Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Three - AM
ฝัง
- เผยแพร่เมื่อ 8 ก.พ. 2025
- 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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