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Welcome to the European Medicines Agency’s online media centre. This page highlights information which is 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.

For more information, please contact the EMA press office

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News for media professionals

Events of interest

  • 15/04/2016

    PDCO

    European Medicines Agency-Industry Stakeholders Platform second meeting on paediatric medicines

    The European Medicines Agency (EMA) is hosting the second EMA-Industry Stakeholders Platform meeting on paediatric medicines. This meeting will serve as stage to discuss among other topics the experience, so far, with paediatric standard paediatric-investigation plans (PIPs), the pilot on early interaction on paediatric development and changes to the summary report and electronic submission. ... Read more

  • 30/06/2016

    EMA

    Workshop on single-arm trials (SAT) in oncology

    Single-arm trials (SATs) have led to regulatory approval of oncology products in case of dramatic activity in well-defined populations with high unmet medical need. Further, when randomized-controlled trials are not possible, SATs augmented with statistical approaches may become the standard basis of evidence of efficacy for new applications. However, what constitutes dramatic activity and high unmet medical need is often debated and there is no regulatory guidance on cancer drug development in these situations and how to manage the remaining uncertainties optimally. This workshop will debate the experience gained with these types of approvals, the strengths and weaknesses of different approaches, explore the views of different stakeholders and underlying principles, and will discuss the need and appropriateness for further regulatory guidance. ... Read more

  • 27/05/2016

    EMA

    Multi-stakeholder advanced therapy medicinal products (ATMPs) expert meeting: exploring solutions to foster ATMPs’ development and patient access in Europe

    With representation from the European medicines regulatory network and the European Commission, EMA is organising this multi-stakeholder expert meeting on ATMPs to address challenges identified to pharmaceutical innovation in Europe. The aim is to understand the current European Union environment for ATMPs and to explore new or different ways for stimulating innovation, facilitating European research and development and accelerating patients’ access to high quality, safe and efficacious ATMPs. EMA has invited a broad range of experienced stakeholders involved throughout the ATMP medicines’ life cycle, from early research and development through to the product supply chain. This includes experienced academics, incubator managers, investors, healthcare professionals, patients, industry representatives (from micro-, small- and medium-sized as well as large companies) and health-technology-assessment bodies. ... Read more

  • 07/06/2016

    EMA

    Targeted consultation on the guideline for development of new medicinal products for the treatment of rheumatoid arthritis

    In the frame of public consultation on the revision of the guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of rheumatoid arthritis, the European Medicines Agency is hosting a meeting to supplement the ongoing debate. ... Read more

  • 02/06/2016 - 03/06/2016

    EMA

    2016 annual workshop of the European network of paediatric research (Enpr-EMA) at the European Medicines Agency

    The first day of the workshop is an open meeting to all stakeholders, including patient and parent organisations, network representatives, pharmaceutical industry staff responsible for paediatric studies and regulators. The main tocpics of the workshop this year will be the deliverables of the working groups and the implementation of the new Clinical Trial Regulation with a focus on ethics related issues. The second day is dedicated to members of Enpr-EMA and its coordinating group. ... Read more

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