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This section of the website contains the European Medicines Agency's news and press releases, information on meetings and events, public consultations and related information.

For a scrolling feed of all of the new and updated information published on the website, see the what's new page.

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This month's events

December 2017

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  • 2017-12-15 - 2017-12-15 : EMA

    EudraVigilance information day

    This EudraVigilance information day provides a forum to discuss the very initial experience of stakeholders with the new EudraVigilance system functionalities following its launch in November 2017, the use of the new ICH E2B(R3) standard, the simplified adverse reaction reporting and the data analysis outputs. The Information Day will also serve as a platform to experts to raise questions on the practical application of the recently revised GVP Modules VI and IX.

  • 2017-12-15 - 2017-12-15 : EMA

    Fourteenth joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting

    The EMA and EUnetHTA have been holding regular dialogue since 2010. The key topics of this meeting are concepts related to orphan medicines (significant benefit vs relative effectiveness), opportunities for collaboration on horizon scanning, reflections on the concept of evidence transfer / extrapolation, principles of the working of the indication as well as ongoing initiatives on post-licensing evidence generation. A report from the meeting will be published later.

  • 2017-12-14 - 2017-12-15 : CHMP

    Workshop on site and histology - Independent indications in oncology

    Biological drivers that define cancer course across anatomical sites and histologies offer an opportunity to select populations sensitive to specific drugs based on those drivers, independently of the specific site or histology. This workshop aims to provide an exchange of views from different stakeholders about situations where a site and histology-independent clinical development might be a viable option and the associated challenges in terms of drug development, benefit-risk evaluation and health-technology assessment.

  • 2017-12-12 - 2017-12-15 : PDCO

    Paediatric Committee (PDCO): 12-15 December 2017

    The Paediatric Committee (PDCO) is the committee that is responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children, as well as waivers and deferrals.