Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Three – AM

This Joint US-FDA, MHRA-UK, Health Canada workshop focused on Global Clinical Trials in Good Clinical Practice, Bioequivalence, and Pharmacovigilance in the post pandemic world. Panelists discussed continuing developments in novel operational approaches, data sources, and technologies used in clinicals trials, as well as novel approaches to regulatory inspections.

Timestamps

00:05 – Day Three Opening Remarks & Keynote

11:33 – Session 1 (BE): Remote Evaluations

49:07 – Session 2 (BE): Bioanalytical Issues

01:23:04 – Session 1 Discussion Panel

01:38:48 – Session 2 Discussion Panel

01:41:33 – Session 3 (BE): Clinical Study Conduct

02:20:03 – Session 3 Discussion Panel

Day Three Keynote Speaker:

Seongeun (Julia) Cho, MD
Division Director
Division of Generic Drug Study Integrity (DGDSI)
Office of Study Integrity and Surveillance (OSIS)
Office of Translational Sciences (OTS)
Center for Drug Evaluation and Research (CDER) | FDA

Speakers | Panelists:

Sean Kassim, PhD
Director
Office of Study I
OSIS | OTS | CDER | FDA

Mei Ou, PhD
Lead Pharmacokineticist
DGDSI | OSIS | OTS | CDER | FDA

Michael McGuinness
Head of GLP & Laboratories | Head UK GLPMA
Medical and Healthcare products Regulatory Agency (MHRA)
Yiyue Cynthia Zhang, PhD, RAC
Senior Staff Fellow
Division of New drug Study Integrity (DNDSI)
OSIS | OTS | CDER | FDA

Jason Wakelin-Smith, BSc
Expert Good Clinical Practice (GCP) Inspector and
Head of the Compliance Expert Circle
MHRA

Doug Pham, JD, PharmD
Associate Director
OSIS | OTS | CDER | FDA

Emma Whale, MSc
Senior GCP & GLP Inspector
MHRA

Jennifer Adams, MPH
Lieutenant Commander (LCDR)
United States Public Health Service (USPHS)
Foreign Cadre Director
Office of Bioresearch Monitoring Operations (OBIMO)
Office of Regulatory Affairs (ORA) | FDA

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

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