Pediatric Investigational Plans
Since the EU Pediatric Regulation came into force in 2007, Aptiv Solutions regulatory experts have worked with sponsor companies to provide solutions to meet the requirements of this legislation.
The Pediatric Investigation Plan (PIP) is a key aspect of this EU Regulation and poses a challenge for many Pharmaceutical companies although it represents an opportunity for additional market exclusivity.
Submission of a PIP and/or a waiver request is obligatory for new medicinal products and also for development of new indications, routes of administration or new pharmaceutical forms for marketed products. Aptiv Solutions is uniquely placed to advise on regulatory and clinical aspects of how and when the PIP should be produced. This includes:
- The generation the high quality documentation necessary to satisfy the regulatory requirements
- An effective interface with the Pediatric Development Committee (PDCO)
- The design and implementation of non-clinical and clinical studies to provide meaningful pediatric data
