This Clinical Trial Regulation Information Day provides a forum to prepare stakeholders from Central and Eastern European Countries for the implementation and launch of the new EU Clinical Trial Regulation (536/2014) which will replace the European Clinical Trials Directive (2001/20/EC). The Information Day will focus on the differences between the present and new requirements for managing clinical trials in the face of forthcoming changes. It further aims to provide a platform for discussion about the compliance with the new Regulation and associated implementing acts in the region. You will hear from experts in the field and regulators from various Member States about their preparedness status for the new legislation and how the new rules will impact clinical trials run in the EU.
Mihaela David Director Regulatory Affairs
PSI Pharma Support Romania SRL, Romania
Steffen Thirstrup, MD, PhD Chief Medical Officer
European Medicines Agency, Netherlands
Radoslaw Sierpinski, MD, PhD Acting President
Medical Research Agency, Poland
Elke Stahl, PhD Senior Expert, Clinical Trials Department
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Massimiliano Sarra, PhD, MPH Permanent official and CTFG Secretary
Italian Medicine Agency (AIFA), Italy
Have an account?