Information for you
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:
Learn more about how EMA interacts with academia.
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.
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.
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.
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.
EMA held a stakeholder workshop in October 2016 to better understand the challenges and barriers to collaboration between stakeholders on patient registries. The Agency published a workshop report in February 2017, which recommends activities for EMA to undertake to improve stakeholder collaboration and optimise the use of registries to support regulatory decisions.
News for academia
European Immunisation Week: Statement of Guido Rasi, the Executive Director of the European Medicines Agency (EMA)
"We all have to fight vaccine fears to win the war against resurging, vaccine-preventable diseases." ... Read more
Eleven medicines recommended for approval, including four orphans ... Read more
Brineura reviewed under accelerated assessment ... Read more
Update completes previous recommendations issued in March 2017 ... Read more
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Events of interest
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
Workshop on revising the guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicines
The European Medicines Agency (EMA) held a public consultation a concept paper which outlined the major areas for revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’, from July to September 2016. Subsequently, EMA published a draft revised guideline for public consultation, from November 2016 to February 2017. This technical workshop aims to finalise the guidance with further involvement of stakeholders including from other regulatory agencies, pharmaceutical industry, contract research organisations and academia. The focus of the workshop will be on discussing comments received during the public consultations, therefore participation of external stakeholders is limited to those individuals and organisations who submitted comments. The output of the workshop will be reflected in the final revised guideline and the published overview of comments. ... Read more
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
First 2017 meeting of the coordinating group of the European network of paediatric research at the European Medicines Agency (Enpr-EMA)
The Enpr-EMA coordinating group contributes to the short and long-term strategy of the network, discusses and solves operational and scientific issues for the network, reports to the Paediatric Committee, which acts as the scientific committee of Enpr-EMA, and acts as a forum for communication. The group meets three times every year. ... Read more
EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting
This joint PCWP/HCPWP meeting will discuss the European Medicines Agency's (EMA) 2016 annual report 2016, its interactions with patients, consumers, healthcare professionals and their organisations, its work plans for 2018/19, the outcome of the Committee for Medicinal Products for Human Use pilot project, European Antibiotic Awareness Day. It will also provide an update on topic groups including biosimilars, the 10 year report on conditional marketing authorisations, regulators’ and health technology assessment bodies’ related activities and feedback from the scientific committees. ... Read more
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