8:50 Registration and coffee

9:10 Chairman’s welcome and opening address

Dr. Nigel Roome
Scientifi c Advisor, Global Drug Safety Evaluation
sanofi -aventis S.A., France

9:20 Project Management: How to ensure successful and seamless integration of paediatric development into the mainstream development process

• The need for a Paediatric Investigation Plan: When to start?
• What did we learn in the 2 years of EU paediatric legislation?
• What do we expect in the future?

Dr. Despina Solomonidou
Global Franchise Head Oncology, Technical Research & Development – Project Management
Novartis Pharma AG, Switzerland

10:00 Non-clinical aspects of paediatric development and its integration in the overall development process

• Timing and role of safety studies in overall development
• Key information generated and its usefulness
• Future of the studies and possible changes linked to experience gained to date and regulatory feedback

Dr. Nigel Roome
Scientific Advisor, Global Drug Safety Evaluation
sanofi -aventis S.A., France

10:40 Outsourcing Paediatric Investigation Plans

• Planning your PIP submission
• Which in-house departments should be involved?
• Interaction with CRO/ writer
• Interaction with PDCO
• Key points for successful PIP outsourcing

Dr. Susan Bhatti
Director International Regulatory Affairs, Regulatory Affairs
Premier Research Germany Ltd, Germany

11:20 Coffee break and networking

11:50 Practical considerations in designing and executing clinical trials

• Building an internal network of paediatric expertise
• Working with Independent Data Monitoring Committees
• Paediatric blood sampling
• Collecting and processing adverse event data in paediatric clinical trials
• The use of paediatric reference ranges in laboratory, ECG and vital sign assessments
• Special issues related to the paediatric assent/consent process

Dr. Joseph Horrigan
Director, Neurosciences Medicines Development Center
Director, Medicines for Children Advisory Network
GlaxoSmithKline plc, USA

12:30 Safety risk management in paediatric drug development and clinical trials

• Factors that can affect therapy and adverse drug reaction in paediatrics
• Risk minimization
• Paediatric pharmacovigilance
• Process for a paediatric safety risk management

Dr. Stephen Heaton
Head of Safety Risk Management Planning and Coordination/Global Pharmacovigilance
Bayer Schering Pharma AG, Germany

13:10 Networking Lunch

14:40 Pharmacokinetics in neonates, infants and children

• Age impact on pharmacokinetics
• Pharmacokinetic studies in paediatric patients
• Sampling for pharmacokinetic studies in paediatric population

Dr. Carlos Camozzi
Medical Director, Head of Medical Department
Orphan Europe, France

15:20 Coffee break and networking

15:50 Juvenile animal toxicity studies: Decision strategies and place in paediatric drug development

• Highlighting strategies for decision making: When are juvenile animal toxicity studies needed and appropriate?
• Designing and conducting juvenile animal studies
• Discussing the value these studies may bring to the clinical trials or product label

Dr. Luc De Schaepdrijver
Research Fellow, Global Preclinical Development
Johnson & Johnson Pharmaceutical R & D, Belgium

16:30 Developing palatable formulations: Making medicines that children will take

• Brief overview of the physiology of taste
• Taste masking strategies: Technologies and specifi c challenges related to paediatric dosage forms
• Taste assessment techniques and associated challenges
• Opportunities for future research

Anne Cram
Senior Principle Scientist, Materials Science & Oral Products
Pfizer Ltd, United Kingdom

17:10 Closing remarks of the chairman and end of conference day two