Academia

The European Medicines Agency (EMA) is committed to maintaining a strong working relationship with European academics and researchers. Collaboration between the Agency and academia is necessary for the Agency to be prepared for future challenges and opportunities offered by advances in science and technology. The Agency has targeted engagement with academia, learned societies and research groups in a range of areas.

EMA provides regulatory and scientific support to foster development of new and innovative medicines, from the early phases in the laboratory all the way to the patient.

EMA achieves it through the following resources:

• Innovation Task Force
• EU Innovation Network
• SME Office
• PRIME scheme
• Qualification advice on novel methodologies
• Scientific advice / protocol assistance
• Post-authorisation

EMA can provide protocol assistance free of charge to academic organisations developing orphan medicines, as of 19 June 2020. EMA offers this incentive to further encourage the development of medicines for rare diseases.

For more information, see Fees payable to the European Medicines Agency.

Through a pilot project, EMA and national competent authorities can offer tailored scientific advice to not-for-profit organisations and academics (institutions and individuals) on repurposing an authorised medicine for a new indication. The deadline to apply was 28 February 2022. For more information, see:

•  Scientific advice on medicine repurposing

For more information on how the Agency supports medicine developers, see  EMA tools available to medicine’s developers from the academic sector.

Regulatory Science to  2025

EMA's Regulatory Science Strategy Plan to 2025 aims to develop strong engagement with regulatory science, covering both human and veterinary medicines.

EMA runs a Cancer Medicines Forum since March 2022, aiming to help advance research into optimising cancer treatments and foster high standards in cancer care in the European Union (EU).

EMA co-chairs the forum with the European Organisation for Research and Treatment of Cancer (EORTC).

It brings together academic organisations from EMA’s Healthcare Professionals Working Party and the European medicines regulatory network. Other members include:

• European Haematology Association (EHA)
• European Society of Medical Oncology (ESMO)
• European Society for Paediatric Oncology (SIOPE)
• International Society of Geriatric Oncology (SIOG)

Observers include health technology assessment bodies, patient and industry organisations, and:

• Organisation for Economic Co-operation and Development (OECD)
• International Association of Mutuals (AIM)
• European Social Insurance Platform (ESIP)

The forum aims to help prioritise actions to fight cancer in EMA's Regulatory Science Strategy to 2025 and Academia Collaboration Matrix Action Plan.

The forum meets quarterly. Agendas, minutes and meeting materials are available:

• Cancer Medicines Forum: March 2023 (07/03/2023)
• Cancer Medicines Forum: December 2022 (21/12/2022)
• Cancer Medicines Forum: June 2022 (28/06/2022)
• Cancer Medicines Forum: kick-off meeting (31/03/2022)

EMA and the Heads of Medicines Agencies (HMA) are running a pilot project to enable clinical-oncology scientists to participate in medicine regulation. The pilot aims to achieve this by providing them with an understanding of basic principles relevant to their field.

The pilot focuses on scientific advice and marketing authorisation assessments for human medicines.

Prospective candidates must have experience in clinical oncology or haemato-oncology.

They do not need to have any prior understanding of regulatory requirements in medicine evaluation.

The pilot consists of live and recorded webinars covering the following areas:

• Basic principles of the regulation of human medicines in the EU
• Basic regulatory aspects relevant to oncology

Prospective candidates can apply by completing a brief registration form.

Participation is free of charge.

EMA and HMA launched the pilot in May 2023. It will be rolled out over 12 months.

It aims to increase collaboration between regulatory authorities and stakeholders in healthcare and academia, in line with the recommendations of the STARS common strategy.

EMA seeks the expert input of healthcare professionals (i.e. academics, researchers, clinicians) and patients in its work through several channels, including:

• as members and experts of its scientific committees, working parties and scientific advisory groups;
• in the preparation of scientific guidelines;
• as seconded national experts;
• as visiting experts;
• as participants in the Agency's conferences, workshops and public consultations;
• as prescribers and handlers of the medicines that the Agency evaluates.

If the Agency needs expert input to help with a particular activity or piece of work, other collaboration opportunities may arise. Such collaborations are non-remunerated and exclude any direct involvement in the authorisation and supervision of human or veterinary medicines.

How to get involved as an expert

All experts need to complete certain forms before their involvement in specific EMA activities, in particular those related to the assessment of medicines. These include:

• the declaration-of-interests and confidentiality-agreement form: EMA has a robust conflicts of interests policy to ensure that experts participating in the Agency's activities have no interests in the pharmaceutical industry that could affect their impartiality. As part of this policy, all patient and consumer representatives working with the Agency must complete a public declaration of interests and confidentiality form;
• the expert-nomination form and e-curriculum vitae (e-CV): all experts need to complete a nomination form and electronic curriculum vitae.

For more guidance on filling in the forms, please see the guidance for submission and validation of eletronic declarations and electronic curriculum vitae

Individual academics, as specialists in their area can contribute their expertise to EMA activities. You can register your interest to be included in the individual stakeholder database, by completing the online registration form at:

• Involvement in EMA activities: registration for interested individuals

For more information on the database, see: 

• EMA’s individual stakeholder database: patients, consumers, healthcare professionals and academia - Frequently asked questions

Programme for young researchers

EMA encourages young researchers/professionals interested in EMA's work to explore the ten-month traineeship programme. This is an opportunity for recent graduates to learn new skills and get a valuable work experience.

How to learn more about EMA activities

EMA provides several training resources in the format of videos, presentation slides and related documents, for those interested in learning more about the Agency activities.

EMA is involved in a number of research projects with academia, learned societies and research groups, as part of its mission to foster scientific excellence in the evaluation and supervision of medicines. EMA believes that performing research following the regulatory standards brings public health benefits.

The research projects are mostly funded by Horizon 2020, the largest ever European Union (EU) funding programme for research and innovation. The Agency provides support to medicine developers and researchers applying for funding and engages in externally funded projects either as consortium member or as part of an advisory board.

The Agency also supports other H2020 initiatives, including Marie Skłodowska-Curie actions (MSCA), giving the opportunity to host visiting students in the framework of the related project.

EMA is involved in other research projects, that are part of the Innovative Medicines Initiative.

For more details on EMA involvement in externally funded projects, including funding arrangements and the process for enquiring about the Agency involvement, see  European Medicines Agency process for engaging in externally funded regulatory sciences and process improvement research activities for public and animal health. 

For more information on EMA's approach to contributing to research:

• see Support to research or
• contact us via regulatory.science@ema.europa.eu.

EMA has a framework for collaboration with academia, since 2017. This aims to:

• raise awareness of EMA's role within the European medicines regulatory network;
• promote and further develop regulatory support for translating academic research into novel methodologies and medicines;
• ensure that the best scientific expertise and academic research is available to inform regulatory decision-making;
• collaborate on areas of research on regulatory science, such as novel approaches, endpoints and methodologies.

The framework is in line with EMA's overarching framework for stakeholder relations management.

EMA's academia collaboration matrix action plan for 2021 to 2023 sets out how EMA intends to create closer ties with academics and researchers.

It lists actions in five areas identified in EMA's Regulatory Science Strategy to 2025:

• Regulatory science and partnerships
• Innovation and support to academia
• Communication
• Events strategy
• Training