Veeva Commercial Summit - Sales, Marketing, Medical

Boston | October 20-21, 2026

Powerful Community, Fresh Ideas

Validation Management Trail Map

Quality

Monday, October 19
8 a.m. - 7 p.m.

Registration Open
8 a.m. - 7 p.m.

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

Join site, sponsor and CRO leaders in a hands-on, collaborative workshop focused on shifting site and sponsor engagements from study-by-study transactions to long-term strategic alliances. From feasibility to data exchange, cross functional teams of sites, sponsors and CROs will partner to tackle challenges throughout the study lifecycle.

Through interactive discussions and fast-pasted presentations, participants will design actionable frameworks that make sites and their sponsors more efficient, learn from each other, and expand their networks along the way.

Join site, sponsor and CRO leaders in a hands-on, collaborative workshop focused on shifting site and sponsor engagements from study-by-study transactions to long-term strategic alliances. From feasibility to data exchange, cross functional teams of sites, sponsors and CROs will partner to tackle challenges throughout the study lifecycle.

Through interactive discussions and fast-pasted presentations, participants will design actionable frameworks that make sites and their sponsors more efficient, learn from each other, and expand their networks along the way.


Welcome Reception
5:30 p.m. - 7 p.m.
Tuesday, October 20
7 a.m. - 9 p.m.

Registration Open
7 a.m.

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

Network with your peers over breakfast and get a preview of tailored programming for the unique challenges and opportunities in the emerging biotech space.


Opening Keynote
9 a.m. - 10 a.m.
Peter Gassner Veeva
Founder and CEO
Tara Aldoory Biogen
SVP, Head of Quantitative Sciences and Development Organization

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

Emerging Biotech C-Suite have a panel discussion on today’s operational
challenges and the innovations redefining the industry. Learn how these three
leaders mitigate risk, optimize resources, and create enduring partnerships.

Rebecca Wright Veeva
Senior Director, Veeva Basics
Jim Thai Veeva
Vice President, Veeva Basics

Merck is ​activating and implementing Vault AI on the connected Vault platform. See how enterprise teams partnered to pioneer AI-enabled ways of working, drive greater standardization, and create a unified foundation from clinical development through commercialization.

Andreas Rauscher Merck & Co.
Executive Director Veeva Platform & Partnership
Jared Katz Veeva
Senior Director, Development Cloud Strategy
Pat McQueen Veeva
Chief Technology Officer

Discover how Lilly leverages agentic AI to reshape its regulatory operations. Gain insight into Veeva’s AI vision and how innovations will work together to augment teams, accelerate processes, and transform regulatory work.

Torkil Fredborg Eli Lilly and Company
Associate VP, Regulatory Delivery & Excellence
Marc Gabriel Veeva
Vice President, Regulatory

As the industry continues to progress and learn with AI, industry leaders share real-world observations on how AI capabilities are taking shape in quality organizations. The panel will discuss evolving regulatory dynamics, practical approaches for achieving ROI, and the organizational change and adaptation needed to enable value with AI.

Mike Jovanis Veeva
President, Veeva Quality Cloud
Robert Famiglietti GSK
Vice President, Quality Systems & Data
Ravi Yalamanchili Merck & Co.
AVP, Digital Manufacturing, Quality & Supply Chain

UCB unified global safety operations and safety science on a single platform with a big bang approach, replacing fragmented legacy systems and establishing a single source of truth for safety data. Hear how UCB improved traceability from signals back to source data, simplified end-to-end processes, and built a foundation for automation and more efficient benefit-risk decision making.

Jonas Maselis UCB
Head of Digital Technology Patient Safety
Elizabeth Humes UCB
Head Global Pharmacovigilance Reporting Operations
Gianfranco Scibelli Veeva
Vice President Veeva Safety – Europe

Sanofi shares how connected process and data, an agentic approach, and human-centered design can make clinical trials more efficient and a better experience. Hear how Sanofi is evolving its operating model and working with Veeva to build a more connected, patient-first clinical ecosystem.

Rachel Nering Sanofi
Global Head of Early Development Clinical Operations and the Head of eDevelopment
Jim Reilly Veeva
President, Development Cloud

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

Join fellow Heads of Clinical Operations for an invite-only discussion on study-level operating models for biotechs. Hear how peers are approaching technology ownership, CRO collaboration, and execution strategy.

Standard agents help Vault users complete manual and repetitive tasks. See an overview and use cases for Vault Platform Standard Agents, including document agents, object agents, version comparison agents, super agents.

Mike Ferrell Veeva
Principal Product Expert, Vault Platform

Learn how to publish an eCTD 4.0 submission using Veeva Submissions Publishing and preview eCTD 4.0 forward compatibility – all within the same process used today.

Radha Maharaj Veeva
Product Manager, Submissions Publishing

Discover how Vault AI can automate the ingestion of supplier batch records directly into Veeva. See how bridging the CDMO-Sponsor divide with intelligent automation eliminates manual file searching, retrieval, and analysis to drive faster, more confident release decisions.

Mike Edwards Veeva
Director, Batch Release Strategy
Chad Mills Veeva
Solution Consultant, Veeva Batch Release

Veeva SafetyDocs enables PV teams to shift from basic document management to strategic safety management, unifying processes and content in a single application. Discover how SafetyDocs enables end-to-end processes including an emerging signal investigation to risk-related updates and associated PVA distributions, all while keeping PSMFs up-to-date.

See how Vault AI gives CRAs real-time visibility into site enrollment, priority issues, and upcoming monitoring visits, helping them work more proactively and focus on trial success.

Rachael Payne Veeva
Senior Solution Consultant

Veeva’s connected platform automates data flow across RTSM, EDC, eCOA, and Safety. See how connected applications eliminate duplicate data entry, reduce reconciliation, and accelerate workflows across the clinical ecosystem.

Lucy McCanna Veeva
Solution Consultant, Clinical Data

AI experimentation is everywhere, but the needle has yet to move on sustainable value. Hear Veeva’s thinking on how to turn innovative potential into bottom-line reality for your organization.

