RD Summit Online

October 14, 2021

2021 Agenda


11:00am
EDT

Join Veeva’s leadership team for an opening keynote covering the latest innovations in R&D and Quality.

Peter Gassner Veeva
Founder and CEO
Jörg Möller LEO Pharma
Head of Global Research and Development

11:30am
EDT

GSK shares its strategy for modernizing clinical data management. Hear their agenda for the future, technology investments priorities, and how partnering with Veeva helps deliver on their vision.

Mayank Anand GSK
VP and Global Head Data Strategy and Management
Leonie Christianson GSK
Business Lead, Vault CDMS Project
Richard Young Veeva
VP, Strategy, Vault CDMS

Learn how Roche is driving greater efficiency and streamlining clinical operations. They will also share their perspective on the trends shaping the future of digital clinical trials.

Michael Rosenblatt Roche
Vice President, Product Development Clinical Operations
James Reilly Veeva
VP, Vault R&D and Quality
Steve Harper Veeva
SVP Product Management – Clinical Operations, Sites and Patients

Hear how Bristol Myers Squibb streamlined operations across domains with a scalable platform operating model. They’ll describe their journey for bringing together Veeva Development Cloud applications, creating a center of excellence, and driving success into the future.

Dinesh Salvi Bristol Myers Squibb
Executive Director, Enterprise Veeva
Andy Han Veeva
VP Product Management, Vault Platform & Technology

Join peers in safety and IT as they share key trends and challenges, their pharmacovigilance vision, and why they’re partnering with Veeva.

Jennifer Koeller AbbVie
VP, Strategic Operations, Pharmacovigilance and Patient Safety
Sandra Strauss AbbVie
Senior Director – Safety, GMA, HEOR and Project Portfolio Management Office
Sara Yerramilli AstraZeneca
IT Lead – Global Regulatory Excellence, Patient Safety, QA & Portfolio Management
Vita Petrik AstraZeneca
Executive Director PV Processes, Partnerships, and Contracts
Kelly Traverso Veeva
VP, Vault Safety Strategy

Gilead shares their journey to driving proactive quality management across quality and manufacturing. Hear how they built a strong quality foundation to streamline content, data, and processes internally and across partner relationships.

Valerie Brown Gilead
SVP, Quality Assurance
Michael Jovanis Veeva
VP, Vault Quality

Roche’s regulatory transformation lead will share how his team is spearheading efforts to bring different regulatory functions together under a common set of modern business capabilities. Learn more about their OneRegulatory strategies and roadmap to meet both present and future patient needs.

Vijay Reddi Roche
Regulatory Transformational Lead
Marc Gabriel Veeva
Senior Director, Vault RIM

12:30pm
EDT

Merck & Co., Inc. discusses the impact of COVID-19 on TMF operations. Hear the steps they took to implement a risk-based approach and adapt to a digital environment.

Bryan Souder Merck & Co., Inc.
Director, TMF Head

9:55 – 10:15am PT / 12:55 – 1:15pm ET
Get all your Vault Study Startup questions answered in this live demo and Q&A session hosted by our product experts.

Tom Frattarola Veeva
Sr. Solution Consultant

9:30 – 9:50am PT / 12:30 – 12:50pm ET
Get all your Vault eTMF questions answered in this live demo and Q&A session hosted by our product experts.

Brandi Bell Veeva
Solution Consultant

Heron Therapeutics will share tips for small to mid-size companies with finite resources to expand beyond Vault eTMF and successfully deploy Vault CTMS in 12 weeks. Hear why they chose Veeva as their implementation partner, how they allocated internal resources, and approaches to CRA training to optimize study execution.

Susan Stamford Heron Therapeutics, Inc
Executive Director, Clinical Business Operations

By unifying clinical on a single platform, Eli Lilly realized significant efficiencies in their operating model. They’ll explore why they chose this path and how they shifted to an agile approach. They’ll also share a use case that highlights newfound operational agility for the delivery team.

Harry Tunnell Eli Lilly and Company
Director, Medicines Development Information and Digital Solutions
Lukas Gogis Eli Lilly and Company
Manager, Medicines Development Information and Digital Solutions

Labcorp Drug Development modernizes technology solutions to streamline the clinical trial delivery model. Hear Labcorp’s president of clinical operations describe the thorough vetting of Vault CDMS to provide clients greater agility and reduced costs, plus the adoption of Vault Clinical Suite to support the next generations of clinical trials.

Mark Morais Labcorp Drug Development
President Clinical Operations and Commercial Solutions

Learn the latest in this interactive demo and Q&A focused on Vault EDC. Discover how to optimize site, CRA, and data management processes with the latest capabilities in these three purpose-built interfaces.

Michelle Munro Veeva
Solution Consultant, Vault CDMS
Faisal Sufi Veeva
Director of Strategy, CDMS

Vault lifecycles and workflows support regulated processes. Hear case studies on how Vault is configured to address key business challenges, workflow updates and benefits, how to convert legacy workflows, and customer experiences.

