Regulatory Zone | 2024 Veeva R&D and Quality Summit, U.S. | Register Now

This video serves as a promotional overview for the Regulatory Zone track at the 2024 Veeva R&D and Quality Summit, U.S., scheduled to take place in Boston. The event is positioned as a critical gathering for the life sciences ecosystem, expecting over 2,200 industry leaders, with a dedicated focus on regulatory affairs drawing over 450 specialized attendees. The core purpose of the regulatory track is to facilitate networking, explore emerging industry trends, and share best practices aimed at significantly improving the efficiency and effectiveness of regulatory processes across the globe.

A major strategic focus of the summit is providing an update on the Veeva Vault RIM (Regulatory Information Management) product strategy. This update centers on critical initiatives to better unify regulatory data and documents, which is essential for maintaining data integrity and streamlining complex compliance requirements. Furthermore, the strategy aims to improve support for advanced submission processes, addressing the increasing complexity of global regulatory filings. The agenda is heavily weighted toward practical application, featuring numerous customer presentations from large biopharma giants like Roche, Sanofi, and Lilly, alongside emerging biotechs such as Vir, Mersana, and Sarepta, offering diverse perspectives on real-world RIM deployment challenges and successes.

Innovation, particularly in the realm of intelligent automation, is a central theme, with several dedicated sessions and live demos highlighting new AI features and strategic partnerships within the Veeva ecosystem. This emphasis underscores the industry shift toward leveraging advanced technology, such as Large Language Models (LLMs) and specialized AI, to automate routine regulatory tasks, enhance content planning, and accelerate submission preparation. The summit also features high-level discussions on regulatory transformation, including a keynote speaker sharing insights on the benefits and challenges of modernizing regulatory functions.

Beyond technology, the summit delves deeply into operational excellence and organizational structure. A key session features Steve Gens, discussing the findings of the newly released Gens and Associates World Class RIM survey, which provides data-backed insights into what constitutes a high-performing regulatory organization. The agenda covers practical operational topics, including report-level content plan best practices, process optimization strategies, the development of global end-to-end operating models, effective data stewardship protocols, and the implementation of agile release management processes for regulatory systems. These sessions are designed to provide attendees with actionable frameworks for enhancing their regulatory infrastructure and maximizing their investment in Veeva technology.

Key Takeaways: • Strategic Focus on Data Unification: The core Vault RIM product strategy is moving toward unifying regulatory data and documents, addressing a critical industry need for single sources of truth to support advanced and complex global submission processes. • Regulatory AI Adoption is Accelerating: The inclusion of multiple sessions and demos dedicated to new AI features and partnerships signals that generative AI and intelligent automation are becoming standard tools for streamlining regulatory content creation, submission management, and compliance tracking. • Operational Benchmarking is Crucial: The presentation of the Gens and Associates World Class RIM survey data provides a vital benchmark for regulatory leaders to assess their organizational performance against industry peers and identify specific gaps in their regulatory operating models. • Shift to Agile RIM Implementation: Discussions on agile release management processes indicate a growing trend away from monolithic system deployments toward iterative, flexible approaches for managing and updating regulatory information systems (RIM). • Importance of Data Stewardship: The inclusion of dedicated customer discussions on data stewardship emphasizes that successful regulatory transformation relies not just on technology, but on establishing robust governance and ownership protocols for critical regulatory data assets. • Global Operating Model Optimization: The agenda highlights the need for life sciences companies to establish global end-to-end operating models, ensuring consistency and efficiency across regional regulatory functions, which is essential for multinational compliance. • Content Planning Best Practices: Specific customer discussions focus on report-level content plan best practices, providing granular, actionable advice on how to structure and manage the content lifecycle required for regulatory filings. • Direct Peer-to-Peer Learning: The format heavily relies on customer presentations (from companies like Roche, Sanofi, and smaller biotechs), offering practical, unfiltered insights into the challenges and successful deployment strategies for Veeva R&D and Quality applications. • Focus on Publishing Advances: The summit includes updates on the latest publishing advances, which remain a critical, high-stakes component of the regulatory submission process, ensuring compliance with evolving electronic submission standards.

Tools/Resources Mentioned:

• Veeva Vault RIM (Regulatory Information Management)
• Gens and Associates World Class RIM survey

Key Concepts:

• Vault RIM Product Strategy: The roadmap and development priorities for Veeva’s Regulatory Information Management suite, focusing on data unification and advanced submission support.
• Regulatory Transformation: The comprehensive process of modernizing regulatory affairs departments, encompassing technology adoption (AI), process optimization, and organizational restructuring to achieve higher efficiency and compliance levels.
• Data Stewardship: The responsible planning, management, and governance of data assets within an organization, ensuring data quality, security, and accessibility for regulatory purposes.
• Agile Release Management: An iterative and flexible approach to deploying and updating enterprise software (like RIM systems), allowing for faster feedback loops and continuous improvement compared to traditional waterfall methods.

Examples/Case Studies (Companies mentioned):

• Roche (Large Biopharma)
• Sanofi (Large Biopharma)
• Lilly (Large Biopharma)
• Vir (Biotech)
• Mersana (Biotech)
• Arcus (Biotech)
• Biocryst (Biotech)
• Beigene (Biotech)
• Sarepta (Biotech)