LONDON, ENGLAND, December 06, 2010 (Press-News.org) 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
About SMi Group
Paediatric Clinical Trials is just one of the many conferences that are a part of the SMi Group portfolio. The SMi Group is a world leader in business to business information. With nearly two decades in the business, thousands of senior executives from blue chip companies have already benefitted from SMi's highly targeted conferences, workshops and publications. For more information visit http://www.smi-online.co.uk
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
2010-12-06
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[Press-News.org] Paediatric investigation plan preparation and submission will be one of the focuses at SMi's Paediatric Clinical Trials conferenceChallenges in conducting paediatric clinical trials in developing countries will be discussed by top 50 pharma companies