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/drugs/news-events...
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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.
Upcoming Training - www.fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accoun...
SBIA 2022 Playlist - • 2022 CDER Small Busine...
SBIA LinkedIn - / cder-small-business-an...
SBIA Training Resources - www.fda.gov/cdersbialearn
Twitter - / fda_drug_info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
Негізгі бет Ғылым және технология FDA Clinical Investigator Training Course (CITC) 2023, Day 1 - Part 3
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