R&D and Quality Summit

Veeva R&D Summit

Madrid | 4-5 June, 2025

Powerful Community, Fresh Ideas

Agenda

Filter Agenda by
Tuesday, 3 June
15:30 - 20:00

Registration Open
15:30 - 18:00

Welcome Reception
18:00 - 20:00
Wednesday, 4 June
7:00 - 22:30

Registration Open
7:00 - 18:30

Breakfast
7:30 - 8:45

Opening Keynote
9:00 - 10:00

Zone Keynotes
10:30 - 11:20

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.

Astrid Scherer Bayer AG
Head Clinical Data & Performance Excellence
Hugo Cervantes Veeva Systems
SVP, Clinical Strategy

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.

Javier Monvoisin Teva Pharmaceuticals
Vice President Regulatory Operations
Paul Attridge Veeva Systems
Vice President Regulatory, Europe

Lunch & Connect
11:30 - 13:00
Innovation Theaters, Networking, Demos, and More

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.

Joseph Briant de Laubrière Veeva Systems
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.

Wilfreid Janière Veeva Systems
Senior Solution Consultant, Clinical Data

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.

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.

Theodora Adamou Veeva Systems
Senior Solution Consultant, Clinical Data

Roadmaps
13:00 - 13:50

Hear the roadmap and vision for Veeva eTMF and Veeva Study Startup. See demos of the latest innovations and get your questions answered.

Hear the roadmap and vision for Veeva Study Training. See demos of the latest innovations and get your questions answered.

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.

Michelle Marlborough Veeva Systems
SVP Product Management, Sites and Patients
Ray Letulle Veeva Systems
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.

Joby George Veeva Systems
Director, Product Management,

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

Manaphan Huntrakoon Veeva Systems
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.

Jason Hardin Veeva Systems
Senior Product Manager
Graham O’Keeffe Veeva Systems
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.

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.

Rich Merrick Veeva Systems
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.


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

Hear the roadmap and vision for Veeva CTMS and Veeva Payments. See demos of the latest innovations and get your questions answered.

Hear the roadmap and vision for Veeva Site Connect. See demos of the latest innovations and get your questions answered.

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.

Wilfreid Janière Veeva Systems
Senior Solution Consultant, Clinical Data

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.

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.

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.

Andrew Gebbie Veeva Systems
Principal Solution Consultant

Sessions
15:00 - 15:50

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.

Thomas Boubal GSK
eTMF/Site Connect Product Owner
Marta Jureczko-Hinzmann AstraZeneca
Global Clinical Solutions Senior Director

A biopharma 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.

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.

Martin Heckenberger Boehringer Ingelheim Pharma GmbH & Co. KG
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.

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.

Chris Pontisso Veeva Systems
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.

Stephen Chelladurai Veeva Systems
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.

Johanna Strandell Camurus AB
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.

Isabelle De Montazet Alvotech
Director Regulatory Information Management

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.

Debbie Stanier Astrazeneca
Senior Director, Regulatory Information Systems
Jenny Häggström AstraZeneca
Enterprise Regulatory Vault Product Manager
Balaji Sukumar AstraZeneca
Director, IT, Global Delivery, Regulatory & QA Platform

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.

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.

Andrzej Dróżyński Haleon
Senior System Engineer, R&D Safety
Karol Glowacki Haleon
QSC System Technology Manager

Connect
16:00 - 16:50
Innovation Theaters, Networking, Demos, and More

Hear how Veeva Disclosures leverages automation and unified systems to improve compliance, accelerate submissions, and further simplify disclosures with new features released in 25R2.

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.

Learn how Veeva eCOA simplifies the design, management, and completion of clinical outcome assessments for sponsors, sites, and patients.

Bipin Patel Veeva Systems
Senior Solution Consultant

Sessions
17:00 - 17:50

A biotech details how to provide study-specific training for internal and external staff in Veeva Study Training, streamlining training administration, reporting, and compliance.

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.

Matthew Jones GSK
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.

Ibrahim Kamstrup-Akkaoui Novo Nordisk A/S
Vice President
Phoebe Benson Syneos Health Consulting
Implementation Manager
FRANCOIS CAIJO Veeva Systems
Senior Director, Strategy – Clinical Data
Srinivasan N Novo Nordisk
Director, Data Systems and Automation
Carsten Johansen Novo Nordisk
Principal Data Management Specialist

Discover insights into strategic approaches for continuous innovation in quality. Learn how proactive roadmap planning supports the evolving needs of business and systems through optimization and innovation.

