For products falling under the mandatory scope of the centralised procedure, integrating a Paediatric Investigation Plan (PIP) into a company's development programme can become very challenging.
Camille Metais, Project Director
She participates in projects which involve the design and implementation of regulatory strategies for the development of drugs, biologics and innovative medicinal products. She has regulatory expertise in writing and assembling of orphan drug designation (ODD) applications in Europe and in the United States. She also makes recommendations on the feasibility of these applications and leads discussions on the optimal path to obtain designation from the EMEA and the FDA.