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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

April 2017

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  • 2017-04-27 - 2017-04-28 : EMA

    eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course

    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.

  • 2017-04-25 - 2017-04-25 : EMA

    Industry stakeholder platform on research and development support

    This is the first event in a series of upcoming, (semi-)annual meetings between regulators and representatives of industry stakeholder organisations. It addresses all areas of product development support, from scientific advice, over specifics for paediatric and orphan medicines and to innovation support. This platform aims to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders. Registration by invitation only.

  • 2017-04-24 - 2017-04-26 : EMA

    EudraVigilance training on electronic reporting of ICSRs in the EEA

    This training course covers all aspects on the functionalities of the EudraVigilance system specifically EVWEB with regard to electronic reporting of ICSRs including practical examples and exercises in the EudraVigilance training environment. It includes fundamentals of electronic transmission of ICSRs and ICH M2 safety and acknowledgment message specifications as well as ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices and current EudraVigilance Business Rules.

  • 2017-04-18 - 2017-04-21 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 18-21 April 2017

    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.

  • 2017-04-18 - 2017-04-21 : PDCO

    Paediatric Committee (PDCO): 18-21 April 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.

  • 2017-04-10 - 2017-04-12 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 April 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.

  • 2017-04-10 - 2017-04-11 : COMP

    Committee for Orphan Medicinal Products (COMP): 10-11 April 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.

  • 2017-04-10 - 2017-04-12 : CAT

    Committee for Advanced Therapies (CAT): 10-12 April 2017

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

  • 2017-04-03 - 2017-04-06 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 April 2017

    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.

  • 2017-04-03 - 2017-04-05 : EMA

    EudraVigilance training on electronic reporting of ICSRs in the EEA

    This training course covers all aspects on the functionalities of the EudraVigilance system specifically EVWEB with regard to electronic reporting of ICSRs including practical examples and exercises in the EudraVigilance training environment. It includes fundamentals of electronic transmission of ICSRs and ICH M2 safety and acknowledgment message specifications as well as ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices and current EudraVigilance business rules.