Hironmay Basu Veeva
Director, Product Management, Vault Workflows

Understand available tools and best practices for managing and extending Vault environments to save time or reduce risk. We’ll demonstrate how to leverage VPKs and apply custom business logic inside Vault and from external systems with advanced object configurations, SDKs, and APIs.

Mark Arnold Veeva
Senior Product Manager, Vault API & SDK
Walid Abou-Chalha Veeva
Senior Product Manager, Vault Platform API Tools

See a demonstration of Vault UI improvements including the new Action UI and the native mobile app. Hear from users on the new Action UI or have downloaded the Vault Mobile native app to securely view documents and complete tasks.

Igor Tsives Veeva
Director of Product Management, Vault Mobile
Bob Ng Veeva
Director of Product Management, Vault Platform

See how Incyte is centralizing PSMF management and making it easier to comply with local PSMF requirements. With Vault SafetyDocs, Incyte is empowering content owners to collaborate and keep content current while providing QPPV and LPPV visibility and oversight.

Jonathan Bolzman Incyte Biosciences International Sàrl
Senior Manager Pharmacvovigilance Affiliate Governance & QPPV Office
Charlotte Quillien Incyte Biosciences International Sàrl
Senior Specialist Pharmacovigilance Affiliate Governance & QPPV Office

12:30 to 12:55 pm
Join our interactive demonstration on case processing, managing adverse events, and gaining real-time oversight with Vault Safety. Make more informed decisions, improve compliance, and see how AI can automate case intake and support case processing.

Colleen Goodman Veeva
Senior Solution Consultant, Vault Safety

1:00 to 1:25 pm
Get an interactive demonstration on leveraging Vault Safety reporting and dashboards to provide greater sponsor and CRO transparency for oversight and better partner alignment.

Scott Immel Veeva
Principal, Vault Safety Solution Consulting

See how Resilience is using a modern quality solution with industry best practices from the start for scaling their business to meet diverse customer demands.

Elliot Menschik Resilience
Chief Digital Officer
Michael Jovanis Veeva
VP, Vault Quality

Astellas shares their journey to improve document accessibility, collaboration, and compliance across R&D and manufacturing. Hear their approach and best practices to consolidating GxP and non-GxP documents from multiple systems to Vault QualityDocs.

Heather Vezner Astellas
Senior Director, Quality Systems Compliance

See how AstraZeneca connects risk management with quality processes to drive continuous quality improvement. Learn about their integrated approach to quality risk management for improving the safety and efficacy of the products.

Alan Johnson AstraZeneca
Global Quality Director, Risk Management

Supernus will share practical tips on organizational change management, migration, and internal training that drove their quality modernization from many of their manual processes to a unified digital solution in less than 12 months.

Stephanie Mungle Supernus
Director, Quality Compliance

Seagen will provide an update on the next phase of their Vault RIM rollout. Hear how they’re implementing Vault Registrations, integrating multiple domains with Vault Connections, and building a foundation for further development.

Verchel Wunpheng Seagen
Senior Manager, Regulatory Information Management
Scott Caparelli Seagen
Senior Regulatory Information Management Specialist

Moderna worked with multiple health authorities and partners during their rapid roll-out of the COVID-19 vaccine. Learn how they shifted their health authority question management from reactive to proactive and aligned global efforts around a common goal.

Jennifer LaFleur Moderna
Sr. Director, Global Regulatory Science Operations
Maulik Mahant Moderna
Sr. Systems Engineer, Regulatory and Clinical Digital Applications and Platforms

1:30pm
EDT

Parexel discusses their decision to standardize on a unified clinical platform. Hear about the expected efficiency gains, their modern approach to running trial operations, and new initiatives they’re implementing to drive innovation.

Amy Adams Parexel
Senior Director, Global Clinical Operations
Ed Fowler Parexel
Executive Director IDEO, Process & Technology

Hear how Cerevel processes documents more quickly and efficiently with the AI-powered TMF Bot. Get a deep dive into the configuration process and learn tips and tricks so you can get started with TMF Bot today!

Stephen van Arcken Cerevel Therapeutics
Sr. Clinical Oversight Lead

10:55 – 11:15am PT / 1:55 – 2:15pm ET
Get all your Veeva eConsent questions answered in the live demo and Q&A session hosted by our product experts.

Kimberly McElman Veeva
Solution Consultant

10:30 – 10:50am PT / 1:30 – 1:50pm ET
Get all of your Vault CTMS and Vault Payments questions answered in this live demo and Q&A session hosted by our product experts.

Lauren Kunz Veeva
Senior Solution Consultant

Bayer shares the value of digitally connected clinical trials. Hear about best practices to implement technology, drive change, and improve collaboration with sites.

Emma Earl Bayer
Head of Systems Support

Join this fireside chat with Vanderbilt for the site’s perspective on when casebooks should go live, reporting and dashboards they’d like, and what makes a good CRF. Also hear about working with Vault EDC from a performance, training, and user experience.

