Debby Arnauts

Background

About Debby Arnauts

About Me With over 20 years of experience in Medical Affairs, Pharmacovigilance, and Regulatory roles, I bring a wealth of expertise across diverse therapeutic areas in both the pharmaceutical and medical device sectors. My career journey has taken me from leading local and international medical departments at Solvay Pharma, Shire and Abbott, to establishing my own consultancy firm. I specialize in providing tailored medical strategies and compliance solutions, supporting companies through product launches, regulatory processes such as reimbursements, and medical education initiatives. My approach combines scientific rigor, creative problem-solving, and a passion for delivering excellence. Key Expertise Medical Affairs & Strategy Development of medical plans and brand strategies KOL management and organization of advisory boards Regulatory liaison with health authorities (FAGG/RIZIV) Review and approval of promotional materials (RIP-certified) Scientific support for reimbursement dossiers Medical Writing Reimbursement dossiers Clinical trial protocols Product monographs Safety reports (CSR, PSUR, RMP) Medical Education & Training Development and delivery of training for MSLs, Medical Managers, and Sales Teams Creation of educational content (podcasts, webinars) Pharmacovigilance & Regulatory Support Roles as QPPV and Local Drug Safety Officer PV reporting, audits, and process compliance checks Therapeutic Areas Covered Oncology, Neurology, Dermatology, Immunology, Gynecology, Gastroenterology, Pulmonology, Aesthetic Medicine, Nephrology, Transplantation, Biosimilars, and Infectious Diseases. How I Add Value I help organizations navigate the complexities of the pharmaceutical landscape by offering a flexible, client-focused approach. My work has supported product launches such as Kogenate, Stelara, Oleogel-10 and Dupixent, and I’ve contributed to various medical projects for Sanofi, Galapagos, Biogen, Merck, Janssen Pharma, and more. With fluency in Dutch, French, and English I’m equipped to support national and international clients in their medical affairs needs. Let's connect to explore how my expertise can help you achieve your goals.