Regulatory Zone | 2025 Veeva R&D and Quality Summit, U.S. | Register Now

This video serves as an invitation to the Regulatory Zone at the 2025 Veeva R&D and Quality Summit in Boston, positioning it as the premier industry event for life sciences leaders focused on enhancing regulatory efficiency and driving innovation. The summit aims to convene over 2,600 life sciences professionals, with a significant portion (over 450) specifically dedicated to the regulatory track. The core message emphasizes the opportunity for attendees to network with peers, explore industry trends, and learn strategies directly impacting regulatory operations and compliance.

The presentation delves into key updates regarding Veeva's RIM (Regulatory Information Management) product strategy. A central theme is the unification of data and documents, aiming to streamline regulatory processes. The strategy also focuses on improving support for advanced submission processes and enabling seamless integration with multi-health authority platforms such as Accumulus and PRISM. These advancements are highlighted as crucial for boosting team productivity and ensuring robust compliance in an increasingly complex regulatory landscape. The speaker underscores that customer presentations will be a focal point, offering real-world insights from a diverse range of biopharmaceutical companies, from large enterprises like Roche and AstraZeneca to mid-sized and smaller biotech firms.

Further expanding on the content, the summit's roadmap sessions will reveal current plans for "Veeva AI for regulatory," alongside the latest developments in publishing, active dossier management, global content planning, and registrations. A significant highlight is a panel discussion featuring biopharma leaders who have successfully implemented generative AI (GenAI) solutions in regulatory contexts. This session promises to share best practices for measuring value, building end-user trust, and achieving scalable adoption of AI technologies. Additionally, a keynote speaker will provide practical strategies for modernizing legacy publishing processes, navigating diverse health authority platforms, and rethinking traditional implementation models, emphasizing the foundational role of internal conversations in driving meaningful change. The event also offers interactive elements, including workshops with product managers for direct input, innovation theater sessions demonstrating end-to-end use cases, and live demos with Veeva's full team.

Key Takeaways:

• The 2025 Veeva R&D and Quality Summit's Regulatory Zone is positioned as a critical event for life sciences leaders seeking to advance regulatory efficiency and innovation. It offers a unique opportunity to connect with over 450 regulatory peers and explore cutting-edge industry trends.
• Veeva's RIM product strategy is evolving with a strong focus on unifying data and documents, which is essential for streamlining complex regulatory workflows and improving overall data governance.
• Significant advancements are planned for supporting advanced submission processes and enabling seamless integration with crucial multi-health authority platforms like Accumulus and PRISM, addressing a key challenge in global regulatory affairs.
• "Veeva AI for regulatory" is a prominent feature on the product roadmap, indicating Veeva's commitment to leveraging artificial intelligence to transform regulatory operations.
• The summit will feature a dedicated panel discussion on regulatory GenAI solutions, offering practical insights from biopharma leaders on how to measure the value of AI, build end-user trust, and achieve scalable adoption within organizations.
• Attendees will gain real-world insights from customer presentations by a wide array of companies, including large biopharmaceuticals (Roche, Sanofi, AstraZeneca), mid-sized firms (Daiichi Sankyo, BeOne, Vertex), and smaller biotechs (Aimmune, BridgeBio, BioCryst, Lexicon).
• Strategies for modernizing legacy publishing processes are a key theme, providing actionable advice on how to update outdated systems and workflows to meet current regulatory demands.
• The event will address the complexities of navigating multi-health authority platforms, offering guidance and best practices for managing diverse regulatory requirements across different regions.
• Discussions will include when a custom solution within Veeva RIM might be the most effective approach for meeting specific organizational needs, with insights from both customers and Veeva's technical services team.
• Opportunities for direct engagement include workshops with Veeva product managers, allowing attendees to provide input and influence future product development in a collaborative setting.
• Innovation theater sessions will provide in-depth demonstrations of end-to-end use cases, showcasing the latest features and how they can be applied in practice to optimize regulatory processes.
• The summit emphasizes the importance of networking, providing a platform for attendees to connect with hundreds of industry peers to learn, share experiences, and forge valuable professional relationships.

Tools/Resources Mentioned:

• Veeva RIM (Regulatory Information Management)
• Veeva AI for regulatory
• Accumulus (multi health authority platform)
• PRISM (multi health authority platform)

Key Concepts:

• Regulatory Efficiency: Optimizing processes and workflows to reduce time, cost, and effort in meeting regulatory requirements.
• Data and Document Unification: Integrating disparate data sources and documents into a single, cohesive system for improved management and accessibility.
• Advanced Submission Processes: Utilizing sophisticated tools and methodologies to prepare and submit regulatory documents to health authorities.
• Multi Health Authority Platforms: Systems designed to manage regulatory interactions and submissions across various global health agencies (e.g., FDA, EMA).
• Regulatory GenAI Solutions: Application of generative artificial intelligence to automate, enhance, or create content and processes within the regulatory domain.
• Legacy Publishing Processes: Traditional, often manual or outdated methods for preparing and publishing regulatory submissions.
• Active Dossier: A dynamic, continuously updated collection of regulatory information and documents for a product.
• Global Content Plan: A strategic framework for managing and distributing regulatory content across different regions and health authorities.

Examples/Case Studies:

• Large Biopharmaceuticals: Roche, Sanofi, AstraZeneca
• Midsized Companies: Daiichi Sankyo, BeOne, Vertex
• Smaller Biotech Companies: Aimmune, BridgeBio, BioCryst, Lexicon