This course is designed to promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products. Participants will acquire a practical understanding of FDA’s approach to the evaluation of clinical trials, associated regulatory requirements, and other scientific issues related to investigational medical products.
This is a clinical investigator training course targeted to all stakeholders in the clinical trial enterprise including industry, academia, and regulators (both local and foreign).The course is designed for clinical investigators, health care professionals (physicians, nurses, pharmacists, other healthcare workers), and individuals involved in biomedical research and the development of medical products.
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