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Follow on Google News | SMi’s Paediatric Clinical Trials Summit to Provide Legal and Regulation UpdateBy: SMi Group The session on regulation will take place on day one and host 6 presentations covering the EMA Report, the EU Commission Report, PIP Submission requirements, the FDASIA and regulatory buy ins. Paediatric Clinical Trials 2014 will provide a forum for attendees to: · Share ideas with industry leaders to identify cutting-edge developments including innovative ideas for rare diseases, latest advances in cardiology drug development in children, new methods for clinical studies in paediatrics and model-based paediatric drug development. · Strategize – Hear case studies from major pharmaceutical companies addressing PIP submission requirements, the Paediatric Study Plan (PSP), extrapolation and paediatric clinical trial strategies used by Novartis and Hoffmann-La Roche · Minimise costs – identify issues to help prevent approval delay and key factors that influence study design to optimise operational execution of paediatric clinical trials. · Regulation - Discuss global paediatric legislations and the impact of EU legislation. · Increase Patient Recruitment – attendees will discuss how to optimise effective communication with parents and children to increase recruitment and learn the difference between consent and assent. · Peer to peer networking – Paediatrics 2014 will include 6 sessions allowing attendees to network including 2 networking lunches, 2 morning coffees breaks and 2 afternoon tea’s. Key Speakers will include Roche Pharmaceuticals, Novartis, Paediatric Neuro-Psychiatry, Lundbeck, Klausrose Consulting, University of Copenhagen, Ghent University Hospital, Austrian Agency for Health and Food Safety, Svabhegy Paediatric Hospital, PPD Consulting plus many more. For the conference agenda visit www.paediatric- For those wishing to attend there is currently an early bird rate of £300 which expires on 20th December 2013. Paediatric Clinical Trials 31st March & 1st April 2014 The Kensington Close Hotel, London, UK www.paediatric- End
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