Madrid | 4-5 June, 2025
Powerful Community, Fresh Ideas
Agenda
Tuesday, 3 June
Wednesday, 4 June
Hear Bayer’s journey to simplify its clinical infrastructure. As an early adopter in Clinical, learn how it pioneered a clinical platform strategy and improved efficiency across clinical operations and data. This includes a “customer-centric” approach to manage change in partnership with sites.
Head Clinical Data & Performance Excellence
SVP, Clinical Strategy
Learn from a leading CDMO how the evolving industry ecosystem impacts quality management across partners. Hear about opportunities and challenges of integrating strategic acquisitions.
Top 20 biopharma discusses how they are innovating their pharmacovigilance operations and improving efficiency within safety teams and across functions. Hear how they are building a trusted data foundation to fuel advanced automation.
In an ever-changing regulatory landscape, innovation and agility are essential. Understand how both internal and external drivers are shaping Teva’s future and how they use Veeva RIM, Development Cloud, and Quality Cloud to drive efficiency, transform business operations, and stay ahead of evolving HA standards. Gain insights on adopting a data-driven, change as usual mindset for RIM excellence.
Vice President Regulatory Operations
Vice President Regulatory, Europe
Novo Nordisk shares strategy on accelerating clinical trials and product launches with Development Cloud. Central to its approach is bringing business and IT teams together through a single platform to improve user experience while enabling cross-collaboration, process automation, and data standards.
Senior Director, Development Cloud Strategy
Vice President of Product Management, Vault Platform
Vice President
See how sponsors can improve site engagement with Veeva Clinical Operations, including reducing email volume, streamlining document exchange and safety letter distribution, and automating training.
Solution Consultant
Discover how the connection between EDC and Safety automates the transfer of serious adverse event (SAE) information, eliminating manual data entry for safety teams and reducing the time and effort spent on reconciliation by data managers.
Senior Solution Consultant, Clinical Data
Discover strategies for optimizing cross-functional workflows in life sciences, and how the Veeva Industry Cloud supports end-to-end processes across multiple applications.
Senior Manager, EU DevCloud Strategy
Discover how this connection eliminates transcription errors, duplicate data entry, and manual tasks with automatic data transfer between EDC and CTMS. Learn how to automate the creation of protocol deviations and payments, and streamline operations with real-time data visibility.
Senior Solution Consultant, Clinical Data
Discover how to harmonize content and improve real-time oversight for QPPVs to stay inspection-ready. Easily manage multiple local PSMFs across regions by reusing global content.
Principal Product Manager, Veeva SafetyDocs
Discover how VeevaID simplifies clinical research site user authentication to all Veeva systems with one SSO login.
Senior Director, Development Cloud Strategy
Learn about recent updates designed to streamline and enhance change management processes. Discover how the QMS-RIM Connector improves efficiency and facilitates data sharing between Veeva Quality and Veeva RIM.
Senior Product Manager, RIM Connections
Learn how small to mid-sized biopharmas maximize the value of Veeva RIM. Veeva experts will showcase strategies for prioritizing business needs and building a strategic feature adoption roadmap.
Principal Consultant and Services Lead, Continuous Innovation, Regulatory
Hear the roadmap and vision for Veeva eTMF and Veeva Study Startup. See demos of the latest innovations and get your questions answered.
Senior Product Manager, Clinical Operations
Hear the roadmap and vision for Veeva Study Training. See demos of the latest innovations and get your questions answered.
Senior Product Manager
Learn what’s next for Veeva EDC, CDB, and eCOA. Hear recent innovations and upcoming enhancements as we deliver for patients, sites, and sponsors. Join the interactive Q&A of your choice in the follow-up discussion.
SVP Product Management, Sites and Patients
Senior Vice President of Product, Clinical Data
Hear the roadmap and vision of Veeva LIMS. See demos of the latest innovations and get your questions answered.
