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Session 9, Track 4: Cross-Functional Collaboration for Regulatory Excellence: Integrations, Digital Innovation, and Inspection Readiness
Session Chair(s)
Katherine Novak, MS
Director, Epista Life Science, United States
As regulatory expectations evolve, seamless collaboration across regulatory, technical, and operational teams has become essential to sustaining compliance and driving innovation. This session brings together insights from integration initiatives and inspection-readiness strategies to illustrate how cross-functional partnerships can accelerate digital transformation, strengthen cloud-based review capabilities, and support regulatory rigor. Through real-world examples and practical frameworks, speakers will explore how unified planning, shared understanding, and intentional team design enhance both integration programs and hybrid/remote inspection activities. Attendees will gain actionable approaches to building connected, inspection-ready organizations that can scale with emerging regulatory interfaces, digital tools, and cloud-enabled review models.
Cross-Functional Collaboration for Regulatory Excellence: Integrations, Digital Innovation, and Inspection Readiness
Dominique Lagrave, Accumulus Technologies
Inspection-Ready by Design: Digital Strategies to Support Hybrid and Remote Regulatory Inspections
Andrea Bastek, Florence Healthcare
Matt Neal, BeOne
Learning Objective : - Identify how regulatory, operational, and technology teams can jointly scope, plan, and execute integration initiatives aligned to real regulatory use cases
- Apply collaborative strategies and digital design principles that enhance inspection readiness—especially for hybrid and remote regulatory inspections
- Evaluate common cross-functional pitfalls and implement practices that strengthen regulatory excellence across the product lifecycle
Speaker(s)
Inspection-Ready by Design: Digital Strategies to Support Hybrid and Remote Regulatory Inspections
Andrea Bastek, MS
VP Market Strategy, Florence Healthcare, United States
Cross-Functional Collaboration for Regulatory Excellence: Integrations, Digital Innovation, and Inspection Readiness
Dominique Lagrave, PharmD
Chief Regulatory Officer, Accumulus Technologies, United States
Speaker
Matt Neal, MA
Executive Director, Global Regulatory Operations Strategy & Innovation, BeOne Medicines USA, Inc., United States
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