• Home
  • News and Events

News and events

  • Email
  • Help

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

June 2018

M T W T F S S
1 2 3
4 5 6 7 8 9 10
11 12 13 14 15 16 17
18 19 20 21 22 23 24
25 26 27 28 29 30
  • 2018-06-26 - 2018-06-29 : PDCO

    Paediatric Committee (PDCO): 26-29 June 2018

    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.

  • 2018-06-25 - 2018-06-28 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 25-28 June 2018

    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.

  • 2018-06-21 - 2018-06-22 : EMA

    Workshop on the development of antimicrobial medicinal products for paediatric patients

    The European Medicines Agency, the Japanese Pharmaceuticals and Medical Devices Agency and the United States' Food and Drug Administration are co-organising this workshop to discuss the development of antibiotics for children. This will provide an opportunity for international regulators to explore with medicine developers, clinicians and clinical trial investigators, clinical development plans that would allow for the timely development of antibiotics for children and discuss a regulatory pathway for their approval. Please send expressions of interest to attend the workshop by 6 June 2018.

  • 2018-06-21 - 2018-06-22 : EMA

    eXtended EudraVigilance medicinal product dictionary face-to-face training course

    The European Medicines Agency (EMA) has prepared this eXtended EudraVigilance medicinal product dictionary (XEVMPD) face-to face training course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) and European Economic Area (EEA) countries outside the EU. 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.

  • 2018-06-20 - 2018-06-22 : CAT

    Committee for Advanced Therapies (CAT): 20-22 June 2018

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

  • 2018-06-19 - 2018-06-21 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 June 2018

    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.

  • 2018-06-19 - 2018-06-21 : COMP

    Committee for Orphan Medicinal Products (COMP): 19-21June 2018

    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.

  • 2018-06-18 - 2018-06-20 : EMA

    The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course

    This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.

  • 2018-06-13 - 2018-06-15 : EMA

    The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Paris

    This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.

  • 2018-06-11 - 2018-06-14 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 June 2018

    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.

  • 2018-06-08 - 2018-06-08 : EMA

    Haemophilia registries workshop

    The objective of this workshop is to ensure the practical implementation of the requirements related to patient registries for haemophilia medicinal products in Europe, in line with the draft revision of the Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products. The aim is to agree on the use of registry data for regulatory purposes for haemophilia medicinal products in terms of data access and data sharing/reporting between all involved stakeholders, including patients, physicians, registry holders, marketing authorisation holders/applicants, regulatory authorities and health technology assessment bodies. In addition the additional data elements that could be collected by registries for novel products (such as gene therapy, PEGylated medicinal products and monoclonal antibodies) will be discussed as well as quality of life elements. This call for expressions of interest is open until 13th April.

  • 2018-06-08 - 2018-06-08 : EMA

    European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting

    The 2018 face-to-face meeting of Enpr-EMA networks and coordinating members takes place after the annual open workshop on 8 June. The networks meeting will focus on the outcome of the 2018 annual workshop of the 7 June and the action plan for 2018/2019.

  • 2018-06-07 - 2018-06-07 : EMA

    2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)

    Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research networks, learned societies, national paediatric associations/societies, ethics committees, regulators, Health Technology Assessment bodies and industry); and ii) an interactive general discussion on how to avoid duplication of trials, how to improve communication, how to divide work between groups and on the challenges of clinical trials in (ultra) rare diseases. The following day is reserved for discussions among the members of Enpr-EMA.

  • 2018-06-07 - 2018-06-08 : EMA

    eXtended EudraVigilance medicinal product dictionary face-to-face training course, Madrid

    The European Medicines Agency (EMA) has prepared this eXtended EudraVigilance medicinal product dictionary (XEVMPD) face-to face training course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) and European Economic Area (EEA) countries outside the EU. 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.

  • 2018-06-06 - 2018-06-07 : MB

    Management Board meeting: 6-7 June 2018

    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.

  • 2018-06-04 - 2018-06-06 : EMA

    The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Madrid

    This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.

  • 2018-06-04 - 2018-06-05 : HMPC

    Committee for Herbal Medicinal Products (HMPC): 4-5 June 2018

    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.

  • 2018-05-30 - 2018-06-01 : EMA

    The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course

    This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.

  • 2018-05-29 - 2018-06-01 : PDCO

    Paediatric Committee (PDCO): 29 May – 1 June 2018

    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.