Archived Web Seminar: REMS, EU-RMP and FDAAA: Navigating Clinical Trial Safety

If you missed the web seminar presented by Dr. Stephen A. Goldman here's your chance to view it at your own leisure. Here's a brief description of the webinar and you can find the archive link below as well. Enjoy!

Current pharmaceutical safety is a sophisticated system in which benefit/risk assessment begins with animal testing and continues throughout human clinical trials, licensing approval and marketing of the product. It is critical to monitor evolving safety profiles of marketed products throughout their life cycles, and optimally employ risk management tools in service of public health.

This seminar will examine current national, regional and international perspectives and approaches to clinical trial safety, pharmacovigilance planning and risk management. Current EMEA and FDA regulatory requirements and standards, in combination with the vital ICH E2E guideline, will be discussed and also examined via case examples of risk assessment, communication and minimization methods.

Watch the archive
https://www1.gotomeeting.com/register/729981465