Hedy De Jager
Hedy De Jager works in Global Regulatory Affairs, Onology, at Merck Group.
CPD SupplementCTIS national pilot – Belgium
Although the CTIS is still under development, several EU countries (eg, Belgium, France, Germany, Finland and the UK prior to Brexit) are running national pilots to test the new way of working introduced by the Clinical Trial Regulation 536/2014. Pilot conditions in the various countries are different. The Heads of ...
CPD SupplementThe EU Clinical Trial Regulation (EU) No 536/2014-The Clinical Trials Information System
This continuing professional development article addresses changes introduced by Regulation (EU) No 536/2014 (the Clinical Trial Regulation/CTR) and focuses on the revised submission process for clinical trial applications in the EU/EEA via the new EU portal