Even with increased efforts to harmonize regulatory requirements between the US and European Union, the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) have different requirements for initiating and conducting clinical trials for medicinal products. Deciding which standards to follow and how to harmonize/organize your own efforts is a daunting task. Thankfully, there are ways to avoid these pitfalls and ensure compliance.
This Webinar will discuss these differences in detail while providing guidance on how to mitigate risk. By attending this interactive, 90-minute session you will:
During the session, you will learn:
- Learn key differences in the regulatory and IRB submission and reporting processes as well as the differences in roles and responsibilities
- Understand the different requirements for conducting and closing a study
- Tips on how to choose the right standard to ensure compliance
- Sort through the noise: Understand what the critical mandates really mean