Director, Product Management,
Hear the roadmap and vision of Veeva QMS. See demos of the latest innovations and get your questions answered.
Senior Director, Vault Product Management, QMS
Learn about Veeva’s GxP training vision and roadmap, see demos of the latest innovations, and get your questions answered.
Senior Product Manager
General Manager Veeva LearnGxP
See recent innovations in global case processing automation, narrative optimization, and operational metrics. We’ll also share how we’re solving for unstructured intake and a preview of how Veeva Safety Workbench and Veeva Safety Signal unlock the full potential of a single unified safety platform.
Vice President, Product Management, Veeva Safety
Hear about key Veeva Registrations, Submissions, Submissions Publishing, and Submissions Archive features that were delivered over the past year, highlights from this year’s roadmap, and how we’re helping biopharmas achieve end-to-end process excellence. We’ll also provide progress updates on eCTD 4.0, Active Dossier, our Global Content Plan connection, and other features designed to reduce data management efforts.
Vice President, Product Management, Regulatory
Discover how Vault Platform advancements improve performance, simplify configuration, and enable innovation. See ways to leverage process monitor, Word formatted outputs, and action triggers as well as get a preview of upcoming enhancements to security, reporting, and Direct Data API.
Vice President of Product Management, Vault Platform
Hear the roadmap and vision for Veeva CTMS and Veeva Payments. See demos of the latest innovations and get your questions answered.
Senior Product Manager, Clinical Operations
Hear the roadmap and vision for Veeva Site Connect. See demos of the latest innovations and get your questions answered.
Director of Product, Clinical Operations
Join industry experts as they share insights on fostering collaboration across internal and external teams. Discover how Veeva enables more efficient, reliable workflows, enhances traceability, and simplifies processes.
Join our Veeva Safety product team for live roadmap Q&A.
Vice President, Product Management, Veeva Safety
Vice President Product Architect, Veeva Safety
Principal Product Manager, Veeva SafetyDocs
Director Product Management, Veeva Safety Signal & Workbench
See how regulatory teams use Global Content Plans to reduce cycle times to complete submission activities. Learn to optimize dispatch processes and update cycles from core packages to local submissions.
Solution Consultant, Regulatory
See the latest capabilities and enhancements in Veeva Connections. Discover how to streamline cross-functional business processes, improve data quality, and automate workflows.
Senior Director, Development Cloud Strategy
Join the Veeva RIM product team to discuss any key features from the past year, the latest in regulatory guidelines and developments, and the future roadmap for Veeva RIM.
Vice President, Product Management, Regulatory
Generate documents from Vault data with the new Microsoft Word formatted outputs. See how to configure, test, and easily use it to display data in specific formats.
Senior Director or Product, Vault Platform
GSK and AstraZeneca share their vision to enhance research site collaboration with Veeva Site Connect. Learn about their implementation approach, success streamlining safety letter distribution and other site-facing processes, and future plans.
eTMF/Site Connect Product Owner
Global Clinical Solutions Senior Director
Senior Director, Site Connect Strategy
Ipsen details how adopting a sponsor-owned eTMF system improved process efficiency and regulatory compliance. Learn best practices for advocating a sponsor-owned eTMF business case and how to facilitate collaboration with CROs to further inspection readiness.
eTMF Systems Manager
Senior System Data Lead
Boehringer Ingelheim transformed its ways of working, shortened cycle times, and established a foundation for innovation. Hear practical tips to automate data cleaning and simplify builds. Learn ways to drive value beyond data management, including optimizing connections and processes with Clinical Operations.
Capability Owner Clinical Data Collection
Join a global biotech company as they share their journey with Veeva LIMS. From selection to real-world results, hear about their implementation best practices, key improvements, and the impact on their QC operations.
Senior Project Lead
Hear Veeva’s vision and roadmap to modernize and accelerate validation management processes. See demos of the latest features in Veeva Validation Management and get your questions answered.
