Agenda
Monday, 3 June
Tuesday, 4 June
Boehringer Ingelheim discusses its data-centric regulatory transformation, highlighting the crucial pillars of people, process, and technology. You’ll also hear about regulatory innovation and trends, strategies for organizational change, and process adoption.
Head of Global Regulatory Operations & RA Digital Innovation
Hear about the latest industry trends and the evolution of quality to become a key driver for innovation. Maite Durrenbach, the chief quality officer at Sanofi, shares their digital transformation journey in Quality and Veeva’s role in the transformation.
Chief Quality Officer
Vice President, Quality Strategy, EU
Teva shares its journey bringing three safety systems into one global solution enabling better end-to-end individual case safety report (ICSR) management and control. Hear how Teva accelerated business process and system transformation, and ways to speed up user adoption in new ways of working. Teva will also discuss its multi-phase safety vision, focusing on plans for Vault SafetyDocs, Vault Safety Signal, and connections with other Vaults to achieve operational excellence and advance patient safety.
Head of Systems & Innovation
Vice President, Vault Safety
Senior Director, Vault Safety Strategy
Hear from an emerging, midsize, and global biopharma on Development Cloud strategies to reduce cost, accelerate processes from clinical trials to product launch, and establish a foundation for growth. They’ll discuss the value of a single view of product and study across functional areas, automating processes such as change control, and submission document collection.
Associate Director, Global IT Services & Procurement
Global Administration of Information Asset
Head, Data Science and AI
Development Cloud Architect
Senior Director of Strategy, Development Cloud
Novo Nordisk shares its strategy for transforming clinical research through the use of data and AI. Hear best practices for building a seamless data infrastructure, breaking traditional silos, driving efficiencies with automation, improving quality by design, and unlocking critical clinical insights.
Senior Vice President
See how clinical and safety teams are reducing manual processes and data reconciliation using connections across Vault Safety, Vault EDC, Vault eTMF, and Veeva Site Connect.
Principal Product Architect, Vault Safety
Solution Consultant, Safety
Showcase how this new class of API simplifies replicating of Vault data for external systems.
Product Expert, Vault Platform
Streamline your Quality Control (QC) process by eliminating paper and standalone solutions with Vault LIMS, a modern laboratory information management system. See how its unification with Quality Assurance (QA) processes enhances teamwork, ease of use, and oversight.
Senior Director, Vault LIMS
Help users keep up with their work on-the-go with Vault Mobile, including uploading files, completing workflows, annotating documents, and viewing dashboards.
Senior Product Expert, Vault Platform
Get started with Process Navigator quickly with new Process Navigator Reference Hierarchies. Learn how to use reference hierarchies in Vault QualityDocs and organize your content by processes.
Vice President, Quality Strategy, EU
Director, Product Management
Senior Solution Consultant, Quality
See Vault EDC’s new Clinical Reporting to easily create single-form, cross-form, and exception listings with zero programming. Learn how users centrally access near real-time listings and navigate directly from listings to manage queries.
Senior Solution Consultant, Clinical Data
Experience the power of Vault RIM platform with registrations, submissions, submissions publishing, and submissions archive. See how the RIM Bot automates document classifications and saves organizations valuable time and resources.
Solution Consultant, Regulatory
See Vault Clinical Operations in action and the value of a unified platform in this live demo.
Product Expert, Clinical Operations
Build submissions in real-time and eliminate content duplication through automated document transfer from Vault Quality, Vault Clinical, and Vaults PromoMats to regulatory’s Vault RIM.
Senior Solution Consultant, Regulatory
Learn how to address the shortcomings of historical approaches to ePRO libraries. Discover an innovative ability to easily incorporate assessments and translations with a single click.
Senior Solution Consultant, Clinical Data
Hear how Teva embarked on a challenging regulatory transformation and broke through silos to centralize operations – all while retaining business continuity; and this is just the start.
Senior Director, IT Regulatory Affairs
Galapagos shares how they increased training effectiveness and compliance with risk-based strategies, navigating organizational changes to build and maintain employee competency.
QMS Operations Head
Learn how Sanofi implemented Vault Quality as a foundational element of their quality transformation. Explore opportunities to advance a quality system with some add-on automation capabilities.
