Vijay Reddi | Roche: Regulatory Transformation Fireside Chat - Register for Veeva Summit on Oct. 14

This video provides an introductory overview of a critical presentation delivered by Vijay Reddi, who heads the regulatory transformational team at Roche, scheduled for the Veeva Summit Connect meeting. The central focus of Reddi’s discussion is Roche’s large-scale initiative to overhaul its regulatory operations globally, aiming to accelerate the delivery of life-saving treatments to patients. This transformation is rooted in the strategic goal of unifying traditionally disparate regulatory functions across the enterprise under a single, cohesive operational model.

The core methodology driving this change is encapsulated in the concept of "one regulatory." This framework is designed to bring diverse global regulatory teams and processes under a common set of standardized business capabilities. This standardization is crucial for a multinational pharmaceutical company like Roche, ensuring consistency in regulatory submissions, data integrity, and compliance adherence across various jurisdictions, including those governed by the FDA and EMA. The implementation of "one regulatory" signifies a move away from regional silos toward an integrated, efficient global system.

Reddi emphasizes that the presentation will serve as a practical guide, sharing the strategies and experiences accumulated during this complex organizational and technological integration. Attendees are invited to learn from Roche’s successes—what the team has accomplished in terms of harmonization and efficiency gains—as well as the challenges encountered and the areas identified for continuous improvement. The ultimate objective of this transformation is directly tied to patient outcomes, highlighting the strategic link between optimizing regulatory processes and enhancing the speed and efficacy of patient access to necessary therapies. The choice of the Veeva Summit as the platform underscores the critical role that enterprise software, particularly Veeva’s R&D and Quality suite, plays in enabling such large-scale regulatory modernization efforts.

Key Takeaways: • Strategic Imperative for Regulatory Transformation: The primary driver for Roche’s initiative is the need to reach patients faster, demonstrating that regulatory efficiency is a strategic competitive advantage directly impacting commercial and medical affairs outcomes, rather than just a cost center. • The "One Regulatory" Framework: This concept represents a comprehensive strategy for global harmonization, requiring the standardization of business processes, data models, and technological capabilities across all regulatory functions worldwide to ensure consistent compliance and operational excellence. • Veeva Ecosystem Integration: The presentation’s setting at the Veeva Summit confirms that leading pharmaceutical companies rely heavily on platforms like Veeva R&D and Quality solutions to serve as the technological backbone for complex, global regulatory transformation projects. • Focus on Business Capabilities over Technology: The transformation is defined by unifying "different functions across the globe under a common set of business capabilities," indicating that organizational change management and process re-engineering are as critical as the underlying software implementation. • Learning from Experience and Improvement: The discussion promises a balanced view, covering not only successful strategies and accomplishments but also detailing areas where continuous improvement is necessary, offering valuable, practical lessons for firms undertaking similar large-scale projects. • Addressing Global Complexity: Implementing a "one regulatory" model within a global enterprise like Roche necessitates overcoming significant challenges related to regional regulatory variations, legacy system integration, and ensuring data quality across diverse geographical data pipelines. • Actionable Governance Models: The strategies shared likely include insights into the governance structures, change leadership, and cross-functional collaboration models required to successfully manage a multi-year, multi-departmental regulatory harmonization project. • Linking Compliance to Patient Needs: The transformation explicitly links improved regulatory processes to better meeting patient needs, reinforcing the idea that streamlined compliance tracking and faster submission cycles directly translate into improved public health outcomes. • Data Engineering and Standardization Requirement: Achieving "one regulatory" requires robust data engineering services to integrate data from disparate sources into a standardized, unified data model that supports global business intelligence and regulatory reporting.

Key Concepts:

• Regulatory Transformation: A comprehensive, strategic initiative within a life sciences organization to modernize and streamline all regulatory processes, systems, and data governance to improve efficiency, reduce risk, and accelerate product approval cycles.
• One Regulatory: A specific organizational and operational framework aimed at unifying all global regulatory functions (e.g., submissions, labeling, intelligence) under a single, standardized set of business processes and shared technological capabilities.
• Veeva Summit: A key industry conference hosted by Veeva Systems, focusing on advancements and best practices in CRM, R&D, Quality, and Medical Affairs software solutions within the pharmaceutical and life sciences sectors.