Anastacia Bilek, Ph.D. 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.
Anastacia M. Bilek, Associate Director Medical Devices & Combination Products
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, Senior Director Medical Devices & Combination Products
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.