Madrid | 4-5 June, 2024
#VeevaSummitEU
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Agenda

Monday, 3 June

15:30 - 20:00 CEST

Registration Opens
15:30 - 18:00 CEST
17:00 BST

Welcome Reception
18:00 - 20:00 CEST
17:00 BST

Tuesday, 4 June

9:00 - 17:30 CEST

Breakfast
8:00 - 8:45 CEST
17:00 BST

Opening Keynote
9:00 - 9:50 CEST
17:00 BST

Connect
10:00 - 10:20 CEST
17:00 BST
Innovation Theaters, Networking, Demos, and More

Zone Keynotes
10:30 - 11:20 CEST
17:00 BST

A top biopharma shares its experience leveraging data to increase regulatory process agility and optimize operations for continuous improvement.

Hear about the latest industry trends and the evolution of quality to become a key driver for innovation. Sanofi’s chief quality officer shares their journey and Veeva’s role in its transformation.

Maite Durrenbach Sanofi
Chief Quality Officer
Robert Gaertner Veeva Systems
Vice President, Quality Strategy, EU

Top biopharma 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 it accelerated business process and system transformation, and ways to speed up user adoption in new ways of working.

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.

Christian Wittrup Ascendis Pharma A/S
Associate Director, Global IT Services & Procurement
Will Hayes Veeva Systems
Development Cloud Architect
Jared Katz Veeva Systems
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.

Thomas Senderovitz Novo Nordisk
Senior Vice President

Lunch
11:30 - 13:00 CEST
17:00 BST

Sessions
13:00 - 13:50 CEST
17:00 BST

Gain insights from a global pharma’s successful expansion of QMS from R&D to manufacturing with minimal configuration adjustments. Hear how they leverage Vault QMS to enhance collaboration, compliance, and efficiency across the product lifecycle.

Learn how a leading biopharma implemented Vault Quality as a foundational element of their overall digital landscape. Explore opportunities to advance a quality system with add-on automation capabilities.

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.

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.

Christian Wittrup Ascendis Pharma A/S
Associate Director, Global IT Services & Procurement
Will Hayes Veeva Systems
Development Cloud Architect

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.

Ibrahim Kamstrup-Akkaoui Novo Nordisk
Vice President
Alex Franklin GSK
Director Data Management
Eboni Russell Fortrea
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.

Aysegul Ozkose Nordic Pharma
Senior Regulatory Database Manager

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.

Lorna Bruce GSK
Head, Regulatory Excellence, Process & Analytics

This top biopharma will share strategies to streamline TMF management – from adopting risk-based approaches to leveraging AI and automation to drive efficiencies.

How do you know it’s time to bring your eTMF in-house? This fast-growing biotech will share its top three signals, how to develop in-house expertise to accommodate the shift, and recommendations for using Vault eTMF.

A specialist Cell and Gene Therapy team shares how they are leveraging Veeva RTSM to bring transparency and efficiency to CGT specific processes, including manufacturing slot reservations and leukapheresis tracking.


Connect
14:00- 14:50 CEST
17:00 BST
Innovation Theaters, Networking, Demos, and More

Sessions
15:00 - 15:50 CEST
17:00 BST

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.

Annette Prelle MAIN5 GmbH & Co. KGaA
Management Consultant
Pauline Carr Boehringer Ingelheim
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 contrast their approach for ongoing management of multiple Vaults. They’ll discuss governance models, managing new releases, meeting changing business or regulatory requirements, and best practices for maximizing Vault investment.

Ewa Siwiec Bayer
Product Manager
Matt Lamming GSK
R&D Development Digital and Tech Senior Product Director
Jared Katz Veeva Systems
Senior Director of Strategy, Development Cloud

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, a top biopharma and Veeva Business Consulting highlight the benefits of a continuous communication plan to increase user adoption and engagement post go-live.

Get insights on evolving into a data-centric regulatory organization as biopharma examines its new operational model and data governance approach. With innovative changes, the regulatory team is experiencing better process adherence and increased agility.

Hear this top biopharma’s 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.

This global biopharma brought clinical systems in-house to get visibility across its portfolio and improve collaboration. Learn how Vault CTMS improves study oversight, compliance, and CRO partnerships for its outsourced trials.