Senior Product Manager, Validation Management
Hear the roadmap and vision for Veeva QualityDocs and Veeva Station Manager, see demos of the latest innovations, and get your questions answered.
Director, Product Management (QualityDocs, Station Manager & Training)
Discover how Camurus improved control and data quality for better oversight. Gain insights into its phased approach to bringing pharmacovigilance operations and technology in-house, and best practices for implementing your own safety solution.
Director Patient Safety/QPPV
Speed and efficiency are critical to achieving world-class RIM operations. Learn how Alvotech enhanced process performance, accelerated product launches, and reshaped roles and responsibilities with a proactive and adaptable approach to change. Discover key publishing success metrics and practical considerations for small biopharmas navigating regulatory process transformation.
Director Regulatory Information Management
Active Dossier delivers incremental value, but implementations can reveal data inconsistencies, driving cleanup and improved data integrity. Explore centralized vs. decentralized regulatory operating models, the importance of collaboration in successful implementation, and strategies for process optimization.
Regulatory Program Director
IT Product Manager
Hear how Veeva Disclosures leverages automation and unified systems to improve compliance, accelerate submissions, and further simplify disclosures with new features released in 25R2.
Solution Consultant
Explore how to automate global post-market case processing. Simplify intake of unstructured data, improve data quality with embedded configurable QC workflows, and use rule-based narrative generation.
Vice President Product Architect, Veeva Safety
Join us as we publish a Japanese eCTD 4.0 submission using Veeva Submissions Publishing and get an early preview of U.S. eCTD 4.0 forward compatibility – all within the same processes used today, without any add-ons.
Senior Product Manager, Submissions Publishing
Join us to hear about the key outputs from the latest Veeva Regulatory Community Meeting in Brussels where we discussed best practices for label management in Veeva RIM. Learn what actions Veeva is taking as a followup from the meeting and in support of the ePI Roadmap implementation.
Director Regulatory Strategy
Join the Veeva Business Consulting team to learn how to optimize your RIM implementation roadmap, taking into consideration technical feasibility, business value, change effort, and cost considerations to find the right path forward for your organization.
Regulatory Practice Lead, R&D Business Consulting
Discuss your experience of deploying Veeva Connections with industry peers. Share successes, challenges and the alue added. Veeva teams will also be available for feedback and guidance
Explore process monitoring, a recent Vault Platform capability that identifies process bottlenecks and measures workflow KPIs to drive greater process efficiency
Senior Director or Product, Vault Platform
Collaborate with CROs in real-time and get data oversight and greater control over safety outputs. Easily identify bottlenecks and track case quality and average handling times to improve operational efficiency.
Solution Engineer
ITM details how to provide study-specific training for internal and external staff in Veeva Study Training, streamlining training administration, reporting, and compliance.
Vice President, Head of Global Clinical Operations
GSK details how it has simplified site communications and accelerated site activation. This includes standardizing and automating feasibility surveys to reduce site burden with Veeva Study Startup.
Strategy Product Owner – SSU
Learn how Novo Nordisk managed transformational changes and results during its first year of the Veeva Clinical Data journey. With ambitious goals and a strong program (DataNow), the team delivered efficiency and operational excellence. In a panel with Syneos Health Consulting, hear the strategy to redesign processes, structure change, adapt to challenges, and plan for the next phase of value.
Vice President
Implementation Manager
Senior Director, Strategy, Clinical Data
Director, Data Systems and Automation
Principal Data Management Specialist
Discover insights into the strategic roadmapping approach that shifts quality management improvements from incremental changes to significant advancements, supporting both immediate and long-term business objectives.
Senior Manager
Explore how a collaborative partnership is laying the foundation for the lab digital core—a connected ecosystem that integrates Veeva LIMS with lab instruments to improve productivity and compliance, setting the stage for labs to harness AI and advanced analytics to drive scientific discovery.
