Agenda
Tuesday, October 18
Wednesday, October 19

Founder and CEO

General Manager, Vault

VP, Development Cloud Strategy

Vice President, Pharmacovigilance and Patient Safety
Boehringer Ingelheim shares its strategic vision for a “One Medicine Platform” to bring treatments to patients faster. They’ll discuss how they are unifying development processes and data in a centralized platform to reduce complexity and drive a new mode of patient-centric digital trials.

Head of Global Clinical Development & Operations

VP, Development Cloud Strategy
AstraZeneca shares how industry trends are influencing quality and quality management systems. Hear their transformation journey and vision for the future.

VP Corporate Quality & Strategy

VP, Vault Quality
The regulatory zone will kick off with a fireside chat featuring Sean McNiff from GSK. Now that his team has unified dozens of systems onto the Vault RIM platform, he will talk about the next steps in their journey to optimize the end-to-end process. Learn about GSK’s strategies for measuring process improvement and speeding the overall go-to-market timeline.

VP Regulatory Platforms and Systems

VP, Vault RIM

Vice President, Pharmacovigilance and Patient Safety

Vice President, Vault RIM and Vault Safety

VP, Vault Safety Strategy
Join a fireside chat with CSL Behring to learn how they unified multiple organizations and systems by adopting a single platform for the full product lifecycle. After the discussion, business leads from CSL’s different domains will take questions from the audience.

Senior Director of Information Technology

Development Cloud Architect
Astellas outlines how their risk-based approach transformed TMF management. They share best practices for streamlining inspection readiness checks and focusing study teams on reviewing the most critical documents.

Associate Director, TMF Management Office

Associate Director, TMF Management Office
AbbVie embarked on an enterprise-wide initiative to define and measure KPIs to improve performance. Join this session to learn a 4-step methodology to operationalize study start-up metrics, AbbVie’s approach to activate sites faster, and how they use Vault Study Startup to successfully reduce cycle times.

Associate Director, Study Start Up Operations

Director, Strategy, Site Startup and Engagement
BMS will discuss how they are preparing for the digital future and their CTMS transformation journey from both the IT and business perspectives. Learn about their implementation strategy, how they overcame challenges, and lessons learned deploying Vault CTMS organization-wide.

Director, Enterprise Veeva – Clinical

IT Business Partner

Business Capability Lead
Learn how Pfizer is modernizing quality management processes with Vault QMS. Hear about their business case, key lessons learned, and what comes next.

Sr Director, Digital QA Lead

Digital QA Solution Owner
Tolmar shares how Vault Training can help streamline business processes and increase training effectiveness when it is unified and connected with quality. Hear how the resulting efficiency gains enable organizations to focus on what truly matters – improving processes, people, products, and patient outcomes.

Director Organizational Development
PwC discusses how building a strong digital foundation — rooted in industry best practices — prepares quality organizations for automation and advancements in artificial intelligence.

Director, Pharma-Life Sciences Cloud, Quality, & Clinical Systems
Syneos Health R&D Advisory Consulting will share how a focus on process development and alignment between sponsor and CRO partners can be used to establish a reproducible level of leading performance in Clinical Data Management using Veeva CDMS. The opportunity to extend this into co-development to drive innovation is discussed.

Senior Managing Director
Data democratization is empowering users to collaborate real time to dramatically speed the business while increasing performance. Hear how Sanofi is leveraging it to enhance user experience and make real time decisions. They’ll discuss their journey and key considerations in going from unification to optimization.

Head of Regulatory Business Process & Innovation

Head of Global Regulatory Affairs Operations
This panel will bring together Agios, Intellia, and Turning Point Therapeutics, Inc., a Bristol Myers Squibb company, to summarize their top lessons learned for maximizing user adoption. They’ll share how they prepared their organizations for change, interacted with different user groups, and addressed challenges leading up to and after the business go-live.

Associate Director, Regulatory Operations

Sr Director, Regulatory Operations

Associate Director, RIM & PromoMats
Gain insight into how CSL Plasma and CSL Behring, partnering with Accenture, evaluated a new safety solution and why they chose Vault Safety for a newly acquired and approved product. Sharing objectives, decisions, and insights on business process optimization and automation, they’ll discuss how they are approaching Touchless Case Processing for non-serious adverse events.

