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Title:Clinical Investigators Training Course 2023 - Day 2
Duration:04:37:41
Viewed:10,751
Published:07-12-2023
Source:Youtube

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



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