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    Strategic Review and Learning Meeting of the scientific committees of the European Medicines Agency in Tallinn

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    The joint Strategic Review and Learning Meeting of the two EMA committees - Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC) will take place in Tallinn on 17-18 October 2017.

    The meeting will be held under the auspices of the Estonian Presidency of the Council of the EU. As the availability of appropriately authorised medicines, as well as innovation and access to new medicines had been selected by the Estonian State Agency as key priorities to progress during its Presidency, meetings of the both committees will cover these aspects.

    The joint session of the two committees will discuss the role of digital solutions in drug development. Presentations will be given by the experts from United Kingdom, United States and Estonia. While the use of electronic health records is well established in epidemiological studies to detect and assess safety signals their use in clinical trials during drug development is so far limited. The discussions will focus on standards, access and confidentiality of digital health data in relation to their secondary use for research purposes. The role of the competent authorities to support the developments in eHealth based research will be explored.

    Another major topic will be the role of the medicines regulators in supporting the adequate development of pharmaceuticals throughout their whole lifecycle to ensure collection of clinically relevant and sufficient information about their benefits and risks. The EU initiatives in the pre- and post-authorisation phase of development (PRIME programme, the use of registries and other observational data) will be reviewed.

    At their meeting the CHMP will further discuss the methodological aspects of the oncology trials, the context and the regulatory back-ground for the risk-benefit assessment, the developments in how the clinical safety of new medicines is analysed, as well as the more regulatory topic of how to best reflect the clinical data in the product information.

    The PRAC meeting will focus on the measurement of the effectiveness of the risk minimisation measures, on the improvement of the safety communication to the health care professionals and on the overlapping aspects of the availability and safety of medicines. Presentations will also cover better utilisation of the observational data reflecting the real-life use of medicines in the process of assessment of the benefit-risk ratio of the medicinal products. Dr Maia Uusküla, the Estonian delegate to the PRAC, will give a presentation on the safety e-communication to the health care professionals and Katrin Kurvits from the Estonian Agency of Medicines will cover the possibilities of using the administrative databases of the Estonian Health Insurance Fund to answer pharmacovigilance related research questions.

    The meeting will be held in Radisson Blu Hotel Olümpia, Tallinn, October 17-18.