FDA Clinical Investigator Training Course (CITC) 2023, Day 1 - Part 2

  Рет қаралды 2,570

U.S. Food and Drug Administration

U.S. Food and Drug Administration

Күн бұрын

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
00:02 - Trial Design Considerations in Rare Diseases
27:24 - Specific Populations in Clinical Trials
57:49 - Q&A Discussion Panel
Speakers | Panelists:
Scott Winiecki, MD
Lead Physician
Rare Diseases Team (RDT)
Division of Rare Diseases and Medical Genetics (DRDMG)
Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORDPURM)
Office of New Drugs (OND)
CDER | FDA
Lynne Yao, MD
Director
Division of Pediatric and Maternal Health (DPMH)
ORDPURM | OND | CDER | FDA
Moderator:
Leonard Sacks, MBBCh
Associate Director for Clinical Methodologies
Office of Medical Policy (OMP)
CDER | FDA
Learn more at: www.fda.gov/dr...
-----------------------
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/cd...
SBIA Listserv - public.govdeli...
SBIA 2022 Playlist - • 2022 CDER Small Busine...
SBIA LinkedIn -  / cder-small-business-an...
SBIA Training Resources - www.fda.gov/cd...
Twitter -  / fda_drug_info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367

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