Veeva Commercial Summit - Sales, Marketing, Medical

Boston | September 3-4, 2025

Powerful Community, Fresh Ideas

Agenda

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Tuesday, September 2
4:30 p.m. - 7:00 p.m.

Registration Open
4:30 p.m.

Meetings, Workshops, and Networking
11:30 - 5:30 p.m.

Welcome Reception
5:30 - 7:00 p.m.

Dinner
5:30 - 9:00 p.m.
Wednesday, September 3
7:00 a.m. - 9:00 p.m.

Registration Open
7:00 a.m.

Breakfast
7:00 - 8:40 a.m.

Opening Keynote
9:00 - 10:00 a.m.

Details coming soon.

Peter Gassner Veeva Systems
Founder and CEO

Zone Keynotes
10:30 - 11:20 a.m.

Quality is constantly evolving, driven by increasing regulatory and patient demands, and supported by digitalization and artificial intelligence. Discover how Pfizer is accelerating change by aligning leadership, standardizing processes and digital enablement, and transforming quality operations from oversight to strategic business partner.

Lynn Bottone Pfizer
Sr. Vice President, Quality, Safety & Environmental Operations
Michael Jovanis Veeva Systems
President, Quality Cloud

Merck shares how it simplified pharmacovigilance operations and improved efficiency within safety and across functions. Hear how it eliminated 10 technology applications and is standardizing data cross-functionally with a connected safety platform.

Cory Gilbert Merck
Sr. Director, Business System Management & Innovation
John Lawrie Veeva Systems
Vice President, Veeva Safety

Attend this fireside chat for a regulatory leader’s real-world insights and practical strategies to modernize legacy publishing processes, navigate multi health authority platforms, and rethink the RIM implementation model. Discover how the right internal conversations are foundational to driving meaningful change.

Marc Gabriel Veeva Systems
Vice President, Regulatory
Matt Neal BeOne Medicines
Executive Director, Global Regulatory Operations Strategy & Innovation
Alison Marjanowski Veeva Systems
Senior Director, Veeva RIM Strategy

Intercept Pharmaceuticals leveraged Veeva Vault to scale operations, simplify trial management, and reduce costs—while improving compliance and oversight. Following its acquisition by Alfasigma, hear how it further accelerated business efficiency and process excellence, with a roadmap for expanding functionality, AI, and harmonizing data.

Bill Wallace Intercept Pharmaceuticals Inc.
Chief Information Officer
Jared Katz Veeva Systems
Senior Director, Development Cloud Strategy
Larry Jovanovic Veeva Systems
Vice President of Product Management, Vault Platform

Learn how Merck simplified clinical operations and data management with the Veeva Clinical Platform. Hear about the value realized and best practices for successful adoption – and how these learnings apply to organizations of all sizes.

Jennifer Sheller Merck
Senior Vice President, Head of Global Clinical Trial Operations
Jim Reilly Veeva Systems
President Development Cloud and EVP Global Strategy

Lunch and Connect
11:30 - 12:50 p.m.
Innovation Theaters, Networking, Demos, and More

Learn how the Document Control Homepage provides a centralized hub to track and manage key document control processes and aids in ensuring processes are completed in a timely manner.

Jessica Kelley Veeva Systems
Senior Product Expert, Veeva QualityDocs & Station Manager

Collaborate with CROs in real-time and get data oversight and greater control over safety outputs. Easily identify bottlenecks and track case quality and average handling times to improve operational efficiency.

AJ Castillo Veeva Systems
Solution Engineer

Learn about recent updates designed to streamline and enhance change management processes. Discover how the Quality-RIM Connection improves efficiency and facilitates data sharing between Veeva Quality and Veeva RIM.

John Tanner Veeva Systems
Senior Product Manager, RIM Connections
Katie Graham Veeva Systems
Team Manager, Veeva RIM Services

Easily automate business process steps by configuring conditional logic in Vault. Reduce dependency on custom code to perform actions such as sending a notification, updating a record, or starting a workflow.

Michael Ferrell Veeva Systems
Principal Product Expert, Vault Platform

Discover strategies for optimizing cross-functional operations in life sciences, and how the Veeva Industry Cloud supports end-to-end processes across multiple applications.

Matthew Cantor Veeva Systems
Senior Director, Development Cloud Strategy

Discover how Veeva OpenData Clinical provides a reliable data foundation for investigator and site information, improving operational efficiency and accelerating clinical trial start-up and execution.

See how the Safety-EDC connection automates the transfer of serious adverse event (SAE) data, removing data managers’ reconciliation effort. Discover the newest release in 25R2 that adds a closed loop process, so Veeva EDC is aware of Safety decisions.

Alice Foltyn Veeva Systems
Solution Consultant, Clinical Data

Explore the benefits of accelerating deviation data sharing across the CDMO-sponsor interface, highlighting how real-time collaboration can enhance product quality, expedite batch release, and strengthen compliance readiness.

Carl Ning Veeva Systems
Senior Director, Veeva QMS Product Strategy

Hear how a connected safety platform seamlessly automates adverse event (AE) intake from medical information, product quality complaints (PQCs), and clinical subject reportable events. Learn how connections with Veeva EDC, QMS, and MedInquiry streamline case intake, reduce reconciliation, and improve efficiency.

Ollie Cooksey Veeva Systems
Senior Solution Consultant

See how Vault action layouts simplify the user experience by providing the right information at the right time for the right role and context.

Michael Ferrell Veeva Systems
Principal Product Expert, Vault Platform

Explore how Process Monitor helps identify bottlenecks, understand cycle times, and visualize KPIs to optimize business processes.

