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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

March 2017

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  • 2017-03-29 - 2017-03-30 : EMA

    Seventh Framework Programme (FP7) small-population research methods projects and regulatory application workshop

    Three projects, Asterix, IDeAl and InSPiRe, are funded by the EU within the Seventh Framework Programme (FP7)to develop new methodology on design and analysis of small population clinical trials since 2013. The projects are in their final phase, and are ready to discuss their results to date. The aim of the workshop is to translate and promote results and novel methodologies into tangible recommendations to advance the clinical research and development of medicines and new treatments for patients with a rare disease and personalized medicine. The results to date and draft recommendations for application will be discussed by international representatives of patient organisations, pharmaceutical industry, academic statisticians and clinical trial methodologists, clinical researchers, pharmaceutical industry and regulators.

  • 2017-03-27 - 2017-03-28 : HMPC

    Committee for Herbal Medicinal Products (HMPC): 27-28 March 2017

    The Committee on Herbal Medicinal Products (HMPC) is the committee that is responsible for preparing the Agency’s opinions on questions relating to herbal medicines.

  • 2017-03-23 - 2017-03-24 : 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.

  • 2017-03-21 - 2017-03-24 : PDCO

    Paediatric Committee (PDCO): 21-24 March 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.

  • 2017-03-20 - 2017-03-23 : CHMP

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

  • 2017-03-20 - 2017-03-20 : EMA

    SME info day on the new clinical trial regulation

    This SME info day provides an overview on the key features and objectives of the new clinical trial regulation. It also covers the future clinical trial authorisation process, the functionalities of the EU CT portal and database, transparency aspects of the new regulation and safety reporting requirements. The event is for companies that have been assigned SME status by the EMA and representatives of stakeholder organisations.

  • 2017-03-20 - 2017-03-22 :

    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.

  • 2017-03-16 - 2017-03-16 : MB

    Management Board meeting: 16 March 2017

    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.

  • 2017-03-16 - 2017-03-17 : CVMP

    European Medicines Agency veterinary medicines info day

    The European Medicines Agency veterinary medicines info day, organised in collaboration with International Federation for Animal Health Europe (IFAH-Europe), provides first-hand information on the latest developments in the scientific review, regulation and marketing authorisation procedure in the field of veterinary medicine regulation. For the first time, this year, European Medicines Agency (EMA) will have dedicated information points on esubmissions, veterinary application submissions and veterinary medicines innovation.

  • 2017-03-15 - 2017-03-17 : CAT

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

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

  • 2017-03-14 - 2017-03-16 : COMP

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

  • 2017-03-14 - 2017-03-16 : CVMP

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

  • 2017-03-10 - 2017-03-10 : EMA

    European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting

    The European Union (EU) International Organisation for Standardization (ISO) identification of medical products (IDMP) / Substance, Product, Organisation and Referential (SPOR) data Task Force meeting with representatives from the European Medicines Agency, national competent authorities, pharmaceutical industries associations, terminology organisations, software vendors and developers of medicinal products dictionaries / databases will discuss aspects of planning, development, implementation and maintenance of the ISO IDMP standards in the EU, in line with requirements defined at international level and based on agreed EU implementation principles.

  • 2017-03-08 - 2017-03-08 : EMA

    Online training course for bioequivalence inspectors

    The online training course provides good clinical practice inspectors in the European Union general information on bioequivalence to help them develop the necessary knowledge and skills to inspect bioequivalence studies.

  • 2017-03-06 - 2017-03-09 : PRAC

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

  • 2017-03-06 - 2017-03-08 : 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.

  • 2017-03-02 - 2017-03-03 : 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.

  • 2017-02-27 - 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.