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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

April 2016

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  • 27/04/2016 - 29/04/2016 : PDCO

    Paediatric Committee (PDCO): 27-29 April 2016

    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.

  • 26/04/2016 - 26/04/2016 : EMA

    Individual case safety report (ICSR) information day

    This information day will provide pharmacovigilance experts of medicines regulatory authorities and marketing authorisation holders an update on the latest developments on the implementation of the new ICSR format as part of the enhanced EudraVigilance functionalities, the revision of the guideline on good pharmacovigilance practices (GVP) ‘Module VI - Management and reporting of adverse reactions to medicinal products’ as well as plans for the future integration with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards.

  • 25/04/2016 - 28/04/2016 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 25-28 April 2016

    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.

  • 21/04/2016 - 22/04/2016 : EMA

    eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course

    The eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) face-to-face training course aims 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 and European Economic Area countries. The training focuses on explaining provided guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicines, 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 medicines.

  • 21/04/2016 - 21/04/2016 : EMA

    Third industry stakeholder platform on the operation of the centralised procedure for human medicinal products

    The European Medicines Agency (EMA) is hosting the third meeting of its industry stakeholder platform on the operation of the centralised procedure, which was established in April 2015. The objective of this series of semi-annual meetings between regulators and representatives of industry stakeholder organisations is to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders. The third meeting will address management of accelerated assessment, pre-submission dialogue, improvements in the post-authorisation management as well as first experience with requests for PRIME.

  • 20/04/2016 - 20/04/2016 : CVMP

    CVMP interested parties’ meeting

    The CVMP will be holding an interested parties meeting as part of regular stakeholder liaison. Topics for discussion this year will include MUMS and JEG 3R (replacement, reduction and refinement), availability of veterinary medicines antimicrobials resistance and discussion on operational excellence.

  • 20/04/2016 - 21/04/2016 : CAT

    Committee for Advanced Therapies (CAT): 20-21 April 2016

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

  • 19/04/2016 - 21/04/2016 : COMP

    Committee for Orphan Medicinal Products (COMP): 19-21 April 2016

    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.

  • 19/04/2016 - 19/04/2016 : EMA

    European Medicines Agency workshop on the collaboration with general practitioners / family physicians

    The European Medicines Agency (EMA) is organising this workshop with a representative group of general practitioners (GPs) and family doctors across the European Union in the context of the implementing the EMA framework of interaction with healthcare professionals’ organisations. EMA strives to reinforce and promote engagement with general practitioners, in close collaboration with their representative European organisations. Participants will discuss how regulatory actions have or could impact general practice and what type of input collected at primary care level would be most valuable and feasible to obtain to inform the regulatory decision-making process. The workshop will identify areas where collaboration would mutually benefit GPs and EMA, with the objective of investigating if a specific area and format of collaboration could be piloted with a group of GPs and how to establish such group as a pool of EMA experts.

  • 19/04/2016 - 21/04/2016 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 April 2016

    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.

  • 18/04/2016 - 20/04/2016 : EMA

    Training on electronic reporting of individual case safety reports (ICSRs) to EudraVigilance in the European Economic Area

    This training course covers all aspects on the functionalities of the EudraVigilance system, specifically EVWEB, the web interface tool for the electronic reporting of ICSRs, with practical examples and exercises in the EudraVigilance training environment. The training will include the fundamentals of electronic transmission of ICSRs and the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2 safety and acknowledgment message specifications as well as the ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices and the current EudraVigilance business rules.

  • 15/04/2016 - 15/04/2016 : PDCO

    European Medicines Agency-Industry Stakeholders Platform second meeting on paediatric medicines

    The European Medicines Agency (EMA) is hosting the second EMA-Industry Stakeholders Platform meeting on paediatric medicines. This meeting will serve as stage to discuss among other topics the experience, so far, with paediatric standard paediatric-investigation plans (PIPs), the pilot on early interaction on paediatric development and changes to the summary report and electronic submission.

  • 11/04/2016 - 14/04/2016 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 April 2016

    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.

  • 05/04/2016 - 06/04/2016 : EMA

    European Union (EU) workshop on ICH Q3D from a quality perspective

    The new ICH Q3D guideline on elemental impurities will be the subject of a workshop at the European Medicines Agency (EMA) between EU regulators, the European Pharmacopoeia and the pharmaceutical industry. The workshop will focus mainly on the quality aspects of the guideline and its implementation in the European regulatory system. The training modules developed and endorsed by the Q3D Implementation Working Group will be used as a basis for the material presented at the workshop.

  • 04/04/2016 - 04/04/2016 : EMA

    Seventh industry stakeholder platform: operation of European Union pharmacovigilance legislation

    The seventh platform meeting with industry stakeholder associations on the implementation and operation of the European Pharmacovigilance Legislation will take place at the European Medicines Agency (EMA) on 4 April 2016. Discussion at the meeting will include a roadmap for periodic safety update reports (PSURs), scientific advice for post-authorisation studies and signal management. The agenda of the meeting is published on the EMA website.

  • 04/04/2016 - 07/04/2016 : HMPC

    Committee for Herbal Medicinal Products (HMPC): 4-7 April 2016

    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.

  • 30/03/2016 - 01/04/2016 : PDCO

    Paediatric Committee (PDCO): 30 March – 1 April 2016

    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.

  • 29/03/2016 - 01/04/2016 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 29 March – 01 April 2016

    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.