Maureen Bennett

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Latest Posts › European Medicines Agency (EMA)

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EMA Calls for Public Consultation on Clinical Trial Protocol, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more

7/3/2017 / Breach of Duty , Clinical Trials , Consultation Periods , EU , European Medicines Agency (EMA) , New Guidance , Pharmaceutical Industry , Product Development Protocols

EMA Green Lights New EudraVigilance System for Adverse Reactions, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...more

7/1/2017 / Adverse Events , Clinical Trials , Databases , EU , European Economic Area (EEA) , European Medicines Agency (EMA) , Pharmaceutical Industry , Risk Assessment , World Health Organization

Guidance for European MA Holders to Prepare for Brexit, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

The EMA has published a Q&A guidance for marketing authorization ("MA") holders of centrally authorized medicinal products to prepare for the United Kingdom's withdrawal from the European Union. This follows an earlier notice...more

6/30/2017 / EU , European Medicines Agency (EMA) , Marketing Authorization Application , Pharmaceutical Industry , UK , UK Brexit

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