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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.

Latest news

This month's events

February 2018

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  • 2018-02-26 - 2018-02-28 : EMA

    The New EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH 2B(R3) format: hands-on training course

    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.

  • 2018-02-21 - 2018-02-23 : EMA

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

    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.

  • 2018-02-20 - 2018-02-23 : PDCO

    Paediatric Committee (PDCO): 20-23 February 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.

  • 2018-02-19 - 2018-02-22 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 19-22 February 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.

  • 2018-02-15 - 2018-02-16 : CAT

    Committee for Advanced Therapies (CAT): 15-16 February 2018

    The Committee for Advanced Therapies (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines.

  • 2018-02-15 - 2018-02-16 : EMA

    eXtended EudraVigilance medicinal product dictionary face-to-face training course

    The European Medicines Agency (EMA) has prepared this eXtended EudraVigilance medicinal product dictionary (XEVMPD) face-to face training course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) and European Economic Area (EEA) countries outside the EU. The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

  • 2018-02-13 - 2018-02-15 : COMP

    Committee for Orphan Medicinal Products (COMP): 13-15 February 2018

    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.

  • 2018-02-13 - 2018-02-15 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 February 2018

    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.

  • 2018-02-12 - 2018-02-14 : EMA

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

    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.

  • 2018-02-09 - 2018-02-09 : EMA

    Chimeric antigen receptor (CAR) T-cell therapy registries workshop

    The objective of this workshops is to facilitate the long-term follow up of CAR-T cell products in a real world setting and enable the generation of meaningful efficacy and safety data using haemato-oncological registries. It will aim to agree on implementable recommendations on core data elements to collect and other matters including patient consent, governance, quality assurance and registry interoperability as well as recommendations to optimise collaboration among registry holders, marketing authorisation holders and applicants and regulators.

  • 2018-02-06 - 2018-02-06 : EMA

    Extraordinary Management Board meeting: 6 February 2018

    The Management Board is an integral governance body of the Agency. It has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director and the monitoring of the Agency’s performance.

  • 2018-02-05 - 2018-02-08 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 February 2018

    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.

  • 2018-02-05 - 2018-02-07 : CHMP

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

    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.