Digital QMS Program and Product Line Leader
QMS Program Head
UCB and LEO Pharma explore how rapid advancements in technology are driving new approaches to safety and making a compelling case for transformation. They’ll discuss simplifying and automating pharmacovigilance and strategically leveraging data for deeper insights. Hear best practices on harmonizing and driving end-to-end pharmacovigilance processes across functions, affiliates, and partners.
Global Safety & Medical Information Vice President
Head of Systems, Patient Safety
Head of IT Patient Safety
Senior Manager, Vault Safety
Learn how Ascendis implemented the Quality-RIM and RIM-Clinical Operations connections, the business impact, and learnings for future implementations. Get an inside view on change management challenges and how they brought the businesses together to support seamless processes and data sharing.
Associate Director, Global IT Services & Procurement
Development Cloud Architect
Improve visibility into operational processes, application usage, and KPIs with Vault reports and dashboards. See recent key enhancements as well as upcoming and important roadmap features.
Director of Product Management, Vault Platform
Clinical data leaders from Novo Nordisk, GSK, Fortrea, and Syneos Health discuss their journeys toward clinical data transformation, including optimization approaches and advice for others considering this path.
Vice President
Director Data Management
VP Global Head Clinical Data Management
SVP FSP360, Head of Customer Success
Nordic Pharma unveils its roadmap for achieving operational excellence in RIM. Explore its transformative journey revolutionizing regulatory processes, expertise, and culture through the adoption of the full Vault RIM platform.
Senior Regulatory Database Manager
AstraZeneca shares its model for implementing a compliant archival process across the entire TMF landscape, including Vault eTMF and other authorised systems. This includes creating an archiving committee, developing metrics to ensure appropriate oversight, and incorporating inspection learnings.
TMF Director Process Quality and Compliance
Alfasigma shares the decision-making flow they follow to migrate completed studies into their sponsor-owned Vault eTMF and drive inspection readiness. This includes assessing the CRO’s environment and weighing the risks and benefits of different approaches.
TMF Specialist
Senior Clinical Innovation & Operational Excellence Manager, Clinical Trials Operations Head a.i.
Randomization and trial supply management impacts multiple different business processes and stakeholders. Learn how Veeva RTSM is challenging the status quo to bring new efficiencies to sponsors, including touchpoints with EDC, CDB, CTMS and eTMF.
General Manager, Veeva RTSM
VP Strategy, Veeva RTSM
See the right information, at the right time, for the right purpose with Vault action layouts for a simplified user experience.
Senior Product Expert, Vault Platform
Learn about Vault Disclosures, Veeva’s flexible and configurable solution for sharing study registrations and results disclosures with CT.gov and CTIS.
Senior Director, Clinical Operations Strategy, Vault Disclosures
Senior Product Manager, Vault Clinical Operations
Manage quality risks more efficiently with new capabilities in Vault QMS, such as Visual Heatmaps and Risk Builder, which provide greater insights for proactive risk mitigation.
Senior Director Strategy, Vault Quality
Principal Solution Consultant, Quality
Explore practical insights and solutions to accelerate technology adoption and drive meaningful change. Learn change strategies for overcoming barriers such as varying levels of understanding and buy-in, usability challenges, and inadequate monitoring of adoption levels.
CTMS Delivery Lead
See a showcase of AI’s role in streamlining Veeva Vault processes including examples for submissions and safety case intake and handling. Learn how a secure AI platform can maximize Veeva Vault efficiency.
Automate and streamline the safety letter distribution process starting from creation in Vault Safety, flowing into the Sponsor/CRO’s Vault eTMF, and then automating ‘distribution to’ and ‘acknowledgement from’ Sites.
Solution Engineer, Clinical Operations
See how Vault Study Training brings sponsors, CROs, and research sites into a single platform to streamline and automate study training. This includes new automation to further reduce the time it takes to create a training plan matrix.
Solution Consultant, Clinical Operations
Join Base Life Sciences in this session to learn how they build Gen AI capabilities into Veeva Vault through seamless API integrations and hyper-scaler-managed services, focusing on automation in translations, content reviews, and audits.