Alesia Pruitt Vanderbilt Clinical Trials Center
Research Coordinator II
Jill Janssen Vanderbilt University Medical Center
Director

Eli Lilly shares best practices and lessons learned from deploying a library of standards in Vault EDC. Gain advice on building a library with visit structures and cross-form edit checks, CRF tracking and management, and naming conventions for rules.

Jenn Showalter Eli Lilly and Company
Research Scientist – Clinical Study Build
Mita Valera Eli Lilly and Company
Senior Team Lead, Study Build Programming

Veeva CDB simplifies data aggregation and alignment. See how Veeva’s clinical query language (CQL) streamlines data cleaning and gets data managers closer to the data.

Eric Jacobson Veeva
Senior Solutions Consultant, Vault CDMS

Join us as we explore what’s new with Vault Platform and how your organization can leverage upcoming capabilities. We’ll also look ahead at scalability, uptime, release windows, Vault Mobile native app, and Google Drive integration.

Andy Han Veeva
VP Product Management, Vault Platform & Technology
John Tanner Veeva
Senior Product Manager
Robert Lin Veeva
Senior Director Product Management, Vault Platform Docs & Data

Clinlogix, a NAMSA company, shares how they leverage dashboards, data analytics, and reporting in Vault Safety for operational management, regulatory compliance, and product vigilance as well as enable oversight and vendor management for clients.

Jennifer Kratz Clinlogix, a NAMSA Company
Director, Safety Services

1:30 to 1:55 pm
See how Vault Safety can accelerate aggregate reporting from generating required tabulations and listings to supporting end-to-end authoring, review, and approval.

Colleen Goodman Veeva
Senior Solution Consultant, Vault Safety

2:00 to 2:25 pm
Join our interactive demonstration on setting up a PSMF structure in Vault SafetyDocs that supports core and local requirements, while providing oversight of each PSMF. We’ll show tracking of periodic reviews, collaborative updates, and how to automatically bring together content into a single PDF file for review and approval by the LPPV.

Scott Immel Veeva
Principal, Vault Safety Solution Consulting

Valiance and Veeva provide an overview on best practices and approaches for migrating data into Vault Safety. We’ll discuss key considerations and pitfalls, cleansing data, and ways to streamline migration while reducing risk.

David Katzoff Valiance Partners LLC
Co-CEO – Managing Director
Raj Hattarki Veeva
Practice Director, Vault Safety

Forge shares how they are meeting the increasing demand for gene therapy manufacturing with a unified quality solution.

Meghan Leonard Forge Biologics, Inc.
Senior Director, Quality Management
Ashley Wentworth Veeva
Director, Vault Quality

See how Vault QMS enables seamless and efficient collaboration with partners on external audit findings, increasing visibility and compliance.

Anastasia Wengrowski Veeva
Director, Vault Quality
Matt Kopecky Veeva
Manager, Solutions Consulting, Vault Quality
Manaphan Huntrakoon Veeva
Senior Director, Vault Product Management, Quality

Dicerna shares their journey of creating a single learning system for GxP and non-GxP training. Hear their approach and lessons learned in combining HR and compliance training in a single end-to-end learning environment.

Julie Lafond Dicerna Pharmaceuticals
Quality Training Manager
Justin Rogers Dicerna Pharmaceuticals
Associate Director, Quality Assurance

Merck shares their quality transformation journey to increase agility, transparency, and partner collaboration, bringing drugs to patients faster. Hear their strategies and roadmap to harmonize quality management across the enterprise.

Diane Larson Merck & Co., Inc.
Director, IT Account Management
Michael Jovanis Veeva
VP, Vault Quality

While the industry awaits the FDA’s upcoming Computer Software Assurance guidance, many biopharmas are developing innovative strategies to focus their validation efforts on what matters most. We’ll hear from Atara, Blueprint, and Vericel about their approach to modernizing system validation to increase adaptability and drive innovation.

Matt Neal Atara Biotherapeutics
Senior Director, Regulatory Affairs Operations
Craig Gassman Vericel Corporation
Sr. Director, Corporate Information Systems
Michael Martelli Blueprint Medicines
Head of Global Regulatory Sciences, Informatics

Hear how Eli Lilly leveraged an agile methodology to decrease the time it takes to deploy Vault RIM capabilities. They’ll review how they pivoted from a traditional waterfall methodology, what worked well, and their top takeaways for others tackling a similar challenge.

Paula Hudson Eli Lilly and Company
Advisor, Global Regulatory Affairs
Amber Karns Eli Lilly and Company
Director, Information & Digital Solutions, Global Regulatory Affairs

Dermavant is one of the first biopharmas to publish a major NDA using Vault RIM. Join this session to hear how they managed that process using Vault Submissions Publishing and hired new strategic resources to support their growing portfolio.

Jason Maze Dermavant Sciences
Director, Global Regulatory Systems and Information Mgmt.
Dan Gray Dermavant Sciences
Regulatory Systems Analyst

2:30pm
EDT

AbbVie and GSK share how they made study start-up an organizational priority, lessons learned deploying Vault Study Startup, and how they continue to evolve processes in collaboration with Veeva to accelerate start-up.

