FDA Clinical Investigator Training Course (CITC) 2024 - Day One - Session One
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- Опубліковано 2 січ 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 one covered topics such as FDA structure and mandate, the basics of clinical trial design, and statistical principles for clinical development.
01:00 - Welcome / Introduction
04:25 - FDA Structure and Mandate
24:00 - Basics of Clinical Trial Design
01:12:34 - Statistical Principles for Clinical Development
01:54:34 - Q&A Discussion Panel
Speakers | Panelists
Leonard Sacks, MBBCh
Associate Director for Clinical Methodologies
Office of Medical Policy (OMP)
CDER | FDA
Kimberly Smith, MD, MS
Captain, United States Public Health Service
Senior Medical Advisor
OMP | CDER | FDA
James P. Smith, MD, MS
Director
Office of New Drug Policy (ONDP)
Office of New Drugs (OND)
CDER | FDA
Mark Levenson, PhD
Acting Deputy Director
Office of Biostatistics (OB)
Office of Translational Sciences (OTS)
CDER | FDA
Learn more at: www.fda.gov/dr...
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