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This page highlights information which of specific interest to media professionals.

The page is kept updated with news, events and information for journalists with a professional interest in the development and availability of medicines in the European Union.

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Events of interest

  • 17/11/2014 - 21/11/2014

    EMA

    European Commission - European Medicines Agency - China Food and Drugs Administration bilateral and International Summit of Heads of Medicines Regulatory Agencies

    The European Union China Working Group on Pharmaceuticals, which brings together the European Medicines Agency (EMA), the European Commission (EC) and the China Food and Drugs Administration, meets on 18 November to progress discussions on active-pharmaceutical-ingredient, good-clinical-practice and good-pharmacovigilance-practice inspection-related topics. The ninth International Summit of Heads of Medicines Regulatory Agencies takes place on 19-21 November, with representatives from EMA, EC, and a number of European, national and international partner regulators, including the World Health Organization. Discussions include registration of generics, biosimilars, access to medicines, innovative products and major public health concerns such as Ebola, antimicrobial resistance and dementia. The International Coalition of Medicines Regulatory Authorities meets on 20 November to review cooperation in good-manufacturing-practice inspection, information-sharing and capacity-building. ... Read more

  • 01/12/2014

    EMA

    Workshop on the 'Guideline on pharmaceutical development of medicines for paediatric use'

    The Quality Working Party is organising a workshop on the 'Guideline on pharmaceutical development of medicines for paediatric use'. The guideline has been in force as of February 2014 and is intended to provide additional guidance to pharmaceutical developers on quality aspects related to medicinal products for children between birth and 18 years of age. As more experience becomes available, further work is required to complement the guideline with additional recommendations on pharmaceutical development of paediatric medicines. The general scope of this workshop is to share the experience gained so far with the use of the guideline among stakeholders (regulators, healthcare professionals, academia and industry) and identify gaps in current knowledge. This workshop should be considered as a starting point for discussions. Registration closed. ... Read more

  • 11/09/2014

    EMA

    Committee for Advanced Therapies (CAT) and the German Society for Transfusion Medicine and Immunohaematology (DGTI) workshop on advanced-therapy medicinal products: How to bring cell-based medicinal products successfully to the market

    The workshop is co-organised by the European Medicines Agency's (EMA's) Committee for Advanced Therapies (CAT) and the German Society for Transfusion Medicine and Immunohaematology (DGTI) in collaboration with the German Stem Cell Network (GSCN) and aims to strengthen dialogue between CAT and the advanced-therapy-medicinal-product (ATMP) developers in industry, academia and hospitals and to facilitate ATMP development and access to the registration procedure. The workshop will allow for the attendees to learn about the development and authorisation of cell-based ATMPs in the European Union and the role of the CAT; to learn about the support provided by EMA and the CAT to ATMP developers; to understand the criteria that CAT applies for the classification of ATMPs; and to hear about CAT’s considerations and recent interactions with experts on cell-based therapies for cardiac repair. It will also allow to interact directly with the Regulators in an open forum discussion. ... Read more

  • 25/09/2014 - 26/09/2014

    EMA

    eXtended EudraVigilance Medicinal Product Dictionary training course

    The training 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. ... Read more

  • 20/11/2014 - 21/11/2014

    EMA

    eXtended EudraVigilance Medicinal Product Dictionary training course

    The training 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. ... Read more

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