505b2, BE studies, In Vitro BE studies and immunogenicity studies.
  • Gain a better understanding of reserve sample requirements.

FDA RESOURCES

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