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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

March 2015

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  • 25/03/2015 - 25/03/2015 : CVMP

    Joint European Medicines Agency/Heads of Medicines Agencies workshop on requirements for the authorisation of veterinary vaccines in the European Union

    The objective of the workshop is to provide a platform for exchanging views on what constitutes an appropriate level of requirements for the authorisation of vaccines in the European Union taking into account the risks and benefits of this class of products, as well as debating the impact that current requirements have on the availability of vaccines. The morning session will include short presentations from regulators and industry representatives. In the afternoon there will be breakout sessions with groups of participants debating the main issues around the authorisation requirements for vaccines. The meeting will close with a presentation on conclusions and recommendations, including proposals for follow-up actions. A report of the meeting will be published on the European Medicines Agency website. Registration by invitation only.

  • 23/03/2015 - 26/03/2015 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 23-26 March 2015

    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.

  • 19/03/2015 - 19/03/2015 : MB

    Management Board meeting: 19 March 2015

    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.

  • 19/03/2015 - 20/03/2015 : EMA

    eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course

    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 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) data-entry tool EVWEB. It includes exercises in the XEVPRM data-entry for the electronic submission and maintenance of different types of medicinal products. Places limited.

  • 19/03/2015 - 20/03/2015 : CAT

    Committee for Advanced Therapies (CAT): 19-20 March 2015

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

  • 18/03/2015 - 18/03/2015 : EMA

    Science, Medicines, Health: Patients at the heart of future innovation conference

    The invitation-only conference is organised to celebrate the 20th anniversary of the European Medicines Agency. Looking back at the past two decades, the Agency is proud of its successes, impressive growth and achievements. Yet, in addition to celebrating past successes, the Agency has its eyes firmly set in the challenges of the future. Cognisant of its pivotal role at the crossroads of life science research and development, patient care, public health policy and law, the Agency will use this event to explore with a range of stakeholders how best to deliver its role in the future.

  • 18/03/2015 - 20/03/2015 : PDCO

    Paediatric Committee (PDCO): 18-20 March 2015

    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.

  • 17/03/2015 - 19/03/2015 : COMP

    Committee for Orphan Medicinal Products (COMP): 17-19 March 2015

    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.

  • 17/03/2015 - 17/03/2015 : EMA

    Collaboration on neonatal issues between researchers and the European Medicines Agency

    The aim of the meeting is to develop ways to work together that optimise the design and conduct of neonatal medicines research in Europe. During this meeting we will share perspectives about the current state of neonatal medicines research in Europe, review “hot topics” and prioritise them, and develop an action plan for 2015. Registration by invitation only.

  • 16/03/2015 - 18/03/2015 : EMA

    EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area

    This training course covers all aspects of the functionalities of the EudraVigilance system, specifically the data-entry tool EVWEB, with regard to electronic reporting of Individual Case Safety Reports (ICSRs), including practical examples and exercises in the EudraVigilance training environment. It includes fundamentals of electronic transmission of ICSRs and International Conference on Harmonisation (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. Places limited.

  • 13/03/2015 - 13/03/2015 : Stakeholder

    Third industry stakeholder platform: operation of European Union pharmacovigilance legislation

    The third platform meeting with industry stakeholder associations on the implementation and operation of the European pharmacovigilance legislation took place at the European Medicines Agency (EMA) on 13 March 2015. Discussion at the meeting focused primarily on pharmacovigilance information systems and services (including Article 57 product database, Eudravigilance, medical literature monitoring and the periodic safety report (PSUR) repository), the introduction of pharmacovigilance fees, as well as a review of experience with PSUR and referrals procedures. The meeting provided a valuable opportunity to obtain practical feedback on the available systems, processes and guidelines. Updates on post-authorisation safety studies (PASS) management through EMA scientific advice and upcoming activities on risk management plan (template and GVP XVI addendum updates) were also presented by the regulators. Registration closed.

  • 12/03/2015 - 13/03/2015 : EMA

    European Medicines Agency/International Federation for Animal Health-Europe info day 2015

    The info day covers the latest developments in the scientific review, regulation and marketing authorisation procedure. It is an opportunity for professionals to get first-hand information on current developments in the veterinary regulatory scene. Registration closed.

  • 11/03/2015 - 13/03/2015 : EMA

    EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area

    This training course covers all aspects of the functionalities of the EudraVigilance system, specifically the data-entry tool EVWEB, with regard to electronic reporting of Individual Case Safety Reports (ICSRs), including practical examples and exercises in the EudraVigilance training environment. It includes fundamentals of electronic transmission of ICSRs and International Conference on Harmonisation (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. Places limited.

  • 10/03/2015 - 12/03/2015 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 March 2015

    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.

  • 10/03/2015 - 10/03/2015 : EMA

    Introduction to pharmacovigilance and rules for expedited reporting of Individual Case Safety Reports in Europe

    This one day course covers the pre-requisites for the three day training course on EudraVigilance – electronic reporting of Individual Case Safety Reports (ICSRs) and is therefore recommended to newcomers in pharmacovigilance, in particular individuals dedicated to data entry and expedited reporting. The attendees will learn about the essentials of pharmacovigilance, the format, structure and content of ICSRs as well as the rules for expedited reporting in Europe for both clinical crials and post-marketing ICSRs. Places limited.

  • 09/03/2015 - 10/03/2015 : HMPC

    Committee for Herbal Medicinal Products (HMPC): 9-10 March 2015

    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.

  • 09/03/2015 - 12/03/2015 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 March 2015

    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.

  • 05/03/2015 - 05/03/2015 : EMA

    European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: Information session on biosimilars

    This is an information session on biosimilars with representatives from patients’, consumers’ and healthcare professionals’ organisations. In addition to providing an overview to PCWP and HCPWP members of the science behind biosimilars and how they are evaluated by regulators, the session will explore how to bridge the scientific evaluation with clinical reality and public acceptability of biosimilars and discuss the role of communication in promoting better understanding of biosimilars. Registration by invitation only.

  • 04/03/2015 - 06/03/2015 : EMA

    EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area

    This training course covers all aspects of the functionalities of the EudraVigilance system, specifically the data-entry tool EVWEB, with regard to electronic reporting of Individual Case Safety Reports (ICSRs), including practical examples and exercises in the EudraVigilance training environment. It includes fundamentals of electronic transmission of ICSRs and International Conference on Harmonisation (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. Places limited.

  • 04/03/2015 - 04/03/2015 : EMA

    European Medicines Agency 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. Further to reporting on the activities undertaken during 2014 and the outcome of satisfaction surveys, participants will discuss working methods for 2015 including concrete areas of focus for targeted subgroups. Participants will be updated on a number of topics including planned activities to mark the EMA’s 20th anniversary, Ebola, survey to national competent authorities on patient engagement, Innovative Medicines Initiative (IMI) projects (PROTECT and WEBRADR) and the EMA public consultation on the EU Clinical Trial Regulation. A dedicated discussion on current challenges faced in encouraging paediatric clinical research in the EU will also take place. Registration by invitation only.

  • 02/03/2015 - 03/03/2015 : EMA

    eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course

    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 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) data-entry tool EVWEB. It includes exercises in the XEVPRM data-entry for the electronic submission and maintenance of different types of medicinal products. Places limited.