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Addressing Challenges in Devices Safety Monitoring
Session Chair(s)
Representative Invited
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
This session will discuss the challenges in safety surveillance for medical devices relating to incident capture, data standards and terminologies. Looking at the impact on signal detection and how these barriers can be overcome to improve patient safety.
Learning Objective : Describe challenges and barriers in the capture of adverse incident data for medical devices; Discuss novel approaches to enhance signal detection for medical devices; Assess opportunities for better ways of working across different stakeholders in device vigilance activities.
Speaker(s)
Industry Perspective
Khaudeja Bano, DrMed, MD, MS
Genentech, United States
Vice President, Combination Product Quality
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