Head of AI & Automation
See how sites can designate the type of visit in hybrid trials, whether patients are seen on-site, virtually, at home, via phone, or elsewhere. With this new Vault EDC feature, visit methods can dictate the CRF schedule, email alerts, and even payable items in Vault CTMS.
Principal Solution Consultant, Clinical Data
Learn how CPI sets new benchmarks in pharma manufacturing through process innovation, industry collaboration, and leveraging advanced technology like Vault Quality as part of a real-time release demonstrator.
Director of Digital (Pharma and Healthtech)
Learn how Boehringer Ingelheim improved the quality oversight of Medicine suppliers by reducing the number of data sources and connecting processes and systems into one platform.
Management Consultant
Head of Vendor Compliance Management
Discover how biotechs achieved operational efficiencies with Vault Safety. Learn best practices on how to collaborate with CROs on a modern platform.
Safety Systems Administrator
Pharmacovigilance Manager
Senior Manager, Strategy Vault Safety
GSK and Bayer continuously improve ongoing management of Vault. Hear how GSK is optimizing release processes and accelerating delivery of new business capabilities across multiple Vaults. Bayer will showcase agile DevOps and validation management tooling implemented as part of their Vault RIM to ensure control, speed, and visibility.
Product Manager
R&D Development Digital and Tech Senior Product Director
Senior Director of Strategy, Development Cloud
Accelerate business processes and improve user experience with the latest capabilities including action layouts, advanced start workflow, notification categories and preferences, and Vault Mobile.
Senior Product Expert, Vault Platform
Hear GSK share fit-for-purpose use cases for automation in lock-related activities. Learn about their practical approach, how these use cases provide value today, and why this also builds a better data foundation for the future.
Data Management Director
Showcasing specific examples of real-life regulatory challenges addressed by Vault RIM, Gilead and Veeva Business Consulting highlight the benefits of a continuous communication plan to increase user adoption and engagement post go-live.
Director, Regulatory Information Management
Engagement Manager
Get insights on evolving into a data-centric regulatory organization as Jazz Pharmaceuticals examines its new operational model and data governance approach. With innovative changes, the regulatory team is experiencing better process adherence and increased agility.
Associate Director Regulatory Information Management
Julius Clinical shares challenges, best practices, lessons learned, and the benefits of implementing three Vault Clinical Operations applications at once.
Director Clinical Operations
Chief Information Officer
This session will analyse how creating a dynamic ecosystem can maximise potential for studies and partnerships. We will share details of how Fortrea and Veeva have partnered to develop innovative technology solutions to benefit key stakeholders including sites and patients.
Global Head, Digital Health and Innovation
A panel representing supply management, data management and IT discusses their different RTSM needs, experiences, and thoughts on how to work together and with vendors to overcome common challenges and silos.
Head of Digital and IT
Snr Director, Clinical Data Management
Discover how safety teams are automating post market case processing globally. See a demo of touchless case processing for MHRA and EMA cases, seamless adverse event intake from Vault MedInquiry, and Japanese case localization.
Principal Product Architect, Vault Safety
Solution Consultant, Safety
Discover how product data is used across the Vault Ecosystem and synced with Vault Connections to support cross-functional business processes.
Senior Product Manager, RIM
Learn best practices for completeness planning and tracking in Vault eTMF. This includes new capabilities like the milestone workspace, which provides a consolidated view of completeness.
Solution Engineer, Clinical Operations
Discover an innovative method for delivering targeted GxP Refresher Training across your organization. Learn how a modular training approach increases efficiency, and courses reflecting the latest industry trends ensure compliance.
General Manager, LearnGxP
See how a top 20 biopharma saves 60+ hours of manual work per week on a single study using Veeva CDB’s autocheck capability. Learn how to create autochecks, set automation rules, and monitor performance.
Principal Solution Consultant, Clinical Data
Learn how content plans streamline and accelerate the overall submissions publishing process in Vault Submissions Publishing.
Senior Solution Consultant, Regulatory
See how to effectively demonstrate oversight by tracking and managing observations, closed-loop issue management, real-time reports and dashboards, and more. We’ll also show how to streamline data exchange between sponsors and CROs in this live demo.
