Paediatric investigation plan preparation and submission will be one of the focuses at SMi's Paediatric Clinical Trials conference
Challenges in conducting paediatric clinical trials in developing countries will be discussed by top 50 pharma companies

LONDON, ENGLAND, December 06, 2010 /24-7PressRelease/ -- The introduction of EU legislation specifically for Paediatric Clinical Trials means the drug developers need guidance on study design. Paediatric Investigation Plans (PIP) needs to be submitted prior to a trial in order to guarantee its safety and value.

SMi is pleased to pronounce its 5th annual conference on Paediatric Clinical Trials to be held on the 24th & 25th January 2011. The event will explore a range of key issues relating to the involvement of children in pharmaceutical development. There will be a strong focus on preparing paediatric investigation plans (PIPs) and complying with legislation laid out by the European Medical Agency's paediatric committee (PDCO). Attendees will have access to presentations from a variety of senior industry professionals and renowned academic experts.

Charing this conference on day one is Stephen Heaton, Head of Safety Risk Management Planning and Coordination, Bayer Schering Pharma and on day two Klaus Rose, Principal Consultant, Granzer Regulatory Consulting & Services

Don't miss an excellent opportunity to share experiences with an expert panel of speakers and discuss key issues including:

• Practical guidance for Phase III and IV paediatric trials
Philippe Auby, Director, International Clinical Research, Paediatric Neuro-Psychiatry, Lundbeck

• How to benefit patients and comply with the regulations
Marcelo Marotti, Global Research and Development Physician, AstraZeneca

• Challenges in conducting paediatric clinical trials in developing countries
Himanshu Upadhyaya, Senior Medical Advisor, ADAP Team, Neuroscience Platform, Eli Lilly

• Tips for successful recruitment and participation in paediatric clinical trials
Sylvie Jouve, Associate Director, Vaccines and Infectious Diseases Department, Pfizer

• Paediatric clinical development plans: A clinical pharmacology perspective
Bruno Reigner, Senior Clinical Pharmacologist, Roche Pharmaceuticals

For more information and to download the brochure visit http://www.smi-online.co.uk/2011paediatric33.asp or alternatively contact Zain Philbey on tel: +44 (0) 20 7827 6722 or email: zphilbey@smi-online.co.uk

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