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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

  • 24/11/2017 - 25/11/2017

    EMA

    Third tripartite meeting held between EMA, PMDA and FDA to discuss regulatory approaches for the evaluation of antibacterial agents

    This meeting built on the work of previous two meetings between the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in the way these regulators approach the evaluation of antimicrobials, aiming at identifying further areas for convergence. The three agencies agreed to further align how clinical trials should be designed to study the effects of new antibiotics in certain indications, such as uncomplicated gonorrhoea or uncomplicated urinary tract infections. They also committed to working together to explore how to better streamline paediatric development of new antibacterial agents and discussed he importance of characterising the pharmacokinetic-pharmacodynamic relationship and monitoring the benefit-risk balance throughout the medicine lifecycle. The agencies plan to meet again in 2018. ... Read more

  • 15/11/2017

    EMA

    Second industry stakeholder platform on research and development support

    This is the second event in a series of (semi-)annual meetings between regulators and representatives of industry stakeholder organisations. It addresses all areas of product development support, from scientific advice, over specifics for paediatric and orphan medicines and to innovation support. This platform aims to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders. Registration by invitation only. ... 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

  • 22/09/2017

    EMA

    PSUR roadmap: joint industry/assessor training

    This joint industry and national competent authority assessors’ training aims to achieve a common understanding of the role of periodic safety assessment reports (PSUR) in the product lifecycle and of the European Union (EU) PSUR single assessment. It is part of the PSUR roadmap activities and will identify key issues encountered by industry and regulators in the preparation of PSURs and share best practices on ways to address them. The webinar will be in the form of a question-and-answer (Q&A) session led by a joint panel of industry and regulators. It will cover the following topics described in the explanatory note to good pharmacovigilance practice (GVP) module VII and the PSUR Q&A for assessors: signals and close monitoring, safety specification, product information / reference safety information and use of summary tabulations. No prior registration is required. Please send questions on any topic to assessors and industry speakers to psurtraining@ema.europa.eu ... Read more

  • 19/09/2017

    EMA

    European Medicines Agency - Payer Community meeting

    The European Medicines Agency and European Union healthcare payers met to explore synergies and foster mutual understanding and cooperation to help improve timely and affordable access for patients to new medicinal products. The meeting aimed to be complementary to EMA's existing cooperation with Health Technology Assessment (HTA) bodies and especially with EUnetHTA. ... Read more

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