Good Clinical Practice & Pharmacovigilance Compliance Symposium Day One – AM скачать в хорошем качестве

Good Clinical Practice & Pharmacovigilance Compliance Symposium Day One – AM

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 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...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367