ICH and Legislation Governing Clinical Research

Course Code: CLRE 5001

Academic Year: 2019-2020

This course is designed to provide a framework for understanding the standards and regulations that affect the conduct of clinical trials. The course will starts with a historical overview of documents such as the Nurnberg Code, the Belmont Report and The Declaration of Helsinki. Ethical issues impacting clinical trials and their relation to creation of regulations will be analyzed. A large part of the course will be dedicated to International Conference on Harmonization (ICH) guidelines, which include GCP, reporting of adverse reactions, trials in special populations and others. Students will study local regulatory requirements pertaining to pharmaceutical products. North American countries will serve as examples. Additionally, the international differences among applications for clinical trial submissions will be reviewed.