Paediatric Drug Development and Clinical Trials Conference

Monday 22 – Tuesday 23 November 2010, Brussels, Belgium

Operating successfully under heavy regulatory expectation to achieve efficient and cost effective paediatric trials

Paediatric Drug Development and Clinical Trials offers a platform to learn the latest and most efficient solutions to major challenges facing the industry today. The only event to offer insight and strategies to overcome operational as well as regulatory issues enabling you to improve efficiency of PIP submission, ethical approval, patient recruitment, pharmacokinetics and formulations at a time when the industry is expected to meet strict regulatory guidelines whilst remaining commercially viable.

Presented by senior industry representatives and experts, networks and the PDCO, this event will give you the opportunity to gain heightened perspective about experiences so far and the approaches that are working. Showcasing practical case studies, expert-led roundtable discussions and extensive networking opportunities, this event will provide you with the advice that you need to succeed in paediatric clinical trials.

Reasons to attend:

• The only conference to cover both operational and regulatory challenges being faced by the industry
• Input from the PDCO about their expectations of the industry and their advice to make studies feasible and successful
• Attendended by representatives of small medium and big pharmaceutical and biotech companies

• Practical case-study based examples which offer real life experiences and the lessons to be learned

As an attendee you will:

• Gain critical insights into the top operational and regulatory challenges you face and essential strategies to overcome them
• Identify new and different methods to eliminate your patient and site recruitment difficulties improving study start-up times and saving you money
• Find out directly from the PDCO how to ensure your study meets regulatory expectations in an efficient and practical way
• Hear  and learn from the real-life experiences from industry experts and what you can learn from them
• Join in on interactive discussions about the future of drug development and how this may impact the industry and your business
• Discover solutions which are working by joining our expert-led roundtables and sharing experiences with industry peers

Key speakers include:

• Carolyn Hynes, Director of Global Regulatory Affairs, J&J
• Ulrika Assargard, Global Regulatory Leader, Hoffman La Roche
• Michael Christensen, Regulatory Affairs Project Manager, Novo Nordisk
• Dirk Mentzer, Head of Pharmacovigilence Unit, Paul Ehrlich Institute and PDCO Member
• Michal Odermarsky, EATG representative and PDCO member
• Lara Renkema-Cajko, Medical Advisor / Clinical Safety Officer, Sanofi-aventis
• Hendrik van den Berg, Dutch Medicines Evaluation Board and PDCO member