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 - Day Two Welcome
01:30 - Chemistry, Manufacturing and Controls: Regulatory Considerations Through Clinical Development
32:33 - Pharmacology & Toxicology Information to Support Early Drug Development
51:31 - Clinical Pharmacology: Early Drug Development
01:14:25 - Q&A Discussion Panel
Speakers | Panelists:
Leonard Sacks, MBBCh
Associate Director for Clinical Methodologies
Offie of Medical Policy (OMP)
CDER | FDA
Paresma Patel, PhD
Director | Division of New Drug API (DNDAPI)
Office of New Drug Products (ONDP)
Office of Pharmaceutical Quality (OPQ)
CDER | FDA
Matthew Thompson, PhD, MPH
Supervisory Pharmacologist
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
Learn more at: www.fda.gov/dr...
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
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Email - CDERSBIA@fda.hhs.gov
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23 окт 2024
