U.S. regulations allow for the submission of foreign clinical data to support marketing applications for new biomedical products. However, there are some important and evolving considerations when conducting global clinical trials, whether to support U.S. submissions or as part of a worldwide strategy. Using U.S. and EU trials as points of reference, the instructor and guest speakers help students develop a framework for examining current issues and challenges related to the conduct of clinical trials in both established and emerging foreign markets, including Eastern Europe, India, China, South America and beyond. Lectures and case studies explore, by region, the current regulatory environment; how local laws and requirements can mesh or differ from ICH guidelines; cultural challenges and procedural differences in trial conduct; working with foreign CROs; how to ensure that useful data are collected; and important implications for the protection of human subjects in clinical research.
This course benefits clinical and regulatory professionals who are involved with ICH-standard clinical trials in emerging markets.
An understanding of Good Clinical Practice (GCP) regulations and the clinical trials process, at least at the level that is covered in "Drug Development Process."
