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Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Basic

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 Objectives

Describe challenges and barriers in the capture of adverse incident data for medical devices; Discuss novel approaches to enhance signal detection for medical devices; Discuss and assess opportunities for better ways of working across different stakeholders in device vigilance activities.

Speaker

Industry Perspective
Khaudeja Bano, DrMed, MD, MS

WHO Perspective
Hiiti Sillo, MSc, RPh


Speakers
avatar for Khaudeja Bano

Khaudeja Bano

Vice President, Combination Product Quality, Genentech, United States
Dr. Bano is the Global Head - Vice President of Device / Combination product Quality at Genentech / Roche. She is a Physician, with a Masters in Clinical Research (UCSD), Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional... Read More →
avatar for Hiiti Sillo

Hiiti Sillo

Unit Head, Regulation and Safety, Department of Regulation and Prequalification, World Health Organization (WHO), Switzerland
Mr Hiiti Sillo is the Unit Head, Regulation and Safety within the WHO Department of Regulation and Prequalification. In this role, he coordinates WHO strategies for strengthening national and regional regulatory systems for medical products, including promoting regulatory harmonization... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

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