Rylan Collins Veeva
Head of R&D Business Consulting

Discover how the Vault MCP Server and Vault Documentation MCP Server allow Vault applications or external AI tools to invoke Vault AI agent actions and search official Vault Documentation.

Eric Matelyan Veeva
Developer Support Engineer

Learn how to locate, review, and bulk-disposition market-specific changes using the interactive Assess Local Activities Viewer. Discover how to utilize the grid’s filters, grouping, and fastfill to manage changes simultaneously.

Caríosa Switzer Veeva
Product Manager, Registrations

Explore recent quiz updates in Veeva Training and preview the future roadmap. See how features like Pre-Quizzes and Dynamic Sections improve training efficiency and test security with live demonstrations.

Nicole Bradley Veeva
Product Expert

See how Vault AI will enable safety teams to improve case quality while increasing case processing efficiency with standard platform and custom agents.

Learn how a trusted reference data foundation drives workflow efficiency, connected-system alignment, and a better experience for investigators, sites, and sponsors.

Learn how Veeva DQS drives RBQM, delivering real-time KRI/QTL metrics to CTMS while promoting compliance with ICH E6(R3). Preview upcoming features that automatically map incoming data to protocol endpoints, classify it by criticality, and link to an executable Data Review Plan.

Alice Foltyn Veeva
Senior Solution Consultant

Automated TMF is the first step on a journey to extraordinary impact. Hear about Veeva’s vision for Agentic ClinOps, and our plan for organizational transformation

Kevin Johns Veeva
VP, Global Clinical Operations Business Consulting

Roadmaps
1 p.m. - 1:50 p.m.

Celcuity explores how adopting Veeva Quality Basics cultivates a modern quality culture focused on people and mindset. Discover actionable change management strategies to drive ongoing process adherence and inspire teams to leverage new Quality workflows to accelerate growth.

Megan Vinett Celcuity Inc.
Director, Quality Management Systems

Explore Vault Platform advancements that simplify implementation, customization, and ongoing management. See how to use process monitor, Word-formatted outputs, action triggers, and reporting, and preview of upcoming Veeva AI capabilities.

Andy Han Veeva
SVP Products, Vault AI and Vault Platform

Review recent enhancements to Veeva Registrations, Veeva Submissions, Veeva Submissions Publishing, and Veeva Submissions Archive, along with this year’s roadmap priorities. Updates include Vault AI for Regulatory, Labeling, eCTD 4.0, Active Dossier, Global Content Plans, and other capabilities that streamline data management and end-to-end regulatory processes.

Rich Merrick Veeva
Vice President, Product Management, Regulatory

Explore the roadmap and vision for Veeva QMS. See how the latest innovations streamline quality management.

Manaphan Huntrakoon Veeva
Senior Director of Product Management

Discover what’s next for Veeva Training and LearnGxP. Explore the roadmap for transforming learner engagement and see the latest innovations in action.

Jason Hardin Veeva
Senior Product Manager
Graham O’Keeffe Veeva
General Manager, LearnGxP
Peter Alcocer Veeva
Director of eLearning Compliance

Discover the vision and roadmap for Veeva Validation Management. See the latest innovations and hear about upcoming enhancements.

Chris Pontisso Veeva
Director – Product Management

Hear the roadmap and vision for Veeva LIMS. Dive into recent highlights and discover upcoming features.

Joby George Veeva
Director, Product Management, LIMS

Hear what’s planned for the Veeva Safety Suite, including automation and Vault AI capabilities to improve process efficiency, increase data quality, and simplify global compliance. See how recent enhancements enable more efficient global processes, deeper patient insights and better informed decision-making.

Eldar Curovic Veeva
VP, Product Management

Discover recent enhancements to Veeva CTMS, Payments, Disclosures, and OpenData Clinical. Learn about upcoming features that streamline risk-based quality management, fee generation, and reference data workflows. Preview AI agents to automate invoice intake, budget creation, and protocol extraction.

Ryan Kimble Veeva
Senior Product Manager
Kayla Mujkanovic Veeva
Senior Product Manager, Clinical Operations

Discover the latest enhancements to Veeva eTMF, Study Startup, Site Connect, and Study Training. Learn how new innovations improve inspection readiness, document exchange, feasibility, and training.

Erita Rothschild Veeva
Senior Product Manager, Site Connect
Erin Coppola Veeva
Senior Product Manager

Discover what’s next for Veeva DQS, EDC, and eCOA. Learn about innovation delivering this year, including RBQM, patient engagement, and AI agents for study build, data classification, and programming.

Ray Letulle Veeva
Senior Vice President, Clinical Data
Igor Altman Veeva
Vice President, Product Management eCOA

Real industry progress happens when site experience drives sponsor strategy. In this inaugural year session, Site Advisory Council leaders take the stage to advocate for the critical needs of site staff and trial participants directly to sponsor and CRO leadership. Gain first-hand insights into site friction points, explore collaborative solution frameworks, and help shape the next era of site-centric technology.

In this executive fireside chat, vTv Therapeutics’ CEO and Veeva’s co-founder share the endurance required to survive clinical timelines and macroeconomic headwinds. Hear about strategies for successful fundraising, building cohesive boards, assessing M&A opportunities, and recruiting top talent.


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

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, Vault AI for Regulatory, and the future roadmap.

Rich Merrick Veeva
Vice President, Product Management, Regulatory
Cindy Ling Veeva
Senior Product Manager, Vault AI (RIM)
Kelly Finlan-Dansbury Veeva
Senior Product Manager, Registrations
Nick Tasse-Guillen Veeva
Director, Product Management, Labeling
Angela Nguyen Veeva
Product Manager, Regulatory

Following the QMS roadmap session, join the Veeva QMS product team for an interactive Q&A session to dive deeper into what was shared.

Following the Veeva Training and LearnGxP roadmap session, join the Veeva product teams for an interactive Q&A session to dive deeper into what was shared.

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

Eldar Curovic Veeva
VP, Product Management
Asi Roll Veeva
Director Product Management, Veeva Safety
Tom Pimental Veeva
Senior Director, Product Management, Veeva SafetyDocs
Tristram Liddiard Veeva
Senior Director of Product Management

Immediately following the Clinical Data roadmap, join Veeva’s product team for an interactive Q&A about Veeva eCOA.

