Navigating the Evolving Regulatory Environment: A Fireside Conversation | PMWS26 Keynote

In this fireside conversation from the Pharma Manufacturing World Summit (PMWS), Michael Rogers, Principal of Quality and Compliance at Canal Row Advisors and former FDA Associate Commissioner, joins Kim Wolfram, Head of Global Regulatory CMC Biologics & ATMP at Biogen, to discuss the changing regulatory landscape facing pharmaceutical manufacturers. As regulatory expectations continue to evolve, manufacturing and quality leaders must adapt their compliance strategies to keep pace with new inspection approaches, emerging risks, and shifting agency priorities. Rogers shares insights from his FDA experience on current trends in regulatory oversight, including the increasing use of generalist inspectors and the expansion of unannounced inspections at foreign manufacturing facilities. The discussion also explores how recent regulatory changes are influencing quality and compliance programs, what manufacturers should be doing differently today, and how organizations can proactively engage with regulators to support innovation, product quality, and patient outcomes. Attendees will gain practical perspectives on preparing for the future of pharmaceutical regulation while maintaining operational excellence in a highly regulated environment. Key topics include: FDA inspection trends and evolving enforcement priorities Generalist inspectors and unannounced foreign facility inspections Regulatory compliance strategies for pharmaceutical manufacturers Quality and compliance leadership in changing regulatory environments Regulatory CMC considerations for biologics and advanced therapies Preparing manufacturing organizations for future regulatory expectations FDA-industry collaboration and engagement strategies Risk management and inspection readiness Pharmaceutical quality systems and compliance programs The future of pharmaceutical regulation and oversight About PMWS: The Pharma Manufacturing World Summit (PMWS) is a premier gathering of industry leaders, pharmaceutical manufacturing executives, and experts dedicated to exploring innovative strategies, emerging trends, and best practices in the evolving world of pharmaceutical manufacturing management. Through curated discussions and expert-led sessions, PMWS brings together manufacturing, quality, technical operations, and supply chain leaders to exchange insights, tackle industry challenges, and drive innovation across pharmaceutical production and operations. Learn more at https://www.executiveplatforms.com/pmws/