FDA Clinical Investigator Training Course (CITC) 2024 - Day Three - Session One
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- Опубликовано: 2 янв 2025
- This annual training course provided participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, and in accordance with regulatory standards. Session one of day three covered topics such as clinical trial quality, investigator responsibilities, and international clinical trials.
02:25 - Achieving Fit-for-Purpose Clinical Trial Quality
35:29 - Investigator Responsibilities - Regulation and FDA Expectations for the Conduct of Clinical Trials
01:02:06 - International Clinical Trials
01:17:49 - Q&A Discussion Panel
Speakers | Panelists
Cheryl Grandinetti, PharmD
Associate Director for Clinical Policy
Division of Clinical Compliance Evaluation (DCCE)
Office of Scientific Investigations (OSI)
Office of Compliance (OC)
CDER | FDA
Miah Jung, PharmD, MS
Senior Pharmacologist
Division of Enforcement and Post-marketing Safety (DEPS)
OSI | OC | CDER | FDA
Kassa Ayalew, MD, MPH
Division Director
DCCE | OSI | OC | CDER | FDA
(Moderator)
Leonard Sacks, MBBCh
Associate Director for Clinical Methodologies
Office of Medical Policy (OMP)
CDER | FDA
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