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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

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Events of interest

  • 01/12/2017

    EMA

    European Medicines Agency (EMA) / Drug Information Association (DIA) statistics forum: The role of observational data in assessing the benefits and risks of medicines

    This forum considers the place of observational research in the clinical evaluation of medicines and seeks views on how to select promising study designs, prospectively specify objective criteria for evaluation of study results and define procedures to ensure the reliability of results. The overall aim is to contribute to the ongoing debate on how to assess research based on observational studies and in particular, how to pre-specify criteria of ‘success’ in an observational study in a way that would allow confident design of a research programme to meet regulatory requirements. These discussions will address the lack of regulatory guidance in this area, which was highlighted by moves to extend the use of epidemiological analyses (previously used primarily for prospective clinical trials) into areas of medicine development due to the increasing availability of more and higher quality observational data. ... 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

  • 14/11/2017

    EMA

    European Medicines Agency information day on measuring the impact of pharmacovigilance activities

    Measuring the impact of pharmacovigilance is essential to allow regulators and pharmaceutical industry to ensure key pharmacovigilance activities are effective and efficient and to support regulatory decisions. Effective risk minimisation balancing benefits and risks of medicines are important tools for patient empowerment and to achieve best public health outcomes. A workshop in 2016 highlighted the need for a sustainable framework, robust scientific methodologies, timely generation of decision-relevant data and clear roles and responsibilities as key pillars of impact research. Based on these recommendations, PRAC is revising its strategy to evaluate EU pharmacovigilance activities in a collaborative approach with clearly defined process indicators and measures of patient health outcomes. At this event stakeholders discuss methodologies for impact research, enablers and barriers to impact, and foster collaboration and sharing of impact relevant information. ... Read more

  • 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

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