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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.

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News for academia

Events of interest

  • 24/09/2018

    EMA

    12th Pharmacovigilance stakeholder forum

    This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years. ... Read more

  • 03/12/2018

    European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)

    This workshop on the development of medicines for chronic non-infectious liver diseases, including primary biliary cholangitis, primary sclerosing cholangitis and nonalcoholic steatohepatitis, provides a platform for discussion on appropriate endpoints including validation of surrogate endpoints/biomarkers, suitable study populations, potentially adequate trial designs and the specific challenges with paediatric medicine development. The workshop will support the drafting of a reflection paper on regulatory requirements for the development of medicines for the treatment of these diseases. ... Read more

  • 25/10/2018

    PRAC

    Risk management plan information day

    This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety specification for biologicals with a special focus on biosimilars, so that only risks that are important for risk management and relevant for the benefit-risk of the product are included in the RMP. The Agency will provide updates on risk management aspects of the new good pharmacovigilance practice (GVP) guidance on special populations such as children and elderly. Other topics will include risk communication and patients’ access to information on the safety of medicines. ... Read more

  • 12/10/2018

    CVMP

    Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation

    This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental approaches for dose optimisation and evaluating the consequences on withdrawal periods, target animal safety, and environmental risk assessment, with the objective of improving the SPC of veterinary antibiotics authorised in the European Union. ... Read more

  • 08/06/2018

    EMA

    European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting

    The 2018 face-to-face meeting of Enpr-EMA networks and coordinating members takes place after the annual open workshop on 8 June. The networks meeting will focus on the outcome of the 2018 annual workshop of the 7 June and the action plan for 2018/2019. ... Read more

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