VCLS Webinar Series
Development and registration of m-health technologies for the EU market
Presenters: Christophe Amiel, Senior Director, Medical Devices and e-health & Marielle Fournier, Senior Director, Medical devices and Combination products
e-health technologies are already today starting to revolutionize the therapeutic processes and patients management paradigm. Unfortunately, e-health developers are very often uncomfortable with the regulatory maze they have to navigate into (or are simply unaware of it) until their e-health products could be placed on the European market.
Key learning objectives:
European regulatory framework applicable to m-health technologies
m-health products development and evaluation
Critical regulatory challenges for the EU market
Christophe Amiel, Senior Director at VCLS, will share his experience on these innovative m-health technologies and the associated development hurdles. He will illustrate critical matters related to the regulatory environment relevant to e-health products and how to best overcome these challenges for derisking market launch in Europe.
About the presenters:
Christophe Amiel, heads the design and implementation of regulatory strategy as Senior Director within Voisin Consulting Life Sciences for medical devices (including in vitro diagnostics), e-health products, as well as combination products (drug-device association) including activities related to Clinical Trials Application and vigilance.
VCLS supports life science companies and engages in communication with regulators and payers to develop, register and launch innovative health products in global markets.