Lorena Gomez AbbVie
Sr. Director, Global Study Start Up, PRO Management and Digital Implementation
Jarek Tanski GSK
Head of Study Start Up
Alex Henderson GSK
Director of Feasibility & Study Startup
Vasthi Becerra AbbVie
Associate Director, Study Start Up Operations

11:30 – 11:50am PT / 2:30 – 2:50pm ET
See the Unified Clinical Operations suite of products working together to streamline study execution. Get all your questions answered in this live demo and Q&A session hosted by our product experts.

Lauren Kunz Veeva
Senior Solution Consultant

A TMF leader at Adaptimmune shares the lessons she’s learned in driving TMF health and quality. Learn how to take a holistic approach to inspection readiness, including people, processes, and technology.

Cristina Monastero Adaptimmune
Associate Director, Clinical Compliance

11:55am – 12:15pm PT / 2:55 – 3:15pm ET
Get all your Veeva Site Connect questions answered in this live demo and Q&A session hosted by our product experts

Tom Frattarola Veeva
Sr. Solution Consultant

The COVID-19 pandemic changed working practices across the clinical trials industry. Hear how Veeva eConsent has helped Celerion transform their onboarding process – to the benefit of sites and patients.

Staci McDonald Celerion
Executive Director, Scientific Clinical Operations

EQRx was founded in January 2020 with a mission to address the rising costs of medicine across the healthcare system by developing and delivering innovative medicines to patients at radically lower prices. With an innovative approach to technology, EQRx built their core development platform in only 12 months. Learn how they implemented a new way of thinking and built a scalable foundation for efficient cross-functional business processes.

Jonathan Weiss EQRx
Senior Director, Informatics
Casey Gresh EQRx
Associate Director, Clinical Systems

Hear how Kronos Bio uses Vault EDC to simplify complex oncology casebooks and to streamline the study build process. Learn three ways they’ve made data entry easier for sites and how automated data flows will reduce duplicate data entry.

Jennifer Neumann Kronos Bio
Director, Clinical Data Management and Programming

Complex trial designs pose challenges for study builds. Learn how Vault EDC speeds study builds and eliminates the need for multiple matrices, repetitive forms, or custom programming.

Sharmin Nasrullah Veeva
Manager, Solution Consulting, Vault CDMS

Join CluePoints and Perkin Elmer to discuss how data visualizations can support risk-based monitoring and patient profile review. Reporting and analytics get you closer to the data and help you respond to questions and requests from the study team. Hear from two experts in the field on how to make the most of these powerful tools.

Richard Davies CluePoints
Vice President, Solution Expert
Brent Meyers PerkinElmer Informatics
Executive Director, Clinical Analytics Solutions

Learn how customers leverage Vault security capabilities such as dynamic access control, atomic security, and restricting access by user roles and lifecycle states to enable more control, greater scalability, and easier collaboration across sites and partners.

Jean-Christophe Meriaux Veeva
Director, Vault Platform Product Management

Make informed decisions with visibility into operational processes, application usage, and KPIs. See how to use excel templates, multipass and flash reports, and dashboards to determine information such as cycle times, overdue processes, and progress towards completion. We’ll also explore what’s coming on the roadmap.

Graham Gelwicks Veeva
Director of Product Management, Vault Platform

Bellerophon, a clinical stage biotherapeutics pharma, shares why they chose Vault Safety over other industry solutions. They will share their experience and best practices to enable an eight-week implementation time in this interactive fireside chat. Veeva services will provide an overview of the Essentials package and guidance on an accelerated implementation.

Rachel Pinto Bellerophon Therapeutics
Drug and Device Safety Scientist
Bo Kim Bellerophon Therapeutics
Senior Director Quality Assurance and Regulatory Affairs
Karteek Sandadi Veeva
Practice Manager, Vault Safety

We’ll discuss key pharmacovigilance outsourcing challenges and strategies as well as ways to leverage technology to improve oversight, alignment, and operational effectiveness.

Jennifer Kratz Clinlogix, a NAMSA Company
Director, Safety Services
Janelle Ibsen Parker Institute for Cancer Immunotherapy
Director, Patient Safety and Pharmacovigilance

2:30 to 2:55 pm
Join our interactive demonstration on case processing, managing adverse events, and gaining real-time oversight with Vault Safety. Make more informed decisions, improve compliance, and see how AI can automate case intake and support case processing.

Colleen Goodman Veeva
Senior Solution Consultant, Vault Safety

3:00 to 3:25 pm
See how to easily manage PVAs and improve alignment between sponsors and external parties with Vault SafetyDocs. We’ll demonstrate managing PVA lifecycles, roles and responsibilities, and sharing content with the PSMF to ensure a single source of truth for safety content.

Scott Immel Veeva
Principal, Vault Safety Solution Consulting

See how upcoming features like Audit Management, Quality Recurrence Check, and On-the-Job Training will enable proactive quality management and increase compliance.

