Fatima Bennai-Sanfourche
Company: Bayer
Job title: Senior Director - QA & RA Compliance, Medical Devices, Combination Products & eHealth
Seminars:
Track Chair 11:01 am
day: Conference Day One - Track 2
Challenges in Conducting Clinical Trials Involving Medicinal Products with Medical Devices or IVDs 2:30 pm
Introducing the categories of devices used in the drug clinical trials and the regulatory pathways to be followed. Understanding how to conduct clinical trials with CE marked devices Where are we now with the Combined trials? Unearthing current challenges for the sponsor of Combined Trials and how to overcome these challengesRead more
day: Conference Day One - Track 2 - PM
Panel Discussion: Building a Better Dynamic Between Biopharma & Diagnostics Developer to Deliver Drugs to Patients Faster 12:30 pm
How are regulations impacting CDx and assay manufacturers? How are they impacting biopharma? What are the performance limitations of current instruments and assays used/needed routinely by biopharma? What are the cultural differences between biopharma and diagnostics developers? How do you manage this from a biopharma perspective? In what ways can we be improving co-development relationship?Read more
day: Conference Day One - Track 2
Chair’s Closing Remarks & End of Conference Day One 6:15 pm
day: Conference Day One - PM
Chair’s Opening Remarks 8:15 am
day: Conference Day One - AM