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On this page, you will find information on the European Medicines Agency’s (EMA) activities that are most relevant to academia, including news and events.

Learn more about the Agency's resources to support medicine development:

Human regulatory: Research and development
Veterinary regulatory: Research and development

Learn more about how EMA interacts with academia.

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News for academia

Events of interest

  • 07/06/2018

    EMA

    2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)

    Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research networks, learned societies, national paediatric associations/societies, ethics committees, regulators, Health Technology Assessment bodies and industry); and ii) an interactive general discussion on how to avoid duplication of trials, how to improve communication, how to divide work between groups and on the challenges of clinical trials in (ultra) rare diseases. The following day is reserved for discussions among the members of Enpr-EMA. ... Read more

  • 26/10/2018

    EMA

    Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers

    The SME info day provides an update on regulatory affairs topics for developers of human medicines and combined devices. It covers subjects such as data exclusivity and market protection, orphan and paediatric rewards, legal basis for submission of a marketing authorisation application, conditional marketing authorisations and approvals under exceptional circumstances, classification of advanced therapies and EMA activities in relation to the new medical device legislation. An update on Brexit-related activities will also be provided at the end of the event. The 'Meet EMA' event will provide an opportunity for SMEs to engage with EMA staff from different departments to increase awareness of the range of support available at EMA. The event is open to companies that have been assigned SME status by EMA and to representatives of stakeholder organisations. It will be broadcast and recorded for interested parties to follow the proceedings. ... Read more

  • 08/06/2018

    EMA

    European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting

    The 2018 face-to-face meeting of Enpr-EMA networks and coordinating members takes place after the annual open workshop on 8 June. The networks meeting will focus on the outcome of the 2018 annual workshop of the 7 June and the action plan for 2018/2019. ... Read more

  • 21/06/2018 - 22/06/2018

    EMA

    Workshop on the development of antimicrobial medicinal products for paediatric patients

    The European Medicines Agency, the Japanese Pharmaceuticals and Medical Devices Agency and the United States' Food and Drug Administration are co-organising this workshop to discuss the development of antibiotics for children. This will provide an opportunity for international regulators to explore with medicine developers, clinicians and clinical trial investigators, clinical development plans that would allow for the timely development of antibiotics for children and discuss a regulatory pathway for their approval. Please send expressions of interest to attend the workshop by 6 June 2018. ... Read more

  • 29/05/2018 - 30/05/2018

    EMA

    EMA / RD-ACTION / DG SANTE workshop: how European Reference Networks can add value to clinical research

    The main objective of this workshop organised by the European Medicines Agency (EMA), RD-ACTION (the European Joint Action for Rare Diseases) and the European Commission’s Directorate General for Health and Food Safety (DG SANTE), is to explore how to work together with the European Reference Networks (ERNs) in the field of complex and rare diseases. The workshop will look at how EMA and ERNs can reinforce each other’s efforts to encourage and facilitate research into new treatments for rare and low-prevalence complex diseases and how ERNs could be engaged in EMA activities. The first ERNs were launched in March 2017, involving more than 900 highly-specialised healthcare units from over 300 hospitals in 26 European Union countries. Presently, 24 ERNs are operational covering a large range of therapeutic areas. ... Read more

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