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MedTech Summit

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10 - 14 June 2024
DoubleTree by Hilton Brussels CityBrussels, Belgium (Hybrid Event)

Fatima Sanfourche
Senior Director of QA & RA Compliance for Medical Devices and eHealth at Bayer Pharma, Germany
Advisor

Profile

Dr. Fatima Bennai-Sanfourche is working currently as Senior Director of QA&RA Compliance for Medical Devices, Combinations Products, 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 20 years of experience in the quality management, Regulatory Affairs and development of medical devices and combination products.

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.

In her current position by Bayer AG her focus is ensuring the regulatory compliance as well as high product quality of medical device, combination products and eHealth components of the Pharmaceuticals 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 MDR 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 to the medical Device regulation.

Since July 2021 she is also a member of the European Commission Post-Market Surveillance (PMS) task force responsible for the preparation of the MDR PMS guidance according to the Article 83.

Agenda Sessions

  • Chairperson’s Opening Remarks: Clinical Evaluations and Investigations & Performance Evaluations

    08:30
  • Medical Devices and In-Vitro Diagnostics Used in Drug Clinical Trials: Principles of Use and Sponsor Responsibilities Under the Medical Device and IVD Regulations Requirements

    08:40
  • Chairperson’s Afternoon Remarks: Clinical Evaluations and Investigations & Performance Evaluations

    14:10
  • Ask the Experts – Clinical Evaluations & Investigations and Post-Market Surveillance

    16:15