Learn how to better engage sites using Veeva Study Startup, Veeva Site Connect, and Veeva Study Training. Streamline key site-facing tasks — including feasibility, training, safety letter distribution, and document exchange — reducing site burden from start-up to closeout.

Tom Frattarola Veeva Systems
Senior Solution Consultant

Discover the automated data transfer between Clinical Operations and EDC that reduces transcription effort and risk. Learn how to automate the creation of protocol deviations and payments. The newest release (25R2) also enables the automatic transfer of Closeout PDFs to Veeva eTMF.

Nick Klatt Veeva Systems
Solution Consultant, Clinical Data

Roadmaps & Innovation Highlights
1:00 - 1:50 p.m.

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 Training’s vision and roadmap, see demos of the latest innovations, and get your questions answered.

Jason Hardin Veeva Systems
Senior Product Manager, Veeva Training

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 of Veeva LIMS. See demos of the latest innovations and get your questions answered.

Joby George Veeva Systems
Director, Product Management

See upcoming AI capabilities for unstructured intake and narratives, and get a preview of how expanding the unified safety solution with Veeva Safety Workbench and Veeva Safety Signal will provide a reliable safety data foundation for faster and more accurate insights.

Eldar Curovic Veeva Systems
Vice President, Product Management, Veeva Safety

Discover key features delivered over the past year for Veeva Registrations, Submissions, Submissions Publishing, and Submissions Archive, and insights into this year’s roadmap highlights. We’ll also provide updates on eCTD 4.0, Active Dossier, our Global Content Plan connection, and other features designed to reduce data management efforts, helping biopharmas achieve end-to-end process efficiency.

Rich Merrick Veeva Systems
Vice President, Product Management, Regulatory

Explore Vault Platform advancements to simplify implementation, customization, and ongoing management. See ways to leverage process monitor, Word-formatted outputs, and action triggers, and get a preview of upcoming AI capabilities and security, reporting, and Direct Data API enhancements.

Larry Jovanovic Veeva Systems
Vice President of Product Management, Vault Platform

Discover the latest enhancements and upcoming features for Veeva eTMF and Veeva Study Startup, designed to accelerate and improve end-to-end trial management. We’ll highlight how electronic CDA and a stronger Veeva RIM to Veeva Clinical Operations connection improve feasibility and study activation. Plus, learn about features like risk-based QC, full study audit trail exports, and a new multilingual TMF Bot model that supports inspection readiness and TMF efficiency.

Jim Horstmann Veeva Systems
Senior Product Manager, Veeva eTMF

Discover the latest enhancements and upcoming features for Veeva Study Training that reduce overtraining and create visibility into training performance. This includes enhancements to automatically file training logs in Veeva eTMF and enable site learners to transfer GCP credits between sponsors. Plus, see planned enhancements, such as the ability to send the training matrix for internal reviews before publishing.

Erin Coppola Veeva Systems
Senior Product Manager

Learn what’s next for Veeva EDC, Veeva CDB, and Veeva eCOA. Hear recent highlights and upcoming innovations as we deliver for patients, sites, and sponsors. Join the interactive Q&A following the presentation.

Ray Letulle Veeva Systems
Senior Vice President of Product, Clinical Data
Michelle Marlborough Veeva Systems
SVP Product Management, Sites and Patients

A site panel will share data from Veeva’s 2025 “What Sites Need from Sponsors” survey, offering candid perspectives and guidance for better partnerships.


Connect
2:00 - 2:50 p.m.
Innovation Theaters, Networking, Demos, and More

Join our Veeva Safety product team for live roadmap Q&A.

Eldar Curovic Veeva Systems
Vice President, Product Management, Veeva Safety
Marius Mortensen Veeva Systems
Vice President Product Architect, Veeva Safety
Eric Woolven Veeva Systems
Principal Product Manager, Veeva AI (Safety)
Tom Pimental Veeva Systems
Sr. Director, Product Management, Veeva SafetyDocs
Tristram Liddiard Veeva Systems
Director Product Management, Veeva Safety Signal & Workbench

Following the Regulatory roadmap session, join the Veeva RIM product team for Q&A. Topics include key features from the past year, the latest in regulatory guidelines and developments, and the future roadmap for Veeva RIM.

Rich Merrick Veeva Systems
Vice President, Product Management, Regulatory
Nick Tasse-Guillen Veeva Systems
Director, Product Management, Registrations
Cindy Ling Veeva Systems
Senior Product Manager & Team Lead, Veeva RIM
Jordan Williams Veeva Systems
Senior Product Manager, Veeva AI (RIM)

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

Jared Katz Veeva Systems
Senior Director, Development Cloud Strategy

Discover the latest enhancements and upcoming features for Veeva CTMS and Veeva Payments that streamline trial execution and site payments. This includes improvements to support complex trials, CTMS Transfer, the Clinical Operations-EDC Connection, and fee schedule management. We’ll also highlight future innovation around study management, site monitoring, site contracting, and invoicing in Veeva Site Connect.

Kayla Mujkanovic Veeva Systems
Senior Product Manager

Discover the latest enhancements and upcoming features for Veeva Site Connect that support sponsor-site collaboration from start-up to closeout. This includes improvements to share unblinded content and enhance automatic document exchange. Plus, see planned enhancements to capture site staff’s roles and responsibilities through Veeva Site Connect and increase automation in safety distribution.

Erita Rothschild Veeva Systems
Senior Product Manager, Clinical Operations

Join our Veeva Clinical Data product team for a live roadmap Q&A.

Discover how NNIT’s AI-enabled solution addresses the complexity of maintaining compliance as organizations scale application usage. Learn how automating routine tasks and aligning actions with defined business rules improves efficiency, and reduces human error.

Janani Moni NNIT
Director

See how regulatory teams use Global Content Plans to reduce cycle times for submission activities. Learn to optimize dispatch processes and update cycles from core packages to local submissions.

