RAFF-6204 : Clinical Research for Regulatory Affairs

This course sources in the evaluation and assessment of regulatory strategies. Topics include protocol development, study design, post-marketing surveillance, evaluation and, assessment of regulatory submissions. Through the framework of clinical trial design, we evaluate and assess strategies for achieving regulatory strategy in clinical development goals. The course introduces students to the planning and conduct of clinical trials. It provides an overview of clinical trial terminology and discusses issues related to clinical trial design. It discusses the components of a clinical trial including considerations regarding planning and carrying out a study. In the course we evaluate alternative clinical trial design options as conduits for achieving regulatory approval.