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Addressing The Impact of The EU Medical Devices Regulation on Combination Products

Post thumbnail Addressing The Impact of The EU Medical Devices Regulation on Combination Products

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.

 

Published on: March, 2019
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    publication by

    Chris Wilson
    Chris Wilson, M.Sc., MTOPRA
    Senior Director, Drugs & Biologics
    As Senior Director Regulatory Science, Drugs, and Biologics Chris provides leadership and support across Market Access, Regulatory, and Medical / Regulatory Writing functions.   In…
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    Stéphanie Francart  thumbnail
    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.