Title: Sex and Gender in Medicines Regulation and Medical Education
Date: 4 March 2015
Location: Brussels
Host: European Institute of Women’s Health (EIWH)


Sex and Gender in Medicines Regulation

The revised Clinical Trials regulation was adopted in April 2014 by the European Parliament and Council of Ministers reaching agreement with member states on new rules for clinical trials. This is good news for women’s health, women traditionally have been underrepresented in clinical trials and consequently the evidence base has been weaker for them. This applies also to older people. Both population groups who are the heaviest users of medicines will now have to be included in clinical studies, and if not included, the reasons have to be justified. The new legislation will also provide rules for the inclusion of pregnant women under the strictest safety conditions. It is hoped that the new legislation will strengthen the protection of patients/clinical trial subjects and streamline the clinical trials process in Europe, thus bringing more evidence-based medicines to the patient faster while providing greater protection for them

Workshop 4: Part 1. Will focus on current medical regulation, clinical trials, legislation, GCP guidelines, healthcare and research policies and how these must be changed to implement sex and gender aspects. The policy briefs on 5 major disease areas will be used as background information providing practical examples of sex and gender differences.

Sex and Gender in Medical Education

Gender sensitive healthcare in the future requires gender sensitive education and training of all health professionals involved in the delivery of care. If we fail to acknowledge the impact of sex and gender differences this will affect the quality of health care provided and this is precisely what good medical education means to prevent. There has to be a commitment to mainstreaming an evidence-based gender perspective throughout medical curriculum including graduate programs, medical programs, nursing, rehabilitation, pharmacy, continuing Medical Education, Continuing Nursing Education.

Workshop 4: Part 2. Will focus on medical education teaching programmes and materials. The ways in which sex and gender influence the health and well-being of patients must be part of future medical and health professional training. Teaching materials already exist and example of these materials will be presented during this workshop.


 - Workshop agenda

 - Medical Education Workshop Notes 04.03.2015

 - Press release

 - Highlights of Workshop 4

 - Workshop Report (Medical Education part)

 - Workshop Report (Medicines regulation part)