Abigail Sasdelli Veeva Systems
Practice Manager, Veeva RIM
Paheli Patel Veeva Systems
Product Manager

Explore how the Document Readiness panel allows users to see the status of asynchronous document content processes, helping to resolve rendering issues.

Jonathan Chickneas Veeva Systems
Director of Product

Sessions
3:00 - 3:50 p.m.

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 of Product Management, QualityDocs, Station Manager, and Training

Hear Veeva’s vision and roadmap to enable faster, more confident GMP release and market-ship decisions with Batch Release. See demos of the latest innovations, and get your questions answered.

Brian Sohmers Veeva Systems
Senior Director of Product Management, Veeva Batch Release

Learn about Veeva LearnGxP’s vision and roadmap, see the latest innovations, and get your questions answered.

Mark Lafferty Veeva Systems
Director of eLearning Strategy

Discover Alvotech’s journey with Veeva LIMS, from selection to real-world results. Learn about implementation best practices, key improvements made, and the resulting impact on QC operations.

Astros Oskarsdottir Alvotech
QC Operation Senior Specialist

Safety leaders discuss how they are efficiently managing pharmacovigilance agreements (PVAs), pharmacovigilance system master files (PSMFs), and other safety-related content, while improving compliance and inspection readiness.

Suzanne Tracy Moderna
Head of Transformation, PV Operations
Michael Kruczek Veeva Systems
Senior Director, Veeva Safety Strategy

Explore Veeva’s government strategy to speed submissions through multi-health authority collaboration platforms. Boehringer Ingelheim will share insights on Project PRISM’s regulatory cloud initiative (i.e., precisionFDA), and advanced analytics on DNAnexus, while Accumulus will highlight real-world pilots with Roche and future opportunities.

Vada Perkins Boehringer Ingelheim
Vice President, Global Regulatory Intelligence & Policy
Francisco Nogueira Accumulus
CEO
Aditi Kumar Roche
VP, Roche R&D Digital Technologies
Crystal Allard Veeva Systems
Senior Director, Government Strategy

Explore the Veeva RIM implementation journeys of Aimmune, a Nestlé Company, and BridgeBio: discover how a change champion fosters collaboration and user adoption, and learn about an innovative Veeva RIM configuration for granular expense tracking and improved financial forecasting.

Sonja Justice Nestle Health Sciences
Senior Director, Regulatory Operations and Information Systems
Karteek Sandadi BridgeBio Inc
Sr Director, Global Regulatory Operations
Amber Queen Nestle Health Sciences
Regulatory Operations Specialist

Get a preview of Veeva AI Agent use cases in Development Cloud and Quality Cloud applications. Understand how Veeva AI in the Vault Platform and embedded into Vault applications will enable broad adoption to help users analyze data, draft documents, and extract information out of unstructured content.

Andy Han Veeva Systems
SVP, Veeva AI Solutions

Immunovant and Precision for Medicine will share how to achieve effective study oversight and better decision-making in outsourced trials with Veeva CTMS. We’ll explore how different outsourcing models inform technology and SOPs, and best practices to increase operational efficiency and quality. You’ll also hear how CTMS Transfer provides real-time access to data from CROs to save time and prevent errors.

Aileen Ilaria Immunovant
Vice President, Clinical Operations
Sarah Dean Precision for Medicine
Executive Director, Clinical Systems
Frank Lin Veeva Systems
Director, Clinical Strategy

Memorial Sloan Kettering Cancer Center shares a site’s perspective on pain points in clinical trials, as well as insights into quick-win programs that sponsors and CROs can implement to address them. The team will also outline how biopharmas can pick technology solutions that improve site success.

Joe Lengfellner Memorial Sloan Kettering Cancer Center
Sr. Director Clinical Research Informatics

Sanofi shares its approach to streamlining study training by implementing Veeva Study Training as a single, inspection-ready solution. Learn how to eliminate the need for multiple disconnected systems across study teams and site staff.

Delphine Maillard Sanofi
Clinical Learning and Development Head

We’re entering a new era of clinical data management. Veeva Clinical Data’s CTO, Drew Garty, will share our vision for advancing this shift and our innovation strategy to enable it. Learn how Amgen is preparing to simplify and standardize operations to scale transformative change.

David Hansen Amgen Inc.
AVP Clinical Systems and Analytical Reporting & Data Management
Drew Garty Veeva Systems
Chief Technology Officer, Clinical Data

Connect with SiteVault product managers in an informal setting. Share feedback, discuss improvements, and shape the future of our products.


Connect
4:00 - 4:20 p.m.
Innovation Theaters, Networking, Demos, and More

Attend for Q&A following the Health Authority Submission Platforms and Veeva RIM: A Collaborative Approach session

Hear about the latest regulatory intelligence updates and timelines impacting Veeva RIM. Stay up-to-date with the latest for eCTD 4.0, eCTD 3.2, ICH task forces, and IDMP.

Brittany Gibson Veeva Systems
Senior Regulatory Intelligence Analyst, RIM

See how Veeva CTMS provides real-time visibility and oversight, reducing compliance risk and improving quality. Discover how CTMS Transfer simplifies and standardizes CTMS data between sponsors and CROs to increase efficiency.

Rachael Payne Veeva Systems
Solution Consultant, Clinical Operations

Sessions
4:30 - 5:20 p.m.

Hear from a panel of leaders on their investments in AI within quality management. Learn how AI has transformed their quality processes, the business case for these investments, and the tangible value realized within Veeva Quality Cloud.

