FDA Clinical Investigator Training Course (CITC) 2023, Day 2 – Part 2 скачать в хорошем качестве

FDA Clinical Investigator Training Course (CITC) 2023, Day 2 – Part 2

This course was designed to promote professionalism in the clinical trial industry for individuals involved with submissions to FDA (Investigational New Drug (IND) application, New Drug Application (NDA), Biologics License Application (BLA)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical drugs and biological products. Timestamps 00:03 – Integrating Quality into Clinical Trials 57:03 – Clinical Investigator Site Inspections – What to Expect 01:16:01 – International Clinical Trials: GCP Perspective 01:21:04 – Q&A Discussion Panel 02:1:00 – Wrap Up and Closing Speakers | Panelists: Ann Meeker-O’Connell, MS Director Office of Clinical Policy (OCLiP) Office of Clinical Policy and Programs (OCPP) Office of the Commissioner (OC) | FDA Stephanie F. Coquia, MD Good Clinical Practice Assessment Branch (GCPAB), Team 1 Division of Clinical Compliance Evaluation (DCCE) Office of Scientific Investigations (OSI) Office of Compliance (OC) CDER | FDA Kassa Ayalew, MD, MPH Branch Chief Division of Clinical Compliance Evaluation (DCCE) OSI | CDER | FDA Leonard Sacks, MBBCh Associate Director for Clinical Methodologies Offie of Medical Policy (OMP) CDER | FDA Moderator: Kimberly Smith, MD, MS CAPT | USPHS Real World Evidence Analytics OMP | 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