Susan Bhatti
Susan Bhatti is Director EU Global Regulatory and Scientific Policy at Merck BV, Amsterdam, Netherlands.
JournalAn industry perspective on the use of patient experience data in medicines development: Is further action needed from European regulators?
Engaging with patients to understand their experiences, needs and preferences provides important information to sponsors of medicines development as well as to decision-makers, and integrating this information into every stage of medical product development can significantly enhance the therapeutic landscape for all stakeholders.
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