Isabelle ABOUSAHL

Information Privacy Manager (CIPM) certified by the International Association of Privacy Professionals (IAPP) Information Privacy Professional for Europe (CIPP/E) certified by IAPP DPO certified by AFNOR (CNIL certification referential - France) Pre-certified Auditor ISO/IEC 27001 (Information Security Management System) by AFNOR February 2021 -- Founder and President of "alcoam by design", a service company specialised in Protection of Personal Data and Data Engineering operating in the field of health / research / innovation. Alcoam by Design supports healthcare and clinical research organisations in their compliance to the personal data protection regulations. For clinical trials, Alcoam by Design delivers a solution unifying “Quality by Design” and “risk adapted monitoring” aiming at an increased prevention of GCP risks -- Data protection officer for biotech companies, not-for-profit health research associations/fundations; healthcare and research institutions, biological ressources centers since march 2018 -- Engineer by background, I have developed a strong expertise in data management and eClinical information systems -- About 26 years of managerial experience and leadership role within Clinical Research organisations, more specifically in the following functions: R&D Data Management; Clinical Operations; Drug Development Resource Planning; Clinical Pharmacology -- An expertise developed over years in clinical studies, from phase 1 to real world studies, including the registration process for market authorisation in various geographies