FDA, MDR, and Global Post-Market Controls

This panel brings together Mike Xie, VP of Quality and Regulatory Affairs at Sol-Millennium Medical Group, and Subhadip Jana, Sr. Director of Global Regulatory Affairs at ADC Therapeutics, to examine the evolving landscape of FDA regulations, EU MDR requirements, and global post-market controls. Regulatory frameworks are becoming more demanding and more divergent, creating significant compliance challenges for companies operating across multiple markets.

Panelists will discuss practical strategies for navigating the FDA's evolving approach to post-market surveillance, the continuing implementation challenges of the EU MDR, and emerging regulatory requirements in key markets such as China, Japan, and Brazil. The session will address how to build regulatory intelligence capabilities that enable proactive compliance rather than reactive scrambling.

Attendees will gain a clearer picture of where regulatory requirements are heading and what investments in people, processes, and technology are needed to stay ahead of the compliance curve.