Health Canada XML PM: What We’ve Learned Since the July 18 Deadline

The 18 July 2025 deadline for Health Canada's mandatory XML Product Monograph (PM) submissions has come and gone — but what has the transition revealed about industry readiness, process challenges, and regulator expectations?

Join us for a post-deadline debrief where regulatory experts share key insights from the initial wave of XML PM submissions. We will explore common hurdles companies faced, lessons learned from successful implementations, and what’s next for those still catching up or preparing for future updates. Whether you submitted on time or are navigating late compliance, this session will provide valuable takeaways to strengthen your regulatory operations moving forward.

Learning Objectives

• Identify key insights and trends from the first wave of XML Product Monograph submissions.
• Recognize common technical and regulatory challenges encountered during the transition to XML—and apply strategies to address them.
• Apply best practices and recommendations for organizations submitting post-deadline or managing ongoing product monograph updates.
• Interpret Health Canada’s feedback and enforcement posture to inform future XML PM submission planning and compliance efforts.

Who Should Attend

• Regulatory affairs professionals
• Medical writers
• Digital publishing teams

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Panelists

• Gary Saner
  LexisNexis Life Sciences Solutions, Sr. Regulatory Principal, Life Sciences
• Mary Frasch
  LexisNexis Life Sciences Solutions, Head of Regulatory Compliance Delivery
• Dennis Lingg
  LexisNexis Life Sciences, Regulatory Consultant

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