Distinguished Scientist, Medical Device and Combination Product Development, Regulatory and Quality Merck
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.