Dr. Fatima Bennai-Sanfourche
Senior Director of QA & RA Compliance for Medical Devices, Combination products and eHealth
Bayer
Dr. Fatima Bennai-Sanfourche is working as Senior Manager for QA&RA Compliance for Medical Devices and eHealth at Bayer AG. Previously she worked in the medical affairs and Pharmacovigilance department at Bayer as Director, Medical Device Safety Global Pharmacovigilance/Medical device Safety officer. She has more than 15 years of experience in the quality management and Regulatory Affairs of medical devices field, and over 20 years of supervisory and leadership experience including hiring, training and performance evaluation. She studied Biology with a focus on Biochemistry, Immunology and Pharmacology, and did her PhD in Pharmacology and Pharmacochemistry in Strasbourg in France. She started her professional life with more university-oriented areas doing research and development in France, Sweden and Germany with a focus on cerebrovascular diseases, such as stroke, regulation of hypertension and development of immunoassays. She moved then from academia to private industry. She was working for more than 20 years in biotechnology, pharmaceutical, in-vitro diagnostic and medical device industry on a management level and was responsible as a team leader for project management with scientific focus, quality management and regulatory affairs tasks. In her current position by Bayer AG her focus is ensuring the regulatory compliance as well as high product quality of medical device and eHealth components of the Pharmaceuticals pipeline and portfolio. She is also responsible for Ensuring compliant use of medical devices and medical software tools in the context of clinical investigations and clinical trials, incl. accordance with medical device Good Clinical Practice (GCP). She is also leading the project of the implementation of euMDR for PH-Bayer AG. She was nominated in 2019 by the European Commission as EFPIA observer for the PMSV (Post-Market Surveillance and Vigilance) subgroup (GROW.D4) responsible for the implementation of these process according the medical Device regulation. The period of nomination is of five years starting on 01 March 2019