Executive Director, Global Head of Pv Operations

Managing Director

Safety System Operations and Integration Manager
GSK will describe how they’ve improved clinical, quality, and regulatory process execution by prioritizing a multi-Vault governance structure. They’ll share their approach to rolling out cross-functional initiatives like Vault Connections through their center of excellence and the intended benefits.

Head Veeva CoE
Hear about Endo Pharmaceuticals’ risk-based approach to computer system validation. They’ll review the framework they use to manage implementations, Vault releases, and self-driven updates to streamline activities and accelerate user enhancements.

Executive Director, IT
Learn how Merck & Co., Inc. and Cerevel use the TMF Bot to automate trial processes, increase document classification accuracy, and enable teams to focus on strategic tasks like post-approval quality reviews. They’ll also share how they quantify the value of AI in TMF.

Senior Director, TMF Head

Senior Clinical Oversight Lead
Vertex shares how a well-orchestrated path to clinical trial technology adoption enabled them to achieve step-change gains in trial efficiency while enhancing patient and site engagement. They’ll discuss their approach to capability prioritization, vendor selection, and deployment – focusing on making informed decisions that enable real-world improvements.

Clinical Technology Innovations Principal
Takeda will share their ‘Future Fit’ vision and how Vault Clinical Suite helps them achieve their goals. Learn considerations when taking ownership of data and operational systems as part of the evolution of trial delivery, Vault Clinical innovations that support their transformation program, and the technology they have implemented to optimize end-to-end clinical trial execution.

Alta Petens – Trial Operations Data Lead

Operational Data Technology Lead
Veeva and Accenture discuss why digital strategy is foundational for creating business value through quality transformation. This fundamental change in how quality is managed will contribute to business agility and efficiency. Learn how unifying quality addresses the critical aspects of compliance, right first time, automation, and laboratory cycle time.

Senior Director, Vault LIMS Strategy

Managing Director, Accenture Scientific Informatics Services
Hear how top pharma companies are taking a structured approach to identify, assess, and mitigate strategic and operational risks to reduce the number of quality issues and drive continuous quality improvement.

Global Quality Risk Management Lead

Director QA compliance

Global Quality Director – Quality Risk
Hear how Ultragenyx leveraged the Veeva Quality Content Reference Model to standardize their document model to drive efficiency and scalability. Learn the importance of establishing a robust document model and best practices for defining the approach, managing implementation timelines, and engaging stakeholders.

Associate Director, QA Document Control
Come join a panel of decision-makers from Ascendis Pharma, Agenus, and Platform Life Sciences, as they discuss how to build a foundation around CDMS, branch outwards to other systems, and how it can make data management more efficient.

CEO

Director, Clinical Data Sciences

Sr. Director, Clinical Data Management

Senior Director of Strategy, Vault CDMS

Director, Vault Clinical Strategy
Moderna will share how they quickly scaled operations by incorporating label management functionality into their end-to-end regulatory solution. They’ll discuss how they identified business requirements, leveraged labeling concepts, and socialized the new streamlined process with users.

Executive Director, Global Regulatory Science Operations

Sr. Director, Global Regulatory Labeling
ICON will share how sponsors can balance objectives of data quality, operational efficiency, and organizational alignment when deploying a regulatory solution. They’ll discuss a range of options in the continuum of centralized, hybrid, and decentralized data management approaches and what impacts that may have on the overall regulatory operating model.

Exec. Director, Global Head of Reg Ops
AbbVie discusses their rapid migration to Vault Safety, change management best practices, and lessons learned on implementation and data migration. Hear AbbVie’s approach and how their safety and IT teams are partnering with Veeva to accelerate deployment and ensure success.

VP, Strategic Operations, Patient Safety

Senior Director, IT

VP, Vault Safety Strategy
Improve your organization’s visibility into operational processes, application usage, and KPIs with Vault reports and dashboards. Learn about Vault reporting’s core tools and how to use them to convert an idea for a metric into an actionable dashboard. Review the notable features released over the past year and planned on the 2023 roadmap.

Director of Product Management, Vault Platform Services

Senior Product Manager
Hear from AbbVie and Gilead on how they incorporated multiple acquisitions into their technology landscape. They’ll discuss how they assessed individual Vaults, standardized data across environments, and streamlined overall business operations.