Ravi Yalamanchili Merck
AVP Digital & Data Products
Robert Famiglietti GSK
Vice President, Quality Systems & Data
Markus Zeitz Takeda
Head of Digital Quality
Carl Ning Veeva Systems
Senior Director, Veeva QMS Product Strategy

Explore FUJIFILM Biotechnologies’ journey from a site-based quality approach to a unified, global quality management system—beginning with document management. Hear how the transformation began with Veeva QualityDocs and how the partnership with Veeva will drive consistency across all quality applications.

Laquisha Crawford FUJIFILM Biotechnologies
Vice President Global Quality Systems
Bradford Booth FUJIFILM Biotechnologies
Director, Global Quality Systems

Hear how Validation Management helped C4 Therapeutics transition from a hybrid paper-based process, using QualityDocs and a PDF e-signature solution, to a fully digital validation approach. Discover how this shift enabled them to increase their workload capacity and ensure compliance through digital transformation.

Khushbu Patel C4 Therapeutics
Manager, GxP Systems
Ann Farnsworth C4 Therapeutics
Vice President, Quality

See how a CDMO strengthened its QC Strategy using Veeva LIMS with Stability Study Management. Gain insights into its workflow impact and the CDMO’s influence on the Veeva LIMS roadmap.

AbbVie, Cognizant, and Veeva partnered to drive safety innovation and optimize operations. Using shared, data-driven goals with metrics for quality, compliance, and efficiency, the teams collaborated to challenge traditional ways of working and deliver measurable improvements.

Martin Marshall AbbVie
Director, Office of Safety Operations – PV Systems
Abhishek Garg Cognizant Technology Solutions
Project Delivery Leader
Michael Kruczek Veeva Systems
Senior Director, Veeva Safety Strategy

Gain insights from a Roche’s end-to-end RIM implementation journey. Hear what worked, what didn’t, and the practical strategies that drove success – along with insights on long-term user adoption and workforce enablement.

Suresh Dorairaj Roche
RIM Informatics Lead
Cindy Ling Veeva Systems
Senior Product Manager & Team Lead, Veeva RIM

Hear two distinct perspectives from Lexicon Pharmaceuticals and Daiichi Sankyo about how they are leveraging Veeva Submissions Publishing. Explore the unique strategies and benefits that each organization used to maximize value to streamline their regulatory processes.

Thomas Noto Lexicon Pharmaceuticals
Senior Director, Regulatory Operations
Vishu Manegari Daiichi Sankyo
Executive Director, Global Head of Regulatory Operations

Explore Pfizer’s journey establishing a Veeva Center of Excellence, including key considerations for defining structure, scope, and responsibilities to maximize operational value and drive innovation.

Muralikrishnan Sundararajan Pfizer
Executive Director

Discover how to use Veeva process monitor to analyze and optimize processes, and leverage Vault reporting and dashboards to create and track business KPIs for greater insights. Get an overview of recent and upcoming enhancements and ways to maximize data value.

Graham Gelwicks Veeva Systems
Senior Director or Product, Vault Platform

GSK shares its vision to enhance research site collaboration with Veeva Site Connect. Learn how to streamline safety letter distribution, automate document exchange, and improve site-facing processes for studies across a portfolio.

Thomas Boubal GSK
eTMF/Site Connect Product Owner

Bristol Myers Squibb shares its approach to improving feasibility and accelerating site activation with Veeva Study Startup. Hear how standard feasibility questions and reusable responses save time and reduce site burden. You’ll also learn how to leverage data and key metrics to speed study start-up for priority trials.

Mano Das Bristol Myers Squibb
Director IT
Kurt Bischoff Bristol-Myers Squibb
Associate Director

Endo and Atorus will showcase how Veeva EDC streamlines trial execution through submission. Discover real-world productivity gains from eliminating redundant activities. Learn how these companies are expanding adoption for improved site experience and efficiency.

Megan Halenda Endo
Associate Director, Clinical Data Management
Christine Kanalis Atorus
Executive Director, Clinical Data Management

Learn how Novo Nordisk navigated change over time. Together with Syneos Health Consulting, they will share tips for adopting change, moving beyond implementation, and maximizing long-term value. Explore methods to improve data flow across systems and proactive action across R&D teams.

Ibrahim Kamstrup-Akkaoui Novo Nordisk
Vice President
Phoebe Benson Syneos Health Consulting
Sr Implementation Manager

Get the site perspective in a unique and entertaining gameshow-style session. Join Brad Hightower and Denali Rose from the Note to File Podcast and explore what sites and sponsors truly value and need from each other in a lighthearted and interactive environment.


Evening Event
5:30 - 9:00 p.m.
Thursday, September 4
7:00 a.m. - 4:30 p.m.

Breakfast
7:00 - 8:45 a.m.

Sessions
9:00 - 9:50 a.m.

Explore how this leading biopharma manages quality processes for combination products. Discover best practices for incorporating MedTech requirements while scaling technology systems.

Learn how a biopharma company is transforming its release decision-making with Veeva Batch Release. From solution selection to go-live, discover lessons learned and the real-world outcomes.

Learn how a CDMO and Sponsor use digital infrastructure to enhance customer experience, from technology transfer through to lifecycle management. Discover how a strategic relationship built on innovation and transparency generates mutual value.

Tracy Guldan Civica Rx
Head of Quality Systems
Jeremiah Genest Just – Evotec Biologics
Senior Director, Quality
Bruce Keisler Veeva Systems
Director, Quality Strategy

Applied Therapeutics improves efficiency and CRO oversight with real-time data visibility and a connected safety solution. Discover its strategic approach to bringing systems in-house, streamline cross-functional processes, and scale operations to prepare for commercialization.

Hear from Alnylam, Eli Lilly, Roche, and Sanofi, who have implemented regulatory Generative AI solutions, on best practices for measuring value, building end-user trust, and driving scalable adoption.

