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

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

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.

Marco Stöhr Boehringer Ingelheim
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.

Maite Durrenbach Sanofi
Chief Quality Officer
Robert Gaertner Veeva Systems
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.

Rinat Lifshitz Shovali Teva pharmaceuticals ltd.
Head of Systems & Innovation
John Lawrie Veeva Systems
Vice President, Vault Safety
Mike Kruczek Veeva Systems
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.

Christian Wittrup Ascendis Pharma A/S
Associate Director, Global IT Services & Procurement
Nath Huybens iTeos Therapeutics
Global Administration of Information Asset
Sai Jasti Bayer
Head, Data Science and AI
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

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.

Jason Boyd Veeva Systems
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.

Robert Gaertner Veeva Systems
Vice President, Quality Strategy, EU
Stephen Chelladurai Veeva Systems
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.

Theodora Adamou
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.

Bipin Patel Veeva Systems
Senior Solution Consultant, Clinical Data

Sessions
13:00 - 13:50 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.

Galapagos shares how they increased training effectiveness and compliance with risk-based strategies, navigating organizational changes to build and maintain employee competency.

Kate Hoegenauer Galapagos
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.

Philippe Barrau Sanofi
Digital QMS Program and Product Line Leader
Helene Nogent-Coste Sanofi
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.

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

Graham Gelwicks Veeva Systems
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.

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

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.


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

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.

Robert Weisz Veeva Systems
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.

Andrew Gebbie Veeva Systems
Principal Solution Consultant, Clinical Data

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 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.

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

Accelerate business processes and improve user experience with the latest capabilities including action layouts, advanced start workflow, notification categories and preferences, and Vault Mobile.

Michael Ferrell Veeva Systems
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.

Geoffrey Williams Gilead Sciences International Ltd.
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.

Gareth Markham Jazz Pharmaceuticals
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.

Emma Earl Bayer
Head of Clinical Trial Management Services and Solutions
Ellen Vanderlinden Bayer
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.


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

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.

Graham O’Keeffe Veeva Systems
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.

Andrew Gebbie Veeva Systems
Principal Solution Consultant, Clinical Data

Learn how Submission Content Plans streamline the overall submissions publishing process.


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

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.

Johanna Skeppstedt AstraZeneca
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.

Izolda Azarov Medison Pharma
Project Manager
Reut Ben-David Medison Pharma
QPPV
David Kolosic Veeva Systems
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.

Tamas Szolyak Gedeon Richter Plc
Global Regulatory Science Director

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

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.

Anna Wenelska AstraZeneca Pharma Poland
Associate Director, Global Clinical Solutions, VCV SSU Product Owner

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

Wednesday, 5 June

9:00 - 15:00 CEST

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.

Eldar Curovic
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.

Andy Han Veeva Systems
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.

Joby George Veeva Systems
Director, Product Management
Graham O’Keeffe Veeva Systems
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.


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

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.

Theodora Adamou
Senior Solution Consultant, Clinical Data

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

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.

Kasper Ingmann Bille Fynbo Ascendis Pharma
Director, Head of QMS
Diane Black Jazz Pharmaceuticals
SVP Global Quality (Chief Quality Officer)
Sven Streit Merck KGaA, Darmstadt, Germany
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.

Adam Sobanski Boehringer Ingelheim
OMP Business Program Manager
Ana Lucia Garcia Ortin Boehringer Ingelheim
Amplify Program Manager
Dawn Waite
Global Program Manager
Emma Maria Calleja Von Peach GmbH
Creative Director and Founder
Yentl Spiteri Von Peach GmbH
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.

Marion Mang Boehringer Ingelheim
Capability Manager
Clare Campbell-Cooper Fortrea
Global Head, Digital Health and Innovation
Stella Waitere-Wijker Boehringer Ingelheim
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.

Lorna Bruce GSK
Head, Regulatory Excellence, Process & Analytics
Claire Doyle GSK
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.

Amel Belloucif Ipsen
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.


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

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.

Iain Searle Veeva Systems
Director, Training Strategy, Europe
Joby George Veeva Systems
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.

Jennifer England
Solution Consultant, Veeva RTSM

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

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.

Michael Ferrell Veeva Systems
Senior Product Expert, Vault Platform
Krisztián Csobályka Veeva Systems
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.

Michelle Marlborough Veeva Systems
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.

Lee Gamble Veeva Systems
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.

Jennifer England
Solution Consultant, Veeva RTSM

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