Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Two - PM
Вставка
- Опубліковано 4 гру 2024
- 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: www.fda.gov/dr...
-----------------------
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming Training - www.fda.gov/cd...
SBIA Listserv - public.govdeli...
SBIA 2022 Playlist - • 2022 CDER Small Busine...
SBIA LinkedIn - / cder-small-business-an...
SBIA Training Resources - www.fda.gov/cd...
Twitter - / fda_drug_info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
