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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

June 2017

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  • 2017-06-27 - 2017-06-28 : EMA

    EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting

    This is a joint meeting with representatives from patients’, consumers’ and healthcare professionals’ organisations. On June 27, EUnetHTA speakers will join the meeting to present on their activities and discuss areas of collaboration with patients and healthcare professionals; on June 28 there will be a presentation on the European Commission’s report on the shortcomings of product information followed by a discussion on the implementation of the report’s recommendations. Also during the two-day meeting, participants will learn about the HMA/EMA Taskforce on availability of authorised medicines and discuss their involvement in the Pharmacovigilance additional monitoring impact analysis; other topics for discussion include a proposal for revision of PCWP/HCPWP mandates and rules of procedure, the principles and practical considerations for streamlining the process for re-assessment of eligibility status, and the drafting process for a joint 2018/19 Work Plan.

  • 2017-06-26 - 2017-06-28 : EMA

    The new EudraVigilance System and the electronic reporting of the individual case safety 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.

  • 2017-06-22 - 2017-06-23 : EMA

    Focus group with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines

    The Agency is organising a Focus group meeting with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines. The scope of the meeting is to explore the specific challenges faced by industry in performing field trials to support efficacy claims in the context of an EU authorisation for veterinary vaccines and how these challenges might be overcome whilst still obtaining adequate assurances of the expected efficacy of a vaccine under field conditions. The focus group meeting is within the scope of the HMA Network Strategy on availability for veterinary vaccines that aims to increase their availability by ensuring efficient and effective cooperation between all stakeholders.

  • 2017-06-21 - 2017-06-23 : EMA

    The new EudraVigilance System and the electronic reporting of the individual case safety 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.

  • 2017-06-20 - 2017-06-23 : PDCO

    Paediatric Committee (PDCO): 20-23 June 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.

  • 2017-06-20 - 2017-06-21 : EMA

    Workshop on generation and use of Health Based Exposure Limits (HBEL)

    The aim of this workshop is to develop understanding of the use and application of Health-Based Exposure Limits (HBELs) in the context of quality risk management of cross contamination during the manufacture of different products in the same manufacturing facilities. The workshop is by invitation only and experts in toxicology and manufacturing quality representing the manufacturing industry will meet with regulators representing GMP/GDP Inspectors Working Group and Safety Working Party (human and veterinary sectors). The workshop will review current experience from the industry in the implementation of recent guidance and experience from GMP inspections.Time will be spent discussing the Questions and Answers on this topic recently published by EMA for public consultation. The need for further industry guidance and the feasibility of developing a training program that could be used for inspectors and industry will also be explored. A summary of the discussions will be published.

  • 2017-06-19 - 2017-06-21 : EMA

    The new EudraVigilance System and the electronic reporting of the individual case safety 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.

  • 2017-06-19 - 2017-06-22 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 19-22 June 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.

  • 2017-06-14 - 2017-06-16 : EMA

    The new EudraVigilance System and the electronic reporting of the individual case safety 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.

  • 2017-06-14 - 2017-06-16 : CAT

    Committee for Advanced Therapies (CAT): 14-16 June 2017

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

  • 2017-06-14 - 2017-06-15 : MB

    Management Board meeting: 14-15 June 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.

  • 2017-06-13 - 2017-06-15 : COMP

    Committee for Orphan Medicinal Products (COMP): 13-15 June 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.

  • 2017-06-13 - 2017-06-15 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 June 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.

  • 2017-06-12 - 2017-06-13 : EMA

    EMA/FDA/Health Canada joint workshop addressing unmet needs of children with pulmonary arterial hypertension

    This joint workshop organised the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and Health Canada brings together experts and stakeholders to discuss requirements for the development of medicines in paediatric pulmonary arterial hypertension (PAH) and to address the need of the current paediatric clinical practice in a timely manner. The objectives are to improve the understanding of problems related to the conduct of clinical trials in the paediatric population, refine endpoints and study design to address the clinical trials challenges in this rare paediatric population, set priorities in future research in the field of pharmacokinetics and pharmacodynamics measurements and post-marketing tools in paediatric PAH medicines and provide medicine developers with more guidance specific to global product development which takes into account current limitations.

  • 2017-06-12 - 2017-06-14 : EMA

    The new EudraVigilance System and the electronic reporting of the individual case safety 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.

  • 2017-06-09 - 2017-06-09 : EMA

    First European Medicines Agency-EuropaBio annual bilateral meeting

    This meeting between European Medicines Agency (EMA) and the European Association for Bioindustries (EuropaBio) is being organised in the context of the EMA annual bilateral meetings with Industry stakeholder organisations. The purpose of the meeting is to exchange views and promote dialogue on topics of common interest.

  • 2017-06-07 - 2017-06-07 :

    EudraVigilance information day

    This EudraVigilance Information Day provides a forum to prepare stakeholders for the implementation and launch of the new EudraVigilance system in the context of the pharmacovigilance legislation and to facilitate change management as part of the Agency’s pharmacovigilance programme. The focus of this Information Day will be on providing a project update and an overview of the Agency’s preparations to launch the new EudraVigilance System including various stakeholder support initiatives. The Information Day will also serve as a platform to experts of medicines regulatory authorities and marketing authorisation holders to share their change management planning experience and to raise specific process related or technical questions. Updates of the work of the ICH E2B Implementation Working Group, which is coordinating the implementation of the ICH E2B (R3) ICSR format at international level, will be also provided.

  • 2017-06-06 - 2017-06-09 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 June 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.

  • 2017-06-02 - 2017-06-02 : EMA

    Eleventh industry stakeholder platform on the operation of pharmacovigilance in the European Union

    The eleventh platform meeting with industry stakeholder associations on the operation of the European pharmacovigilance system includes discussions on GVPs and signal mangement process.