Christophe Amiel is heading 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. Christophe has a broad technical expertise in clinical trial regulations and associated country-specific requirements, and has extensive experience in various trial phases, product types, indications and geographical areas. As a Project Manager, he supervises clinical programs design and implementation including the preparation of the core documents (protocol, Investigator’s Brochure, etc.), and study regulatory set-up and management from the clinical trial application (CTA) to the submission to both Competent Authorities and Ethics Committees. The management of large complex projects gives him the opportunity to actively interact with the different departments within the study sponsors, as well as with the regulatory teams of the Clinical Research Organizations involved. He also participates in strategic clinical decision meetings.