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
Marie Deneux, Senior Director Regulatory Science Drugs & Biologics
As Senior Director, Regulatory Science, Drugs and Biologics, Marie assists international clients in the design and implementation of global product development plans and associated regulatory strategy, in particular in the area of rare diseases. She is involved in the development of biotech products, new chemical entities, cell and gene therapy medicinal products and repurposed drugs.
David Uguen, Executive Director Drugs and Biologics
David Uguen is responsible for the management of projects involving the design and implementation of regulatory strategies for the development of drugs and biologics. David gained a 18-year experience in European regulatory affairs applied to the development, registration and maintenance of both pharmaceutical and biotechnology medicinal products.