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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

May 2018

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  • 2018-05-30 - 2018-06-01 : EMA

    The new EudraVigilance system and the electronic reporting of 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 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.

  • 2018-05-29 - 2018-06-01 : PDCO

    Paediatric Committee (PDCO): 29 May – 1 June 2018

    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.

  • 2018-05-28 - 2018-05-30 : EMA

    The new EudraVigilance system and the electronic reporting of 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 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.

  • 2018-05-28 - 2018-05-31 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 28-31 May 2018

    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.

  • 2018-05-23 - 2018-05-25 : CAT

    Committee for Advanced Therapies (CAT): 23-25 May 2018

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

  • 2018-05-23 - 2018-05-25 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 23-25 May 2018

    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.

  • 2018-05-22 - 2018-05-24 : COMP

    Committee for Orphan Medicinal Products (COMP): 22-24 May 2018

    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.

  • 2018-05-18 - 2018-05-18 : EMA

    Third industry stakeholder platform on research and development support

    This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine development programmes, co-development with companion diagnostics and cross-decision maker collaboration in the space of horizon scanning activities. It also provides an opportunity for updates on post-authorisation evidence generation activities, paediatric medicines and the PRIME scheme.

  • 2018-05-14 - 2018-05-16 : EMA

    The New EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH 2B(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 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.

  • 2018-05-14 - 2018-05-17 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 May 2018

    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.

  • 2018-05-04 - 2018-05-04 : EMA

    Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: identifying solutions for big data challenges

    The aim of this workshop is to inform thinking on big data and related challenges as the HMA/EMA Joint Big Data Task Force is planning to make recommendations in this field in November 2018. In 2017, the task force undertook detailed landscaping of the entire big data field (genomics through to m-health) as viewed through the lens of the regulator. It also performed online surveys of both national regulatory agencies and the pharmaceutical industry on perspectives, expertise and challenges. This work helped develop an understanding of the challenges and the current state of expertise in the regulatory network. The taskforce now aims to move onto considering solutions. The task force was established in March 2017 to identify the emerging challenges created by the increasing availability of data and related opportunities for supporting regulatory decision-making.

  • 2018-05-03 - 2018-05-04 : EMA

    Workshop on the reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

    The European Medicines Agency has published a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (EMA/CHMP/138502/2017), for a 1-year public consultation until 31 March 2018. In order to facilitate multidisciplinary interaction between regulators and stakeholders on statistical methodology applied to the quality of medicines, a 1.5-day workshop is held. The main focus of the workshop is the discussion of comments received during the public consultation. Stakeholders are therefore encouraged to provide comments well in advance (ideally by the end of November 2017). Stakeholders can express their interest to participate in this workshop by writing to RP-stats-QA@ema.europa.eu. Due to limited spaces, priority will be given to those who provided relevant comments. The output of the workshop will have a direct impact on the finalisation of the reflection paper.