• 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

October 2017

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 31
  • 2017-10-04 - 2017-10-04 :

    Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicines

    The European Medicines Agency (EMA) is holding this meeting with European Union trade associations in the context of Brexit. The purpose of the meeting is update the pharmaceutical industry on EMA's Brexit preparedness activities.

  • 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 : 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.

  • 2017-10-03 - 2017-10-05 : EMA

    European Union Good Clinical Practice Inspectors Working Group workshop

    This workshop is for good clinical practice (GCP) inspectors of European Union (EU) and European Economic Area (EEA) Member States as well as inspectors from non-EU countries. It consists of presentations, discussions and 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 focuses on sponsor site inspections (covering centralised monitoring and computer system validation), difficulties when performing un-announced GCP inspections, patient reported outcome (PRO)/e-PRO and things 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 and assessors’ perspectives, inspections of oncology trials and GCP international collaboration.

  • 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.

  • 2017-10-02 - 2017-10-04 : EMA

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

    The European Medicines Agency (EMA) will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in November 2017. The system will make use of the individual case safety report (ICSR) standards developed by the International Organization for Standardization (ISO), in collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 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.