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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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  • 2017-11-29 - 2017-11-30 :

    Innovation and biomarkers in cancer drug development (IBCD) 2018

    The innovation and biomarkers in cancer drug development (IBCD) 2018 event will embrace the full environment and explore routes through the constantly evolving scientific, methodological and regulatory environment. The combined efforts of the European Organisation for Research and Treatment of Cancer (EORTC), National Cancer Institute (NCI), European Medicines Agency (EMA), and American Association for Cancer Research (AACR) with the involvement of Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA) and health technology assessment specialists will result in a unique program. The 2018 edition will build upon the recommendations and action points decided upon at the IBCD 2016 edition. Topics, which will be developed, will include items like health technology assessment (HTA) of biomarker assays, comparative effectiveness research and the translation of findings of clinical trials into daily practice.

  • 2017-11-27 - 2017-11-30 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 27-30 November 2017

    The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use.

  • 2017-11-27 - 2017-11-29 : 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.