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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

October 2014

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  • 28/10/2014 - 29/10/2014 : EMA

    Workshop on viral safety of plasma-derived medicinal products with respect to hepatitis E virus

    The purpose of this workshop is to obtain further information on the safety of plasma-derived medicinal products with respect to the hepatitis E virus (HEV). It will provide the basis for deciding what further action may be needed, including the possible update of the current guidance on plasma-derived medicinal products and/or development of a reflection paper specifically on viral safety of plasma derived medicinal products with respect to HEV. Registration by invitation only. Registration open until 30 September 2014.

  • 20/10/2014 - 23/10/2014 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 20-23 October 2014

    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.

  • 16/10/2014 - 17/10/2014 : CAT

    Committee for Advanced Therapies (CAT): 16-17 October 2014

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

  • 15/10/2014 - 17/10/2014 : EMA

    EudraVigilance training on the electronic reporting of individual case safety reports (ICSRs) in the European Economic Area

    Participants who pass the knowledge evaluation following the course will receive a notification from the European Medicines Agency (EMA) that will allow them to register with the EudraVigilance and report ICSRs to the EMA and / or the National Authorities in the European Economic Area. Places limited.

  • 13/10/2014 - 17/10/2014 : EMA

    European Medicines Agency excellence in pharmacovigilance: Clinical trials and post-marketing training course

    This course is designed to provide a firm grounding in key aspects of global and mainly European clinical pre- and post-marketing safety regulatory requirements. This five-day training course now also includes highlights and updates on the implementation of the new pharmacovigilance legislation and the latest news on the international harmonisation and standardisation activities in pharmacovigilance. Places limited.

  • 10/10/2014 - 10/10/2014 : EMA

    Regulatory workshop on clinical trials designs in neuromyelitis optica and spectrum disorders

    This workshop brings together patient representatives, healthcare professionals, regulators, pharma and ethicists to discuss trial designs in neuromyelitis optica (NMO), a rare neurological disorder. For evidence of efficacy, in NMO, the choice of comparator is problematic. The severity/lack of reversibility of NMO relapses, indicate that placebo comparators are difficult but evidence for current treatments appears lacking. Different regulatory agencies have different views on comparators in NMO attack prevention. For a rare debilitating disease with unmet medical need, a wider debate is being held to facilitate drug development for the benefit of NMO patients. See 'Documents’ tab for agenda and 'Multimedia' tab for video of the workshop.

  • 09/10/2014 - 10/10/2014 : EMA

    eXtended EudraVigilance Medicinal Product Dictionary training course

    This training course focuses on explaining the guidance, 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 also known as EVWEB. Places limited.

  • 08/10/2014 - 10/10/2014 : PDCO

    Paediatric Committee (PDCO): 8-10 October 2014

    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.

  • 07/10/2014 - 09/10/2014 : COMP

    Committee for Orphan Medicinal Products (COMP): 7-9 October 2014

    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.

  • 07/10/2014 - 09/10/2014 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 7-9 October 2014

    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.

  • 06/10/2014 - 09/10/2014 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 October 2014

    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.

  • 02/10/2014 - 02/10/2014 : MB

    Management Board meeting: 2 October 2014

    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.

  • 01/10/2014 - 03/10/2014 : EMA

    EudraVigilance training on the electronic reporting of individual case safety reports (ICSRs) in the European Economic Area

    Participants who pass the knowledge evaluation following the course will receive a notification from the European Medicines Agency (EMA) that will allow them to register with the EudraVigilance and report ICSRs to the EMA and / or the National Authorities in the European Economic Area. Places limited.

  • 30/09/2014 - 01/10/2014 : EMA

    Joint European Forum for Good Clinical Practice / Drug Information Association / European Medicines Agency: Better medicines for children conference

    The aim of this conference is to discuss on a high level how the European Union paediatric regulation is working and how it contributes to children’s health. This will include a discussion on the preparedness for the 10-year report, strategic thoughts within the European Medicines Agency on how to streamline paediatric development and a session dedicated to paediatric oncology. Experts from all involved parties will be present, and on day one, participants will discuss more specialised issues in four breakout sessions. Places limited.