Fatima BENNAI-SANFOURCHE
Global Senior Director for QA & RA Compliance, Medical Devices, Combination Products & eHealth
- Company
- BAYER AG
- Position
- Global Senior Director for QA & RA Compliance, Medical Devices, Combination Products & eHealth
- Biography
- Dr. Fatima Bennai-Sanfourche is an accomplished regulatory and quality assurance leader with over 20 years of experience in the medical device, pharmaceutical, and eHealth sectors. She has a proven track record of leading complex regulatory and compliance projects, with a particular focus on the integration of medical devices and combination products within large pharmaceutical environments. Dr. Fatima Bennai-Sanfourche currently serves as the Global Senior Director of QA&RA Compliance for Medical Devices, Combination Products, and eHealth at Bayer AG. In this role, she ensures regulatory compliance and high product quality across Bayer’s medical device and eHealth portfolio. She also oversees the compliant use of medical devices and software tools in clinical investigations and trials, adhering to Good Clinical Practice (GCP). She has a rich background in the medical field, with over 20 years of experience in quality management, regulatory affairs, and the development of medical devices, including software, in vitro diagnostics, and combination products. Her career at Bayer began in the medical affairs and pharmacovigilance department, where she served as the Director of Medical Device Safety and Global Pharmacovigilance/Medical Device Safety Officer. Beyond her corporate roles, Fatima is a recognized thought leader in the regulatory field. She regularly participates in high-level conferences and working groups, including with the European Medicines Agency (EMA) and the European Commission, where she advocates for the development of better regulatory practices. Her commitment to the broader regulatory community underscores her passion for Her extensive experience and leadership in the pharmaceuticals, medical device, and regulatory fields make her a pivotal figure in the Medtech and pharma regulatory landscape in Europe.
Speaker on
Navigating Drug Clinical Trials with Medical Devices and In-Vitro Diagnostics: Compliance with MDR/IVDR and CTR
Educational
THE NEXT FRONTIER IN COMBINATION PRODUCTS
05/28/2026
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10:00 - 10:15
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TPD Room
The next frontier in combination products
Panel Discussion
THE NEXT FRONTIER IN COMBINATION PRODUCTS
05/28/2026
|
11:15 - 11:30
|
TPD Room