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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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  • 2017-10-27 - 2017-10-27 : EMA

    European Medicines Agency (EMA) / Drug Information Association (DIA) signal management information day

    This information day provides an update on essential signal detection and management activities in the European Union (EU) for the overall surveillance and risk management of medicines. It explores the final guidance provided following the finalisation of the good pharmacovigilance practices module IX on signal management and related aspects of the EU pharmacovigilance legislation. It also covers marketing authorisation holders’ access to EudraVigilance and the resources and training the Agency provides to support stakeholders. Finally, it discusses stakeholders’ approaches and perspectives on signal management.

  • 2017-10-25 - 2017-10-27 : EMA

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

    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.