Sr. Director – IT

Senior Director, Business Technology Solutions
Eric Hardy from Innovaderm shares experiences on selecting and partnering with Veeva RTSM for repeated successful project delivery

Senior Director, Biometrics
Global Blood Therapeutics (GBT) embarked on a journey to establish a framework for TMF health. They share how they leveraged well-defined metrics, reports, dashboards, and cross-functional partnership to drive accountability and improve TMF quality.

Business Operations Manager
Bayer shares their experience as an early adopter of Veeva Site Connect. Hear about best practices to implement technology, drive change, and improve collaboration with sites.

Head of Systems Support
Incyte shares their holistic quality transformation case study, including its justification for modern cloud solutions. Learn how harmonizing quality systems improved collaboration across all GxP stakeholders and increased adoption, efficiency, and visibility.

Sr. Director, Global QMS
Industry leaders share best practices for fostering effective collaboration across internal and external partners, including contract manufacturers, contract test labs, and suppliers. Hear how to digitally connect processes and systems for efficiency and effectiveness.

Director, Quality Information Systems

Director, IT QA Platforms

Director, QMS
Discover how GSK accelerated drug development by modernizing clinical data management with Vault CDMS and the positive impact it had on clinical trials. They will share their implementation journey, key learnings, and the most effective ways to ensure successful adoption.

VP and Global Head of Data Strategy and Management
Sarepta and Vertex will share how they’re improving cross-functional processes by connecting key data points between regulatory and quality teams. They’ll discuss why they decided to implement the Vault Quality to RIM Connection, how they transformed legacy variation management processes, and their top lessons learned for other companies that are considering a similar project.

Director, Regulatory Information Management

Director, Global Regulatory Operations, RIMS/DMS Lead
Hear how Cerevel increased visibility and collaboration between their regulatory and clinical operations teams. They’ll share tips for gaining buy-in across the organization, assimilating product, study, and site data, and driving stronger compliance in Vault.

Senior Director, Head of Global Regulatory Operations
Join our fireside chat to hear how Vault Safety is streamlining PV workflows, provides real-time visibility, and enables oversight when outsourcing. We’ll also discuss ways to manage new releases, address resource changes, and use Vault cross-linking to eliminate duplication of PV content.

Sr. Director, Regulatory Systems, Info Mgmt., and Validation

Pharmacovigilance Manager
Hear from our migration experts on what tools are currently available to aid companies that are moving documents and data into Vault Platform. They’ll review Veeva’s migration methodology, top lessons learned from past projects, and how Veeva will support migration efforts in the future.
Last year, EQRx shared how they built a core development platform in only 12 months. Hear how they’ve grown those initial capabilities through synergy between their Informatics and Business teams to deliver innovation to end users.

Director, GxP Systems

Senior Manager Quality Systems

Veeva Vault Technical Lead
Mingyue Xuan shares how Innovent are fulfilling complex adaptive trial designs by leveraging Veeva RTSM.

Senior Director, Global Head of Data Operation
Abiomed shares its experience as an early adopter of Vault Study Training. They’ll discuss how they plan to eliminate manual processes and improve real-time inspection readiness by bringing together research sites, CROs, and internal study teams into a single platform for end-to-end clinical study training.

Manager, Clinical Systems

Senior Strategy Director, Study Training
Thursday, October 20
Come see how Veeva provides a complete and connected technology ecosystem that spans patients, research sites, and trial sponsors. You’ll see first-hand how the Vault Clinical Suite, SiteVault, and MyVeeva for Patients enable seamless execution and flow of data across all stakeholders.

Product Manager, Clinical Operations

Principal Product Manager, Site Connect

Senior Product Manager, eConsent
See how new features like TMF Bot, Email Ingestion, EDL and milestone automation, and monitoring enhancements drive informed decisions and streamline processes. We’ll also share upcoming innovations for Vault Clinical Operations Suite that enable intelligent study start-up planning, end-to-end document QC, and more.

VP Product Management, Vault Clinical Operations

Product Manager, Clinical Operations

Director, Product Management, Clinical Operations
Get a demo of External Notifications, Annual Product Quality Review automation, and Quality Risk Management enhancements in Vault QMS. Also, see how upcoming features like Duplicate Detection and Quality Event Recurrence Check will improve decision making and enable proactive quality management.

