• 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

September 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
  • 2018-09-26 - 2018-09-26 : CHMP

    European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP)

    This Healthcare Professionals' Working Party (HCPWP) plenary meeting will include discussions on advances in clinical practice and the scientific and regulatory challenges. Members will also be invited to present how they are including regulatory sciences in fellowships and young researchers’ training. Feedback will be given from the representatives of the Scientific Committees.

  • 2018-09-25 - 2018-09-25 : CHMP

    European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP)

    This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised medicines.

  • 2018-09-25 - 2018-09-25 : CHMP

    European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP)

    This Patients' and Consumers' Working Party (PCWP) plenary meeting will include discussions on patient engagement along the regulatory lifecycle and visibility of patient input throughout scientific procedures. Feedback will also be given from the representatives of the Scientific Committees.

  • 2018-09-24 - 2018-09-26 : EMA

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

    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.

  • 2018-09-24 - 2018-09-25 : HMPC

    Committee for Herbal Medicinal Products (HMPC): 24-25 September 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.

  • 2018-09-24 - 2018-09-24 : EMA

    12th Pharmacovigilance stakeholder forum

    This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

  • 2018-09-20 - 2018-09-21 : 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.

  • 2018-09-19 - 2018-09-19 : CVMP

    Risk assessment guideline focus group meeting

    The Antimicrobials Working Party of the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) is holding a focus group meeting with stakeholders to discuss the revision of the antimicrobial veterinary medicinal product risk assessment guideline, following a public consultation on the draft revised guideline ending on 31 October 2018. The meeting will focus on topics identified during this public consultation. This guideline aims to provide guidance to marketing authorisation applicants on the data requirements and methodology to be used for assessing the risk to public health from antimicrobial resistance from use of those products in food-producing animals.

  • 2018-09-18 - 2018-09-21 : PDCO

    Paediatric Committee (PDCO): 18-21 September 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.

  • 2018-09-17 - 2018-09-19 : 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.

  • 2018-09-17 - 2018-09-20 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 17-20 September 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.

  • 2018-09-12 - 2018-09-14 : CAT

    Committee for Advanced Therapies (CAT): 12-14 September 2018

    The Committee for Advanced Therapies Committee for Advanced Therapies The committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines, including medicines classified as gene-therapy, somatic-cell-therapy or tissue-engineered products. Abbreviated as CAT. For more information, see Committee for Advanced Therapies (CAT). (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines.

  • 2018-09-11 - 2018-09-13 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 September 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.

  • 2018-09-11 - 2018-09-13 : COMP

    Committee for Orphan Medicinal Products (COMP): 11-13 September 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.

  • 2018-09-05 - 2018-09-06 : PDCO

    Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients

    The third multi-stakeholder Paediatric Strategy Forum, jointly organised by EMA and ACCELERATE will focus on checkpoint inhibitors used in combination therapy, in children and adolescents. This Forum will reviewed the immunological environment of paediatric malignancies, checkpoint inhibitors in early phase clinical studies in paediatrics, strategies combining checkpoint inhibitors with other products and alternative immunotherapy strategies. Participation is restricted and on invitation only. Interested parties, including patients and parent-representatives, academia, clinicians and industry, should express their interest using the forms linked to this page.

  • 2018-09-03 - 2018-09-06 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 September 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.