Igor Altman Veeva
Vice President, Product Management eCOA

Immediately following the Clinical Data roadmap, join Veeva’s product team for an interactive Q&A about Veeva DQS and EDC.

Ray Letulle Veeva
Senior Vice President, Clinical Data

Explore the current research technology landscape as industry leaders from UPenn, AMR Clinical, and UCLA unpack the biggest headwinds and top priorities for Principal Investigators today.

Emma Meagher Perelman School of Medicine, University of Pennsylvania
Senior Vice Dean, Clinical and Translational Research
Peter Silas AMR-Clinical
Principal Investigator and Regional Medical Director
Arash Naeim UCLA
Chief Medical Office for Clinical Research
Nick Frenzer Veeva
General Manager, Site Solutions

Learn how to build and configure custom Vault AI agents in Vault Platform to automate business processes.

Megan Watson Veeva
Principal Solution Consultant

Learn how Vault AI in Veeva LIMS speeds laboratory workflows through automation. See AI in action, including SOP-to-test definition generation, COA ingestion, and a stability review chat agent.

Kristie Petrella Veeva
Senior Solution Consultant, Veeva LIMS

Learn how Veeva’s TMF Maturity Model supports your eTMF success and paves the way for adoption of autonomous TMF.

Jim Markley Veeva
Director, TMF Strategy

AI will reshape Clinical Data Management, drastically reducing effort for builds and cleaning, and accelerating DBL. Hear about Veeva’s vision for the future and what it will take to achieve it.

Cindhuja Pandian Veeva
Associate Vice President, Global Clinical Data Business Consulting

Hear from the general manager of Veeva Falcon as they showcase how AI-enabled agentic labor can help emerging biotechs stay lean longer.


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

Structure Therapeutics demonstrates bringing regulatory publishing in-house to eliminate unpredictable bottlenecks and fragmented data. Learn how unification across regulatory applications enables a faster, stress-free strategy of continuous submissions for lean teams.

Darryl Clarke Structure Therapeutics
Senior Director, Global Head of Regulatory Operations
Steve Stenavage Veeva
Senior Product Owner – RIM Basics

Amgen will share how Vault Platform, data, AI, and digital product strategies shaped a scalable foundation for digital transformation. Applying Clean Core principles and cross-functional governance across Vaults, the team is reducing complexity, strengthening standards, and enabling faster innovation.

Wolfgang Bradler Amgen
Executive Director, Technology – Veeva Enterprise Lead
Manish Sikligar Amgen
Director, Technology Strategy Lead
Randhir Singh Amgen
Senior Manager, Technology Veeva Governance Lead

Discover how administrators and developers can better design, build, and manage solutions on Veeva Vault with Vault DX tools. See platform capabilities such as Vault CLI, and open-source tools including Claude Plugins.

Mark Arnold Veeva
Directory, Product Management – Developer Experience
David Mills Veeva
Director of Product Management, Vault Platform

See agentic regulatory in action. Experience Veeva’s newest AI capabilities through demonstrations and previews of Falcon Regulatory and Falcon Writer.

Pratyusha Pallavi Veeva
Executive Director, Falcon Regulatory Strategy
Jordan Williams Veeva
Senior Product Manager, Falcon
Brad Arnold Veeva
Director, Product Management, Falcon Writer

Learn how Veeva is evolving document management and shop-floor access. Explore the vision and roadmap for QualityDocs and Station Manager.

Stephen Chelladurai Veeva
Director of Product Management

Discover the vision and roadmap for Veeva Batch Release. Review recent highlights and preview what’s next.

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

Hear how Pfizer is leading the industry by modernizing quality control and transitioning from legacy systems. Learn strategies to approach a transformative project while achieving quick wins and managing change.

Gisele Fahmi Pfizer
Director, QC Operations Digitization and Master Data (IMOQ)

Learn about our newest product, Veeva EHS. Hear the vision and strategy for a modern, streamlined approach to managing environmental, health, and safety processes.

Beth Tanner Veeva
Vice President, EHS Strategy
Bryden Waggott Veeva
Vice President Product – EHS

After migrating from a vendor-hosted legacy database to a heavily customized in-house solution, Amylyx redesigned safety to align with Veeva standard configurations. By adopting modern best practices, Amylyx is working more effectively with its CRO partner and gaining greater PV insights while scaling operations to prepare for commercialization.

Joe Wong Amylyx Pharmaceuticals, Inc.
Vice President, Patient Safety & Pharmacovigilance
Dawn Cox Amylyx Pharmaceuticals, Inc.
Director, Pharmacovigilance Operations

Learn how Falcon drives value across clinical operations with a live demo showcasing streamlined eTMF management. Get an exclusive look at the product roadmap and change management strategies, followed by interactive Q&A.

Jim Reilly Veeva
President, Development Cloud

Explore the vision to revolutionize clinical data, from AI to RBQM and eSource. Hear the world’s largest CRO share its partnership journey over the past year, along with the plan ahead to scale critical innovations.

Sabrina Steffen IQVIA
Vice President, Head of Clinical Data Management and Data Sciences Innovation
Drew Garty Veeva
Chief Technology Officer, Clinical Data

Discover how Veeva SiteVault’s unified platform has created a connected core framework for site business operations, sponsor integration, and intelligent automation.

Cooper VanLare Veeva
Vice President Product

In this panel discussion, a biotech CEO, a capital investor, and a head of partnerships analyze what it takes to fund, develop, and exit an asset successfully in today’s landscape. Discover how these distinct perspectives align to navigate capitalization, optimize clinical trial management, and secure high-value co-development deals.


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

Agent observability in Vault transforms AI from an opaque “black box” into a fully auditable system. See how Vault AI captures the complete lifecycle of every agent interaction, including step-by-step reasoning, context, tool invocations, and generated outputs.

Mollie Gaede Veeva
Manager, North American Solution Consulting, Clinical Operations

Join this discussion to learn how to prepare for Falcon Regulatory.

