The EU Clinical Trials Regulation (Regulation No 536/2014) will enter in force in January 2022, changing clinical trial processes in Europe and impacting clinical trial activities worldwide. At the center of this new CT Regulation is the EU Clinical Trials Portal, a single-entry point for Sponsors, Health Authorities, and the public. For the first time, European citizens and the rest of the world will have access to almost all study documents and data. This webinar will explore how the new CT Regulation will impact sponsors, and will take a closer look at changes to clinical trials processes, protocols, Informed Consent for minors, and impact to lay summaries. To prepare for this major step, Sponsors will have to rethink their clinical trial disclosure and transparency policies and supporting processes.
In this Expert Insights webinar, attendees will learn:
-Key takeaways from the EU Clinical Trials Regulation
-How the EU CT Regulation will impact Sponsors
-Tips for Sponsors as they prepare for the changing regulation
-Insights into how these changes will impact worldwide clinical trials activities
-Brief review of the impact to talent planning and core competencies
Presenter(s)
-Karim Ibazatene, Associate Director, Transparency
-Alan Nicolle, Senior Director, EU & SA Operations
-Kelly Vaillant, Director, Global Transparency Strategy and Compliance
This webinar is presented in partnership with TrialAssure.
