SMi’s Paediatric Clinical Trials Summit to Provide Legal and Regulation Update

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Following on from the European Commission report published earlier this year on The Paediatric Regulation, SMi’s Paediatric Clinical Trials conference in London next March 2014 will look to address global paediatric legislation's, the best practice and strategies in paediatric clinical trials.

Paediatric Clinical Trials | 31st March & 1st April 2014

Paediatric Clinical Trials | 31st March & 1st April 2014

"PIP procedure can become a serious potential obstacle in drug development...this conference will be a key event to discuss industry experience with the PIP procedure and lessons learned" - Dr Klaus Rose

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 legislation's 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

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

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Sonal Patel

Sonal Patel
SMi Group Ltd
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