Luke Rooney Veeva
Associate Vice President, Global Regulatory Business Consulting
Pratyusha Pallavi Veeva
Executive Director, Falcon Regulatory Strategy

Discover how Veeva Competency uses role-based assessment and adaptive learning to create a personalized approach to GMP development. See how quality and manufacturing leaders can gain real-time visibility into role readiness and actionable insights into developmental gaps to drive better employee competency.

Peter Alcocer Veeva
Director of eLearning Compliance

Veeva Clinical Platform uses AI and automation to speed data flow from Veeva eSource, EDC, eCOA, and RTSM into Veeva DQS. See how DQS uses AI to classify incoming data by criticality, and automatically creates protocol deviations in Veeva CTMS.

Eric Jacobson Veeva
Senior Manager, North American Solution Consulting, Clinical Data

Join site leaders and clinical operations experts for a practical guide to upgrading your CTMS. Learn how to recognize when it’s time to make a move, what to look for in a next-generation provider, and the critical factors for successful implementation.

Laura Fluharty Penn Medicine
Executive Director of clinical operations
Theresa Oswald Stanley Manne Children’s Research Institute at Ann & Robert H. Lurie Children’s Hospital of Chicago
Director, Research Operations and Conduct
Ashley Hoambrecker Ann & Robert H. Lurie Children’s Hospital of Chicago
Senior Director, Clinical and Community Trials, Chief Clinical and Behavioral Research Operations Officer
Lorri A Schieri University of Pennsylvania, Penn Medicine
Chief Operating Officer

Organizational Designs will need to evolve with Agentic ways of working. It’s not as simple as “finding efficiencies”. Hear Veeva’s perspective on how to think about this source of value, and how Veeva can help.

Rylan Collins Veeva
Head of R&D Business Consulting

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

The Veeva Basics Product Team will demonstrate how native application connectivity eliminates data silos across Quality, Clinical, and Regulatory operations. This interactive showcase features our highest-impact application spotlights and seamless cross-functional workflows.

Rebecca Wright Veeva
Senior Director, Veeva Basics
Steve Stenavage Veeva
Senior Product Owner – RIM Basics
Madison Schubert Veeva
Senior Product Owner – Quality Basics
Molly Baechler Veeva
Product Owner, Veeva Clinical Basics

GSK streamlines end-to-end quality and regulatory processes with the Quality-RIM Connection. Hear key strategies and realized efficiencies, including how a connected approach speeds up regulatory assessments and ensures compliance.

Brian Grant GSK
Sr Dir, Regulatory Systems Operations
Bob Reid GSK
Product Owner, Senior Manager
Laura Corrado GSK
Sr. Director, Quality Systems & Data Process

AI is fundamentally changing how biopharma operates, and IT teams must drive the transition in partnership with the business. Success requires an operational blueprint for modernizing GxP validation and release management, guiding end-users, and governing token spend to drive measurable business value.

Nathan Thomas Veeva
Associate Vice President, R&D Business Consulting

Discover how Merck and Takeda are using Veeva Registrations to build a robust data foundation, giving the business greater ownership and visibility into its data.

Joseph McDonnell Merck & Co.
Senior Director Health Registration Management
Kelsey Edwards Takeda Pharmaceuticals
Director, RIM

Join Cytokinetics, Kailera, and Novavax to examine how the RegOps role has expanded to include submission management, data strategy, system ownership, and cross-functional leadership. Learn how evolving regulations and technology are reshaping the role.

Michael Epstein Cytokinetics, Incorporated
Executive Director, Regulatory Operations and Submission Management
Dee DeOliveira Kailera Therapeutics
Senior Director, Regulatory Operations
Jared Lantzy Novavax, Inc.
Executive Director, Global Regulatory Affairs Operations
Nader Girgawy Veeva
Director, Regulatory Strategy

Veeva shares its 2030 vision of humans and agents working together and how this will drive efficiency and proactive quality. Learn successful transformation strategies that center on key business problems, focus on value, and align people, processes, applications, and agents to drive results. Understand how Veeva solutions are evolving to support the industry journey.

Fernando Londoño Veeva
VP, Global Quality Business Consulting

Experience agentic safety in action. See how Falcon Router and Falcon Safety orchestrate multi-channel intake and triage and significantly reduce overall case processing time and effort.

John Lawrie Veeva
Vice President, Safety
Gianfranco Scibelli Veeva
Vice President Veeva Safety – Europe
Marius Mortensen Veeva
Vice President Product, Falcon

Discover how Kailera uses Veeva eTMF and Study Training for real-time oversight and compliance amid rapid trial growth. Learn how the company drives inspection readiness through a risk-based approach and QC risk rules.

Stephen van Arcken Kailera Therapeutics
Associate Director, Clinical Systems

Amgen implemented a single rollout of Veeva CTMS, Study Startup, Study Training, and Site Connect to streamline trial execution. Hear best practices for increasing productivity through automation, improving data quality, and strengthening site engagement.

Tine De Pla Amgen
Development Operations Innovation Director

Oruka Therapeutics optimized data quality and achieved faster database lock. Learn how it brought data ownership in-house to allow for greater oversight, visibility, and streamlined collaboration using Veeva EDC and DQS across multiple CROs.

Evelyn Dorsey Oruka Therapeutics
Senior Director Clinical Data Management
Catherine Munera Oruka Therapeutics
Vice President, Biometrics
Jon Young Veeva
Senior Director, Strategy, Clinical Data (SMB)

Sanofi and Amgen are rethinking clinical processes and adopting an entirely new way of working at speed. Hear Sanofi’s novel model to innovate with the Clinical Platform, with a path to RBQM, site success, and patient engagement. Learn how Amgen switched to the Veeva Clinical Platform and see its next phase of innovation, including tackling the complexity of Integrated Data Review Plans (IDRPs).

Erin Stackowitz Sanofi
Senior Director, Clinical Digital Transformation Implementation Lead
Petra Cramer Amgen
Director, Clinical App and Analytical Services
Harshal Mahajan Amgen
Senior Manager, Data Management

Join Clinical Leader’s Chief Editor and Veeva’s VP of Public Policy for an interactive discussion on current policy issues, their impact on clinical trials, and how Veeva is advocating for sites.

