Tuesday, Feb 28th 2017, 17:00 CET | 11:00 EDT
Voisin Consulting Life Science - 3, rue des Longs Prés 92100 Boulogne

Presenters: Anastacia Bilek, ex-FDA reviewer, Associate Director, Medical Device, and Christophe Amiel, Senior Director, Medical Device


Date:          February 28, 2017

Duration:    45 Minutes

Time:          17:00 CEST / 11:00 EDT / 08:00 PDT
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Advances in m-Health products promise to revolutionize healthcare from everyday healthy choices to smart drug delivery to the integration of connected devices into hospitals and clinics. As such, m-Health products are not just standard IT technologies used for a medical purpose and should be developed like any other medical device.

Key learning objectives:


  • Expanding role of m-Health

  • FDA framework for regulating m-Health

  • Robust development activities

Anastacia Bilek, Ph.D., Associate Director at VCLS, will share her experience in the regulation of m-Health products as a guide for product developers. She will discuss the definition and uses of m-Health, the regulatory environment for m-Health, and the key development and evaluation activities of m-health technologies.


About the presenters:

Anastacia M. Bilek, Ph.D. works as Associate Director, Medical Devices & Combination Products at VCLS. She is responsible for multiple client projects involving the implementation of US regulatory strategies and submissions for the development and marketing of medical devices and combination products.

Christophe Amiel, M.Sc. is Senior Director, Medical Devices & Combination Products at VCLS. Christophe is leading design & implementation of regulatory strategies for medical devices (incl. IVD), combination (drug, biologic) & borderline products. His areas of expertise encompass clinical development, EU/US market approval & MD vigilance.

About VCLS:

VCLS supports life science companies and engages in communication with regulators and payers to develop, register and launch innovative health products in global markets.


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