A key step in the preparation of a paediatric investigation plan (PIP) for a new medicinal product is to define the PIP strategy, ie, to define how the studies/data extrapolation/waiver/deferral combination will cover, for each targeted indication, all subsets of the paediatric population.
David Uguen, Marie Deneux
2009 – Regulatory Rapporteur
Defining a PIP strategy for a new medicinal product: A step by step approach,TOPRA Vol 6, No.5
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