Dan Schell Clinical Leader
Chief Editor
Anthony Corso Veeva
Vice President, Public Policy

Learn how clinical research sites can safely adopt AI without introducing new validation burdens or data risks, as well as the practical questions to ask any AI vendor before deploying technology at your site. This session will center interactive Q&A with SiteVault product leaders to get direct answers about both Veeva AI in SiteVault in addition to site specific AI questions.


Evening Event
5:30 p.m. - 9 p.m.
Wednesday, October 21
7 a.m. - 4:30 p.m.

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

Attend this invite-only session with Joel White, owner of Marketcap Consulting, to
explore how an AI-powered platform drives real CRO business value from internal
cost management to commercial opportunities. We’ll discuss how Veeva supports
CROs to stay competitive and deliver for sponsors.


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

Explore three proven clinical strategies for selecting a study-specific operating model and establishing effective trial oversight. Ranging from in-house execution to full outsourcing, learn how Veeva Clinical Basics helps biotechs maintain control and drive success across whichever model is right for your study.

Molly Baechler Veeva
Product Owner, Veeva Clinical Basics

Understand how Vault AI in the Vault Platform enables businesses to scale AI adoption within the same environment that manages data and documents. Explore Vault AI agent use cases across clinical, regulatory, safety, and quality.

Andy Han Veeva
SVP Products, Vault AI and Vault Platform

AstraZeneca will share insights and early lessons learned from piloting use cases for Vault AI. Veeva will highlight current Vault AI capabilities and what’s coming next.

Debbie Stanier AstraZeneca
Senior Director, Regulatory Systems
Cindy Ling Veeva
Senior Product Manager, Vault AI (RIM)

Learn how BeOne, Emergent, and Regeneron are building a high-quality data foundation to move beyond document-centric processes. Discover how a data-driven approach helps proactively manage regulatory changes, increase confidence in submission data, and improve global regulatory operations.

Nihar Baxi Emergent BioSolutions
Senior Director, Regulatory Affairs
Amha Lawson Regeneron Pharmaceuticals
Senior Manager, Regulatory Information Management & Innovation
Jesse Gonzalez BeOne Medicines
Director, Global Regulatory Solutions Enablement (GRSE), GROSI

Brook Darnell shares how Tolmar’s learning ecosystem evolved to empower both GxP qualification and professional development. Hear how they went from paper based read and understand training to an engaging cross domain learning experience.

Brook Darnell Tolmar Inc
Senior Quality Systems Specialist – Training

Gilead shares insights on driving global process unity through its QMS enhancement program. Hear key considerations for navigating a changing product portfolio, aligning optimized business processes with system configuration, and fostering organizational alignment.

Michael Morad Gilead Sciences
Executive Director, Quality
Jennifer Ly Gilead Sciences
Director, Quality Systems
Alex Margolis Veeva
Principal, Quality Business Consulting
Jennifer Trundle Gilead Sciences
Director, Global Digital Quality

Hear from ISPE Digital Validation Subcommittee expert Matthew McMenamin on transitioning to Digital Validation Tools (DVTs). Learn practical strategies to overcome implementation challenges, manage organizational change, apply eGDP, and ensure audit readiness.

Matthew McMenamin The Sentinel Consulting Group LLC
Principal

Discover ideas for successfully executing multiple Veeva implementations. Learn how anchoring a massive software rollout to company values supports alignment.

Shane Dickinson Bora Pharmaceuticals
Senior Director, Global Quality Systems
Kailash Rathi Kindeva
Director of Global Quality Systems and Engineering

Lilly modernized management of its pharmacovigilance agreements (PVAs) by centralizing content and related PVA processes, including contract and obligation creation, management, and tracking. Explore how a digital solution automates global partner oversight and improves audit readiness and scalability.

Merry Chu Eli Lilly & Co
Senior Director, Global Patient Safety, External Collaborations

Learn how Sarepta established a foundation for an optimized Veeva CTMS through process standardization. Discover the impact on data quality, user adoption, and trial oversight—and why aligning processes before configuring the system was key to its success.

Jamison Johnson Sarepta Therapeutics
Associate Director, Clinical Systems

Parexel shares how it standardized studies with an academic medical center on a connected clinical platform to improve oversight, accelerate site activation, and improve data quality. Hear how simplifying site technology reduced risk and improved study execution.

Christie Wilkins Parexel
Senior Director, Solution Enablement, Operational Excellence

Learn how Pacira, Indero, and Bayer modernized eCOA delivery. This session addresses traditional eCOA pain points to build faster, standardize processes, improve compliance, and simplify experiences for sites and patients.

Jennifer Budich Pacira BioScience
Director, Clinical Data Management
Eric Hardy Indero
Senior Director, Biometrics
Robert Bergann Bayer
VP, Clinical Digital Transformation

Discover a site-centric eSource strategy that breaks the cycle of disconnected tools. Unpack how FHIR-based APIs enable automated data transfer from EHR to EDC, eliminate manual re-entry and source data verification (SDV), and empower sites to manage one unified platform across their entire portfolio.


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

Machine translation for documents within Vault eliminates manual Vault user workflows and custom code. See how to initiate automatic translations to accelerate localization workflows and streamline global delivery.

Amos Kendall Veeva
Senior Product Manager, Vault Platform

Roche expanded their existing drug environment to support medical device processes. Join this discussion and Q&A about lessons learned and best practices in scaling Veeva RIM.

Learn how to facilitate accurate batch release and product lifecycle management with Active Dossier by maintaining a list of current documents for a product in multiple markets.

Angela Nguyen Veeva
Product Manager, Regulatory

Learn about how Veeva QualityDocs can provide regulation change impact assessments through document to regulation mapping.

Paola DePaso Veeva
Senior Director, QualityDocs Strategy
Ryan Clemens Veeva
Senior Solution Consultant, Quality

Explore ways to streamline and accelerate case intake, including customizable web forms, follow-up questionnaires, and Veeva Connections with medical, clinical, and quality Vaults.

Mariya Bevzyuk Veeva
Product Manager, Veeva Safety
Asi Roll Veeva
Director Product Management, Veeva Safety

Learn how Veeva’s milestone planning capabilities simplify complex trial timelines and how Vault AI streamlines feasibility and site activation.

