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Session 6, Track A: Navigating AI Capabilities for a Safe Evolution of Regulatory Workflows used to Manage Regulatory Content and Submissions
Session Chair(s)
Angelina Habimana
Sr. Dir. Regulatory Affairs, Teva Canada Innovation, Canada
Rebecca Humecky
Associate Director, Regulatory Affairs CMC, Cytokinetics Inc., United States
This session explores how regulatory operations are transforming through digitalization, structured content, and advanced technologies. It highlights the transition to eCTD v4.0 as a key enabler of content reuse, improved lifecycle management, and more efficient global submissions, while also addressing the challenge of fragmented, manual processes in both submission authoring and clinical disclosure. The presentations propose integrated, tech-enabled solutions—including component-based authoring, centralized digital workbenches, and AI-driven tools—to enhance consistency, reduce rework, and ensure real-time coordination across functions and regions. Together, they provide a practical roadmap for organizations to modernize workflows, safeguard confidential information, and achieve greater efficiency and compliance in an increasingly complex regulatory landscape.
Learning Objective : - Explain how eCTD v4 combined with AI-enabled authoring (content generation, reuse, quality checks) enhances structured data, lifecycle management, and submission efficiency
- Identify practical steps to implement AI-supported component-based authoring, validation gates, and metrics to improve right first time quality and reuse
- Integrate digital workflows and AI tools to protect confidential data while ensuring compliant global disclosure
Speaker(s)
From Document Push to Intelligent Exchange: eCTD v4 as the Foundation for AI-Enabled Regulation
Iqra Ali
Junior Consultant Publishing Services, EXTEDO Inc., United States
The Digital Guardian: Harmonizing AI and Strategy for Protection of Confidential Information
Anaya Rehman, MD, MS
Regulatory Services Manager, Veristat, Canada
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