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| Name | FDA Clinical Investigator Training Course (CITC) 2023, Day 1 – Part 1 |
| Video Uploader | Video From U.S. Food and Drug Administration |
| Upload Date | This Video Uploaded At 04-01-2024 11:15:37 |
| Video Discription | 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 00:01 – Day One Welcome 00:36 – FDA Structure and Mandate 20:25 – Basics of Clinical Trial Design – Design, Population, Intervention, Outcomes 52:02 – Digital Health Technologies & Decentralized Clinical Trials 01:22:19 – Real-World Evidence (RWE) 01:39:00 – Q&A Discussion Panel Speakers | Panelists: Leonard Sacks, MBBCh Associate Director for Clinical Methodologies Offie of Medical Policy (OMP) CDER | FDA Kimberly Smith, MD, MS CAPT | USPHS Real World Evidence Analytics OMP | CDER | FDA Fortunato Fred Senatore, MD, PhD, FACC Lead Physician Division of Cardiology and Nephrology (DCN) Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN) Office of New Drugs (OND) CDER | FDA John Concato, MD Associate Director of Real-World Evidence OMP | CDER | FDA Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/fda-clinical-investigator-training-course-citc-2023-12062023 ----------------------- 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/accounts/USFDA/subscriber/new?topic_id=USFDA_352 SBIA 2022 Playlist - https://www.youtube.com/playlist?list=PLey4Qe-UxcxbzCGn90m38cXN2DL2i3VmD SBIA LinkedIn - https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter - https://twitter.com/FDA_Drug_Info Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367 |
| Category | Science & Technology |
| Tags | FDA | CDER | SBIA | Clinical | Investigator | Training | Course | Clinical Trials | Design | Trial design | Decentralized Clinical Trials | DCT | Digital Health Technologies | DHT | Real-World Evidence | RWE |
