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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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  • 2017-10-13 - 2017-10-13 : EMA

    Industry stakeholder teleconference on Brexit and operation of the centralised procedure for veterinary medicinal products

    This is the first European Medicines Agency teleconference with the veterinary industry stakeholder associations, namely with AnimalhealthEurope (formerly IFAH Europe), European Group for Generic Veterinary Products (EGGVP) and the Association of Veterinary Consultants (AVC), on the United Kingdom's withdrawal from the European Union ('Brexit'), and on the operation of the centralised procedure for veterinary medicinal products. This meeting is expected to be the first in a series of meetings and teleconferences promoting open dialogue on Brexit-related matters with EU Trade Associations.

  • 2017-10-11 - 2017-10-13 : 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.

  • 2017-10-10 - 2017-10-13 : PDCO

    Paediatric Committee (PDCO): 10-13 October 2017

    The Paediatric Committee (PDCO) is the committee that is responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children, as well as waivers and deferrals.