Paediatric Investigation Plans (PIP) in the EU 2015

Overview:
The European Medicines Agency plays an important role in the development of medicines for children. In the past, many medicines authorized in Europe were not studied adequately or authorized in children. This caused difficulties for prescribers and pharmacists treating children, as well as for their patients and carers.

To help to solve this problem, the European Union's Paediatric Regulation gave the EMA new responsibilities in 2007. These responsibilities allowed the EMA to stimulate research into the uses of medicines in children and to lead to their authorization in all ages. The Paediatric Regulation's main aim is to improve the health of children in Europe without subjecting children to unnecessary trials, or delaying the authorization of medicinal products for use in adults.

Areas Covered in the Session:
Paediatric Legislation
The PDCO
The COMP
PIP's
Timing of the PIP
Incentives
Application procedure
Results of the legislation

Who Will Benefit:
Regulatory Affairs personnel
CRAs
Clinical Operations personnel
Speaker Profile
Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands.