BOULOGNE
I am a Senior Director in Voisin Consulting Life Science’s office in Cambridge, MA, USA.
I assist international clients in the design and implementation of global product development plans. I am involved in the development of biotech products, new chemical entities, advanced therapy medicinal products and combination products.
I have extensive experience in interactions with the regulators in both the European Union and the US, in particular in coordinating Briefing Meetings, ATMP classifications requests, Scientific Advice Request/Protocol Assistance and FDA meetings, while taking into consideration global development constraints.
I am also in charge of preparing and coordinating centralized Marketing Authorization Applications and New Drug Applications, including writing CTD Modules and managing the team of experts involved, as well as coordinating the preparation of written and oral answers as part of the assessment procedures.
I have significant regulatory expertise in writing and assembling of orphan drug designation (ODD) applications in Europe and in the US. I also make recommendations on the feasibility of these applications and lead discussions on the optimal path to obtain designation from the European Commission and the FDA. I am also involved in defining the optimal path to the maintenance of the designation at time of registration (similarity assessment and confirmation of significant benefit).
I am also actively involved in the European activities generated by the implementation of Regulation (EC) No 1901/2006 on medicinal products for pediatric use. This includes recommendations on the design of Paediatric Investigation Plan (PIP) strategies - i.e. on the possible combinations of pediatric studies, extrapolation of data obtained in adults or in other pediatric subsets, partial or total waiver and/or deferral - preparation and submission of PIPs and interactions with the Paediatric Committee (PDCO).
Mes compétences :
affaires réglementaires
conseil
biotechnologies
Paediatric Investigation Plans (PIP)
Drug development
Regulatory strategy
Marketing autorisation applications
Orphan drugs
