FDA Clinical Investigator Training Course (CITC) 2023, Day 1 - Part 3

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 - Safety Considerations in Clinical Drug Development
44:27 - Statistical Principles for Clinical Drug Development
01:14:40 - Q&A Discussion Panel
Speakers:
Shabnam Naseer, DO, MMS
Medical Team Leader
Division of Anti-Infectives (DAI)
Office of Infectious Diseases (OID)
Office of New Drugs (OND) | CDER | FDA
Mark Levenson, PhD
Director
Division of Biometrics VII (DBVII)
Office of Biostatistics (OB)
Office of Translational Sciences (OTS)
CDER | FDA
Moderator:
Kimberly Smith, MD, MS
CAPT | USPHS
Real World Evidence Analytics
OMP | CDER | FDA
Learn more at: www.fda.gov/dr...
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