Paediatric Drug Development

Since the European Paediatric Regulation was introduced in 2007, companies developing new medicinal products or new indications/routes of administration/pharmaceutical forms are obliged to present age-appropriate formulations for the paediatric population within a Paediatric Investigation Plan (PIP) to the European Medicines Agency. Paediatric drug development has become an essential part of drug development in general, it is a very complex area encouraging coherent strategies and close collaborations and communications between industry and health authorities.

This half day masterclass under the expertise of Klaus Rose Consulting, will provide a focus on: paediatric clinical trials, legislation considerations, Paediatric Investigation Plan (PIP) and the impact of paediatric legislations in both US and EU.

Why You Should Attend:

Whatever your position in drug development, you should have sufficient background knowledge. You might be directly involved in PIPs, you might be asked for advice, or you might work in a management, regulatory affairs, technical or clinical development position; without background understanding you might miss job opportunities or not have sufficient background for good decisions.