Making it Happen—European Institute of Women’s Health hosts expert workshop on sex and gender in medicines regulation and medical education
As part of the FP7-funded European Gender Medicine (EUGenMed) Project, the European Institute of Women’s Health (EIWH) organised a workshop on 4 March 2015, bringing together a multidisciplinary, multi-sectorial group of experts to discuss Sex and Gender in Medicines Regulation and Medical Education.
Dr. Ingrid Klingmann, of the European Forum for Good Clinical Practice (EFGCP) and Hildrun Sundseth, President of the EIWH opened and co-hosted the morning session exploring Sex and Gender in Medicines Regulation. Dr. Klingmann explained the need for the event, “There is not enough data on 50% of the population—on women.”
During the morning session, experts presented important issues around sex and gender in medicines regulation. Dr. Kevin Blake of the European Medicines Agency (EMA) explained how Sex and Gender issues are currently addressed in EU Regulatory practice and how in future the new EU Clinical Trials Regulation and Pharmacovigilance initiative will generate more evidence how medicines work in different patient population groups, such as in women.
Prof. Dr. Marco Stramba-Badiale of the IRCCS Istituto Auxologico Italiano, a leading expert in cardiovascular disease (CVD) in women, provided evidence how in the past women have often been underrepresented in CVD clinical trials and when they were included, the data had not been analysed. He was followed by Dr. Christiane Druml, Vice Rector of the Medical University of Vienna, who presented the University’s Ethical Guidelines for including women in clinical trials.