Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation


The European Commission (EC) highlighted in its report on 10 years of the EU Paediatric Regulation certain areas for specific actions to better foster the development and availability of medicines for children in Europe.

This workshop is a crucial step for the development of a concrete plan to address the challenges identified.

Main objectives of the workshop:

  • To learn from experiences and ideas regarding criteria and methodologies thatcould be used to identify diseases/conditions of unmet paediatric medical needs.
  • To exchange ideas on measures to proactively address obstacles to timely completion of paediatric investigation plans (PIPs).
  • To identify operational challenges in relation to paediatric procedures and exchange ideas for process improvements.
  • To inform stakeholders about ongoing and future initiatives of international collaboration of regulators for paediatric medicine development
  • To inform stakeholders about planned transparency measures regarding clinicalresearch and new medicines for children.

Live broadcast

20 March 2018
09:00 – 17:30 UK time


20/03/18, Martina Barcaroli