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The conference will discuss how drug development can be further optimised to the benefit of children's health. This will include a discussion on lessons learned during the years of full operation of the European Union (EU) Paediatric Regulation, new concepts and strategies for an integrated approach at each and every step of paediatric development and sessions dedicated to specific areas of expertise such as neonatology as well as evolving concepts such as the approach to extrapolation from adult data. On day one participants will discuss more specialised and hot topic issues in five breakout sessions. Day two will discuss the holistic integrated approach and global issues. This event is organised by European Forum for Good Clinical Practice (EFGCP), with the partnership of Drug Information Association (DIA) and European Medicines Agency (EMA).