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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

September 2017

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  • 2017-09-22 - 2017-09-22 :

    Follow up information session on the TransCelerate initiative

    The meeting provides an opportunity for TransCelerate to update the European Medicines Agency on progress with ongoing initiatives and new areas of work, which focuses on the development of practical solutions to overcome inefficiencies in clinical trials.

  • 2017-09-22 - 2017-09-22 : EMA

    PSUR roadmap: joint industry/assessor training

    This joint industry and national competent authority assessors’ training aims to achieve a common understanding of the role of periodic safety assessment reports (PSUR) in the product lifecycle and of the European Union (EU) PSUR single assessment. It is part of the PSUR roadmap activities and will identify key issues encountered by industry and regulators in the preparation of PSURs and share best practices on ways to address them. The webinar will be in the form of a question-and-answer (Q&A) session led by a joint panel of industry and regulators. It will cover the following topics described in the explanatory note to good pharmacovigilance practice (GVP) module VII and the PSUR Q&A for assessors: signals and close monitoring, safety specification, product information / reference safety information and use of summary tabulations. No prior registration is required. Please send questions on any topic to assessors and industry speakers to psurtraining@ema.europa.eu

  • 2017-09-21 - 2017-09-22 : EMA

    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.

  • 2017-09-20 - 2017-09-22 : EMA

    The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course

    The European Medicines Agency (EMA) will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in November 2017. The system will make use of the individual case safety report (ICSR) standards developed by the International Organization for Standardization (ISO), in collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.