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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

October 2017

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  • 2017-10-30 - 2017-10-31 : COMP

    Committee for Orphan Medicinal Products (COMP): 30-31 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.

  • 2017-10-30 - 2017-10-31 : CAT

    Committee for Advanced Therapies (CAT): 30-31 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.

  • 2017-10-27 - 2017-10-27 : EMA

    European Medicines Agency (EMA) / Drug Information Association (DIA) signal management information day

    This information day provides an update on essential signal detection and management activities in the European Union (EU) for the overall surveillance and risk management of medicines. It explores the final guidance provided following the finalisation of the good pharmacovigilance practices module IX on signal management and related aspects of the EU pharmacovigilance legislation. It also covers marketing authorisation holders’ access to EudraVigilance and the resources and training the Agency provides to support stakeholders. Finally, it discusses stakeholders’ approaches and perspectives on signal management.

  • 2017-10-25 - 2017-10-27 : EMA

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

    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.

  • 2017-10-23 - 2017-10-25 : 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.

  • 2017-10-23 - 2017-10-26 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 23-26 October 2017

    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.

  • 2017-10-19 - 2017-10-20 :

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

    This eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) face-to-face training course has been prepared 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.

  • 2017-10-18 - 2017-10-20 : 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.

  • 2017-10-16 - 2017-10-18 : EMA

    2017 Pharmacovigilance Inspectors Working Group training course

    The three-day pharmacovigilance inspectors training course is for inspectors and assessors of both, veterinary and human units of EU/EEA Member States, and delegates from non-EU countries. The training will consist of presentations as well as breakout sessions during which participants will be given case studies and examples to discuss and analyse within their group. The topics to be covered this year include: PhV inspection of third parties/contractors and contracts, signal management, harmonisation in grading of findings, the electronic submission of data on medicines to the EudraVigilance medicinal product dictionary (XEVMPD), harmonisation of detailed description of pharmacovigilance system (DDPS) of veterinary MAHs / management of corrective and preventive actions, reporting to EudraVigilance, use of EudraVigilance data analysis system and the use of medical dictionary for regulatory activities for human medicines (MedDRA) and veterinary medicines (VedDRA).

  • 2017-10-16 - 2017-10-18 : 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.

  • 2017-10-16 - 2017-10-17 :

    Joint Drug Information Association (DIA) / European Forum for Good Clinical Practice (EFGCP) /European Medicines Agency (EMA) conference on how to optimise children's access to innovative medicines

    The 2017 DIA/EFGCP/EMA Annual Paediatric Conference focuses on how to optimise children’s access to new medicines. With more than 10 years of the EU Paediatric Regulation, all stakeholders involved in paediatric drug development have seen progress in developing new medicines for children. This conference explores how to build on the successes from the past 10 years of EU Paediatric Regulation, and how to overcome challenges that still exist. The objectives of this year's conference include: - To update participants on current paediatric regulatory requirements, scientific and operational success and challenges; - To exchange experiences with regulatory authorities, academia and industry when developing medicines for children globally; - To discuss visions, daily challenges and potential ways to move forward and further improve processes for paediatric drug development. The registration form is included in the published agenda.

  • 2017-10-13 - 2017-10-13 : EMA

    Industry stakeholder teleconference on Brexit and operation of the centralised procedure for veterinary medicinal products

    This is the first European Medicines Agency teleconference with the veterinary industry stakeholder associations, namely with AnimalhealthEurope (formerly IFAH Europe), European Group for Generic Veterinary Products (EGGVP) and the Association of Veterinary Consultants (AVC), on the United Kingdom's withdrawal from the European Union ('Brexit'), and on the operation of the centralised procedure for veterinary medicinal products. This meeting is expected to be the first in a series of meetings and teleconferences promoting open dialogue on Brexit-related matters with EU Trade Associations.

  • 2017-10-11 - 2017-10-13 : 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.

  • 2017-10-10 - 2017-10-13 : PDCO

    Paediatric Committee (PDCO): 10-13 October 2017

    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.

  • 2017-10-09 - 2017-10-11 : 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.

  • 2017-10-09 - 2017-10-12 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 9-12 October 2017

    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.

  • 2017-10-09 - 2017-10-11 : EMA

    The new EudraVigilance system and the electronic reporting of individual case safety reports (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 International Organization for Standardization (ISO)/ the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (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. The new EudraVigilance system and enhanced functionalities will go live in November 2017.

  • 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 : 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 : 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 - 2017-10-04 :

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

    This meeting between European Medicines Agency (EMA) and EU trade associations is being organised in the context of Brexit. The purpose of the meeting is update industry on the EMA “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 : 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.