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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

October 2017

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  • 2017-10-18 - 2017-10-20 : 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.

  • 2017-10-16 - 2017-10-18 : EMA

    2017 Pharmacovigilance Inspectors Working Group training course

    The three-day pharmacovigilance inspectors training course is for inspectors and assessors of both, veterinary and human units of EU/EEA Member States, and delegates from non-EU countries. The training will consist of presentations as well as breakout sessions during which participants will be given case studies and examples to discuss and analyse within their group. The topics to be covered this year include: PhV inspection of third parties/contractors and contracts, signal management, harmonisation in grading of findings, the electronic submission of data on medicines to the EudraVigilance medicinal product dictionary (XEVMPD), harmonisation of detailed description of pharmacovigilance system (DDPS) of veterinary MAHs / management of corrective and preventive actions, reporting to EudraVigilance, use of EudraVigilance data analysis system and the use of medical dictionary for regulatory activities for human medicines (MedDRA) and veterinary medicines (VedDRA).

  • 2017-10-16 - 2017-10-18 : 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.