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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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  • 2017-10-03 - 2017-10-05 : COMP

    Committee for Orphan Medicinal Products (COMP): 3-5 October 2017

    The Committee for Orphan Medicinal Products (COMP) is the committee that is responsible for reviewing applications for 'orphan medicinal product designation' for medicines intended for the diagnosis, prevention or treatment of rare diseases.

  • 2017-10-03 - 2017-10-05 : EMA

    2017 European Union Good Clinical Practice Inspectors Working Group workshop

    Good Clinical Practice (GCP) inspectors of European Union (EU) / European Economic Area (EEA) Member States as well as inspectors from non-EU countries will be taking part in this workshop. The workshop will consist of presentations, discussions as well as a number of breakout sessions during which participants will be given case studies and examples of inspection findings to discuss and analyse within their group. This year’s workshop will focus on the following topics: sponsor site inspections (covering centralized monitoring and computer system validation), difficulties when performing un-announced GCP inspections, patient reported outcome (PRO)/e-PRO: what to consider during a GCP inspection, GCP inspections of phase I units, updates on the Clinical Trials Regulation no. 536/2014, GCP inspections of biosimilars (assessors’ perspectives), inspections of oncology trials and GCP international collaboration.

  • 2017-10-03 - 2017-10-05 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 October 2017

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

  • 2017-10-02 - 2017-10-04 : 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.