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Tuesday, 14 March 2017

Personalised Medicines and the European Medicines Agency

London, 14th - 15th March
The European Medicines Agency is hosting workshops for its Working Parties of  Patients', Consumers' and Health Professionals' organisations.

The 14th March workshop aims to create awareness among these organisations of how the work of the European Medicines Agency (EMA) relates to personalised medicines

The 15th March workshop provides updates on other EMA and relevant external acfivities including feedback on topic groups on Social Media and on Risk Minimisation from medicines, European Antibiotic Awareness, Action plans on Biosimilars, feedback from key EMA committees and synergies with other organisations.

Key aims
- understanding how European and global landscapes are shaping policy developments
- illustrating how activities of the European medicines regulatory network contribute to personalised medicine with existing legislation and regulatory tools
- discussing how clinical practice and public participation can support personalised medicine in the context of European Union (EU) regulatory activities
- identifying areas requiring attention from EU regulators, patients, healthcare professionals and civil society at large
- reflection by the working parties on priority areas for future contributions in broader multi-stakeholder discussions. 

Speakers include:  
- Sandra Kweder from the US Food and Drugs Administration, discussing  the US precision medicine initiative. She highlighted the need to personalise medicines with cancer a key driver - only 80% of patients estimated to respond better when individual genomic and proteomic information is available.

- briefings from EMA's Scientific Committees e.g.  PRAC chair June Raine discussing pharmacogenomics in pharmacovigilance e.g. preventing serious skin reactions to abacavir in HIV patients and limiting toxicity of anti-cancer agents e.g. 5-fluoro-uracil and capecitabine

- updates from research organizations e.g. Denis Lacombe from EORTC  (European Organisation for Research and Treatment of Cancer) on changing clinical research pathways, very expensive drugs and data-driven healthcare from "-omics" to "economics".
- developing diagnostics and treatments for rare diseases e.g. from Julian Isla on improving management of Dravet Syndrome - a rare, catastrophic, lifelong form of epilepsy that begins in the first year of life with frequent and/or prolonged seizures. 

- Ulrich Jäger from the European Haematology Association on health professional perspectives on precision medicine, including practical challenges to applying precision medicine within a typical 7-12 minute consultation.    

- Dominique Monnet from the ECDC [European Centre for Disease Prevention and Control] reported on progress in developing European Antibiotic Awareness days, held annually on 18th November. The ECDC is mandated to monitor current and potential future risks to human health from communicable disease. Individual EU member states are responsible for risk management of established communicable disease.

The EACPT was founded 24 years ago and now includes as members all national organisations for clinical pharmacology in Europe, as well as organisations from further afield internationally. The EACPT aims to provide educational and scientific support for the more than 4000 individual professionals interested in clinical pharmacology and therapeutics throughout the European region, with its congresses attended by a global audience. The EACPT also advises policy makers on how the specialty can contribute to human health and wealth.

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