Madhavi Gidh-Jain Sanofi
Global Head Medical Writing and Document Management
Janet Sherman Eli Lilly and Co
IT Senior Director – Global Regulatory Affairs
Pratyusha Pallavi Veeva Systems
Executive Director, Veeva RIM Strategy
Vijay Reddi Roche
Regulatory Digital Transformation Lead
Paul Miller Alnylam Pharmaceuticals
VP, Regulatory Operations

Hear how a top biopharma is gaining value by streamlining cross-functional processes and improving efficiencies across Safety, Clinical, Regulatory, and Quality with Veeva Connections.

Discover Vault Platform tools for managing configurations, best practices, and methodologies for complex changes using software development lifecycle concepts such as config-as-code.

David Mills Veeva Systems
Director of Product Management
Eric Fabricant Veeva Systems
Principal Product Manager

Astellas and Biogen share how to unify systems and processes and increase data access with Veeva Clinical Operations. Discover how they execute new operating and governance models and plan to use study-level data across their portfolios to review study progress and improve trial execution.

Kristen Sorokti-Grimm Astellas
Head, Clinical Systems – Strategic Business Operations and Execution
Jeff Kearney Biogen
Head of Business Performance Management
Lauren Garson Veeva Systems
Senior Director, Veeva Clinical Operations

Apellis and University of Pennsylvania share how lean TMF teams can help transform sponsor-site relationships from transactional exchanges to collaborative partnerships. Learn how emerging biopharmas and sites can leverage better communication, processes, and technology to improve TMF completeness and timeliness.

Steph Viscomi Apellis Pharmaceuticals
Director, Clinical Documentation & TMF
Meghan Blair University of Pennsylvania, Abramson Cancer Center
Director, Regulatory Affairs
Frank Lin Veeva Systems
Director, Clinical Strategy

Learn how clinical data leaders maximize value from the Clinical Data Platform. You’ll hear best practices from enterprise to emerging biopharma companies and diverse adoption approaches, both highly structured and agile. Delve into features and process changes that delivered efficiency gains like saving two days per data manager, per week, on data review.

We’ll delve into tangible examples of how sponsors are actively demonstrating their commitment to site success. This session will highlight lessons learned, innovative initiatives, and concrete actions taken by leading sponsors to truly partner with and support their research sites.


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

Hear how Veeva RIM connects key data and business processes with Clinical, Quality, Safety, and PromoMats. Discover key enhancements over the last 12 months and future features.

John Tanner Veeva Systems
Senior Product Manager, RIM Connections
Angela Nguyen Veeva Systems
Product Manager, RIM Connections

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.

Michael Ferrell Veeva Systems
Principal Product Expert, Vault Platform

Automate creation and transfer of end-of-study media directly into eTMF. And, SiteConnect users can digitally deliver PDFs to sites, eliminating physical shipments at closeout.

Matthew Cantor Veeva Systems
Senior Director, Development Cloud Strategy
Margaret Wehner Veeva Systems
Senior Product Manager, EDC

Explore product enhancements that simplify protocol registrations and results disclosure submissions in the United States. This includes automating submissions to ClinicalTrials.gov and providing visibility into Protocol Registration and Results System (PRS) status.

Kaitlyn Moore Veeva Systems
Senior Product Manager, Veeva Disclosures

Hear authentic perspectives on the impact and value of eConsent for research patients, sites and their sponsors, and gain practical insights to adopt eConsent with your research team.

Learn how Veeva Validation Management improves the efficiency and traceability of equipment qualification activities.

Bernat Rocarols Veeva Systems
Senior Solution Consultant

Hear the site perspective on why current site CTMS systems are falling short, how next generation CTMS systems will bring positve change and brainstorm on the future of a connected site CTMS.

Learn how Veeva RIM publishes a U.S. eCTD 4.0 submission using Veeva Submissions Publishing and preview U.S. eCTD 4.0 forward compatibility – all within the same processes used today, without any add-ons.

Jordan Williams Veeva Systems
Senior Product Manager, Veeva AI (RIM)
Ron Hernando Veeva Systems
Practice Manager, Veeva RIM Services

Learn how to access extracted text from your uploaded Vault documents. Without exporting Vault source files, the unformatted text can be sent to and leveraged by LLMs and Gen AI services.

Jonathan Chickneas Veeva Systems
Director of Product

Automate approved label distribution with Veeva Connections across Veeva Submissions, SafetyDocs, PromoMats, and Medical.

Jared Katz Veeva Systems
Senior Director, Development Cloud Strategy
Jeff Steward Veeva Systems
Director, North American Solution Consulting

Discover how Veeva OpenData Clinical provides a reliable data foundation for investigator and site information, improving operational efficiency and accelerating clinical trial start-up and execution.

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.

Alice Foltyn Veeva Systems
Solution Consultant, Clinical Data

Sessions
11:00 - 11:50 a.m.

Discover how Eli Lilly transformed quality management at scale by empowering people, standardizing processes, and modernizing technology.

Sue Busse Eli Lilly
Executive Director, Quality Technology & Transformation

Learn from industry leaders in this panel discussion on balancing training compliance with consumer learning behaviors. Discover how they are evolving their strategies to stay current.

John Constantine Orchestrall, Inc.
Senior Vice President, US Consulting
Kari Borroel AstraZeneca
Head of Operations Quality Learning & Development
Sonja Broyles Amgen
Senior Director GxP Learning

Discover how an effective cloud technology strategy drives inorganic growth. You’ll learn best practices for migration, accelerated onboarding, and managing through change.

Jennifer DiMinni Minaris Advanced Therapies
Director, Documentation, ITQA & Training
Adela Balducci Minaris Advanced Therapies
Executive Director, Site Quality Head

See how Avidity Biosciences uses Veeva LIMS to enhance partner oversight, ensure compliance, and scale operations. Explore its selection process and its organizational impact.