Manaphan Huntrakoon Veeva
Senior Director, Vault Product Management, Quality
Prannoy Kothari Veeva
Senior Product Manager
Nima Shah Veeva
VP Product Management, Vault Quality & Manufacturing
Joby George Veeva
Principal Product Manager
Gerome Yabut Veeva
Associate Product Manager
Chris Boschen Veeva
Senior Product Manager, Vault Quality

Join this interactive discussion to learn best practices for creating a sustainable training strategy and training matrix of value for increased efficiency and GxP compliance.

Kent Malmros Veeva
Senior Director, Vault Training
Graham O’Keeffe Veeva LearnGxP
General Manager

Join industry and Veeva experts in this interactive roundtable to hear considerations for implementing Veeva Vault out of the box (OOTB) and see how it compares with a configured Vault. Learn configuration best practices to meet your company’s current and future needs.

Lexie Pieper quaLexity, LLC
VP Quality
Anastasia Wengrowski Veeva
Director, Vault Quality

Get an overview of the new functionality on our Vault RIM roadmap. We’ll explore how we’re enhancing our IDMP capabilities, deploying Active Dossier and global content plans, streamlining submission and regulatory objective creation, and improving publishing with support for new formats, better linking functionality, and paper submissions.

Eldar Curovic Veeva
Vice President, Product Management, Vault RIM
Rolando Sa Veeva
Director, Product Management, Vault RIM
Rich Merrick Veeva
Director, Product Management, Vault RIM
Nicolas Tasse-Guillen Veeva
Principal Product Manager, Vault RIM – MedTech
Kelly Finlan-Dansbury Veeva
Product Manager, Vault Registrations
Cindy Ling Veeva
Product Manager, Vault RIM Submissions
Sara Carper Veeva
Product Manager, Vault Registrations
Vera Lvovich Veeva
Senior Product Manager, Vault RIM Submissions Archive

3:30pm
EDT

Learn about key enhancements for the clinical operations suite of applications including Vault Study Startup, Vault eTMF, Vault CTMS, Vault Payments, and Site Connect. See new features in action and learn how your organization can leverage these capabilities to improve trial performance.

Tom Dekker Veeva
VP Product Management, Clinical Operations
Brian Bialkowski Veeva
Senior Product Manager, Vault Study Startup
Anna Linker Veeva
Product Manager, Clinical Operations

As their business expanded organically, Seagen grew into a platform approach to development systems. Learn how they adopted more mature processes, evolved their operating model, and built a connected enterprise across regulatory, clinical, and quality business units to provide even greater visibility.

Predrag Denkovski Seagen
Executive Director, Regulatory Operations
Muralikrishnan Sundararajan Seagen
Senior Director, IT Business Application Management

Learn how Vault CDMS will change, and why, over the next 12 months, from meeting customer requests, to expanding Vault Connections, and launching Veeva CDB.

Drew Garty Veeva
Chief Technology Officer, Vault CDMS
Richard Young Veeva
VP, Strategy, Vault CDMS

Learn how clinical teams can share enrollment, monitoring, and subject visit information using the Vault CDMS to Clinical Operations Connection. The demo will show how data flows to facilitate trip reports, automate site payments, and manage protocol deviations.

Alice Foltyn Veeva
Solutions Engineer

12:30 – 12:55pm PT / 3:30 – 3:55pm ET
IRT setup challenges abound in complex trials. Using real-world examples, Suvoda shares best practices for IRT & EDC integrations, questions to ask prior to IRT setup, and good up-front processes that help you avoid costly change orders.

Marc Lisi Suvoda
Co-Founder, Director of Business Development
Wilmer Barndt Suvoda
Manager, Services Delivery

1 – 1:25pm PT / 4 – 4:25pm ET
4G Clinical shares lessons learned and best practices for building flexibility into the RTSM/IRT to handle highly complex, rapidly changing oncology trials.

Ashley Stocchi 4G Clinical
Client Manager

After successfully adopting Vault PromoMats, Pacira decided to expand their regulatory capabilities with Vault RIM. Hear how they plan to integrate regulatory and commercial data, streamline their publishing process, and prepare for the technical and business go-lives later this year.

Marie Murtagh Pacira BioSciences
Associate Director, Regulatory Compliance
Joy Piva Pacira BioSciences
Sr. Associate, Regulatory

With an effective governance model, companies can strategically implement enhancements from new releases across Vault applications. We’ll review different governance models, best practices for incorporating new capabilities, and risk-based approach to validation.

Karen Gorman Veeva
RIM Customer Success Manager
Jessica Kelley Veeva
Customer Success Manager, Quality

Hear key highlights of the Vault Safety Suite to improve support of global pharmacovigilance and AI driven enhancements for greater automation and efficiency in case processing and intake. Get a preview of ‘case compare’ and learn how we’re streamlining processes from intake to signal detection and risk management.

Marius Mortensen Veeva
VP Product Management, Vault Safety

Learn how to ensure functional job readiness and compliance by capturing on-the-job training evaluation as part of a curriculum with Vault Training.