VP, Product Management, Vault Quality

Senior Director, Vault Product Management, QMS
Hear Veeva’s vision and roadmap to simplify life sciences training with solutions that meet the needs of trainers throughout an organization. Also, get a demo of recent enhancements and upcoming features like Curriculum View, Admin Alerts, and new Classroom Training that advance this vision.

Senior Director, Vault Training

Director, Product Management
Hear about upcoming innovations and enhancements in Vault CDMS, including Vault EDC improvements in the study build & amendment process, bulk locking and freezing, and other new features such as file attachments. Learn how Veeva CDB simplifies data management with advancements like data provider query workflow, the clean patient tracker dashboard, and automated query management.

Senior VP Product, Vault CDMS

VP, Strategy, Vault CDMS

General Manager, CDB

VP Product, Veeva CDB
The Vault RIM product team will highlight key features from the past year including detailed roadmaps for Vault Submissions, Archive, and Publishing. They’ll also demo the new Submissions Archive Viewer designed to improve navigation, filtering, and searching.

VP, Product Management, Vault RIM

Director, Product Management, Vault RIM

Product Manager, Vault RIM Submissions

Senior Product Manager, Vault RIM Submissions Archive
Hear Veeva’s vision and roadmap for Vault Safety. See touchless case processing, capabilities to make reporting and compliance easier, and get a first look at how Vault Safety is connecting to Vault RIM and Vault Clinical. We’ll also discuss our automation strategy.

VP, Product Management, Vault Safety

Director, Product Management
Explore what’s new with Vault Platform and Veeva Development Cloud. We’ll review how upcoming releases will help organizations improve scalability, workflows, reporting, and integrations with Vault Connections.

VP Product Management, Vault Platform
Hear how new functionality on our Veeva RTSM roadmap will drive innovation.

VP Strategy, Veeva RTSM

General Manager, Veeva RTSM

Vice President, RTSM Product
Get any additional product questions answered by the Vault Clinical Operations product management team.

VP Product Management, Vault Clinical Operations

Product Manager, Clinical Operations

Director, Product Management, Clinical Operations
Join us for a preview of Veeva eConsent, Veeva ePRO, and Veeva SiteConnect. See how Veeva is streamlining study execution for sponsors and clinical research sites, and making trial participation easier for patients.

SVP Product Management, Digital Trials

Senior Product Manager

Director of Product Management, ePRO
See a demo of how Vault Validation Management will accelerate validation and reduce costs. Also, hear about upcoming investments in product excellence, innovation and automation, and collaboration.

VP, Product Management, Vault Quality

Director, Product Management

Director, Product Management
Hear how Vault LIMS will modernize quality control lab operations for faster batch release and reduced inventory carrying costs. Get a demo of how it enables manufacturing organizations to connect their QC labs with the broader quality ecosystem.

Senior Director, Vault LIMS Strategy

VP Product Management, Vault LIMS
Hear about how Vertex is moving beyond phase one of their adoption of Vault CDMS to now running all of their new studies on Vault EDC. They will discuss some of their wins and challenges thus far.

Director, Clinical Data Management
The Vault RIM product team will share the latest developments related to DADI and IDMP for Vault Registrations and they’ll also provide a sneak peek into a new usability initiative. See how we’re building compliance, automation, and productivity into upcoming releases to optimize the overall Vault RIM experience.

VP, Product Management, Vault RIM

Principal Product Manager, Vault RIM – MedTech

Product Manager, Vault Registrations

Product Manager, Vault Registrations

Product Manager, Vault RIM Submissions

Product Manager RIM Submissions Publishing
See upcoming capabilities for Vault SafetyDocs, including expanded PSMF management, PVA management, and literature review. Get a demo of modular PSMF management, logbook tracking, and compliant eSignatures to help make compliance easier and remain inspection ready.

Senior Product Manager, Vault SafetyDocs
Join this session to learn how Vault APIs and the Spark framework enable organizations to integrate external tools with the Vault Platform. Mulesoft will also share how to manage middleware to create a bridge between applications.

