Updated November 28, 2023
FDA Clinical Investigator Training Course (CITC) 2023: December 6-7 2023
ABOUT THIS EVENT
This course is 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. Participants will acquire a practical understanding of:
FDA’s approach to trial design
Safety concerns in the development of medical products
Statistical issues in the analysis of trial data
Clinical investigator responsibilities
INTENDED AUDIENCE
This is a clinical investigator training course targeted at all stakeholders in the clinical trial enterprise including industry, academia, and regulators (both local and foreign). The agenda is designed for:
Clinical investigators
Health care professionals (physicians, nurses, pharmacists, other healthcare workers), and
Individuals involved in biomedical research and the development of drugs and biological products.
TOPICS COVERED
Design and conduct of clinical trials
Innovative trial designs
Considerations for rare disease drug development
Enhancing diversity in clinical trials
Addressing specific populations in drug development
Statistical evaluation of clinical trials
Understanding the investigator brochure
Clinical trial quality
For more information, please follow this link.