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.

Geoff Gerhardt Scitara
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.

Laura Prada Alonso Recipharm
Corporate eQMS Manager
Andreas Särnberger Recipharm
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.

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.

Annalisa Forlenza CHIESI FARMACEUTICI
Head of Global Regulatory Affairs Digital and Publishing
Nicholl Grove Veeva Systems
Engagement Manager, R&D Business Consulting

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.

See the latest capabilities and enhancements in Veeva Connections. Discover how to streamline cross-functional business processes, improve data quality, and automate workflows.

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.


Evening Event
19:30 - 22:30
Thursday, 5 June
7:00 - 14:50

Registration Open
7:00 - 14:50

Breakfast
7:30 - 8:45

Sessions
9:00 - 9:50

A top biopharma shares how to centralize portfolio-wide training in Veeva Study Training, moving from disparate systems to one inspection-ready platform. This includes supporting site partners to meet new training requirements outlined in ICH (E6)R3.

Hear industry leaders 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.

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.

Hanna R Kviat Antonsen Ascendis Pharma A/S
Senior Manager

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.

Mike Edwards Veeva Systems
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.

Andrea Barz Bayer AG
Lead Digital Quality
Olaf Ehses Bayer AG
S&T Senior Project Manager
Aniela Heidebrecht Bayer AG
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.

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.

Kamal El Bakali OM Pharma
Regulatory Operations Team Lead
Kim Brownrigg Veeva Systems
Regulatory Practice Lead, R&D Business Consulting

Explore Veeva’s government strategy, designed to help customers achieve compliance through harmonized data and streamlined submissions. Learn how Veeva drives global interoperability, ensuring compliance across diverse markets and evolving Health Authority requirements while accelerating time-to-market.

Crystal Allard Veeva Systems
Senior Director, Government Strategy
Vada A. Perkins Boehringer Ingelheim
Vice President, Global Regulatory Intelligence & Policy
Dominique Lagrave Accumulus Synergy
Senior Vice President Regulatory Innovation

Hear how biopharmas are 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 integrations, and practical applications across product development.

Boehringer Ingelheim shares their successes, lessons learned, and value of implementing four vaults in parallel. Get an inside look at how they optimized to decrease cycle times and increase data accessibility.

Carina Reinicke Boehringer Ingelheim
Head of ClinDev Operations Capabilities

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

Understand how Veeva Study Training, Veeva Site Connect, and Veeva Study Startup streamline processes and reduce administrative overhead for research sites.

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.

Nicholas Klatt Veeva Systems
Solution Consultant, Clinical Data

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.


Sessions
11:00 - 11:50

A biopharma discusses its vision for a site-centric, insourced, and connected approach to trial research. Learn how the company will leverage the Veeva Clinical Platform to connect workflows and data flow between clinical operations, clinical data, and site partners.

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.

Learn how top biopharmas 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.

Krisztian Fodor Gedeon Richter
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.

Anand Kanhere Novartis
Head, Data Strategy & Management
Denise Burkett Novartis
RA CMC Senior Manager Data & Digital
Ardit Ndoka Veeva Systems
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.


Lunch and Connect
12:00 - 13:00
Innovation Theaters, Networking, Demos, and More

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.

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.

Andrew Gebbie Veeva Systems
Principal Solution Consultant

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.

Wilfreid Janière Veeva Systems
Senior Solution Consultant, Clinical Data

Choose Your Own Adventure
13:00 - 13:50
Deep Dives, Community Meetings, Demos, and More

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.

Andrea Grau Veeva Systems
Solution Consultant

Learn how the Study File Format API provides the infrastructure to power downstream applications, including AI-driven ones, with incremental CDMS data extracts. See how this enables near real-time analytics capabilities with Veeva product partners.

Andrew Gebbie Veeva Systems
Principal Solution Consultant

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.

See how CTMS Transfer automates information exchange between sponsors and CROs using Veeva CTMS, improving study oversight, eliminating custom reports, and strengthening study partnerships.

Francesca Massa Veeva Systems
Senior Solution Consultant

Closing Keynote
14:00 - 14:50