A long-standing challenge for regulators has been how to incorporate new technologies into the current regulatory framework. This is especially applicable to telemedicine and e-health systems.
Sylvie Le Glédic, Marielle Fournier, Sabah Malek
Sylvie Le Glédic, Director Medical Devices & IVD
Sylvie Le Glédic is in charge of the design and implementation of global regulatory strategies for the development and registration of in vitro diagnostics medical devices (IVDs). Sylvie helps IVD manufacturers in the creation of CE mark technical files and US regulatory dossiers for FDA approval, advising on the required Quality Management System. She assists pharmaceutical companies developing Companion Diagnostics (CDx) in the drug/CDx co-development and facilitates liaison between both pharmaceutical and diagnostic developers.
Marielle Fournier, Senior Director Drugs Devices & Combination Products
As Senior Director, Marielle has several responsibilities within the management of projects involving the design and implementation of global regulatory strategies for the development, evaluation and marketing of medical devices & medicinal products, as well as combination products (i.e. drug/device, including combined ATMPs) and borderline products. She actively participates to the redaction and review of ATMPs and Combined ATMPs US/EU dossiers. She closely follows the evolution of new regulations.