An overview of major challenges in the EU for the safety of investigational products from first-in-human clinical trials to the marketing approval stage will be presented. A connection between safety of the investigational product during the post marketing experience and clinical trials and vice versa will be discussed. Regulatory requirements and changes to recommendations with regards to safety reporting in the EU during the transition to the Clinical Trials Regulation EU No 536/2014 will be addressed. A brief overview of the recommendations that are currently under preparation by the Clinical Trials Facilitator Group (CTFG) will be given. Key recommendations that are outlined in these documents and advice on their implementation will be presented.
Dr. Elena Prokofyeva is head of the drug safety unit at the Department of Research & Development, DG PRE, FAMHP, Brussels, Belgium. She represents Belgium within the CTFG safety subgroup where she initiated and led an update of the Q&A-RSI document. She is also actively involved in the preparation of the safety related part of the Clinical Trials Regulation (EU) No 536/2014 Questions & Answers document and the Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials.
Dr. Prokofyeva holds a research doctorate from the University of Tuebingen, Germany, a Ph.D. and an M.D. from the Northern State Medical University, Arkhangelsk, Russia, and a Master of Public Health from the University of Umeå, Sweden. Harmonization of safety assessment across members of states in Europe, preparation for the implementation of safety related parts of clinical trial regulation, and safeguarding the safety of trial participants are the main objectives of her work.