Senior Product Manager, Vault API & SDK

Life Sciences SE Manager
Learn how Roche defines success for organizational changes beyond an initial project go-live. They’ll review incentives, goals, and systemic support structures that mitigate productivity gaps associated with new functionality.

Senior Organizational Change Lead
Sean Parr from the Veeva Services team discusses his experiences in planning the wider supply chain and how a modern RTSM can support activities such as relabelling, recalls and new batch releases.

Senior RTSM Project Manager
Learn how Celerion is leveraging the Veeva Digital Trials Platform to improve participant experience during clinical trials and increase efficiency for sites and study teams. They’ll discuss their implementation journey with MyVeeva, eConsent, and ePRO and share lessons learned along the way.

Vice President, Global Scientific Clinical Operations

VP of Strategy, MyVeeva for Patients
Learn about Lilly’s journey to simplify monitoring and track recruitment more effectively with the Vault Clinical Operations to CDMS Connection. They will share their implementation journey, key learnings when automating data transfers, and the most effective ways to partner with Veeva to ensure successful adoption.

Senior Director

Associate Director
Hear how a modern approach to technology is supporting the rapid expansion of Forge Biologic’s manufacturing facility to meet growing demand for gene therapy manufacturing. Learn how unified quality systems helps them accelerate quality processes and build trusted partnerships.

Associate Director, Quality Management
Industry leaders share examples of how Vault Quality supported their organization’s goals during acquisitions, mergers, and spin-offs. Learn best practices and lessons learned to help navigate the implementation of Vault Quality solutions during M&A and to create business value.

Director BTS Quality CMS

Quality Manager

Tech Head of Quality Products

Executive Director, Global Quality Systems & Compliance
All Vault RIM customers are invited to attend a community meeting to discuss industry trends and share best practices. We will break out into three groups that will cover submission content plans, release and change management, and KPIs.
Join us for a preview of Vault Signal and learn how Veeva is streamlining signal detection, analysis, and management.

Director Product Management
Vault workflows help streamline and automate regulated processes. Learn how to use the tools workflow offers and the benefits of OneWorkflow. Review impactful features being released like Multi-Record Workflows and what is targeted on the 2023 roadmap.

Senior Product Manager, Vault Platform Lifecycles & Workflows

Director of Product Management, Vault Platform Services
This is your second chance to explore what’s new with Vault Platform and Veeva Development Cloud. We’ll review how upcoming releases will help organizations improve scalability, workflows, reporting, and integrations with Vault Connections.

VP Product Management, Vault Platform
The pandemic highlighted opportunities for clinical teams to more effectively respond to crises, such as quickly identifying active sites in a particular region that can still operate and understanding patient status to decide if they should be moved to a different site to continue treatment. Learn Vault CTMS configuration suggestions from Veeva and Accenture that will enable your organization to proactively prepare for global conflicts and events.
Gilead shares their quality transformation journey, and dives deep into how Vault QMS is helping them streamline processes and systems, improve external access and collaboration, and harmonize across multiple sites and business units. Hear their business drivers, lessons learned, and guiding principles for quality systems projects.

Director, Quality Information Systems

Director, Quality Systems

Director IT, Quality Systems
Sarepta Therapeutics shares the value of taking a systematic approach to implementing key enhancements and adopting new Vault Quality features. Learn the importance of establishing a robust process and best practices for engaging stakeholders, managing implementation timelines, and defining change management.

Manager, Global eQMS & Administration
Join other Vault Safety customers to share challenges, industry trends, and best practices.
Learn how to build Vault eTMF reports and dashboards for key TMF health metrics. In this interactive workshop, you will connect with other Vault eTMF customers and have the opportunity to request demonstrations of customized reports and dashboards.
Join this interactive demo and Q&A session to learn how to enable seamless and efficient collaboration with partners on external audit findings with Vault QMS. Also, get a preview of the External Collaboration capability planned in Vault QualityDocs.
Join this customer panel to learn best practices for configuring and implementing Enhanced Periodic Review in Vault QualityDocs.
Engage with Veeva’s Vault Training solution experts and get your questions answered.
We’ll wrap up the regulatory zone with an interactive discussion around the Vault RIM user experience. Eldar Curovic, VP of Product Management for Vault RIM, will share several new ideas and collect live feedback from participants.

VP, Product Management, Vault RIM