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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.

Featured information

  • Clinical data website survey

    EMA has launched a survey on its clinical data website to collect users’ views on the content and usability of the website. EMA launched the website on 20 October 2016 in line with EMA’s policy on the publication of clinical data (Policy 0070). The survey should take less than 10 minutes to complete and user feedback will contribute to further developing EMA’s transparency policies as well as to improving the website. Start the survey

  • biosimilars

    Biosimilar medicines

    EMA and the European Commission have published an information guide for healthcare professionals on the science and regulation underpinning the use of biosimilar medicines. EU scientific experts and organisations representing doctors, nurses, pharmacists and patients contributed to the development of this guide.

  • knowlodge sharing

    Academia framework

    EMA’s Management Board adopted a framework for collaboration between the Agency and academia in March 2017. The framework aims to reinforce and formalise collaboration and clarify its scope in the context of the European medicines regulatory network. Its objectives include raising awareness of the network and further develop regulatory support for translating academic research into novel methodologies and medicines.

  • Personalised medicine

    EMA held a workshop in March 2017 on the challenges and opportunities for personalised medicines and the role of patients and healthcare professionals. The workshop discussed policy developments in Europe and globally, the contribution of the European medicines regulatory network and how clinical practice and public participation can support personalised medicine. EMA will publish the presentations, video recording and a workshop report on the event page.

  • Big data

    Rapid developments in technology have led to the generation of vast volumes of data, which can potentially transform the way the benefit-risk of medicinal products is assessed. EMA held a workshop in November 2016 to gather information on the latest developments in big data from the perspective of all stakeholders. This helps EMA and the European medicines regulatory network to identity how and when the multitude of data sources may contribute to medicine development, authorisation and post-marketing surveillance.

  • Adaptive pathways

    In collaboration with the European Commission, EMA held a workshop to gather the views and proposals from stakeholders on the adaptive pathways approach, following the publication of the final report on the adaptive pathways pilot project. A summary report of the meeting is available.

News for academia

Events of interest

  • 12/06/2017 - 13/06/2017

    EMA

    EMA/FDA/Health Canada joint workshop addressing unmet needs of children with pulmonary arterial hypertension

    This joint workshop organised the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and Health Canada brings together experts and stakeholders to discuss requirements for the development of medicines in paediatric pulmonary arterial hypertension (PAH) and to address the need of the current paediatric clinical practice in a timely manner. The objectives are to improve the understanding of problems related to the conduct of clinical trials in the paediatric population, refine endpoints and study design to address the clinical trials challenges in this rare paediatric population, set priorities in future research in the field of pharmacokinetics and pharmacodynamics measurements and post-marketing tools in paediatric PAH medicines and provide medicine developers with more guidance specific to global product development which takes into account current limitations. ... Read more

  • 19/05/2017

    EMA

    First anniversary of PRIME: experience so far

    The European Medicines Agency (EMA) launched the PRIME (PRIority Medicines) scheme in March 2016. The scheme provides early and enhanced support to medicines that have the potential to address patients’ unmet needs. This meeting is organised by EMA to review the experience gained with PRIME one year after it was launched. The aim of the meeting is to receive feedback from users and potential users of the scheme, provide information on how the rules on eligibility have been applied and what types of support applicants have received so far and discuss practical examples that illustrate the benefits of PRIME and how it builds on the existing tools.  ... Read more

  • 22/06/2017 - 23/06/2017

    EMA

    Focus group with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines

    The Agency is organising a Focus group meeting with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines. The scope of the meeting is to explore the specific challenges faced by industry in performing field trials to support efficacy claims in the context of an EU authorisation for veterinary vaccines and how these challenges might be overcome whilst still obtaining adequate assurances of the expected efficacy of a vaccine under field conditions. The focus group meeting is within the scope of the HMA Network Strategy on availability for veterinary vaccines that aims to increase their availability by ensuring efficient and effective cooperation between all stakeholders. ... Read more

  • 13/11/2017 - 14/11/2017

    PDCO

    Second paediatric strategy forum on medicine development for mature B cell malignancies in children

    This second multi-stakeholder paediatric strategy forum, jointly organised by ACCELERATE and the European Medicines Agency, will focus on mature B cell malignancies (lymphoma and leukaemia) in children. The goal of this meeting is to share information, in a pre-competitive setting, which will inform a paediatric drug development strategy and subsequent decisions and facilitate the developments of innovative medicines for the treatment of children with B cell malignancies. Participation is restricted and on invitation only. Interested parties, including patients and parent-representatives, academia, clinicians and industry, should express their interest. For clinicians and researchers, priority will be given to those who have expertise and experience in clinical trials for B cell malignancies in children or intend to design such studies in the future. ... Read more

  • 14/03/2017

    EMA

    Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised medicines

    The joint PCWP/HCPWP workshop on personalised medicines aims to create awareness among patient, consumer and healthcare professional organisations of how the work of the European Medicines Agency (EMA) relates to this topic. The working parties will also reflect on priority areas for future contributions in broader multi-stakeholder discussions. The objectives of the workshop include understanding how European and global landscapes are shaping policy developments, illustrating how activities of the European medicines regulatory network contribute to personalised medicine with existing legislation and regulatory tools, discussing how clinical practice and public participation can support personalised medicine in the context of European Union (EU) regulatory activities and identifying areas requiring attention from EU regulators, patients, healthcare professionals and civil society at large. EMA will publish the presentations, video recording and a workshop report. ... Read more

  • See all Events of interest

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