A US based Biotech company was unaware of the EU’s requirement for a Pediatric Investigation Plan (PIP) until their product development was at Phase III. It was understandable as orphan drugs do not require a Pediatric Study Plan (PSP) in the US. The VCLS team were quick to identify the risks and informed the Client of all possible scenarios. The VCLS team drafted the required documentation which met the EMA requirements, saving both time and investment.
Conducting a Pediatric Investigation Plan (PIP) at Late Clinical Stage
Within a rapidly evolving regulatory scene, medical devices are under high scrutiny. Regulatory requirements are currently being reinforced, in particular to ensure patient safety.