Cindy Novak Avidity Biosciences Inc
Director, IT

Merck and UCB are streamlining end-to-end safety processes with a unified solution from intake through case processing, reporting, and analysis. Hear how they are driving efficiencies and improving signal detection while maintaining compliance.

Suzanne Skarzynski Merck
Clinical Safety & Risk Management Business Systems Lead
Sandy Farrell Merck
Sr. Director, Business Processes and Systems
Diane Sitki-Green UCB
Benefit Risk Excellence Lead
Christine Hunter Veeva Systems
Senior Consultant

Hear from a panel of leaders from Sanofi, Amgen, and AstraZeneca about how their RIM data management models and associated organizational constructs are evolving due to drivers like Veeva RIM process unification, data quality demands, and internal restructuring.

Christine Glenn Sanofi
Head, Global Submission Management and Data Operations
Edsel Calliste-David Amgen
AVP, Global Regulatory Affairs
Debbie Stanier AstraZeneca
Senior Director, Regulatory Systems
Pratyusha Pallavi Veeva Systems
Executive Director, Veeva RIM Strategy

Discover how Vertex unlocked the power of the Veeva Platform for RIM Planning by engaging with Veeva’s Technical Services team to build a custom Submission Planning feature, based on data from their Veeva Clinical & Safety applications.

Kate Wilber Vertex
Sr. Director, Regulatory Compliance, Data and Technology
Ryan McCullough Veeva Systems
Sr. Director, Global Technical Services

IT leaders share how Vault Platform helps prepare for future growth and scale. Hear lessons learned from implementations, ways to foster effective IT-business partnerships, and how to establish robust data standards and governance.

John Savage Crinetics Pharmaceuticals
Sr. Director, IT R&D
Mike Tarsa Arcus BioSciences
Executive Director, IT Quality and Compliance
Matthew Cantor Veeva Systems
Senior Director, Development Cloud Strategy

Dive into powerful Vault Platform enhancements that streamline and automate critical business processes, customize user experiences, and measure processes with actionable insights. Hear how these new capabilities enable more robust and efficient Vault solutions.

Michael Ferrell Veeva Systems
Principal Product Expert, Vault Platform
David Mills Veeva Systems
Director of Product Management

Astellas details how it will ensure accurate site and investigator data with Veeva OpenData Clinical. Hear how access to a global data directory unified with Veeva Clinical Operations ensures reliable information, simplifies processes, and accelerates trial execution.

Atar Libovitch Astellas
Chapter Lead – Veeva Clinical & Safety, R&Dx, DigitalX

Bayer shares its plans to accelerate registry submissions with Veeva Disclosures. Learn how centralizing disclosures on a unified platform with Veeva eTMF and Veeva CTMS enables automation, simplifies processes, and ensures compliant submissions.

Emma Earl Bayer AG
Head of Clinical Trial Management Services and Solutions
Matthew DeFranco Veeva Systems
Senior Director Disclosures Strategy

GSK shares how it moved feasibility into Veeva Study Startup, replacing manual tools with standardized, technology-enabled processes. Learn how early engagement, data reuse, and process improvements are helping reduce site burden, improve data quality, and build stronger site relationships.

Matthew Jones GSK
Strategy Product Owner – SSU

See how effective collaboration between an emerging biopharma and CRO resulted in end-to-end study benefits. Gain practical examples of how to align people, process, and technology to support sponsor oversight (ICH E6 R3).

Alcon and Syneos Health share their vision for a new approach to eCOA delivery. This session highlights practical strategies to build faster, simplify processes, and accelerate timelines across organizations.

Leianne Ebert Alcon
Sr. Director, Clinical Data Management & Medical Intelligence • Global Biometrics

Lunch and Connect
12:00 - 1:20 p.m.
Innovation Theaters, Networking, Demos, and More

See new eCDA functionality in Veeva Study Startup aimed to standardize and digitize CDAs during feasibility. We’ll share how a streamlined and compliant process embedded into the overall study-start-up workflow accelerates site selection.

Abby Warburton Veeva Systems
Product Manager, Clinical Operations

Explore Veeva’s upcoming product approach to helping organizations master the complexities of jurisdictional control with Veeva Batch Release.

Mike Edwards Veeva Systems
Director of Batch Release Strategy

Explore how to automate global post-market case processing. Simplify intake of unstructured data, improve data quality with embedded configurable QC workflows, and use rule-based narrative generation.

Marius Mortensen Veeva Systems
Vice President Product Architect, Veeva Safety

See how Quick Queries creates significant time savings for sites and CRAs in EDC, and for data managers in CDB. Discover how this feature enables users to create and respond to queries in just a few clicks, eliminating hours of manual effort.

Nick 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.

Pam Pagnotta Veeva Systems
SMB Services Lead, Veeva RIM
Cindy Ling Veeva Systems
Senior Product Manager & Team Lead, Veeva RIM

Discover open-source tools that increase administrator and developer productivity. Built with Vault API and an intuitive user interface, easily modify configurations, execute queries, clean up sandboxes, and more.

Mark Arnold Veeva Systems
Director of Product Management, Developer Experience

See the latest Veeva Governance best practices and how a Center of Excellence can help drive collaboration across multiple functions and Vaults.

Thilo Rattay Veeva Systems
Senior Director, Development Cloud Strategy

Learn about new Veeva eTMF innovations to further enhance collaboration and efficiency. This session will highlight advanced automation and content management capabilities to reduce manual effort and ensure inspection readiness.

