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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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  • 2017-11-17 - 2017-11-17 : EMA

    SME info day: supporting innovative medicines' development and early access

    The info day provides an overview of EU initiatives supporting development stage small and medium-sized enterprises in the human medicines field. It highlights future EU funding opportunities and platforms for early regulatory dialogue with the European Medicines Agency (EMA) and the EU network. It covers recent developments in scientific advice, the range of support that companies can access to optimise their development plans, and feedback on experience at stage of the marketing authorisation. It is organised in collaboration with the newly launched EU Innovation Network, a platform created to support pharmaceutical innovation both at national and EU level. In the breaks the “Meet the EU Innovation Network Regulators” event will provide an opportunity to engage with its representatives. An update on Brexit related activities will also be provided. The info day is open to companies that have been assigned an SME status by EMA and to representatives of stakeholder organisations.

  • 2017-11-15 - 2017-11-17 :

    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.