Tom Frattarola Veeva
Senior Solution Consultant

Join peers and Veeva experts in roundtable discussions for topics ranging from strategies to scale automation, governance, study migration, and change management. Share your experience, swap best practices, and build connection with the clinical data community.

Discover how Veeva eCOA Studio redefines industry standards by enabling sponsors to directly configure and manage their own study builds. See how this self-build approach eliminates vendor bottlenecks and outdated workflows, driving faster and more efficient execution.

Alexis Pyles Veeva
Senior Solution Consultant, eCOA

Drop in and meet sponsors aligned with your therapeutic areas, patient populations, or studies of interest. Take advantage of dedicated networking time to build connections that can lead to future collaborations.

Agents will not replace strategic thinking or health authority relationships, but there’s considerable potential for efficiency in the highly complex processes of RegOps. Hear from Veeva about our vision for the transformation potential and the organizational steps to get there.

Luke Rooney Veeva
Associate Vice President, Global Regulatory Business Consulting

Connect with fellow clinical leaders from biopharmas and CROs to discuss strategies for better collaboration to drive trial success. You can also get a deep-dive into Veeva CTMS vision and share your feedback directly with the Veeva product team.

Enjoy your morning breakfast while walking through a Site’s day in the life. This interactive demo session will highlight end to end workflows in SiteVault and other Veeva tools, with emphasis on improving efficiencies between sites and sponsors.

Join fellow TMF leaders for an interactive roundtable on how AI and automation are reshaping TMF operating models. Gain actionable insights on upskilling teams, evolving sourcing strategies, and preparing your operations for the future of agentic labor.

Formation Bio and Snowflake share how directly connecting Veeva Vault to Snowflake creates an AI-ready foundation with near real-time data. Learn how an automated pipeline supports downstream data normalization and transformation, streamlining clinical monitoring and trial analysis.

Melanie Hullings Formation Bio
Director, Data Management & Analytics
Emily Ashby Snowflake
Data Cloud Product Partnerships Director

Learn how to create a Global Content Plan as a baseline from a reference application using documents from Active Dossier, accelerating time to submission and approval.

Angela Nguyen Veeva
Product Manager, Regulatory

Explore key considerations for building a modern validation strategy. Learn how a data-centric approach to digital validation can overcome the limitations of early paperless solutions.

Nina Ricciardelli Veeva
Senior Director, Validation Management Strategy
Ruben Gottardi Veeva
Senior Solution Consultant, Validation Management

Discover new Clinical Transfer and Oversight Planning capabilities that improve sponsor-CRO collaboration and streamline study oversight.

Taylor Kiakotos Veeva
Principal Consultant, North America R&D Business Consulting
Mustafa El Shatshat Veeva
Senior Product Manager

Preview how Veeva Study Builder Agent ingests a study protocol and uses agentic AI to drive configuration across Veeva EDC and DQS, with every step gated by human-in-the-loop validation.

Nick Klatt Veeva
Senior Solutions Consultant

The appropriate governance of Agents in the workforce goes far beyond traditional software governance. New skills and capabilities are required, new structures need to be stood up. Hear Veeva’s perspective on what should be in place to make Agentic R&D work inside your company.

Nathan Thomas Veeva
Associate Vice President, R&D Business Consulting

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

Hear from Heads of Quality, Regulatory and Clinical as they share their approaches to cross-departmental alignment. Explore how to mitigate risks, manage clinical trials through harmonious collaboration, shared accountability, and clear operational focus.

Robert ‘Bob’ Satterfield Whitehawk Therapeutics
Executive Director, Head of Quality
Madison Schubert Veeva
Senior Product Owner – Quality Basics

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

Jared Katz Veeva
Senior Director, Development Cloud Strategy

Discover how National Marrow Donor Program uses Veeva Process Monitor to analyze and optimize business processes. This session will demonstrate how to visualize process flows, identify bottlenecks, and easily track process KPIs like cycle time.

Jody McNaughton NMDP
Senior Application Business Owner
Amos Kendall Veeva
Senior Product Manager, Vault Platform

See how Lilly used Global Content Plans to deliver 40 submissions across 40 countries in just 40 days.

Todd Gerig Eli Lilly and Company
Product Owner, RIM Publishing
Ashik Sunny Eli Lilly and Company
Manager, Global Regulatory RD&E

Learn how Aquestive built a business case for continuous publishing. Hear how working with a skilled publishing partner mitigates risk while keeping teams in control of timelines and quality.

Sadia Chaudhry-Zutshi Aquestive Therapeutics, Inc.
Regulatory Technical Writer
Ilona Barskaya Votum Consulting
Managing Partner
Anthony Ochoa Votum Consulting
Managing Partner

Discover how Asahi Kasei Therapeutics demonstrates training value beyond “checkbox compliance” using a focused, organizational Training Matrix and applying ROI principles.

Michelle Royals Asahi Kasei Therapeutics (formerly Veloxis Pharmaceuticals)
Senior Director, QMS and Compliance

Sumitomo Pharma America (SMPA) shares its global quality transformation journey to establish a unified QMS across seven separate companies that merged together to create SMPA as well as the inclusion of existing global entities. Learn how streamlining supplier quality and document management improves efficiency across the organization.

Explore release management best practices that derive maximum value from your Quality Cloud investment. Learn proven strategies for small and midsize businesses to stay current with Veeva releases.

Praveen Vangeti Exelixis
Executive Director, IT – Drug Development, Supply Chain and Quality

Discover how a virtual biopharma built a commercial-grade release process across a multi-CMO supply chain while racing toward its first NDA.

Biogen modernized global pharmacovigilance operations with a connected safety platform. Explore how the PV team brought global and affiliate case processing into a single safety solution, improving data quality and oversight while simplifying compliance. Hear operational readiness best practices that supported a seamless implementation and go-live.

Sharon Chan Biogen
Director, Global ICSR Processes and Systems

Bayer shares best practices to centralize disclosures on the Veeva Clinical Platform. Learn how standardizing workflows across Veeva eTMF and CTMS improves compliance and efficiency.

