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.

Richard Matt, Principal Consultant at Aspen Medical Risk Consulting, leads a breakout session on achieving post-market excellence through evolved vigilance practices. As regulatory expectations for post-market surveillance continue to intensify, safety organizations must transform their approaches to adverse event detection, signal management, and benefit-risk assessment. Richard will present a maturity model for post-market vigilance that helps organizations benchmark their current capabilities and identify priority areas for improvement. The session will cover advanced signal detection methodologies, the integration of real-world data sources into safety monitoring, and strategies for building a continuous improvement culture within safety teams. This session is designed for safety and quality professionals who want to move beyond minimum compliance and build post-market capabilities that create genuine competitive advantage.

Leo Park, Sr. Director of Cyber Security at Click Therapeutics, facilitates a hands-on workshop exploring how organizations can future-proof their safety and compliance workforce while leveraging AI-driven tools. The intersection of cybersecurity, digital health, and safety is creating new risk categories that traditional safety teams are not equipped to address. Workshop participants will examine emerging AI tools for safety signal detection, automated adverse event reporting, and predictive safety analytics. Leo will share practical guidance on evaluating AI tools for safety applications, including how to assess their reliability, validate their outputs, and maintain regulatory compliance when using AI-assisted processes. The workshop will also address workforce development strategies for building teams that can effectively combine domain expertise in safety and compliance with the technical skills needed to leverage advanced digital tools.

Edward Chekan, VP of Medical Affairs and Professional Education at Asensus Surgical, and Humberto Valbuena, Director of Medical Affairs for US and LATAM at Alcon, lead a panel on the interconnected challenges of complaint handling, CAPA effectiveness, and staying current with regulatory updates. Effective complaint handling and CAPA processes are foundational to product safety, yet many organizations struggle to close the loop between customer complaints, root cause analysis, and corrective actions. The panelists will share best practices for building complaint handling systems that capture meaningful data, CAPA processes that drive real corrective action rather than paperwork, and regulatory monitoring systems that flag relevant changes before they create compliance gaps. Edward and Humberto will draw on their diverse experiences across surgical robotics and ophthalmic devices to illustrate these principles. Attendees will leave with practical tools and techniques for strengthening the complaint-to-CAPA pipeline and maintaining regulatory currency in a rapidly evolving landscape.

Ras Viswanadha, Associate Director of Research (Biological Safety) at Zimmer Biomet, delivers a keynote on innovation, digitalization, and AI in safety and compliance. The digital transformation of safety functions is no longer optional; it is a strategic imperative driven by growing data volumes, rising regulatory expectations, and the need for faster, more accurate safety assessments. Ras will present a vision for the digitally enabled safety organization, drawing on Zimmer Biomet's experience applying advanced technologies to biological safety challenges. The keynote will cover the digitalization journey from manual processes to automated workflows, and from reactive monitoring to predictive safety intelligence. This session will help attendees understand the technology landscape for safety digitalization, identify high-impact use cases for their organizations, and develop a practical roadmap for digital transformation of their safety and compliance functions.

Leo Park of Click Therapeutics and Aparna Ahuja of Abbott return for a panel discussion focused specifically on the application of AI and machine learning in post-market surveillance. As the volume and variety of safety-relevant data continue to grow exponentially, traditional manual approaches to signal detection and adverse event review are becoming unsustainable. The panelists will examine real-world applications of machine learning for automated adverse event classification, natural language processing for mining unstructured safety data, and predictive analytics for early signal detection. The discussion will also address the regulatory perspective on AI in safety, including FDA and international guidance on the validation and use of AI/ML in safety-critical applications. This session is essential for safety leaders who want to understand both the current capabilities and the limitations of AI/ML in post-market surveillance, and to develop a practical strategy for integrating these technologies into their safety workflows.

Subhadip Jana, Sr. Director of Global Regulatory Affairs at ADC Therapeutics, presents a breakout session on global safety data sharing and the integration of real-world evidence into safety decision-making. As regulators worldwide increasingly demand real-world evidence to complement clinical trial data, safety organizations must develop new capabilities for collecting, analyzing, and sharing safety data across borders. The session will explore emerging frameworks for international safety data sharing, including the challenges of data harmonization, privacy compliance across jurisdictions, and the technical infrastructure needed to enable real-time global safety intelligence. Subhadip will share practical examples of how organizations are integrating electronic health records, patient registries, and social media monitoring into their safety evidence base. Attendees will gain insights into how to build a real-world evidence strategy for their safety organizations and navigate the regulatory and operational complexities of global data sharing.