The EFGCP Children’s Medicines Working Party 4th Annual Conference

EU & US Paediatric Legislation: What is Changing in Practice in Paediatric Drug Treatment, Research & Development?

26 November 2008, Management Centre Europe, Brussels, Belgium

The EU Paediatric Regulation has now been in force for 1½ years. Regulatory authorities, clinical organisations and pharmaceutical companies have made their first experiences with preparing, submitting and discussing Paediatric Investigation Plans (PIPs).This conference will on a high level compare the experiences and lessons learned in the European regulatory authorities, pharmaceutical companies and evolving paediatric research networks and will continue the dialogue how to further improve child health and paediatric research in Europe. Furthermore, this conference will also address the WHO initiative ‘make medicines child size’ and will reflect its place within the US and EU paediatric legislation. The conference audience will include representatives and participants from regulatory authorities, academic paediatric research, health professionals, pharmaceutical & biotech companies, and patient and parents’ organisations.