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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

March 2018

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  • 2018-03-20 - 2018-03-20 : PDCO

    Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation

    This workshop, organised by the European Medicines Agency (EMA) and the European Commission, follows the publication of the Commission’s ten-year report on implementation of the Paediatric Regulation and the state of paediatric medicines in the European Union. The aim is to discuss potential improvements of the implementation of the Regulation. It will explore opportunities regarding paediatric needs, timely completion of paediatric investigation plans (PIP), and processes and expectations for handling PIP applications. This workshop is a crucial step for the development of a concrete action plan to address challenges identified with medicine development for children in Europe. Invited stakeholders include patients, academia, healthcare professionals and industry. The deadline for expressions of interest is 14 February. EMA will select industry stakeholders via registered associations. The Agency will contact all selected participants on 1 March.

  • 2018-03-20 - 2018-03-20 : EMA

    Thirteenth industry stakeholder platform - operation of EU pharmacovigilance

    The thirteenth platform meeting with industry stakeholder associations on the operation of the European pharmacovigilance system will take place at the European Medicines Agency on 20 March 2018. Discussions will focus on the new EudraVigilance system and the pilot of MAHs EudraVigilance signal detection.

  • 2018-03-20 - 2018-03-23 : PDCO

    Paediatric Committee (PDCO): 20-23 March 2018

    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.

  • 2018-03-19 - 2018-03-22 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 19-22 March 2018

    The Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning human medicines.

  • 2018-03-19 - 2018-03-21 : EMA

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

    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.