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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

September 2017

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  • 2017-09-19 - 2017-09-19 : EMA

    EudraVigilance information day

    EudraVigilance information day provides a forum to discuss the final steps in preparation of the simplified adverse reaction reporting, the new signal management for marketing authorisation holders in the European Economic Area (EEA) as well as the initial testing experience by stakeholders. More specifically, the focus of this information day will be on the EudraVigilance go-live planning and the preparations and actions required by national competent authorities in the EEA, marketing authorisation holders and sponsors of clinical trials. The information day will also serve as a platform to experts to share their testing experience based on the use of the new EudraVigilance XCOMP (test) environment, which was released on 26 June 2017 and to raise specific process related and technical questions.

  • 2017-09-19 - 2017-09-19 : EMA

    European Medicines Agency - Payer Community meeting

    The European Medicines Agency and European Union healthcare payers met to explore synergies and foster mutual understanding and cooperation to help improve timely and affordable access for patients to new medicinal products. The meeting aimed to be complementary to EMA's existing cooperation with Health Technology Assessment (HTA) bodies and especially with EUnetHTA.

  • 2017-09-19 - 2017-09-19 : EMA

    EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: info session on antimicrobial resistance

    The joint Patients' and Consumers' Working Party (PCWP) / Healthcare Professionals' Working Party (HCPWP) meeting on antimicrobial resistance aims to raise awareness of the work of European Union institutions, Member States and World Health Organization in the fight against antimicrobial resistance. It will also explain how the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control can support the European- and global-level fight against antimicrobial resistance. The meeting will also stimulate an exchange of ideas with patients and consumer and healthcare professional organisations on how to join efforts for improving communication, education and training in the fight against antimicrobial resistance.

  • 2017-09-18 - 2017-09-20 : 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.

  • 2017-09-18 - 2017-09-19 : HMPC

    Committee for Herbal Medicinal Products (HMPC): 18-19 September 2017

    The Committee on Herbal Medicinal Products (HMPC) is the committee that is responsible for preparing the Agency’s opinions on questions relating to herbal medicines.

  • 2017-09-18 - 2017-09-19 : EMA

    Introduction to the European Union regulatory system and European Medicines Agency for international regulators and non-governmental organisations

    This two-day awareness session is for international regulators and non-governmental organisations. It gives an insight into the European Union (EU) regulatory system for medicines and the role of the European Medicines Agency (EMA). Insight into the EU system is of prime importance in an increasingly globalised world where worldwide regulators rely on close cooperation. The EU system is one of the most advanced in the world, but it is also one of the most complex. It is based on a network of decentralised agencies in the EU Member States, supported and coordinated by EMA.