Emma Earl Bayer
Head of Clinical Trial Management Services and Solutions

Johnson & Johnson shares how it replaced legacy technology with a unified site training approach. Learn how integrating training with eTMF reduced site burden, improved compliance, and lowered overhead.

Tara Foltz Johnson & Johnson
Manager, Clinical Trial Learning & Training

Sponsors can get quick access to Veeva innovations through accredited CRO partners. Hear how Celerion delivered studies on their Veeva platform for sponsor speed, flexibility, and oversight.

Staci McDonald Celerion
Vice President Global Scientific Clinical Operations
Angie Badgett Celerion
Executive Director, Global Project Management & Strategic Solutions
Megan Shannon Celerion, Inc.
Director, Clinical Data Management – EDC
Dylan Berger Celerion
Veeva Vault Administrator

Hear how Lilly and Bayer maximize clinical data value with Veeva DQS, EDC, and Clinical Platform connections. Learn how they automate data ingestion and up to 50% of queries to speed cycle times, reduce manual effort, and improve data quality.

Nancy Wetzel Eli Lilly and Company
Director, Clinical Trial Foundations, Clinical Result Systems
Swathi Veluri Bayer
Head Of Data Provisioning

SiteVault customers describe their experiences adopting innovative site technology. Learn how it has improved site operations and their approach to successful implementation.


Lunch and Connect
12 p.m. - 12:50 p.m.
Networking, Innovation Hub, and More

Process Monitor is a Vault Platform capability that enables Vault users to measure and analyze critical business processes with zero configuration. See how to visualize processes, detect bottlenecks, and use key metrics to optimize performance.

Mike Ferrell Veeva
Principal Product Expert, Vault Platform

Discover how optimized complaint intake, via intelligent automation, can help reduce errors, drive consistency, improve data quality, and shorten cycle times.

Carl Ning Veeva
Senior Director, Veeva QMS Strategy
Lisa Greene Veeva
Principal Product Manager

Explore the new Site Connect – Study Plan capability and learn how to implement it successfully with change management strategies that accelerate adoption.

Kevin Johns Veeva
VP, Global Clinical Operations Business Consulting
Sheng-wei Chang Veeva
Engagement Manager

See how Veeva DQS automates the detection and transfer of PDs into Veeva CTMS via the new Clinical Operations – DQS Connection, cutting protocol deviation processing time from weeks to hours.

Nick Klatt Veeva
Senior Solutions Consultant

In ten years, the Safety function will look very different and be focused on high-value, judgement-based tasks. Hear from Veeva how we see this developing and what it will take to get there.

Mrinal Pahwa Veeva
Associate Vice President, Global Safety Business Consulting

Veeva Claude Plugins organize Vault work by role, with specific skills for administrators, developers, and data migration, and clear handoffs as work moves from one role to the next. See how a plain-English request progresses from sign-in through configuration and data load to a finished page live in a sandbox using Vault CLI.

Reeves Bell Veeva
Developer Support Engineer

Discover how the Veeva Safety and RIM Connection can increase downstream business process efficiency, including case processing, product quality complaints, and adverse event document intake highlighting.

John Tanner Veeva
Senior Product Manager, RIM Connections

Explore key considerations and strategies for assessing your current technology environment. Learn how to approach legacy technology and make an informed decision to achieve your digital transformation goals.

Ken Raiche Astrix
Vice President, Client Solutions and Innovation

Discover how the new Contract Ingestion Agent works alongside Veeva EDC and Site Connect to accelerate site payments.

Rachael Payne Veeva
Senior Solution Consultant

Preview Veeva eSource, a new application for sites. See how Veeva eSource connects with Veeva EDC to eliminate paper, reduce the need for SDV, and simplify data collection for sites, data managers, and CRAs.

Kimberly Brown Veeva
Solution Consultant, Site Solutions

An Agentic Quality transformation involves identifying high-value business problems, developing agents to address them, embedding their usage in workflows, changing operating models, and upskilling talent to orchestrate. Hear from Veeva how we can help structure the journey.

Tanya Rosenblut Veeva
Quality Business Consulting Principal

Sessions
1 p.m. - 1:50 p.m.

TG Therapeutics gives document and record owners direct visibility into their Quality Vault workload. By consolidating assigned tasks, in-flight documents, and QMS records into a single view–owners can better act on aging items, improve cycle times, and apply usage data to target training for adoption. Plus, get an early look at upcoming enhancements and the roadmap.

Amanda Hancock TG Therapeutics
Associate Director, Digital Quality Solutions
Graham Gelwicks Veeva
Senior Director of Product, Vault Platform
Pukar Bhandari Veeva
Senior Product Manager

Learn how Fortrea creates an impactful user experience leveraging help sections and controls. See walkthroughs of action layouts, working in multiple Vaults, intelligent flash reporting, search enhancements, keyboard shortcuts, and more.

Robert Windsor Fortrea
Senior Quality Metrics & Data Analyst
Mike Ferrell Veeva
Principal Product Expert, Vault Platform

Learn how BeOne is reducing duplication, increasing visibility, and simplifying health authority interactions using Veeva RIM and the Accumulus Connector.

Crystal Allard Veeva
Senior Director, Government Strategy
Christopher Doan BeOne Medicines
Associate Director, Global Regulatory Solutions Enablement
Melody Chessia Accumulus Technologies
Director of Product Management

Discover how Roche and Teva are relieving the downstream burden on publishers and accelerating high-volume regulatory submissions with Veeva Submissions Publishing.

Amy Keum Roche
Senior Regulatory Submission Manager
Ryan Hernandez Teva Pharmaceuticals
Senior Director, Head of Global Regulatory Operations

Regeneron discusses how bringing together Quality and IT stakeholders during its QMS implementation helped advance its paperless plant and digital transformation goals. By establishing early alignment and leaning into out-of-the-box configuration, Regeneron streamlined validation, reduced timelines, and built a scalable foundation for quality management.

Annette Travis Regeneron Pharmaceuticals
Senior Director Quality Systems

Top biopharmas share how they broke down IT and quality silos to reimagine validation. Learn practical takeaways on shifting from fragmented legacy tools to a modern, unified platform for validation and quality.