Kent Malmros Veeva
Senior Director, Vault Training
Joby George Veeva
Principal Product Manager
Kyle Boelter Veeva
Sr. Solutions Consultant

This interactive demo session will answer your questions and share how Vault QMS enables proactive quality management by bringing all stakeholders into quality processes.

Matt Kopecky Veeva
Manager, Solutions Consulting, Vault Quality
Snehal Srikrishna Veeva
Senior Director, Strategy – Manufacturing & Quality

Get your questions answered on unifying quality content, processes, and training on a single platform and how it streamlines business processes and increases efficiency.

Glen DeGuzman Veeva
Solutions Consultant

Join this interactive discussion on use cases and best practices for maximizing your Vault QMS investment through the inclusion of your clinical stakeholders.

Danielle Pund Veeva
Director, Vault Quality

Product experts Nicolas Tasse-Guillen, Kelly Finlan-Dansbury, and Sara Carper will provide a deep dive into the Vault Registrations roadmap and answer your questions.

Nicolas Tasse-Guillen Veeva
Principal Product Manager, Vault RIM – MedTech
Kelly Finlan-Dansbury Veeva
Product Manager, Vault Registrations
Sara Carper Veeva
Product Manager, Vault Registrations

Product experts Rolando Sa, Cindy Ling, and Vera Lvovich will provide a deep dive into the Vault Submissions and Vault Submissions Archive roadmaps and answer your questions.

Rolando Sa Veeva
Director, Product Management, Vault RIM
Cindy Ling Veeva
Product Manager, Vault RIM Submissions
Vera Lvovich Veeva
Senior Product Manager, Vault RIM Submissions Archive

Product expert Rich Merrick will provide a deep dive into the Vault Submissions Publishing roadmap and answer your questions.

Rich Merrick Veeva
Director, Product Management, Vault RIM

4:30pm
EDT

Join us for a brief recap of the day’s sessions and get a final chance to ask questions of the clinical operations leadership team.

James Reilly Veeva
VP, Vault R&D and Quality
Jason Methia Veeva
VP, Vault Clinical Operations Strategy
Tom Dekker Veeva
VP Product Management, Clinical Operations

Join us for a brief recap of the day’s highlights and a final chance to ask questions of the Vault CDMS leadership team.

Richard Young Veeva
VP, Strategy, Vault CDMS
Drew Garty Veeva
Chief Technology Officer, Vault CDMS

The Veeva Development Cloud and Vault Platform leads across Strategy, Product, and Services will join key customer speakers for a short track recap and final Q&A.

Andy Han Veeva
VP Product Management, Vault Platform & Technology
Seth Taylor Veeva
Director, Vault Connections
Graham Gelwicks Veeva
Director of Product Management, Vault Platform
Igor Tsives Veeva
Director of Product Management, Vault Mobile
Jean-Christophe Meriaux Veeva
Director, Vault Platform Product Management
Mark Arnold Veeva
Senior Product Manager, Vault API & SDK
Karen Gorman Veeva
RIM Customer Success Manager
Hironmay Basu Veeva
Director, Product Management, Vault Workflows

Join us for a brief recap of the day’s sessions and get a final chance to ask questions of the safety team.

Kelly Traverso Veeva
VP, Vault Safety Strategy
Marius Mortensen Veeva
VP Product Management, Vault Safety
Saba Darvesh Veeva
Senior Director, Vault Safety Strategy
Mike Kruczek Veeva
Director, Vault Safety
Karteek Sandadi Veeva
Practice Manager, Vault Safety
Raj Hattarki Veeva
Practice Director, Vault Safety
Colleen Goodman Veeva
Senior Solution Consultant, Vault Safety
Scott Immel Veeva
Principal, Vault Safety Solution Consulting

Join quality leaders across strategy, product, and services for track recap and Q&A.

Michael Jovanis Veeva
VP, Vault Quality
Kent Malmros Veeva
Senior Director, Vault Training
Nima Shah Veeva
VP Product Management, Vault Quality & Manufacturing
Bhupesh Joshi Veeva
Practice Directory, Vault Quality Services

The Regulatory leads across Strategy, Product, and Services will join key customer speakers for a short track recap and final Q&A.

Marc Gabriel Veeva
Senior Director, Vault RIM
Eldar Curovic Veeva
Vice President, Product Management, Vault RIM
Melissa Aron Veeva
Vice President, Vault RIM Services

On Demand

Learn how sites trigger the creation of dynamic visits and forms precisely when relevant for their subjects. See the rules-based progressive display in action and also how Veeva’s Local Labs module, real-time edit checks, and form linking save time and reduce data entry for sites.

Sharmin Nasrullah Veeva
Manager, Solution Consulting, Vault CDMS

CRAs receive a dedicated interface, optimized for data review. Learn how dynamically generated task lists help CRAs focus on what matters and how queries and protocol deviations are incorporated directly into the interface for easy management and resolution.

Sharmin Nasrullah Veeva
Manager, Solution Consulting, Vault CDMS

See the operational reports and dashboards that help data managers stay on top of progress collecting and cleaning data. We highlight cross study reporting that helps identify systemic problems and site-specific issues as well as study-level reporting that drills down to actionable tasks.