Senior Solution Consultant, Clinical Operations
Senior Product Expert, Clinical Operations
Explore real-world customer stories on how Vault Validation Management drives agility and efficiency across the end-to-end validation lifecycle. Hear insights from customers who have successfully implemented the product, digitally transforming their validation processes.
Director, Vault Validation Management Europe
Learn how AstraZeneca enhances user experience and improves productivity with Process Navigator in QualityDocs to simplify search and speed access to critical procedures and content for casual users.
Associate Director
Incorporating affiliates and partners into safety processes unifies pharmacovigilance data onto one global platform and eliminates data reconciliation. We’ll discuss how real-time transparency improves oversight from case intake through distribution while streamlining workflows.
Project Manager
QPPV
Roche and Chiesi provide insights for a path to successfully manage multiple Vaults and maximize Development Cloud value. We’ll explore drivers influencing the adoption approach, data and process governance model, and strategies for effective organizational change management.
Product Manager
Product Manager Study Startup & Conduct
Head Global Regulatory Affairs
Principal & Team Manager, Clinical Business Consulting
See how Vault APIs, including Direct Data API, allow organizations to integrate external applications and tools with the Vault Platform. We’ll review recommended approaches as well as pitfalls to avoid.
Product Expert, Vault Platform
See Veeva’s vision for clinical data through an end-to-end demo spanning patients, sites, and sponsors/CROs. This live demo showcases what’s available today using Veeva’s EDC, CDB, RTSM, ePRO, CTMS, and safety systems.
Principal Solution Consultant, Clinical Data
Senior Solution Consultant, Clinical Data
Senior Solution Consultant, Clinical Data
Charting a course to improve data and regulatory process management, hear Gedeon Richter biopharma identified value-add opportunities, implementation challenges, and assessed business impact.
Global Regulatory Science Director
Discover Novo Nordisk’s methodologies to improve regulatory data quality, paving the way for continuous operational improvement.
Product Manager, NextGen Labelling
Practice Manager, Regulatory Business Consulting
Hear these top biopharmas’ journey from legacy technology to modern cloud CTMS to improve trial speed and quality. Learn techniques to optimize monitoring and the most effective KPIs to track trial progress.
Explore AstraZeneca’s journey to faster study start-up across 40+ countries. Learn challenges faced, lessons learned, and best practices to optimize system configuration and collaboration.
Associate Director, Global Clinical Solutions, VCV SSU Product Owner
Wednesday, 5 June
Hear the roadmap and vision of Vault QMS. See demos of the latest innovations and get your questions answered.
Senior Director, Vault Product Management, QMS
See enhancements on global case processing, reducing case handling time, and new operational metrics. Get a sneak peek of Vault Safety Workbench, Vault Safety Signal, new use cases for Vault SafetyDocs, and the next phase of safety automation.
Vice President, Product Management, Vault Safety
Explore recently released capabilities, including action layouts, and discuss upcoming Vault Connections and scalability, availability, and user productivity enhancements. See new management metrics and key architectural changes to improve data and document performance and scale.
SVP Product Management, Vault Platform & Technology
Learn about Veeva’s GxP training vision and roadmap, see demos of the latest innovations, and get your questions answered.
Director, Product Management
General Manager, LearnGxP
Learn what’s next for Vault CDMS, including upcoming innovations and enhancements coming to Vault EDC and Veeva CDB this year. Plus, ask the Veeva team questions during an interactive Q&A.
SVP Products, Vault CDMS
Hear about the key Vault Registrations, Submissions, Publishing, and Archive features that were delivered over the past year, highlights from this year’s roadmap, and how we’re improving end-to-end process optimization. We’ll also provide updates on health authority question extraction and progress on Active Dossier.
Senior Director, Product Management, Vault RIM
See how the milestone workspace simplifies EDL and milestone management in Vault eTMF and our plans to help you conduct periodic, risk-based QC. Learn how we’ve streamlined feasibility surveys in Vault Study Startup and how standard questions will enable you to provide default answers for sites.
Director of Product Management, Clinical Operations
Site Connect is changing to make it easier than ever to exchange documents and study information with sites! See how you’ll be able to exchange documents with any site directly in Vault Clinical Operations, regardless of what eISF the site uses.
