Posts Tagged ‘European Medicines Agency’
EMA Biennial Report 2016/2017: Joint CVMP/CHMP Working group on the Application of the 3Rs in Regulatory Testing of Medical Products
This report is aimed at informing pharmaceutical companies and the public of the EMA activities in relation to “3Rs” (replacement, reduction, refinement) during 2016 and 2017. The report summarises the recommendations developed and the organisational structure enabling the development of such guidance. It also looks into the future with details about a new mandate to…
Read MoreSSFAoggi meets Dr. Honorio Silva, IFAPP President
SSFA was one of the 12 founding members of IFAPP, the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine. Indeed, it was during a Conference held in Florence in September 1975 that IFAPP was officially launched, as the first name of the federation was IFAMAPI (International Federation of Associations of Medical…
Read MoreCountdown to launch of new EudraVigilance System
Final preparations for change-over to new system underway for go live date on 22 November 2017 On 22 November 2017, the European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area…
Read MoreExploring opportunities for collaboration between regulators and healthcare payers
European Medicines Agency and healthcare payer organisations held joint meeting on 19 September The European Medicines Agency (EMA) and European Union (EU) healthcare payers met for the first time on 19 September 2017 at EMA’s offices in London to explore synergies and foster mutual understanding and cooperation to help improve timely and affordable access of…
Read MoreFacilitating submission of post-approval data
EMA implements new submission form for post-authorisation measures The European Medicines Agency (EMA) has launched a new form to help marketing authorisation holders submit data generated to satisfy post-authorisation measures(PAMs) for centrally authorised products. PAMs require marketing authorisation holders (MAHs) to provide additional data on the safety, efficacy or quality of the medicine once it is authorised. They fall into several categories, depending…
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