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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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  • 2017-11-22 - 2017-11-22 : EMA

    European Medicines Agency Human Scientific Committees’ Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting with all eligible organisations

    This final meeting for 2017 brings together members of the Patients and Consumers Working Party (PCWP) with all eligible patient and consumer organisations. Topics for discussion include highlights from 2017, feedback on EMA’s first public hearing, some new EMA shareable communications, big data and real world evidence, EMA Action Plan following Commission’s recommendations on product information and EMA’s new EPAR summary template. Other topics for discussion include the PCWP and HCPWP work plans and topic groups for 2018/19, scientific committees’ feedback and Members’ voice. Participants will also be updated on relocation preparedness.

  • 2017-11-20 - 2017-11-22 : 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.