Sharmin Nasrullah Veeva
Manager, Solution Consulting, Vault CDMS

See how easy it is to build and modify a study design with reusable library templates, configurable rules and dynamics, and a powerful rules engine that eliminates the need for custom functions.

Sharmin Nasrullah Veeva
Manager, Solution Consulting, Vault CDMS

Our product management team will provide a deep dive into new capabilities and what’s on the roadmap for Veeva Site Connect

Vinny Tuminelli Veeva
Senior Product Manager, Site Connect

Our product management team will provide a deep dive into new capabilities and what’s on the roadmap for Vault Study Startup

Brian Bialkowski Veeva
Senior Product Manager, Vault Study Startup

Our product management team will provide a deep dive into new capabilities and what’s on the roadmap for Vault eTMF

Brian Bialkowski Veeva
Senior Product Manager, Vault Study Startup
Kyle Stephenson Veeva
Senior Product Manager, CTMS

Our product management team will provide a deep dive into new capabilities and what’s on the roadmap for Vault Payments.

Ryan Kimble Veeva
Senior Product Manager

Our product management team will provide a deep dive into new capabilities and what’s on the roadmap for Vault CTMS.

Tom Dekker Veeva
VP Product Management, Clinical Operations
Anna Linker Veeva
Product Manager, Clinical Operations
Brian Bialkowski Veeva
Senior Product Manager, Vault Study Startup

Learn about key enhancements for the clinical operations suite of applications including Vault Study Startup, Vault eTMF, Vault CTMS, Vault Payments, and Site Connect. See new features in action and learn how your organization can leverage these capabilities to improve trial performance.

Tom Dekker Veeva
VP Product Management, Clinical Operations
Brian Bialkowski Veeva
Senior Product Manager, Vault Study Startup
Anna Linker Veeva
Product Manager, Clinical Operations

Hear Veeva’s vision and roadmap for Vault QMS.

Nima Shah Veeva
VP Product Management, Vault Quality & Manufacturing
Manaphan Huntrakoon Veeva
Senior Director, Vault Product Management, Quality

Hear Veeva’s vision and roadmap for Vault QualityDocs, Vault Training, and Vault Station Manager.

Nima Shah Veeva
VP Product Management, Vault Quality & Manufacturing
Joby George Veeva
Principal Product Manager
Gerome Yabut Veeva
Associate Product Manager

Automate the recurrence check of a Quality Event (Deviation, Complaint) for more effective and efficient quality management.

Manaphan Huntrakoon Veeva
Senior Director, Vault Product Management, Quality

See how Audit Management in Vault QMS will enable proactive quality management and increase compliance.

Manaphan Huntrakoon Veeva
Senior Director, Vault Product Management, Quality

See how the latest features like On-the-Job Training in Vault Training increase learners’ competencies.

Joby George Veeva
Principal Product Manager
Erin Hough Veeva
Senior Product Manager

See how enhanced Document Periodic Review in Vault QualityDocs enables greater automation and simplifies reporting and tracking.

Gerome Yabut Veeva
Associate Product Manager

Ensure the right content is always available for the right station on the manufacturing floor with Vault Station Manager, a modern, easy-to-use mobile application.

Gerome Yabut Veeva
Associate Product Manager

See how Vault QualityDocs simplifies and securely manages GxP documents across their entire life cycle – from creation through review and approval, and beyond.

Ruben Gottardi Veeva
Senior Solutions Consultant

Watch how Vault Quality Suite brings together quality content, processes, and training applications on a single platform to automate and harmonize business processes globally.

Matt Kopecky Veeva
Manager, Solutions Consulting, Vault Quality

Easily manage all your quality processes like CAPA, Deviation, Lab Investigation, Audits, Quality Risk, and more in one place with Vault QMS.

Tieme Stoutjesdijk Veeva
Solution Consulting Manager, Quality/Dev Cloud

Ensure job readiness and compliance by creating and managing role-based training requirements in one place with Vault Training.

Kyle Boelter Veeva
Sr. Solutions Consultant

Learn how quality teams can easily manage lab investigations along with other quality processes to drive continuous improvements.

Danielle Pund Veeva
Director, Vault Quality
Jason Boyd Veeva
Senior Director, Vault LIMS
Steven St. Germain Veeva
Solutions Consultant

Learn how Vault QMS helps companies efficiently identify, assess, and mitigate strategic and operational risks for continuous quality improvement.

Chris Boschen Veeva
Senior Product Manager, Vault Quality

See how a process-centric quality design dramatically simplifies and accelerates document navigation and access.

Anastasia Wengrowski Veeva
Director, Vault Quality
Glen DeGuzman Veeva
Solutions Consultant

Watch how Veeva LearnGxP enables life sciences companies to maximize the use of eLearning content libraries.

Graham O’Keeffe Veeva LearnGxP
General Manager
Steven St. Germain Veeva
Solutions Consultant

See how Vault QMS enables seamless and efficient collaboration with partners on external audit findings, increasing visibility and compliance.

