Beginning December 6, 2023, the FDA is hosting its Clinical Investigator Training Course. 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 the following:
- 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.
And the topics covered are…
- 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
Access more information and enroll here.
Disclaimers
- The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
- Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
- No official support by any organization(s) has been provided or should be inferred