CTO
Learn how harmonizing quality systems standardizes operations across 14 facilities and creates consistency for customers. Hear how Veeva Quality Cloud streamlines processes and improves service to global markets.
Corporate eQMS Manager
Group IT QA Lead
Hear about organizational change management strategies that drive successful QMS harmonization across an enterprise. Learn actionable insights on how to foster user adoption and deliver maximum value through effective implementation.
Head of Corporate eQA Systems & IT Validation
Program Lead
Achieving full value of Veeva RIM requires strategic feature adoption and seamless deployment. Learn AstraZeneca’s best practices for leveraging new capabilities to enhance regulatory efficiency, ensure compliance, drive continuous improvement, and respond to user feedback.
Senior Director, Regulatory Information Systems
Enterprise Regulatory Vault Product Manager
Director, IT, Global Delivery, Regulatory & QA Platform
Maximizing the value of your Veeva RIM investment requires effective change management and training. Join Chiesi and Veeva Business Consulting as they share insights and best practices for optimizing adoption.
Head of Global Regulatory Affairs Digital and Publishing
Engagement Manager, R&D Business Consulting
See how a biopharma leverages Vault Reporting and Dashboards, including new process reporting and KPIs, to drive operational improvements, mitigate risks, and better allocate resources. Get a sneak peek into the roadmap and upcoming capabilities.
Get an overview of AI technologies used in Development Cloud applications, and explore how Direct Data API and AI partners can support innovation. Discover lessons learned, best practices, and future R&D AI applications.
SVP, Veeva AI Solutions
Boehringer Ingelheim shares the business value of implementing multiple vaults with Development Cloud. Get an inside look at how they optimized their operating model to decrease cycle times and maintain data quality.
Head of ClinDev Operations Capabilities
Head of Global Regulatory Operations & RA Digital Innovation
Executive Director – Program Manager One Medicine Platform
Head Learning, Processes & Digitalization
Thursday, 5 June
Sanofi shares its approach to streamlining study training by implementing Veeva Study Training as a single, inspection-ready solution. The team discusses how to eliminate the need for multiple disconnected systems across study teams and site staff.
Transformation Catalyst
Digital Product Line Owner
Two biotechs share their transformation journeys to bring key clinical operations systems in-house with CROs working in their systems. Learn why change was needed, how they evaluated new applications, and how Veeva Clinical Operations is helping improve oversight and quality.
Hear industry leaders from UCB, Boehringer Ingelheim, and Allucent share their vision to raise the standards of eCOA delivery. The discussion will address the challenges that increased adoption presents for sites and study teams. Discover practical strategies to expand use without adding workload and hear real-world examples of successful implementation.
SVP Product Management, Sites and Patients
Capability Manager
Global Head Patient Engagement
Chief Digital Technology Officer
Learn how Veeva Batch Release streamlines CMO inputs, third-party testing, manufacturing, and quality data into a single execution point. See how new features, like jurisdictional control, automate batch releases based on market approval updates.
Director of Batch Release Strategy
Learn why adopting an integrated quality management approach creates a strong foundation for digital transformation. Discover how Bayer consolidated their fragmented legacy system landscape to drive efficiency and progress in their strategic journey towards predictive quality.
Lead Digital Quality
S&T Senior Project Manager
IT Program Lead
Explore a game-changing approach to data migration for Veeva LIMS with a powerful integration solution that simplifies data import. Learn how to seamlessly migrate data from any source, accelerating implementation, reducing resource needs, and minimizing disruption.
Global Account Partner
Vice President – Service Delivery
Top biopharmas dive into how they streamlined case processing and gained efficiencies with Veeva Safety. Explore their continued plans for advanced automation and connections across business functions. They’ll also share best practices for adopting new capabilities and driving user and operational success.
Learn how Submission Content Plans and high data quality are enhancing decision-making and capacity management for regulatory operations in a small biopharma company.
