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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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…

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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…

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Sex and gender in medicines regulation

EUGenMed Experts Workshop Held on 4 March 2015, European Economic and Social Committee, Brussels, Belgium Translating the evidence from S&G research into regulatory practice will lead to more targeted, effective opportunities for prevention, treatment and care. This workshop examined how S&G consideration are integrated into Medicines Regulation and information. Download this information as a Pdf…

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