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Community Events

Updated November 28, 2023

FDA Clinical Investigator Training Course (CITC) 2023: December 6-7 2023


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


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.


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.



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