Jim Horstmann Veeva Systems
Senior Product Manager, Veeva eTMF

Learn how three new CDB features make data managers more effective. See how new visualization tools in the Query Metrics Dashboard and Clean Patient Tracker enable risk-based approaches, and how assignable Observations let data managers collectively evaluate data points before creating queries.

Eric Jacobson Veeva Systems
Senior Manager, North American Consulting

Learn how to create efficiency and accelerate cycle times with a seamless end-to-end QC workflow, including embedded test execution, embedded control charts, and review by exception.

Ashley McMillan Veeva Systems
Senior Director, Veeva LIMS Strategy
Joby George Veeva Systems
Director, Product Management

See how a unified safety solution accelerates data flow for earlier signal detection and aggregate reporting, links signals back to source case data, supports more detailed analysis, and streamlines RMPs and aRMMS based on signal outcomes.

Tom Pimental Veeva Systems
Sr. Director, Product Management, Veeva SafetyDocs
Sandra Komadinic Veeva Systems
Senior Product Manager

Discover how VeevaID simplifies clinical research site user authentication to all Veeva systems with one SSO login.

Bryan Lim Veeva Systems
Senior Product Manager, VeevaID

Explore how real-time data sharing and automated workflows between Clinical Operations and Vault CRM can strengthen site relationships and speed clinical trial execution.

Anna Lee Veeva Systems
Product Manager

Discover how Veeva Payments ensures sites are paid on time by leveraging Veeva CTMS data to automate payment tracking and Veeva Site Connect to increase site visibility. Learn how standardizing end-to-end processes for site payments reduces administrative burden.

Ryan Kimble Veeva Systems
Senior Product Manager

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

Alexis Cavalli Veeva Systems
Senior Solution Consultant, Clinical Data
Lucy McCanna Veeva Systems
Solution Consultant, Clinical Data
Eric Jacobson Veeva Systems
Senior Manager, North American Consulting

Sessions
1:30 - 2:20 p.m.

Hear how a biopharma company is optimizing their Quality Cloud with a plan for continuous investments in innovation. Learn how to prioritize and synthesize internal requests, new features, and ongoing improvements into an actionable plan that drives long-term value and efficiency.

Learn how Biogen successfully evaluated and implemented Veeva Training for its GxP-first needs. It’ll share their approach to maintaining standard configuration while optimizing business processes.

Hear how Resilience optimized validation processes, enhanced user experience, and increased efficiency by transitioning from a paperless solution to one unified with the quality ecosystem. Discover key lessons learned, best practices, and the business impact achieved.

Shashank Kadam Resilience
Head of IT Compliance
Kate Brattlie Resilience
Sr. Manager, Digital Compliance & Assurance

Explore the importance of fostering a culture of compliance excellence through executive support, cross-functional communication, and proactive governance. Gain insights into how Jazz Pharmaceutical manages its expanding compliance infrastructure, including PVAs and vendor oversight, processes and procedures, M&A support, and inspection readiness.

Colleen Severyn Jazz Pharmaceuticals
Head of Alliance Management for Global Regulatory Affairs & Drug Safety
Jessica Chinault-Jalboot Jazz Pharmaceuticals
Executive Director, Head of Regulatory and PV Compliance

Discover how Pfizer’s change management strategy will position them for rapid implementation, strong user adoption, and lasting success.

Joe McLaughlin Pfizer
Regulatory Head of Innovation, Data Gov & Excellence

Explore the implementation strategies and process transformations undertaken by two global companies as they share key insights and approaches that led to operational improvements and streamlined work on a global scale.

Goutham Reddy Kancharla AstraZeneca
Director, RIMS Product Owner
Matt Neal BeOne Medicines
Executive Director, Global Regulatory Operations Strategy & Innovation

AstraZeneca streamlines regulatory and clinical processes end-to-end with the RIM-Clinical Operations Connection. Discover key strategies and realized efficiencies, including how a connected approach accelerates submissions and enhances global trial execution.

Debbie Stanier AstraZeneca
Senior Director, Regulatory Systems
Jeanette Glenn AstraZeneca
ERV Product Owner

Discover how Vault Platform extracts large datasets at high-speed, and how to move away from traditional API extraction methods with Direct Data API and open-source accelerators.

Mark Arnold Veeva Systems
Director of Product Management, Developer Experience

See how the Quality-Safety Connection automates intake by sharing product quality complaint and adverse event (AEs) data between Veeva QMS and Veeva Safety.

Michael Carbone Veeva Systems
Product Manager, Veeva QMS

Explore Veeva CTMS monitoring events. Learn to leverage new functionality like seeding relevant issues into event records and managing multi-site monitoring via schedules. We’ll also share tips for customizing Word Formatted Output trip report templates to maximize flexibility and usability.

Kayla Mujkanovic Veeva Systems
Senior Product Manager

BASE Life Science explores how AI can be practically deployed in clinical operations, including how to streamline and enhance TMF processes such as expected document list (EDL) management. Learn how AI can move beyond theory to reduce manual effort, increase operational efficiency, and enable proactive oversight.

Freddie Soerensen BASE life science
Head of AI & Automation

Hear real-world examples of automating clinical data collection from sites and downstream data flow. Learn initial lessons from Lilly’s recent EHR-EDC integration, while MSK will offer insights on approaching interoperability.

Mike Ward Eli Lilly and Co
Sr. Director, eSource Capabilities
Joe Lengfellner Memorial Sloan Kettering Cancer Center
Sr. Director Clinical Research Informatics

Learn how data managers can focus on the data that truly matters. We’ll explore risk-based data management, how it differs from risk-based quality management, and tangible steps to achieve it. Hear how Veeva CDB enables risk-based strategies today and our vision for the future.

Discover how the eCOA design studio and pre-built instrument library facilitate sub-4-week builds and rapid mid-study changes.

