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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

May 2017

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  • 2017-05-29 - 2017-05-30 : HMPC

    Committee for Herbal Medicinal Products (HMPC): 29-30 May 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.

  • 2017-05-19 - 2017-05-19 :

    First anniversary of PRIME: experience so far

    The European Medicines Agency (EMA) launched the PRIME (PRIority Medicines) scheme in March 2016. The scheme provides early and enhanced support to medicines that have the potential to address patients’ unmet needs. This meeting is organised by EMA to review the experience gained with PRIME one year after it was launched. The aim of the meeting is to receive feedback from users and potential users of the scheme, provide information on how the rules on eligibility have been applied and what types of support applicants have received so far and discuss practical examples that illustrate the benefits of PRIME and how it builds on the existing tools. 

  • 2017-05-18 - 2017-05-19 : EMA

    Visit of the East African Community (EAC)

    As part of the European Medicines Agency's (EMA) ongoing collaboration with African regulators, it hosted a delegation from EAC which is one of the most advanced regional economic communities in Africa. It is composed of 6 countries: Burundi, Kenya, Rwanda, South Sudan, Tanzania and Uganda. EAC is an observer in ICH and the International Pharmaceutical Regulators Forum. The delegation included the heads of these six agencies, the EAC Secretariat, and representatives from the World Health Organization and the World Bank. The event discussed the role of EMA in the European medicines regulatory network, focusing on its collaboration with national competent authorities. It also discussed the structure and operation of EMA, internal controls, human resources management, training, information technology and infrastructure, as well as lifecycle management of medicines and medicines approval, veterinary medicines, pharmacovigilance and inspections, committee and procedure management.

  • 2017-05-18 - 2017-05-19 : 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.

  • 2017-05-17 - 2017-05-17 :

    Second 2017 meeting of the coordinating group of the European network of paediatric research at the European Medicines Agency (Enpr-EMA)

    The 2017 face to face meeting of Enpr-EMA networks and coordinating group members takes place after the annual open workshop on 16 May. The networks meeting focuses on the outcome of the open workshop and the action plan for 2017/2018.

  • 2017-05-16 - 2017-05-16 : PDCO

    2017 Annual workshop of the European network of paediatric research at the EMA (Enpr-EMA)

    The ninth annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) aims to bring relevant stakeholders together to discuss requirements, barriers and opportunities for high-quality clinical studies in children. Among the highlights of this year’s workshop are the recent efforts to increase cooperation between the European Union and the United States to facilitate global paediatric trials and medicine developments.

  • 2017-05-16 - 2017-05-19 : PDCO

    Paediatric Committee (PDCO): 16-19 May 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.

  • 2017-05-15 - 2017-05-18 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 15-18 May 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.

  • 2017-05-15 - 2017-05-17 : 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.

  • 2017-05-10 - 2017-05-12 : CVMP

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

  • 2017-05-10 - 2017-05-12 : COMP

    Committee for Orphan Medicinal Products (COMP): 10-12May 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.

  • 2017-05-10 - 2017-05-12 : CAT

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

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

  • 2017-05-02 - 2017-05-05 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 May 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.