This annual training course provided participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, and in accordance with regulatory standards. Session two of day one covered topics such as safety considerations in clinical drug development and specific populations in clinical trials.

01:40 – Safety Considerations in Clinical Drug Development
46:46 – Specific Populations in Clinical Trials
01:14:00 – Q&A Discussion Panel

Speakers | Panelists

Shabnam Naseer, DO, MMS
Lead Physician
Division of Anti-Infectives (DAI)
Office of Infectious Diseases (OID)
Office of New Drugs (OND)
CDER | FDA

Lynne Yao, MD
Director
Division of Pediatrics and Maternal Health (DPMH)
Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM)
OND | CDER | FDA

(Moderator)
Leonard Sacks, MBBCh
Associate Director for Clinical Methodologies
Office of Medical Policy (OMP)
CDER | FDA


Learn more at: [ Ссылка ]

-----------------------

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 - [ Ссылка ]
SBIA Listserv - [ Ссылка ]
SBIA 2024 Playlist - [ Ссылка ]
SBIA LinkedIn - [ Ссылка ]
SBIA Training Resources - [ Ссылка ]
Twitter - [ Ссылка ]
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367

свернуть