Fatima Bennai-Sanfourche

Company: Bayer

Job title: Senior Director of QA & RA Compliance for Medical devices, Combination products, & eHealth

Seminars:

How to Handle IVDs in Clinical Trials: Sponsor Responsibilities According to the IVDR Requirements 3:30 pm

Addressing regulatory landscape changes and sponsor responsibilities Discovering IVDs used in drug clinical trials Deciphering clinical trial submission including IVDsRead more

day: Day Two PM

Panel Discussion: Taking Control of Your IVD Regulatory Submissions to Turbocharge the Future of CDx 11:30 am

What have learned from the recent submission under the new IVDR to turbocharge future submissions? How to avoid IVDR to become a barrier to develop future precision medicine therapies for patient in oncology, NASH and beyond? How to bring harmonisation amongst stakeholders (regulators, notified bodies, drug developers, CDx developers and payers) to ensure successful submissions…Read more

day: Day Two AM

Panel Discussion: Pre-Analytical Sample Preparation & Handling: What can We do Better? 2:20 pm

What is the impact of different sampling methods on the assay outcome? How to improve sample collection and viability to improve accuracy and reliability of outcome? From training the staff to different study designs, what have learned to improve the process? Read more

day: Day One Track A PM