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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

December 2017

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  • 2017-12-19 - 2017-12-19 : EMA

    European Medicines Agency information day on risk management planning: implementation of GVP V and RMP template rev. 2 guidance

    This information day is aimed primarily at providing marketing authorisation holders and marketing authorisation applicants with practical advice on risk management plans (RMP) drafting using the principles of risk assessment and management included in good pharmacovigilnce practice (GVP) module V rev. 2. Content requirements and procedural advice for RMP submission will be presented with practical examples provided, based on frequent questions from applicants, assessors, and European Medicines Agency (EMA) Risk Management Specialists. Highlights will include types of products with different legal basis application (e.g. generics, fixed dose combination products, biosimilars). Feedback from the industry will be discussed and EMA and Pharmacovigilance Risk Assessment Committee (PRAC) view on topics raised will be provided. The Q&A and panel discussion sessions will include the response to questions received in advance or raised during the presentations.

  • 2017-12-15 - 2017-12-15 : EMA

    Fourteenth joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting

    The EMA and EUnetHTA have been holding regular dialogue since 2010. The key topics of this meeting are concepts related to orphan medicines (significant benefit vs relative effectiveness), opportunities for collaboration on horizon scanning, reflections on the concept of evidence transfer / extrapolation, principles of the working of the indication as well as ongoing initiatives on post-licensing evidence generation. A report from the meeting will be published later.

  • 2017-12-15 - 2017-12-15 : EMA

    EudraVigilance information day

    This EudraVigilance information day provides a forum to discuss the very initial experience of stakeholders with the new EudraVigilance system functionalities following its launch in November 2017, the use of the new ICH E2B(R3) standard, the simplified adverse reaction reporting and the data analysis outputs. The Information Day will also serve as a platform to experts to raise questions on the practical application of the recently revised GVP Modules VI and IX.

  • 2017-12-14 - 2017-12-15 : CHMP

    Workshop on site and histology - Independent indications in oncology

    Biological drivers that define cancer course across anatomical sites and histologies offer an opportunity to select populations sensitive to specific drugs based on those drivers, independently of the specific site or histology. This workshop aims to provide an exchange of views from different stakeholders about situations where a site and histology-independent clinical development might be a viable option and the associated challenges in terms of drug development, benefit-risk evaluation and health-technology assessment.

  • 2017-12-13 - 2017-12-14 : MB

    Management Board meeting: 13-14 December 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.

  • 2017-12-12 - 2017-12-15 : PDCO

    Paediatric Committee (PDCO): 12-15 December 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.

  • 2017-12-11 - 2017-12-12 : EMA

    A common data model in Europe? – Why? Which? How?

    This meeting will aim to define the opportunities and challenges in applying a common data model in Europe to support regulatory decision-making and agree guiding principles for the development of such a model, including key criteria for validation in the context of regulatory decision-making. A common data model could help harmonise healthcare data across multiple data sets and provide a mechanism to conduct pan-European studies in a timely manner to address regulatory questions. At the same time, applying a common model to European data has multiple challenges. The meeting will bring together regulators with academia, data holders and the pharmaceutical industry.

  • 2017-12-11 - 2017-12-14 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 11-14 December 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.

  • 2017-12-07 - 2017-12-08 :

    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.

  • 2017-12-06 - 2017-12-08 : CAT

    Committee for Advanced Therapies (CAT): 6-8 December 2017

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

  • 2017-12-05 - 2017-12-07 : COMP

    Committee for Orphan Medicinal Products (COMP): 5-7 December 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.

  • 2017-12-05 - 2017-12-07 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 5-7 December 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.

  • 2017-12-04 - 2017-12-06 : 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.

  • 2017-12-04 - 2017-12-06 : 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.

  • 2017-12-01 - 2017-12-01 : EMA

    European Medicines Agency (EMA) / Drug Information Association (DIA) statistics forum: The role of observational data in assessing the benefits and risks of medicines

    This forum considers the place of observational research in the clinical evaluation of medicines and seeks views on how to select promising study designs, prospectively specify objective criteria for evaluation of study results and define procedures to ensure the reliability of results. The overall aim is to contribute to the ongoing debate on how to assess research based on observational studies and in particular, how to pre-specify criteria of ‘success’ in an observational study in a way that would allow confident design of a research programme to meet regulatory requirements. These discussions will address the lack of regulatory guidance in this area, which was highlighted by moves to extend the use of epidemiological analyses (previously used primarily for prospective clinical trials) into areas of medicine development due to the increasing availability of more and higher quality observational data.

  • 2017-11-30 - 2017-12-01 : EMA

    Data anonymisation workshop

    The data anonymisation workshop focuses on anonymisation as a key enabler for clinical data sharing. The scope of the workshop includes clinical trial data including individual patient level data and real world data in the context of patient registries and individual cohort studies.