An inter-regulatory and stakeholder workshop on combination products, organised by TOPRA and RAPS, was held in Brussels in November 2018. Reported by Stéphanie Francard, Senior Regulatory Scientist, VCLS, and Chris Wilson, Senior Director, Regulatory Science, Drugs and Biologics, VCLS.
Chris Wilson, B.Sc., M.Sc., MTOPRA, Senior Director, Drugs & Biologics
Chris has two responsibilities within Voisin Consulting Life Sciences (VCLS). As Senior Director, he manages projects involving the design and implementation of global regulatory strategies for the development, evaluation and marketing of small molecules and biologics; and as Head, Medical Writing, he provides leadership for this function.
Stéphanie Francart, Senior Regulatory Scientist, Medical Devices & Combination Products
As a Senior Regulatory Scientist at VCLS, Stéphanie is responsible for the design and implementation of regulatory strategies for medical devices and drug-device combination products. She works closely with clients from early development through to market access, and is responsible for the submission of clinical trial applications in Europe, interactions with regulatory bodies (for example Notified Bodies and Competent Authorities), assistance with the preparation of Technical Files and support for post-market medical device activities.