Nearing a decade of the EU Paediatric Regulation, with close to 2,000 submitted Paediatric Investigation Plans (PIPs), paediatric needs are recognised as an integrated part of drug development, with the inclusion of children now accepted as standard procedure. However, challenges remain, which can result in delayed access by children to innovative medicines. This year’s DIA/EFGCP/EMA annual paediatric conference will focus on ways to overcome these challenges, such as through collaboration, extrapolation, modelling & simulation and adaptive pathways. This is the conference to interact with EMA paediatric coordinators, Paediatric Committee (PDCO) members and other stakeholders interested in paediatric drug development. Patients’ and Healthcare professional’s views will complement the reports of practical experience. In addition you have the possibility to send your question already beforehand to be sure that the topic will be addressed during the conference.
Who Should Attend
Regulatory, clinical and drug development professionals from Health Authorities and Industry
Paediatricians, Representatives from Academia, Paediatric Societies and Networks Employees from Clinical Research Organisations (CROs) involved in paediatric clinical trials
Any stakeholder interested in the development of better medicines for children
Learning Objectives
Update participants on current paediatric regulatory requirements, scientific and operational success and challenges
Exchange experiences with regulatory authorities, academia and industry
Discuss visions, daily challenges and potential ways to move forward and further improve processes for paediatric drug development
