Good Clinical Practice & Pharmacovigilance Compliance Symposium Day One - PM
ฝัง
- เผยแพร่เมื่อ 6 ม.ค. 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
00:01 - Session 4 - ICH E6 (R3) Draft - Good Data Governance Practices
54:24 - Session 1 Discussion Panel
01:06:32 - Session 2 Discussion Panel
01:20:14 - Session 3 Discussion Panel
01:33:48 - Session 4 Discussion Panel
01:42:45 - Day One Wrap-Up & Closing Remarks
Speakers | Panelists:
Cheryl Grandinetti, PharmD
Clinical Pharmacologist
Division of Clinical Compliance Evaluation (DCCE)
Office of Scientific Investigations (OSI)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | FDA
Shila Rastegar, MSc
Regulatory Compliance and Enforcement Specialist
Clinical Trial Compliance Program (CTCP)
Regulatory Operations and Enforcement Branch (ROEB)
Health Canada (HC)
Andrew Fisher, BSc
Lead Senior Good Clinical Practice (GCP) Inspector
Medicines and Healthcare products Regulatory Agency (MHRA)
Regina Zopf, MD
Senior Medical Officer
Good Clinical Practice Assessment Branch (GCPAB)
DCCE | OSI | OC | CDER | FDA
Leigh Marcus, MD
Senior Physician
DCCE | OSI | OC | CDER | FDA
Hocine Abid, MD, MBA
National Manager
Regulatory Operations and Enforcement Branch (ROEB)
Health Canada (HC)
Debbi Fox, BSc
Compliance Specialist
ROEB | HC
Elena Boley, MD, MBA
Senior Physician
DCCE | OSI | OC | CDER | FDA
Mandy Budwal-Jagait, MSc
Head of GCP and Lead Senior GCP Inspector
MHRA
Jason Wakelin-Smith, BSc
Expert GCP Inspector and Head of the Compliance Expert Circle
MHRA
Lee Pai-Scherf, MD
Senior Medical Officer
Good Clinical Practice Assessment Branch (GCPAB)
DCCE | OSI | OC | CDER | FDA
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