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…
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…
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…
Use in pregnancy and women of childbearing age of valproate
Review of valproate use in pregnancy and women of childbearing age EMA to consider risks of these medicines require further restrictions of use The European Medicines Agency (EMA) has started a review looking at the use of valproate containing medicines in the treatment of women and girls who are pregnant or of childbearing age. These…
Alzheimer’s: Study in mice show new drugs could restore memory loss
Alzheimer’s advance: Early stage study in mice show new drugs could restore memory loss and prolong life An international team has announced a new advance in the fight against Alzheimer’s disease by identifying a new drug target that not only improves symptoms of brain degeneration it also extends the life-span of terminally ill mice. The…
EIWH Newsletter 1- 2016 priorities
Greeting from the EIWH Wishing you a Happy and Healthy New Year! Newsletter January 2016 Making the health of women and their families a priority across the European Union As we start the New Year, we are very pleased to share some highlights from our work in 2015 and to provide you with an overview…
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…
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…
Tribute to pioneer in public health and patient safety!
EIWH pays tribute to pioneer in public health and patient safety. 17 August 2015 – Last week, Dr. Frances Oldham Kelsey, the FDA regulator and worldwide pioneer in medicines safety and the protection of patients, died at the age of 101. As a young scientific officer, freshly employed by the FDA, she stubbornly questioned the…
eu: Sex and gender in bio medicine and health research
Roadmap for implementation of sex and gender into biomedicine and health research in Europe The overall objective of EUGenMed is to improve the health of European citizens, women and men, by improving biomedical and health research through a sex and gender (S&G) sensitive approach. For this purpose we will develop a Roadmap to implement sex…