A customer shares experiences and lessons learned from their recent Veeva RTSM implementation. Discover best practices for collaborating with the RTSM services team on design meetings, data integrations and UAT processes.


Connect
16:00 - 16:20 CEST
17:00 BST
Innovation Theaters, Networking, Demos, and More

Sessions
16:30 - 17:20 CEST
17:00 BST

Join Samsung Biologics 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.

Calvin Kim Samsung Biologics
Senior Director, Head of Data Integrity Governance, IT Quality Systems and Validation

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.

Johanna Skeppstedt AstraZeneca
Associate Director

Incorporating affiliates and partners into safety processes unifies pharmacovigilance data on one global platform and eliminates data reconciliation. We’ll discuss how real-time transparency improves safety oversight from case intake through distribution while streamlining workflows.

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.

Join Veeva strategy and product experts to hear our clinical data vision and see an end-to-end digital trial demo — using Veeva EDC, CDB, RTSM & ePRO.

Charting a course to improve data and regulatory process management, hear how a biopharma identified value-add opportunities, implementation challenges, and assessed business impact.

Discover Novo Nordisk’s methodologies to improve regulatory data quality, paving the way for continuous operational improvement.

Kristian Kragelund Novo Nordisk
Product Manager, NextGen Labelling

Explore how moving beyond Excel trackers and checklists enables this top biopharma to activate sites faster. Learn best practices for milestone management, country-specific EDLs, and workflow automation in Vault Study Startup.

This biotech will share its approach to keeping Vault eTMF up-to-date across releases with limited resources and budget.


Evening Event
19:30 - 22:00 CEST
17:00 BST

Wednesday, 5 June

9:00 - 15:00 CEST

Breakfast
8:00 - 8:45 CEST
17:00 BST

Roadmaps
9:00 - 10:00 CEST
17:00 BST

Hear the roadmap and vision of Vault QMS. See demos of the latest innovations and get your questions answered.

Manaphan Huntrakoon Veeva Systems
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.

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.

Learn about Veeva’s GxP training vision and roadmap, see demos of the latest innovations, and get your questions answered.

Joby George Veeva Systems
Director, Product Management

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 organizations and investigators.

Site Connect is changing to make it easier than ever to exchange documents 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.


Connect
10:00 - 10:50 CEST
17:00 BST
Innovation Theaters, Networking, Demos, and More

Hear the roadmap and vision for Vault QualityDocs and Vault Station Manager, see demos of the latest innovations, and get your questions answered.

Stephen Chelladurai Veeva Systems
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.

Peter Alouche Veeva Systems
Director, Product Management, Vault Validation Management

Learn how we’ve made monitoring more flexible and hear planned enhancements such as subject visit scheduling, issue tracking for outsourced studies, 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 curricula creation, study team role additions, and end-of-study training automation. Join this roadmap to hear about all of the exciting new things coming to Vault Study Training!


Sessions
11:00 - 11:50 CEST
17:00 BST

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.

Join your peers 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.

Top biopharma simplified PSMF management by harmonizing processes and supporting seamless collaboration across internal/external content owners and reviewers. Learn how QPPVs improved global oversight, maintained inspection readiness, and enabled regional teams to produce a complete PSMF in minutes with a modular approach.

Discover how a top 20 biopharma 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.

Hear from a leading biopharma on 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.

Outlining its path towards continuous regulatory process improvement, learn how a top biopharma measured and improved baseline performance, prepared for publishing integration, and decentralized its operational model to create additional value.

Reducing the burden of running clinical trials for research sites is a top priority for this global biopharma. Hear about its site-centric initiatives and lessons learned with Vault Study Training and Veeva Site Connect.


Lunch
12:00 - 13:00 CEST
17:00 BST

Connect
13:00 - 13:50 CEST
17:00 BST
Innovation Theaters, Networking, Demos, and More

Hear best practices and lessons learned from several Vault EDC adoptions, and learn more about how the Veeva Services team can support your move to Vault EDC during an interactive discussion.

Learn how Veeva RTSM supports planned and unplanned mid-study changes with speed and accuracy, and hear about our vision for driving further efficiencies through product and services initiatives.


Closing Keynote
14:15 - 15:00 CEST
17:00 BST