Navigating the Post-Market Landscape of Combination Products: Surveillance Best Practices, Risk Management and Change Management

Friday, November 14, 2025

9:50 AM - 10:50 AM East Coast USA Time

Moderator(s)

Jiaying Shen

Executive Director, Medical Device and Combination Product Development, Regulatory and Quality
Merck

Speaker(s)

ChiaYee Ang

Global Regulatory Affairs, Delivery Device & Digital Health Advisor
Lilly
Khaudeja Bano

Vice President Combination Product Quality
Genentech/Roche
Susan Neadle (she/her/hers)

Principal Consultant & President
Combination Products Consulting Services, LLC, Florida, United States

This session will focus on the critical aspects of post-market surveillance, risk management, and change management for combination products. As the intersection of pharmaceuticals and medical devices continues to expand, understanding the regulatory frameworks, surveillance mechanisms, and effective risk management and change management processes becomes essential for ensuring patient safety and product effectiveness. Attendees will benefit from engaging discussions led by industry experts, who will share insights on best practices and innovative approaches to navigate the complexities of combination products in the post-market phase.