Approaches to electronic product information for human medicines

Key principles for harmonised approaches to develop and use electronic product information (ePI) for human medicines across the European Union EMA, the Heads of Medicines Agencies (HMA) of EU Member States and the European Commission (EC) have published key principles outlining a harmonised approach to develop and use electronic product information (ePI) for human medicines…

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Guide on biosimilars for healthcare professionals

EMA published the information guide on biosimilars for healthcare professionals in 15 additional EU languages. It now includes Bulgarian, Czech, Danish, Greek, Estonian, Finnish, Croatian, Hungarian, Lithuanian, Latvian, Maltese, Romanian, Slovak, Slovenian and Swedish. These educational materials on biosimilar, and link to the Q&A for patients, can be found on EMA’s webpage on biosimilar medicines…

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Cooperation with EU Institutions and Agencies

European Medicines Agency (EMA) The EIWH is a member of the Patient and Consumer Working Party of the European Medicines Agency (EMA). This group provides recommendations to EMA human scientific committees on all matters of interest to patients in relation to medicinal products. The European Medicines Agency is the European Union (EU) body responsible for…

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Cooperating with EU Institutions and Agencies: The EMA

Our cooperation with EU institutions and agencies: The EMA European Medicines Agency (EMA) The EIWH is a member of the Patient and Consumer Working Party of the European Medicines Agency (EMA). This group provides recommendations to EMA human scientific committees on all matters of interest to patients in relation to medicinal products. The European Medicines…

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HPV vaccines: confirms they do not cause CRPS or POTS

PRESS RELEASE HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS EMA has now completed its review of evidence surrounding reports of two syndromes: complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women given human papillomavirus (HPV) vaccines. These vaccines are given to protect them…

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European Gender Medicine Workshops

Press Release 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…

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Expert Workshops: Sex and Gender in Medicine Regulation, Medical Education

EVENT Expert Workshops on Sex and Gender in Medicines Regulation and Medical Education 4th March 2015, 0900-1730. Room TRE7701, 7th floor, Trèves Building, 74 Rue de Trèves. European Economic and Social Committee, Brussels Research addressing Sex and Gender (S&G) in biomedical science and health research is a novel and highly promising field. The interaction of…

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