Hear key takeaways on LIMS selection and implementation from a panel of virtual biotechs. Discover ways to enhance partner oversight, ensure compliance, and scale operations.

Shailesh Thapa Deciphera Pharmaceuticals
Director, Analytical Operations and QC
Charles Brunet Disc Medicine
Director, Clinical Quality Control
Eric Zubee Zubee Consulting Inc
President / Principal Consultant
Justin Lavimodiere Veeva
Senior Director, Veeva LIMS Strategy

Hear Ionis discuss implementing Audit Room within QMS to transform regulatory audit management. Learn how this tool helps GxP business functions maintain continuous inspection readiness.

Vanessa Flemming Ionis Pharmaceuticals, Inc.
Assistant Director, GxP Quality Systems | GMP Vendor Management
JT Soley Ionis Pharmaceuticals, Inc.
Assistant Director, Development IT Portfolio

Incyte shares its strategy and business case for a global, connected safety system. Discover how eliminating redundant technology and standardizing data and workflows is improving data quality while establishing a scalable foundation for automation.

Kathy Roberts Incyte
Vice President, Global Pharmacovigilance
Ancy Johnson Veeva
Principal Business Consultant

Keenova shares how it is moving TMF quality reviews from spreadsheets to Veeva eTMF. Managing review scope, findings, and corrective actions in a single system improves efficiency and enables a proactive approach to inspection readiness.

Sandi Harrison Keenova Therapeutics
Director eTMF & Inspection Readiness

Hear how Takeda is managing change to shift from “check-everything” to “quality-by-design,” and why the human perspective is more important than ever in the age of AI. Veeva experts will share strategies for implementing RBQM with Veeva DQS and Veeva CTMS while aligning with evolving ICH E6 standards.

Kristin Stallcup Takeda
Head, RBQM Operations
Kinjal Shah Veeva
Senior Business Consultant

Engage with real-world case studies of sponsors who brought site-identified challenges back to their organizations and built concrete, burden-reducing solutions for sites, patients, and caregivers.

Join academic research leaders for a candid look at today’s IIT landscape. Explore the real-world impact of recent NIH funding changes, strategies for workforce development and retention, and how modern technology platforms can help AMCs run complex, multi-site academic protocols more efficiently and cost-effectively.

Jessica Collins Vanderbilt Health
Director, Vanderbilt Coordinating Center
Laura Fluharty Penn Medicine
Executive Director of clinical operations
Meghan Blair Academic Medical Center
Director, Regulatory Affairs

Connect
2 p.m. - 2:20 p.m.
Innovation Theaters, Networking, Demos, and More

Get a look into 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
Directory, Product Management – Developer Experience

Learn how Veeva Disclosures streamlines EU CTR compliance and global submissions with the new Protocol Extraction Agent.

Kaitlyn Moore Veeva
Senior Product Manager

Connect Veeva EDC with Veeva Safety to reduce transcription by up to 75% and speed case processing by 50%. Automatically transfer adverse event data to eliminate duplicate entry, reduce intake errors, and simplify reconciliation.

Alice Foltyn Veeva
Senior Solution Consultant

AI will streamline business processes. But on a granular level, there will be new complexities and decisions that go into each re-engineered process. Human in/on the loop, human-agent teaming, and more. Hear from Veeva how we can support your Agentic process redesign.

Sarah O’Hora Veeva
AVP, Clinical Operations Business Consulting

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

Connect with Veeva product managers and peers for an in-depth discussion on Veeva Submissions Publishing. Discuss how to streamline submission workflows, reduce redundant local market tasks, and strike the right balance between strict Health Authority (HA) requirements and traditional internal practices.

Radha Maharaj Veeva
Product Manager, Submissions Publishing

Connect with your peers and the Veeva product team for a discussion and feedback session about Active Dossier, Global Content Plans, and Submission Content Plans.

Taylor Richardson Veeva
Product Manager, Submissions
Angela Nguyen Veeva
Product Manager, Regulatory

The Create and Manage Event Details (CMED) wizard is the starting point for managing changes in Veeva RIM, eliminating repetitive, manual entry. Join your peers to preview the product roadmap and share feedback.

Kelly Finlan-Dansbury Veeva
Senior Product Manager, Registrations
Caríosa Switzer Veeva
Product Manager, Registrations

Explore best-practice Labeling workflows, data model, and implementation accelerators to prepare for Veeva Labeling in 2027.

Alison Marjanowski Veeva
Senior Director, Veeva Labeling
Nick Tasse-Guillen Veeva
Director, Product Management, Labeling

Explore the major 2026 enhancements that bring Risk-Based Quality Management (RBQM) to Veeva CTMS. Learn how to establish Critical to Quality (CtQ) factors and define study-specific risks, mitigations, and critical processes within the system. See how automated Key Risk Indicator (KRI) data ingestion triggers real-time risk remediation workflows when thresholds are breached.

Kayla Mujkanovic Veeva
Senior Product Manager, Clinical Operations

Learn how to set up and configure the TMF Quality Understand feature in Veeva eTMF. Review how to use risk-based or flat sampling to target finalized documents by country, site, or trial event. Discover how these workflows confirm documentation cohesiveness directly in Vault to drive continuous inspection readiness.

Jim Horstmann Veeva
Senior Product Manager, Veeva eTMF

Connect with Veeva services and product experts for an in-depth discussion on Veeva DQS. Discuss how to utilize the Autochecks feature to run automated checks across EDC and non-EDC data, launch queries against preset rules, and automatically close once resolved. Participants will receive a certificate of completion.

Jon Young Veeva
Senior Director, Strategy, Clinical Data (SMB)

Discover Veeva’s vision to elevate and scale Clinical Data teams on strategic activities through agentic AI automation. Explore how to build organizational readiness, accelerate AI adoption, and establish a clear path to maximize your Return on AI (ROAI).

Cindhuja Pandian Veeva
Associate Vice President, Global Clinical Data Business Consulting
Drew Garty Veeva
Chief Technology Officer, Clinical Data
Advance Life Sciences R&D and Quality

Boston | October 20-21, 2026

Register Now