Director of Product Management, Site Connect
Hear the roadmap and vision for Vault QualityDocs and Vault Station Manager, see demos of the latest innovations, and get your questions answered.
Director, Product Management
Leverage sandbox snapshots for efficient Vault environment management and a more resilient release process.
Product Expert, Vault Platform
Hear Veeva’s vision and roadmap to modernize and accelerate validation management processes. See demos of the latest features in Vault Validation Management and get your questions answered.
Director, Product Management, Vault Validation Management
See how Vault Registrations helps teams capture, manage, and track regulatory events for registered products and facilitates quick assessment of planned changes for immediate action.
Solution Consultant, MedTech Regulatory
Ask questions live with the Vault Safety product team.
Vice President, Product Management, Vault Safety
Learn how we’ve made monitoring more flexible and enhanced support for outsourced trials with oversight issue tracking and streamlined data transfers between sponsors and CROs in Vault CTMS. See how we’ve improved site fee management and our plans to support master protocols and complex trials across arms and cohorts in Vault Payments.
Product Manager, Clinical Operations
Streamlining processes through automation is key in Vault Study Training – from released features such as automated user creation and training assignments to planned enhancements such as training completion monitoring and delegated responsibility training. Join this roadmap session to hear about all of the exciting new things coming to Vault Study Training!
Director, Product Management
See how data flows in real-time from Veeva Randomization and Trial Supply Management (RTSM), to Vault Electronic Data Capture (EDC), and Vault Clinical Trial Management System (CTMS) to reduce duplicate data entry and ensure enrollment metrics and subject progress reports are always up-to-date.
Principal Solution Consultant, Clinical Data
Discover how Veeva RTSM will deliver cross study reporting to proactively identify randomization and trial supply management issues.
Solution Consultant, Veeva RTSM
Join Jazz Pharmaceuticals and Ascendis Pharma as they reflect on their Summit learnings about unifying QA and QC, driving collaboration across the value chain, and digitizing quality across the product lifecycle. Hear how they will apply these best practices to advance quality management in their organizations.
Director, Head of QMS
SVP Global Quality (Chief Quality Officer)
BioNTech shares how it brought safety in-house to scale operations for its growing clinical pipeline. Explore the pros and cons of different pharmacovigilance operating models, considerations for insourcing, and lessons learned. With a strong business and IT partnership, BioNTech discusses how it defined business processes and enabled operational agility while maintaining compliance.
Director R&D DD&I Business Partner
Director Clinical Safety Management
Discover how Boehringer Ingelheim uses storytelling, anchored in authentic Vault user experiences, as a powerful tool to maintain engagement in a multi-year transformation. See how the team advocates for change and showcases progress in internal communication and training to inspire continued transformation.
OMP Business Program Manager
Amplify Program Manager
Global Program Manager
Creative Director and Founder
Founder and Creative
Discover the latest Vault Connections and enhancements and see how they are transforming biopharma processes, improving data quality, and making compliance easier.
Development Cloud Architect
Boehringer Ingelheim and Fortrea share their efforts to improve site and patient experience. Discover how and why they have recently refocused their strategies based on past experiences and how an industry professional can bring personal insights into this journey.
Capability Manager
Global Head, Digital Health and Innovation
Senior Principle Capability Manager Patient & Site Engagement
Explore the transformative impact of automation on regulatory information management as illustrated by GSK. Learn how to seamlessly blend legacy and modern solutions to streamline processes and data handling.
Head, Regulatory Excellence, Process & Analytics
Head, Regulatory Information Management
Outlining its path toward continuous regulatory process improvement, learn how Ipsen took the advantage of the Vault RIM platform to support and optimize its regulatory activities.
Director Data & Systems
Reducing the burden of running clinical trials for research sites is a top priority for Bayer. Hear about its site-centric initiatives and lessons learned with Vault Study Training and Veeva Site Connect.
Head of Clinical Trial Management Services and Solutions
Cluster Lead CD&O Training
Hear PharmaMar’s strategy for implementing sponsor-owned Vault eTMF. The growing biotech will also share how they leverage CTMS data in eTMF and when they plan to bring additional processes in-house.