Connect with Site Connect product managers in an informal setting. Share feedback, discuss improvements, and shape the future of our products.

A data foundation across clinical is driving efficiencies for sites and sponsors. See how connections between RTSM and clinical reduce cycle times, effort, risk, and cost.

Veeva Business Consulting shares how to simplify processes and enable a unified clinical operations environment. This includes a case study from a top biopharma’s implementation of the Veeva Clinical Operations platform to standardize clinical trial execution.

Sarah O’Hora Veeva Systems
Team Manager, NA R&D Business Consulting

This session will include strategic approaches and key considerations for migrating legacy EDC systems to Veeva EDC, the capabilities in development to streamline and de-risk migration, and ways to unlock the full value of Veeva’s modern data platform.


Connect
2:30 - 3:20 p.m.

Discover how to extend and customize your document processes using Document Type Triggers in Vault Java SDK.

David Mills Veeva Systems
Director of Product Management

Discover how recent enhancements to the Quality-RIM Connection improves efficiency in the change control process and data sharing between Veeva Quality and Veeva RIM.

John Tanner Veeva Systems
Senior Product Manager, RIM Connections

Explore new updates in Veeva Study Training designed to streamline training and reduce site burden. This session will cover automating training assignments by responsibility, increasing CRA visibility with the My Study Team page, and exempting PIs from duplicate training

Rob Arnold
Senior Solution Consultant

Connect with EDC and eCOA product managers in an informal setting. Share feedback, discuss improvements, and shape the future of our products.

Connect with Feasibility, Study Training and randomization and supply tracking product managers in an informal setting. Share feedback, discuss improvements, and shape the future of our products.

Connect with Veeva product managers and peers for an in-depth discussion on Veeva Submissions Publishing, provide feedback on our roadmap, and exchange best practices to optimize your use.

Jordan Williams Veeva Systems
Senior Product Manager, Veeva AI (RIM)

Connect with Veeva product managers and peers for an in-depth discussion on Veeva Registrations, provide feedback on our roadmap, and exchange best practices to optimize your use.

Nick Tasse-Guillen Veeva Systems
Director, Product Management, Registrations

Connect with Veeva product managers and peers for an in-depth discussion on Active Dossier, Global Content Plans, and Submissions Content Plans, exchange feedback on our roadmap, and exchange best practices to optimize your use.

Cindy Ling Veeva Systems
Senior Product Manager & Team Lead, Veeva RIM
Paheli Patel Veeva Systems
Product Manager

Get the latest updates on Station Manager with a live demo of real manufacturing use cases. Learn how it drives productivity and enhances compliance on the shop floor.

Samantha Cook Veeva Systems
Solution Consultant, Quality
Paola DePaso Veeva Systems
Sr. Director, QualityDocs Strategy

See how the Safety-EDC connection automates the transfer of serious adverse event (SAE) data, removing data managers’ reconciliation effort. Discover the newest release in 25R2 that adds a closed loop process, so Veeva EDC is aware of Safety decisions.

Learn how to leverage Direct Data API and Veeva’s open-source accelerators to build integrations that can extract all Vault data at high speed.

Mark Arnold Veeva Systems
Director of Product Management, Developer Experience

See how Veeva Connections automatically transfers data between RIM and Clinical to reduce effort for initial global clinical trial approval.

Thilo Rattay Veeva Systems
Senior Director, Development Cloud Strategy
Angela Nguyen Veeva Systems
Product Manager, RIM Connections

Discover how a connected clinical operations platform delivers comprehensive trial oversight and compliance. This session will demonstrate how platform connectivity helps study teams meet regulatory standards by ensuring document quality, optimizing workflows, and automating key processes across all trial functions.

Rob Arnold
Senior Solution Consultant

Sessions
3:30 - 4:20 p.m.

Discover how to make your refresher training more effective, efficient, and engaging. Learn best practices for managing refresher content and assignments, and get a preview of upcoming features designed to enhance the refresher training experience.

Kent Malmros Veeva Systems
VP, Training Strategy
Laycee Mendez Veeva Systems
Solution Consultant, Quality

Explore how an emerging biotech can maximize investment and accelerate innovation with Development and Quality Clouds. Dive into real-world examples to break down silos, streamline processes, enhance data flow, and provide a single source of truth from clinical trials to manufacturing.

Get a preview of Veeva AI Agent use cases in Development Cloud and Quality Cloud applications. Understand how Veeva AI in the Vault Platform and embedded into Vault applications will enable broad adoption to help users analyze data, draft documents, and extract information out of unstructured content.

Andy Han Veeva Systems
SVP, Veeva AI Solutions

Optimize TMF document quality control for inspection readiness and maximized team resources. This session introduces Veeva eTMF’s new risk-based document QC feature, which automates document filtering based on risk levels and sampling percentages to ensure the most critical documents are reviewed.

Jim Horstmann Veeva Systems
Senior Product Manager, Veeva eTMF

Learn best practices to simplify clinical processes, including monitoring and protocol deviations, directly from Clinical Operations and Data Manager experts. Explore the current Clinical Operations-EDC connection and the future state with expanded products and use cases. Plus, discuss standardizing data flows for eSource and non-EDC sources across study phases.

Staci McDonald Celerion
Vice President Global Scientific Clinical Operations
Angie Badgett Celerion
Executive Director, Global Project Management and Strategic Solutions
Thilo Rattay Veeva Systems
Senior Director, Development Cloud Strategy

That’s a wrap! Veeva’s GM of Site Solutions, Nick Frenzer, concludes the inaugural site zone along with a panel of sites and sponsors. This panel will reflect on opportunities to partner for progress for the collective future of clinical trials.

Moving the Industry Forward

Boston | September 3-4, 2025

Register Now