Preparing comprehensive clinical studies and writing a Paediatric Investigation Plan
3rd international congress of Integrated Paediatric Drug Development 13 - 15 April 2011 in Berlin-Potsdam
The two main conference days on 14 and 15 April will focus on the following topics:
• Preparing for paediatric trials
• Clinical pharmacology in paediatric drug development
• Developing a Paediatric Investigation Plan that meets the FDA and EMA regulations.
• Meeting pharmacological requirements for the successful implementation of trials in neonates, infants and children
Companies and institutions presenting hands-on experiences with paediatric drug development at the conference will include Bayer Schering Pharma AG, F. Hoffmann-La Roche Ltd., the German Federal Institute for Drugs and Medical Devices, Astellas Pharma Global Development Europe and Novartis Pharma AG. At the event, delegates will have the opportunity to discuss with and learn from experts and their peers to reach the industry’s common goal of meeting global paediatric standards in clinical trials.
On the Interactive Workshop Day on 13 April, delegates can select from the following workshops to intensify their knowledge in their chosen areas:
• Designing a successful PIP that complies with the EU regulation and EMA/PDCO specifications
• Pharmacokinetics in neonates, infants and children
• Practical considerations in regards to paediatric studies: design, structure, strategy and implementation
• Outsourcing of paediatric studies: How to optimise the cooperation in developing the PIP
Further information, including the full congress program and additional content downloads, are available on www.paediatrics-congress.com/...
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