IT Senior Manager
A CRO alongside experts from the Veeva RTSM Services team share their experiences, learnings, and advice on best practices from their recent Veeva RTSM implementations.
Associate Director Data Management
Practice Director
Senior Consultant
Remove double data re-entry common with E2B. Using Safety-EDC Connection, SAEs are automatically linked to subject and existing cases (follow-up), and clinical teams receive a case number – eliminating reconciliation.
Principal Product Architect, Vault Safety
Learn how recent enhancements in Vault Training automatically manage access and job roles after training completion and speed up new employee readiness with phased onboarding.
Director, Training Strategy, Europe
Director, Product Management
Solution Consultant, Quality
See how Vault EDC and Veeva RTSM seamlessly connect to provide a better end user experience for sites and eliminate data reconciliation efforts for data managers.
Solution Consultant, Veeva RTSM
Learn how to harmonize content and improve real-time oversight for QPPV teams using a modular-based PSMF management solution. Easily manage multiple PSMFs across regions by reusing content globally.
Senior Product Manager, SafetyDocs
Unified with Vault CTMS and connected with Vault EDC, see how Vault Payments provides accuracy and visibility to ensure sites are paid on time.
Senior Solution Consultant, Clinical Operations
Go beyond E2B with automated SAE reporting that transfers all relevant EDC data and allows safety users to choose what’s relevant. Safety case IDs are automatically added to corresponding SAEs so Vault EDC users can rest assured the SAEs were received. This deep connectivity eliminates duplicate data entry and time-consuming reconciliations.
Senior Solution Consultant, Clinical Data
Join Vault Safety customers to share best practices, hear from product experts, and discuss latest and upcoming capabilities.
Senior Manager, Vault Safety
Join peers from the Veeva Vault Platform community to share best practices for managing Vault and new releases. Bring your questions/challenges and get them answered by Vault experts, or hear how other customers approached it.
Senior Product Expert, Vault Platform
Product Expert, Vault Platform
Improve compliance, user experience, and automation with Vault workflow enhancements.
Director of Product Management, Vault Platform
Learn about Veeva’s vision for digital TMF management to drive efficiencies and increase compliance. In this educational session for Vault eTMF customers only, you’ll hear from strategy and product experts about eTMF business processes and Vault features you can leverage for an optimal digital TMF environment.
Senior Product Expert, Clinical Operations
Discover how Vault Batch Release addresses complex manufacturing challenges by automating the aggregation and review of critical data, enabling faster and more confident release decisions.
Director of Strategy, Batch Release
Learn about the innovations and enhancements coming to Veeva ePRO and eClinRO, and ask the Veeva team questions during an interactive Q&A.
SVP Product Management, Sites & Patients
Learn how Veeva is bringing innovation to RTSM. Hear about our overall strategic vision and roadmap for this mission critical product and ask the Veeva RTSM leadership team questions during an interactive Q&A.
Director, Product Management Veeva RTSM
Join this interactive session to learn best practices for successful Vault EDC adoption. Ask Veeva’s Services team questions around implementation, change management, and lessons learned.
For CRO attendees, join Veeva’s Product team for a discussion around recent and upcoming capabilities for CRO usability. This open conversation will begin with a summary of the CRO Data Council feedback and how Veeva is planning to address key items.
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 Engineer, Regulatory
Learn how implementing and leveraging cross vault connections with RIM can increase regulatory efficiency, improve data quality, and speed up submissions.
Merck KGaA shares its journey toward IDMP and product experts discuss the future of structured data reporting in Vault RIM.
Associate Director, Regulatory Information Management
Senior Product Manager, Vault Registrations
Discuss challenges, best practices, and approaches to conduct oversight and provide evidence to inspectors. This meeting is for current Vault CTMS customers only.
Senior Product Expert, Clinical Operations
Novo Nordisk and Translations.com explain how Novo Nordisk went from a manual and error-prone translation process for library content to automated, secure, and centralized within Vault. The improved workflow reduced risks and costs as well as accelerated content translation.
Solution Architect
See Vault EDC’s new Clinical Reporting to easily create single-form, cross-form, and exception listings with zero programming. Learn how users centrally access near real-time listings and navigate directly from listings to manage queries.
Senior Solution Consultant, Clinical Data