Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Two – PM скачать в хорошем качестве

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... ----------------------- 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 - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2022 Playlist -    • 2022 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367