After 10 years of the EU Paediatric Regulation, considerable experience has been gained by all involved in paediatric drug development: companies, regulators, academia, healthcare professionals and, last but not least, patients. How success has been achieved? What could be challenges and options for the future?
Many products have now obtained a paediatric indication and new data are produced on a daily basis. Nevertheless many paediatric trials recruit slowly and drug development plans are not completed. Furthermore, new paths and strategies are becoming available to advance the integration of paediatric drug development with the development of medicines for adults. Paediatric research is high on the global political agenda.
The aim of this conference is to discuss how drug development can be further optimised to the benefit of children’s health. This will include a discussion on what has been learned during these years of full operation of the 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.
Experts from all involved parties will be present. 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 the global issues. This will allow participants to discuss face-to-face with all stakeholders, which otherwise usually occurs by email or phone. Questions on any topic relating to the Agency’s activities can be submitted before the conference to paediatrics@efgcp.eu, and will be answered by the Paediatric Medicines office at the EMA.
More information and registration: www.luxclin.lu/Events/Details/?c=EVT0543SFB
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Healthcare professionals who wish to be part of a unique network, providing access to up-to-date, accurate and validated information about clinical research.
Investigators and study staff who wish to be part of a unique network, in order to stay abreast of clinical trials taking place in Luxembourg and who are willing to further develop their competencies.
