This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Conducting a Pediatric Investigation Plan (PIP) at Late Clinical Stage
Published on: Apr 26th, 2021
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.
Download the full resource now
Fill in the form to download the content