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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

Featured information

News for media professionals

Events of interest

  • 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

  • 14/06/2016

    EMA

    10th anniversary of European Medicines Agency’s Patients' and Consumers' Working Party (PCWP)

    2016 marks the 10th anniversary of the European Medicines Agency’s (EMA) PCWP. A working group of patients' organisations was first created in 2003. Following endorsement of its framework of interaction by EMA’s Management Board, the working group was formalised into an official working party, the PCWP. Building on the importance of multi-stakeholder dialogue, the PCWP regularly holds its annual meetings jointly with the Healthcare Professionals’ Working Party. The PCWP is a unique platform for exchange and dialogue with patients and consumers on all issues related to medicines. The EMA is proud of the work of the PCWP and this anniversary meeting will be an opportunity to reflect on past successes and to plan for the future. ... 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, co-organised with the European Society for Medical Oncology (ESMO), 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

  • 28/10/2016

    EMA

    Periodic safety update report information day

    This information day provides a forum to discuss ongoing activities and status of periodic safety update report (PSUR) single assessment procedures, with a particular emphasis on the PSUR roadmap and how it supports reaching a common understanding of the single assessment. The roadmap is key to optimising the process and content of PSURs and the EU single assessment (PSUSA). The information day will also look into the procedural improvements that are already implemented and discuss further improvements based on views from the pharmaceutical industry. The event will also provide an opportunity for industry, EMA and national competent authorities to share experiences on the mandatory use of the PSUR repository lessons learned from the transition. It will also outline the role of PSURs in inspections from inspectors’ and industry’s point of view. ... 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

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