Good Clinical Practice & Pharmacovigilance Compliance Symposium Day One - AM
ฝัง
- เผยแพร่เมื่อ 4 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 - Day One Opening Remarks & Keynote
13:05 - Session 1: Good Clinical Practice (GCP) Harmonization: Updates to ICH E6(R3)
01:02:31 - Session 2: Technology in Clinical Trials - Digital Health Technology (DHT)
01:45:41 - Session 3: Clinical Trials with Decentralized Elements and GCP Inspections
Day One Keynote Speaker:
Patrizia Cavazzoni, MD
Director
Center for Drug Evaluation & Research (CDER) | FDA
Speakers | Panelists:
Kassa Ayalew, MD, MPH
Division Director
Division of Clinical Compliance Evaluation (DCCE)
Office of Scientific Investigations (OSI)
Office of Compliance (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)
Andrew Fisher, BSc
Lead Senior Good Clinical Practice (GCP) Inspector
Medicines and Healthcare products Regulatory Agency (MHRA)
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
Karen Bleich, MD
Lead Physician
Division of Clinical Trial Quality (DCTQ)
Office of Medical Policy Initiatives (OMPI)
Office of Medical Policy (OPM)
CDER | FDA
Lee Pai-Scherf, MD
Senior Medical Officer
Good Clinical Practice Assessment Branch (GCPAB)
DCCE | OSI | OC | CDER | FDA
Alicja Kasina, MSc
Senior Regulatory Advisor
ROEB | HC
Hayley Dixey, BSc
Lead Senior GCP Inspector
MHRA
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