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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 2015

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  • 23/02/2015 - 26/02/2015 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 23-26 February 2015

    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.

  • 19/02/2015 - 20/02/2015 : CAT

    Committee for Advanced Therapies (CAT): 19-20 February 2015

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

  • 19/02/2015 - 20/02/2015 : EMA

    PROTECT symposium

    The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) is a five-year public-private partnership of 34 partners, which was initiated in 2009 to enhance the monitoring of the safety of medicinal products and contribute to better evaluate and communicate their benefit-risk profile throughout their lifecycle. To this end, PROTECT planned to develop and test methodological standards and innovative tools. The objective of this final PROTECT symposium is to present the main results and recommendations of PROTECT and discuss their implications from a methodological perspective and for the evaluation of the benefits and risks of medicines. Four parallel pre-symposium training courses provide in-depth training on specific aspects of the research work performed in PROTECT. Registration closed.

  • 19/02/2015 - 20/02/2015 : 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 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) data-entry tool EVWEB. It includes exercises in the XEVPRM data-entry for the electronic submission and maintenance of different types of medicinal products. Places limited.

  • 16/02/2015 - 18/02/2015 : EMA

    EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area

    This training course covers all aspects of the functionalities of the EudraVigilance system, specifically the data-entry tool 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 International Conference on Harmonisation (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. Places limited.

  • 11/02/2015 - 13/02/2015 : PDCO

    Paediatric Committee (PDCO): 11-13 February 2015

    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.

  • 10/02/2015 - 12/02/2015 : COMP

    Committee for Orphan Medicinal Products (COMP): 10-12 February 2015

    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.

  • 10/02/2015 - 12/02/2015 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 February 2015

    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.

  • 09/02/2015 - 12/02/2015 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 February 2015

    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.