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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.

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This month's events

October 2017

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  • 2017-10-05 - 2017-10-05 : EMA

    First EMA workshop on non-animal approaches in support of medicinal product development: challenges and opportunities for use of micro-physiological systems

    The workshop aims to map the current state-of-science in the field of non-clinical development of medicines, develop a common understanding of the benefits and limits of these methods, identify gaps in non-clinical safety testing and stimulate research using these methods to address these gaps and encourage use in regulatory testing. The workshop will also encourage dialogue between developers, users and regulators and to facilitate the regulatory acceptance of innovative non-animal methods for a defined context of use for the approval of safe medicines while promoting the 3Rs (replacement, reduction and refinement principles.

  • 2017-10-05 - 2017-10-05 : EMA

    2017 Forum on bioequivalence inspections

    The European Medicines Agency (EMA) together with the National Institute of Pharmacy and Nutrition OGYEI is organising the annual bioequivalence (BE) forum. The forum brings together bioequivalence senior inspectors from the European Union and US FDA to exchange expertise in key areas of bioequivalence inspections.

  • 2017-10-05 - 2017-10-05 : MB

    Management Board meeting: 5 October 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.

  • 2017-10-04 - 2017-10-06 : CAT

    Committee for Advanced Therapies (CAT): 4-6 October 2017

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

  • 2017-10-03 - 2017-10-05 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 October 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.

  • 2017-10-03 - 2017-10-05 : EMA

    2017 European Union Good Clinical Practice Inspectors Working Group workshop

    Good Clinical Practice (GCP) inspectors of European Union (EU) / European Economic Area (EEA) Member States as well as inspectors from non-EU countries will be taking part in this workshop. The workshop will consist of presentations, discussions as well as a number of breakout sessions during which participants will be given case studies and examples of inspection findings to discuss and analyse within their group. This year’s workshop will focus on the following topics: sponsor site inspections (covering centralized monitoring and computer system validation), difficulties when performing un-announced GCP inspections, patient reported outcome (PRO)/e-PRO: what to consider during a GCP inspection, GCP inspections of phase I units, updates on the Clinical Trials Regulation no. 536/2014, GCP inspections of biosimilars (assessors’ perspectives), inspections of oncology trials and GCP international collaboration.

  • 2017-10-03 - 2017-10-05 : COMP

    Committee for Orphan Medicinal Products (COMP): 3-5 October 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.