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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

  • Horizon 2020 research funding

    EMA has published a dedicated webpage with information that may be helpful for researchers applying for funding under the European Commission's Horizon 2020 programme in the area of health.

  • Key acheivements of ENCePP in its first ten years

    To mark the tenth anniversary of the EMA-coordinated European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), the Agency has published an infosheet highlighting its key achievements. ENCePP has made significant impact on the benefit-risk evaluation of medicines in Europe by providing methodological recommendations that complement regulatory guidance on post-authorisation safety studies.

  • Ten-year report on implementation of the Paediatric Regulation

    In October 2017, the European Commission published a report on progress made in children's medicines since the Paediatric Regulation came into force 10 years ago. The report shows an increase in medicines for children in many therapeutic areas in the last ten years, most notably in rheumatology and infectious diseases. However, it also shows that little progress has been made in diseases that only affect children or where the disease shows biological differences between adults and children, particularly rare diseases. The Commission and EMA and its Paediatric Committee will develop an action plan to improve the implementation of the Regulation.

  • 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. 

  • Antibiotic awareness initiatives, 13-19 November 2017

    EMA has published a package of information in support of World Antibiotic Awareness Week from 13 to 19 November and European Antibiotic Awareness Day on 18 November. This includes a visual guide to how the EU agencies support the fight against antibiotic resistance and a meeting report and video on its joint info session with the European Centre for Disease Prevention and Control on antimicrobial resistance in September, involving EMA's working parties for patients and consumers and for healthcare professionals. For more information, see Antimicrobial resistance.

News for academia

Events of interest

  • 14/12/2017 - 15/12/2017

    CHMP

    Workshop on site and histology - Independent indications in oncology

    Biological drivers that define cancer course across anatomical sites and histologies offer an opportunity to select populations sensitive to specific drugs based on those drivers, independently of the specific site or histology. This workshop aims to provide an exchange of views from different stakeholders about situations where a site and histology-independent clinical development might be a viable option and the associated challenges in terms of drug development, benefit-risk evaluation and health-technology assessment. ... Read more

  • 30/11/2017 - 01/12/2017

    EMA

    Data anonymisation workshop

    The data anonymisation workshop focuses on anonymisation as a key enabler for clinical data sharing. The scope of the workshop includes clinical trial data including individual patient level data and real world data in the context of patient registries and individual cohort studies. ... Read more

  • 24/11/2017 - 25/11/2017

    EMA

    Third tripartite meeting held between EMA, PMDA and FDA to discuss regulatory approaches for the evaluation of antibacterial agents

    This meeting built on the work of previous two meetings between the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in the way these regulators approach the evaluation of antimicrobials, aiming at identifying further areas for convergence. The three agencies agreed to further align how clinical trials should be designed to study the effects of new antibiotics in certain indications, such as uncomplicated gonorrhoea or uncomplicated urinary tract infections. They also committed to working together to explore how to better streamline paediatric development of new antibacterial agents and discussed he importance of characterising the pharmacokinetic-pharmacodynamic relationship and monitoring the benefit-risk balance throughout the medicine lifecycle. The agencies plan to meet again in 2018. ... Read more

  • 29/11/2018 - 30/11/2018

    EMA

    Innovation and biomarkers in cancer drug development (IBCD) 2018

    The innovation and biomarkers in cancer drug development (IBCD) 2018 event will embrace the full environment and explore routes through the constantly evolving scientific, methodological and regulatory environment. The combined efforts of the European Organisation for Research and Treatment of Cancer (EORTC), National Cancer Institute (NCI), European Medicines Agency (EMA), and American Association for Cancer Research (AACR) with the involvement of Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA) and health technology assessment specialists will result in a unique program. The 2018 edition will build upon the recommendations and action points decided upon at the IBCD 2016 edition. Topics, which will be developed, will include items like health technology assessment (HTA) of biomarker assays, comparative effectiveness research and the translation of findings of clinical trials into daily practice. ... Read more

  • 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

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