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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

  • bacteria

    Antimicrobial resistance: information session

    On 19 September, EMA’s patients and consumers and healthcare professionals working parties attended an information session to raise awareness of the work of European Union institutions and agencies, Member States and World Health Organization in the fight against antimicrobial resistance. The meeting stimulated an exchange of ideas on improving communication, education and training. The presentations and recording of the session are available.

  • public_hearing_report

    Public hearing at EMA

    Patients, carers, doctors, pharmacists and academics shared their experiences with valproate, a medicine currently prescribed for epilepsy, bipolar disorder and migraine, at EMA’s public hearing on 26 September 2017. 65 people attended including 28 patients and patient representatives, 19 healthcare professionals and academics, 11 attendees from pharmaceutical industry and 7 from media. There were 25 speaker contributions,grouped into 16 speaker slots. The European Parliament representative concluded that the hearing was a positive experience. A summary report is available. 

  • 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.

  • Encepp

    Updated methodological guidance on pharmacoepidemiology studies

    The European network of centres for pharmacoepidemiology and pharmacovigilance (ENCePP) has published a major revision of its guide on methodological standards in pharmacoepidemiology. Changes include new chapters on patient registries and on surveys, as well substantial updates to existing sections on protocol development, bias and confounding, pragmatic trials and large simple trials, quality management and scientific integrity and ethical conduct. For more information, see ENCePP Guide on Methodological Standards in Pharmacoepidemiology.

News for academia

Events of interest

  • 16/10/2017 - 17/10/2017

    Joint Drug Information Association (DIA) / European Forum for Good Clinical Practice (EFGCP) /European Medicines Agency (EMA) conference on how to optimise children's access to innovative medicines

    The 2017 DIA/EFGCP/EMA Annual Paediatric Conference focuses on how to optimise children’s access to new medicines. With more than 10 years of the EU Paediatric Regulation, all stakeholders involved in paediatric drug development have seen progress in developing new medicines for children. This conference explores how to build on the successes from the past 10 years of EU Paediatric Regulation, and how to overcome challenges that still exist. The objectives of this year's conference include: - To update participants on current paediatric regulatory requirements, scientific and operational success and challenges; - To exchange experiences with regulatory authorities, academia and industry when developing medicines for children globally; - To discuss visions, daily challenges and potential ways to move forward and further improve processes for paediatric drug development. The registration form is included in the published agenda. ... Read more

  • 05/10/2017

    EMA

    First EMA workshop on non-animal approaches in support of medicinal product development: challenges and opportunities for use of micro-physiological systems

    The workshop aims to map the current state-of-science in the field of non-clinical development of medicines, develop a common understanding of the benefits and limits of these methods, identify gaps in non-clinical safety testing and stimulate research using these methods to address these gaps and encourage use in regulatory testing. The workshop will also encourage dialogue between developers, users and regulators and to facilitate the regulatory acceptance of innovative non-animal methods for a defined context of use for the approval of safe medicines while promoting the 3Rs (replacement, reduction and refinement principles. ... Read more

  • 01/12/2017

    EMA

    European Medicines Agency (EMA) / Drug Information Association (DIA) statistics forum: The role of observational data in assessing the benefits and risks of medicines

    This forum considers the place of observational research in the clinical evaluation of medicines and seeks views on how to select promising study designs, prospectively specify objective criteria for evaluation of study results and define procedures to ensure the reliability of results. The overall aim is to contribute to the ongoing debate on how to assess research based on observational studies and in particular, how to pre-specify criteria of ‘success’ in an observational study in a way that would allow confident design of a research programme to meet regulatory requirements. These discussions will address the lack of regulatory guidance in this area, which was highlighted by moves to extend the use of epidemiological analyses (previously used primarily for prospective clinical trials) into areas of medicine development due to the increasing availability of more and higher quality observational data. ... Read more

  • 03/05/2018 - 04/05/2018

    EMA

    Workshop on the reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

    The European Medicines Agency has published a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (EMA/CHMP/138502/2017), for a 1-year public consultation until 31 March 2018. In order to facilitate multidisciplinary interaction between regulators and stakeholders on statistical methodology applied to the quality of medicines, a 1.5-day workshop is held. The main focus of the workshop is the discussion of comments received during the public consultation. Stakeholders are therefore encouraged to provide comments well in advance (ideally by the end of November 2017). Stakeholders can express their interest to participate in this workshop by writing to RP-stats-QA@ema.europa.eu. Due to limited spaces, priority will be given to those who provided relevant comments. The output of the workshop will have a direct impact on the finalisation of the reflection paper. ... Read more

  • 15/03/2017

    EMA

    EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting

    This joint PCWP/HCPWP meeting discusses the European Medicines Agency's 2016 annual report, 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 also provides 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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