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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

December 2016

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  • 2016-12-16 - 2016-12-16 : EMA

    EMA / European Biopharmaceutical Enterprises (EBE) fifth annual regulatory conference on optimising the development of advanced therapies to meet patient needs

    The fifth annual regulatory conference organised by European Biopharmaceutical Enterprises (EBE), with the collaboration of the European Medicines Agency (EMA), will discuss initiatives to improve advanced therapy medicinal products (ATMPs) access to patients, specific requirements for gene-therapy medicinal products, meeting specific standards for development and commercialisation of ATMPs and listening to the stakeholders of innovative medicines. It will bring together speakers and panellists from a broad range of public and private stakeholders, including patients, academia, regulators, investors and industry.

  • 2016-12-14 - 2016-12-15 : MB

    Management Board meeting: 14-15 December 2016

    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.

  • 2016-12-13 - 2016-12-16 : PDCO

    Paediatric Committee (PDCO): 13-16 December 2016

    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.

  • 2016-12-13 - 2016-12-13 : EMA

    European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) task force meeting

    European Union (EU) International Organisation for Standardization (ISO) identification of medical products (IDMP) / SPOR task force meeting with the representatives from the European Medicines Agency (EMA), terminology organisations, software vendors and developers of medicinal products dictionaries / databases to discuss aspects of planning, development, implementation and maintenance of the ISO IDMP standards in the EU, in line with requirements defined at international level and based on agreed EU implementation principles.

  • 2016-12-12 - 2016-12-15 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 12-15 December 2016

    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.

  • 2016-12-12 - 2016-12-14 : EMA

    EudraVigilance training on electronic reporting of ICSRs in the EEA

    This training course covers all aspects on the functionalities of the EudraVigilance system, specifically EVWEB, the web interface tool for the electronic reporting of ICSRs, with practical examples and exercises in the EudraVigilance training environment. The training will include the fundamentals of electronic transmission of ICSRs and the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2 safety and acknowledgment message specifications as well as the ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices and the current EudraVigilance business rules.

  • 2016-12-08 - 2016-12-08 : EMA

    Adaptive pathways workshop

    The European Medicines Agency is organising this workshop in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach, in light of the practical experience gained during the pilot project EMA ran between March 2014 and August 2016, and to plan the next steps in the exploration of this concept. Adaptive pathways is a scientific concept of medicines development and data generation intended for medicines that address patients’ unmet medical needs.

  • 2016-12-07 - 2016-12-09 : CAT

    Committee for Advanced Therapies (CAT): 7-9 December 2016

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

  • 2016-12-07 - 2016-12-07 :

    Twelfth joint EMA/EUnetHTA dialogue meeting

    The 12th joint meeting between the EMA and the European network for Health Technology Assessment (EUnetHTA) will be held on 7th December. The EMA and EUnetHTA have been holding such regular dialogue since 2010. The key topics of this meeting are multi-stakeholder scientific advice to developers, post-licensing data generation plans (including registries and real world evidence), sharing the regulatory review and related information in view of joint relative effectiveness assessments, collaboration on horizon scanning to assist in joint priority setting and experience with patient engagement.

  • 2016-12-06 - 2016-12-08 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 December 2016

    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.

  • 2016-12-06 - 2016-12-08 : COMP

    Committee for Orphan Medicinal Products (COMP): 6-8 December 2016

    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.

  • 2016-12-05 - 2016-12-06 : EMA

    Workshop on measuring the impact of pharmacovigilance activities

    In January 2016 the Pharmacovigilance Risk Assessment Committee (PRAC) adopted a strategy for measuring the impact of pharmacovigilance activities performed at European Union (EU) and Member States level which relies on a collaborative approach of all stakeholders. Measuring the impact of key pharmacovigilance activities will allow regulators and stakeholders to determine which activities are most successful and to identify enablers and barriers for generating positive health impacts which will contribute to the further development of proactive pharmacovigilance systems and to promote best practice across the EU. The aim of this workshop is to facilitate the implementation of the PRAC strategy with a particular focus on the development of methodologies and the fostering of collaboration.

  • 2016-12-05 - 2016-12-07 : EMA

    EudraVigilance training on electronic reporting of individual case safety reports

    This training course covers all aspects on the functionalities of the EudraVigilance system specifically EVWEB with regard to electronic reporting of of individual case safety reports (ICSR) including practical examples and exercises in the EudraVigilance training environment. It includes fundamentals of electronic transmission of ICSRs and ICH M2 safety and acknowledgment message specifications as well as ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices and current EudraVigilance business rules. The Agency updates the course content regularly to comply with new regulations and requirements.

  • 2016-12-02 - 2016-12-02 : EMA

    Signal detection and management information day

    This information day will review signal detection and management activities essential to the overall risk management process of a medicinal product. The event will explain the impact of the implementation of the 2010 pharmacovigilance legislation, with a strong focus on signal detection and management within the European Union, emphasising the requirements to be implemented in 2017.

  • 2016-12-01 - 2016-12-01 : EMA

    Enpr-EMA awareness webinar

    This webinar aims to showcase to pharmaceutical companies the benefits of working with the European Network for Paediatric Research at EMA (Enpr-EMA) and the clinical research networks it represents in the development of medicines for children. The speakers include the Enpr-EMA chair, Mark Turner, and co-chair, Irmgard Eichler. They will outline the role of European Medicines Agency in this network and the practical support Enpr-EMA can offer to developers of paediatric medicines. Further details and information on how to connect is included in the agenda on this page under the 'Documents' tab.

  • 2016-12-01 - 2016-12-02 :

    The annual European Medicines Agency review of the year and outlook for 2017

    This key end of year conference jointly organised by TOPRA and EMA will provide an annual review of the activities of the European Medicines Agency (EMA) and the national agencies within the European regulatory system, providing European regulatory professionals a chance to reflect and plan for the challenges ahead. The conference will discuss major areas of medicines legislation coordinated by the EMA and provide practical advice on the work of EMA within the European regulatory network and on how national agencies contribute. It will feature a range of speakers and panellists from EMA and national agencies, industry, patient and healthcare professional organisation representatives and policy-makers.

  • 2016-11-28 - 2016-12-01 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 28 November-1 December 2016

    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.