Regulatory Operations Team Lead
Regulatory Practice Lead, R&D Business Consulting
Explore Veeva’s strategy to help customers speed submissions with multi-health authority collaboration platforms. Boehringer Ingelheim will highlight Project PRISM – its Regulatory cloud and advanced analytics initiative, while Accumulus will demonstrate its regulatory collaboration, current pilots, and future opportunities.
Senior Director, Government Strategy
Vice President, Global Regulatory Intelligence & Policy
Senior Vice President Regulatory Innovation
Hear how Haleon is managing and maintaining five Vaults and optimizing the release process across these environments. Get an overview on their approach to simplify configuration management and automate deployment.
Senior System Engineer, R&D Safety
QSC System Technology Manager
Senior Director – Development Cloud Strategy
Hear how a biopharma is leveraging Direct Data API to drive business value and enhance decision-making. Discover how to seamlessly export Vault data into data lakes / warehouses for advanced analytics and reporting and practical applications across product development.
Understand how Veeva Study Training, Veeva Site Connect, and Veeva Study Startup streamline processes and reduce administrative overhead for research sites.
Solution Consultant, Clinical Operations
Learn how two of the newest CDB features enable data managers to work more effectively. See how Observations lets data managers collectively evaluate data points before creating queries, and how the Query Metrics Dashboard helps them prioritize the most critical queries to action.
Senior Solution Consultant, Clinical Data
Approach and ways to leverage Github to automate deployment of new releases.
Veeva Product & Platform Architect
Senior System Engineer
Sr. System Engineer
See how Vault Action Layouts simplify the user experience by providing the right information at the right time for the right role and context.
Principal Product Expert, Vault Platform
Learn how to facilitate accurate batch release and product lifecycle management with Active Dossier by maintaining a list of current documents for a given product in multiple markets.
Solution Consultant, Regulatory
Explore key Veeva Publishing value drivers and learn to effecitvely leverage them for a strong business case for implementation.
Senior Director, Regulatory Strategy
See a preview of the new quick queries feature, releasing this year, and how it will create significant time savings for sites and CRAs. Use standard phrases to create or resolve queries with a single click. This new and innovative capability automates query authoring and responses, saving organizations hours of time and effort.
Principal Solution Consultant
See how a unified safety solution accelerates data flow for earlier signal detection and aggregate reporting, links signals back to source case data, supports more detailed analysis, and streamlines RMPs and aRMMS based on signal outcomes.
Principal Product Manager, Veeva SafetyDocs
Senior Product Expert, Veeva Safety
A biopharma and a CRO discuss how CROs can work effectively in a sponsor-owned eTMF. Learn how this approach improves sponsor oversight and efficiency while leveraging CRO expertise.
See real examples of how expanded automation—spanning AI-driven medical coding, protocol authoring, and fully automated study builds—is transforming clinical data management. Hear about the value one biopharma gained from these advancements, and how a connected data foundation supports innovation.
Principal Solution Consultant
Hear how Quality Intake in Veeva QMS ensures that only relevant supplier events are initiated as Quality Events. Learn how the controlled intake process streamlines the registration, assessment, and retrieval of cases, providing full oversight and efficient management.
Senior Manager
Explore how modern, unified quality systems can enhance customer service and improve quality within CDMO operations. Learn from Richter Biologics’ experience in expanding their quality ecosystem to drive greater value and collaboration with their customers.
Teamlead GMP Compliance
Explore how a biotech company scaled its quality system to support rapid growth from start up to global operations. Gain insights into challenges faced, strategies applied and lessons learned on building a robust, scalable quality framework.
Senior Director Global Systems Quality
Discover how UniQure advanced their digital transformation with Veeva Validation Management for optimization, digitization and standardization. Learn about their project approach, key drivers, and success factors.
Vice President, Global Head Digital Transformation
Learn how a biopharma simplified PSMF management by harmonizing processes and supporting seamless collaboration across internal/external content owners and reviewers. Hear how their QPPVs improved global oversight, maintained inspection readiness, and enabled regional teams to produce a complete PSMF in minutes.
