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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

February 2017

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  • 2017-02-27 - 2017-03-01 : EMA

    EudraVigilance training on electronic reporting of ICSRs in the European Economic Area

    This training course covers all aspects on the functionalities of the EudraVigilance system specifically EVWEB with regard to electronic reporting of individual case safety reports (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.

  • 2017-02-21 - 2017-02-24 : PDCO

    Paediatric Committee (PDCO): 21-24 February 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.

  • 2017-02-20 - 2017-02-22 : EMA

    EudraVigilance training on electronic reporting of ICSRs in the European Economic Area

    This training course covers all aspects on the functionalities of the EudraVigilance system specifically EVWEB with regard to electronic reporting of individual case safety reports (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.

  • 2017-02-20 - 2017-02-23 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 20-23 February 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.

  • 2017-02-15 - 2017-02-17 : CAT

    Committee for Advanced Therapies (CAT): 15-17 February 2017

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

  • 2017-02-14 - 2017-02-16 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 14-16 February 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.

  • 2017-02-14 - 2017-02-16 : COMP

    Committee for Orphan Medicinal Products (COMP): 14-16 February 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.

  • 2017-02-08 - 2017-02-08 : EMA

    Joint EMA / European Directorate for the Quality of Medicines and Healthcare (EDQM) event on biosimilars

    The European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines and Healthcare (EDQM) designed this programme to enable participants to expand their knowledge and familiarise themselves with the current regulatory framework in the field of biosimilar products. A European Union (EU) regulator with practical experience in this area will present an overview of the EU regulatory framework and EMA’s role within this framework, an outline of where European Pharmacopoeia (Ph. Eur.) fits in the framework and the role of Ph. Eur. monographs and how to apply them and perspectives on quality assessment of biosimilars.

  • 2017-02-06 - 2017-02-09 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 February 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.

  • 2017-02-03 - 2017-02-03 : EMA

    Tenth industry stakeholder platform on the operation of pharmacovigilance in the European Union

    The tenth platform meeting with industry stakeholder associations on the operation of the European pharmacovigilance system will discuss good pharmacovigilance practices, periodic safety update reports and registries.