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This section of the website contains the European Medicines Agency's news and press releases, information on meetings and events, public consultations and related information.

For a scrolling feed of all of the new and updated information published on the website, see the what's new page.

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This month's events

November 2017

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  • 2017-11-23 - 2017-11-23 : CHMP

    Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications

    Prior knowledge has always been an important tool in designing both manufacturing processes and control strategies for medicinal products. The use of prior knowledge in regulatory application dossiers, to support manufacturing and control strategies, could be justifiable in certain circumstances. For prior knowledge to be used in this way, good understanding among regulators and industry of the expectations of how it should be documented in regulatory application dossiers is essential. This joint regulator/industry workshop will address exactly what prior knowledge entails and how it can be used to support product development, manufacturing and control strategies. These general discussions will be further elaborated through a number of specific industry case studies and a discussion of experiences to date of accelerated access schemes. The conclusions from the workshop will be captured in a report, which will be published. Further follow-up guidance may be considered.

  • 2017-11-23 - 2017-11-24 :

    eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course

    This eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) face-to-face training course has been prepared to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) and European Economic Area (EEA) countries outside the EU. The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.