Call for comments – European Paediatric Regulation
The European Paediatric Regulation has now been in force for nearly ten years. The European Commission has requested stakeholders to submit their comments on the consultation paper provided by the European Medicines Agency (EMA) by 20 February 2016. The Paul-Ehrlich-Institut expressly supports this request in the interest of paediatric health.
The updated research programme of the Paul-Ehrlich-Institut defines cross-divisional research areas of the PEI. These areas result from the synergies of regulatory expertise and research. The update of the research programme was carried out on the basis of recommendations from the Wissenschaftsrat (German Council of Science and Humanities) and the Scientific Advisory Board of the Paul-Ehrlich-Institut.
Voluntary Harmonisation Procedure (VHP) for clinical trials – 1000th procedure co-ordinated by PEI
The European Voluntary Harmonisation Procedure for clinical trials (VHP) has become established since many years: In the meantime, the 1000th application for the evaluation of a clinical trial has been received in several European countries.