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: 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
Phone - (301) 796-6707 I (866) 405-5367
3 янв 2024
