FDA Clinical Investigator Training Course (CITC) 2024 - Day Two - 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 two covered topics such as Chemistry, Manufacturing, and Controls (CMC) and Why Clinical Pharmacology is Essential in Drug Development.
01:42 - Chemistry, Manufacturing and Controls: Regulatory Considerations Through Clinical Development
31:17 - Pharmacology & Toxicology in the Investigator's Brochure
59:30 - Clinical Pharmacology: Early Drug Development
01:22:20 - Q&A Discussion Panel
Speakers | Panelists
Paresma Patel, PhD
Director
Division of Product Quality Assessment XIX (DPQAXIX)
Office of Product Quality Assessment (OPQA)
III Office of Pharmaceutical Quality (OPQ)
CDER | FDA
Nikolett Biel, PhD
Senior Biologist
Division of Hematology Oncology Toxicology (DHOT)
Office of Oncologic Diseases (OOD) Office of New Drugs (OND) | CDER | FDA
Shirley K. Seo, PhD
Director
Division of Cardiometabolic and Endocrine Pharmacology (DCEP)
Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS)
CDER | FDA
(Moderator)
Leonard Sacks, MBBCh
Associate Director for Clinical Methodologies
Office of Medical Policy (OMP)
CDER | FDA
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