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
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.
Sr. Director Clinical Strategy, Vault Disclosures
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
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 full Vault RIM platform from registrations, submissions, submissions publishing, and submissions archive. Also see how the RIM Bot automates document classifications and saves organizations valuable time and resources.
Learn and contribute to Veeva’s vision for addressing the new EMA guidelines for EDC archiving. This will be an interactive discussion sharing opinions, ideas, and feedback on Veeva’s proposed designs. This conversation is most relevant for existing customers of Vault EDC.
Senior Solution Consultant, Clinical Data
Hear how a top biopharma embarked on a challenging regulatory transformation and broke through silos to centralize operations – all while retaining business continuity; and this is just the start.
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
Top biopharmas 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.
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 a top CRO 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
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
This top biopharma will share strategies to streamline TMF management – from adopting risk-based approaches to leveraging AI and automation to drive efficiencies.
A biopharma 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.
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.
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
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
A leading manufacturer discusses the latest trends in life sciences manufacturing, focusing on innovation and sustainability in medicine development.
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 implement an accelerated model and collaborate with CROs on a modern platform.
Bayer and GSK share their complementary approach for ongoing management across Vaults. Hear how GSK is optimizing release processes and accelerating delivery of new business capabilities. Leveraging a system-agnostic approach, Bayer will dive into agile processes for CSV documentation and efficient risk-based validation while continuing to ensure control 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
What are the practical, fit-for-purpose use cases for AI, ML, and automation in clinical data? Learn more about these approaches and how they can provide value today, while also building a foundation for the future.
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
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
A CRO shares challenges, best practices, lessons learned, and the benefits of implementing three Vault Clinical Operations applications at once.
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
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.
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 Submission Content Plans streamline the overall submissions publishing process.
Join a global CDMO for an in-depth discussion on how a redefined validation process supports enhanced risk management and an enterprisewide data integrity governance program. Gain insights into a comprehensive strategy that places validation at the heart of operational and data integrity control programs, including considerations for technical (technology), procedural (processes), and organizational (people) controls.
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
Senior Manager, Vault Safety
Gain insights on the path to multiple Vaults and maximizing Development Cloud value from emerging to top 20 biopharmas. We’ll explore drivers influencing the adoption approach, data and process governance model, and strategies for effective organizational change management.
See Veeva’s vision for clinical data in digital trials 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.
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
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.
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.
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.
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.
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
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 RIM helps teams capture, manage, and track regulatory events for registered products, facilitates quick assement of planned changes, and enables immediate action.
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.
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!
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
Join Jazz Pharmaceuticals, Ascendis Pharma, and Merck KGaA, Darmstadt, Germany 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)
Head of Corporate eQA Systems
Learn how a top biopharma scales pharmacovigilance operations for market expansion. Explore challenges that come with rapid growth, lessons learned, and how to gain operational agility while maintaining compliance.
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
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
Hear this biotech’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.
Streamlining the administrative burden on research sites is top of mind for this top CRO. Learn about their overall approach and how Veeva Launch Pad and Veeva Site Connect support the strategy.
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.
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
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
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
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
Learn how Active Dossier maintains an up-to-date list of approved documents for each product and market, incorporating all approved variations.
Discover how Veeva RTSM will deliver cross study reporting to proactively identify randomization and trial supply management issues.
Solution Consultant, Veeva RTSM