Regulatory affairs has become a data-driven operation, requiring enhanced automation and streamlined processes to leverage data from multiple sources, improving submission quality and speed. Learn how Gedeon Richter uses Veeva RIM to drive efficiency across the entire RIM process – enabling growth and innovation.
Global Head Regulatory Science Strategy & Operation
A Master Data Management system is key for a long-term data strategy and robust cross-functional technology infrastructure. Learn Novartis’ experience building an MDM system to seamlessly integrate product data into Veeva RIM.
Head, Data Strategy & Management
RA CMC Senior Manager Data & Digital
Engagement Manager
Explore how to extend Vault through advanced configuration and customization with real-world examples. Learn how to create custom data objects, tailor the user interface, connect with external systems to automate business processes.
Vice President of Product Management, Vault Platform
See how to use existing data and documents from Veeva Clinical Operations, including TMF documents, to automate sponsor, CRO, and site training in Veeva Study Training. Then, automatically file evidence of training completion in Veeva eTMF to increase compliance.
Senior Solution Consultant
Learn how Veeva eCOA simplifies the design, management, and completion of clinical outcome assessments for sponsors, sites, and patients.
Senior Solution Consultant
Learn how to access the raw text extracted from your documents after they are uploaded to Vault. This unformatted text can be sent to LLM’s and Gen AI services with the need to export source files from Vault.
Director of Product
See how the latest updates in Veeva Study Training further streamline training. Learn how to automate training assignments based on responsibilities, increase CRA visibility with the My Study Team page, and exempt PIs from duplicate training.
Solution Consultant
See how the seamless connection between RTSM and EDC automates data transfer to reduce the risk of errors from manual transcription, eliminate duplicate data entry for sites, and reduce data review and reconciliation efforts for data managers.
Solution Consultant, Clinical Data
Discover how process reporting can be leveraged across the organization to measure operational health and efficiency
Senior Director, Veeva Regulatory Strategy
See the latest best practices for Veeva Governance and how a Center of Excellence can help drive cross-functional collaboration across multiple Vaults.
Senior Director – Development Cloud Strategy
Development Excellence Practice Lead, Europe R&D Business Consulting
See how TMF Transfer enables daily transfers of approved documents from CROs to sponsors, improving oversight and visibility. Sponsors can then ensure ongoing compliance after a study ends with TMF Archive.
Solution Consultant
In this session for Veeva eTMF customers only, you’ll learn about risk-based approaches for TMF management and features you can use to create additional efficiencies.
Product Expert, Clinical Operations
Senior Directory, Clinical Strategy
Join this session to discuss the assessment and documentation of decision-making throughout a trial, in alignment with the latest ICH E6 (R3) guidelines. Share insights on current processes and opportunities for improvement. Open to Veeva CTMS customers only.
Senior Product Expert, Clinical Operations
Senior Director of Strategy, Veeva Clinical Operations
Join this session to share best practices, hear from product experts, and discuss latest and upcoming capabilities. Open to Veeva Safety customers only.
Get the latest updates on EMA’s PMS activities and roadmaps, including insights from a customer’s current PMS Pilot preparations. Learn how an IDMP Ontology project at Pistoia Alliance is advancing semantic interoperability, based on FAIR principles, to enhance existing IDMP standards
Vice President Regulatory, Europe
Discover open-source tools, built using Vault API, that increase administrator and developer productivity with an intuitive user interface.
Senior Product Expect, Vault Platform
Director of Product Management, Developer Experience
See how CTMS Transfer automates information exchange between sponsors and CROs using Veeva CTMS, improving study oversight, eliminating custom reports, and strengthening study partnerships.
Senior Solution Consultant
eCTD4.0 roll out is starting. Join us to learn about the enhancements and benefits eCTD4.0 brings and how to prepare.
Director Regulatory Strategy