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On this page, we highlight information of partcular relevance for media, including news, events and featured information for journalists with a professional interest in the development and availability of medicines in the European Union.

For more information and details relevant for media, see our News & events section. 

For enquiries from media, please contact the EMA press office

Featured information

News for media

Events of interest

  • 20/06/2017 - 21/06/2017

    EMA

    Workshop on generation and use of Health Based Exposure Limits (HBEL)

    The aim of this workshop is to develop understanding of the use and application of Health-Based Exposure Limits (HBELs) in the context of quality risk management of cross contamination during the manufacture of different products in the same manufacturing facilities. The workshop is by invitation only and experts in toxicology and manufacturing quality representing the manufacturing industry will meet with regulators representing GMP/GDP Inspectors Working Group and Safety Working Party (human and veterinary sectors). The workshop reviews current experience from the industry in the implementation of recent guidance and experience from GMP inspections. Time will be spent discussing the Questions and Answers on this topic recently published by EMA for public consultation. The need for further industry guidance and the feasibility of developing a training program that could be used for inspectors and industry will also be explored. A summary of the discussions will be published. ... Read more

  • 29/06/2017

    EMA

    Update on the implementation of policy on publication of clinical data (Policy 0070) – Industry associations webinar

    This webinar with industry associations provided an update on the implementation of the Agency's policy on publication of clinical data (Policy 0070). ... Read more

  • 13/11/2017 - 14/11/2017

    PDCO

    Second paediatric strategy forum on medicine development for mature B cell malignancies in children

    This second multi-stakeholder paediatric strategy forum, jointly organised by ACCELERATE and the European Medicines Agency, will focus on mature B cell malignancies (lymphoma and leukaemia) in children. The goal of this meeting is to share information, in a pre-competitive setting, which will inform a paediatric drug development strategy and subsequent decisions and facilitate the developments of innovative medicines for the treatment of children with mature B cell malignancies. Participation is restricted and on invitation only. Interested parties, including patients and parent-representatives, academia, clinicians and industry, should express their interest. For clinicians and researchers, priority will be given to those who have expertise and experience in clinical trials for mature B cell malignancies in children or intend to design such studies in the future. ... Read more

  • 12/06/2017 - 13/06/2017

    EMA

    EMA/FDA/Health Canada joint workshop addressing unmet needs of children with pulmonary arterial hypertension

    This joint workshop organised the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and Health Canada brings together experts and stakeholders to discuss requirements for the development of medicines in paediatric pulmonary arterial hypertension (PAH) and to address the need of the current paediatric clinical practice in a timely manner. The objectives are to improve the understanding of problems related to the conduct of clinical trials in the paediatric population, refine endpoints and study design to address the clinical trials challenges in this rare paediatric population, set priorities in future research in the field of pharmacokinetics and pharmacodynamics measurements and post-marketing tools in paediatric PAH medicines and provide medicine developers with more guidance specific to global product development which takes into account current limitations. ... Read more

  • 18/09/2017 - 19/09/2017

    EMA

    Introduction to the European Union regulatory system and European Medicines Agency for international regulators and non-governmental organisations

    This two-day awareness session is for international regulators and non-governmental organisations. It gives an insight into the European Union (EU) regulatory system for medicines and the role of the European Medicines Agency (EMA). Insight into the EU system is of prime importance in an increasingly globalised world where worldwide regulators rely on close cooperation. The EU system is one of the most advanced in the world, but it is also one of the most complex. It is based on a network of decentralised agencies in the EU Member States, supported and coordinated by EMA. ... Read more

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