Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Two – PM

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

00:02 – Session 4: Agency Updates: Policies, Guidances, and Initiatives

45:03 – Session 5: Collaboration Between Agencies and Future Expectations

01:11:39 – Session 1 Discussion Panel

01:25:12 – Session 2 Discussion Panel

01:36:58 – Session 3 Discussion Panel

01:49:00 – Session 4 Discussion Panel

02:00:08 – Session 5 Discussion Panel

02:11:43 – Day Two Wrap-Up & Closing Remarks

Speakers | Panelists:

Emily Gebbia, JD
Associate Director of Regulatory Development
Office of Scientific Investigations (OSI)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | FDA

Stephen Vinter, BSc, CChem
Head of Compliance Team 1
Medicines and Healthcare products Regulatory Agency (MHRA)

Hocine Abid, MD, MBA
National Manager
Regulatory Operations and Enforcement Branch (ROEB)
Health Canada (HC)

Mandy Budwal-Jagait, MSc
Head of GCP and Lead Senior GCP Inspector
MHRA

LaKisha Williams, MSN
Commander (CDR)
United States Public Health Service (USPHS)
Good Clinical Practice (GCP) International Liaison
Division of Clinical Compliance Evaluation (DCCE)
OSI | OC | CDER | FDA

Reza Salehzadeh-Asl, MSc
National Supervisor
ROEB | HC

Adil Nashed, BVSc, DHMS
Regulatory Compliance and Enforcement Specialist
HC

Barbara Wright, BA
Foreign Cadre Director
Foreign BIMO Cadre
Office of Bioresearch Monitoring Operations (OBIMO)
Office of Medical Products and Tobacco Operations (OMPTO)
Office of Regulatory Affairs (ORA) | FDA

Jason Wakelin-Smith, BSc
Expert GCP Inspector and Head of the Compliance Expert Circle
MHRA

Iram Hassan, PhD
Lieutenant Commander (LCDR) | USPHS
Reviewer
Good Clinical Practice Compliance Oversight Branch (GCPCOB)
DCCE | OSI | OC | CDER | FDA

Jennifer Evans, BSc
Regulatory Compliance and Enforcement Specialist
HC

Richard Berning
Foreign Cadre Inspector
OBIMO | ORA | FDA

Kassa Ayalew, MD, MPH
Division Director
DCCE | OSI | OC | CDER | FDA

Jenn Sellers, MD, PhD
Branch Chief
Good Clinical Practice Assessment Branch (GCPAB)
DCCE | OSI | OC | CDER | FDA

Jennifer Adams, MPH
LCDR | USPHS
Foreign Cadre Director
OBIMO | ORA | FDA

Rachel Mead, BSc
Senior GCP Inspector
MHRA

Cheryl Grandinetti, PharmD
Clinical Pharmacologist
DCCE | OSI | OC | CDER | FDA

Learn more at: https://www.fda.gov/drugs/news-events...

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