Paediatric Investigation Plan
Since the Pediatric Regulation entered into force on January 2007, the European Medicines Agency (EMA) requires an approved Paediatric Investigation Plan (PIP) before the submission of a Marketing Authorization Application (MAA).
The PIP should be submitted after Phase 1 clinical trials in adults; non-compliance with the agreed PIP measures will negatively impact any potential to obtain a Marketing Authorization (MA).
DDR’s experience allows us to provide a high quality service, leading to successful PIP procedures.
How can DDR help?
- DDR will give advice on the writing and organization of the PIP and will submit the required documentation to the EMA.
- DDR will provide strategic and regulatory recommendations on the deferral and waiver of regulatory provisions together with other relevant aspects that are specific to the pediatric population (i.e. pediatric formulations of choice, need for juvenile animal studies and specific pediatric clinical trial considerations).
- DDR will support companies attending EMA oral explanations, if required.
- DDR will support companies by drafting annual reports and/or carrying out compliance checks at the time of the MAA.