Anastasia Wengrowski Veeva
Director, Vault Quality
Shanul Srivastava Veeva
Solutions Consultant, Vault Quality

Ensure functional job readiness and compliance by capturing on-the-job training evaluation as part of a curriculum with Vault Training.

Kent Malmros Veeva
Senior Director, Vault Training
Kyle Boelter Veeva
Sr. Solutions Consultant

Get an overview of the new functionality on our Vault RIM roadmap. We’ll explore how we’re enhancing our IDMP capabilities, deploying Active Dossier and global content plans, streamlining submission and regulatory objective creation, and improving publishing with support for new formats, better linking functionality, and paper submissions.

Eldar Curovic Veeva
Vice President, Product Management, Vault RIM
Kelly Finlan-Dansbury Veeva
Product Manager, Vault Registrations
Rolando Sa Veeva
Director, Product Management, Vault RIM
Cindy Ling Veeva
Product Manager, Vault RIM Submissions
Rich Merrick Veeva
Director, Product Management, Vault RIM
Nicolas Tasse-Guillen Veeva
Principal Product Manager, Vault RIM – MedTech
Sara Carper Veeva
Product Manager, Vault Registrations
Vera Lvovich Veeva
Senior Product Manager, Vault RIM Submissions Archive

Learn how continuous publishing works for non-eCTD submissions. We’ll review how to leverage additional submission content plan templates and reuse content plans for publishing CTAs to new countries.

Ben Rocus Veeva
Solution Consultant

See how Vault Registrations can help you manage product registration data in multiple regions and improve efficiencies throughout your process.

Connor George Veeva
Solution Consultant

See how submission content plans help users project manage all aspects of a submission including deliverable owners and due dates.

Jonathan Benzimra Veeva
Solution Consultant

See how active dossier helps users maintain a list of current documents for a given product and market.

Ann-Marie Gardner Veeva
Principal Solution Consultant

Learn how Vault Safety is re-imagining ‘case compare,’ visually making it easy to filter and analyze highlighted changes, as well as improving follow ups for more efficient case processing.

Eric Woolven Veeva
Product Manager, Vault Safety
Asi Roll Veeva
Director Product Management, Vault Safety

Get an overview of Vault Signal and see how a unified safety solution will improve signal detection from identification through risk mitigation.

Sandra Komadinic Veeva
Senior Product Manager

Hear key highlights of the Vault Safety Suite to improve support of global pharmacovigilance and AI driven enhancements for greater automation and efficiency in case processing and intake. Get a preview of ‘case compare’ and learn how we’re streamlining processes from intake to signal detection and risk management.

Marius Mortensen Veeva
VP Product Management, Vault Safety

3:00 to 3:25 pm
See how to easily manage PVAs and improve alignment between sponsors and external parties with Vault SafetyDocs. We’ll demonstrate managing PVA lifecycles, roles and responsibilities, and sharing content with the PSMF to ensure a single source of truth for safety content.

Scott Immel Veeva
Principal, Vault Safety Solution Consulting

Join our interactive demonstration on case processing, managing adverse events, and gaining real-time oversight with Vault Safety. Make more informed decisions, improve compliance, and see how AI can automate case intake and support case processing.

Colleen Goodman Veeva
Senior Solution Consultant, Vault Safety

Join our interactive demonstration on case processing, managing adverse events, and gaining real-time oversight with Vault Safety. Make more informed decisions, improve compliance, and see how AI can automate case intake and support case processing.

Colleen Goodman Veeva
Senior Solution Consultant, Vault Safety

Get an interactive demonstration on leveraging Vault Safety reporting and dashboards to provide greater sponsor and CRO transparency for oversight and better partner alignment.

Scott Immel Veeva
Principal, Vault Safety Solution Consulting

See how Vault Safety can accelerate aggregate reporting from generating required tabulations and listings to supporting end-to-end authoring, review, and approval.

Colleen Goodman Veeva
Senior Solution Consultant, Vault Safety

Join our interactive demonstration on setting up a PSMF structure in Vault SafetyDocs that supports core and local requirements, while providing oversight of each PSMF. We’ll show tracking of periodic reviews, collaborative updates, and how to automatically bring together content into a single PDF file for review and approval by the LPPV.

Scott Immel Veeva
Principal, Vault Safety Solution Consulting

Join us as we explore what’s new with Vault Platform and how your organization can leverage upcoming capabilities. We’ll also look ahead at scalability, uptime, release windows, Vault Mobile native app, and Google Drive integration.

Andy Han Veeva
VP Product Management, Vault Platform & Technology
John Tanner Veeva
Senior Product Manager

See how the Vault Clinical Operations to RIM Connection drives more efficient collaboration by linking product, study, and site data along with investigator CVs, 1572s, protocols, and investigator brochures.

Jeff Steward Veeva
Manager, Solution Consulting, Vault RIM & Vault Safety

See how the Vault Quality to RIM Connection improves change control and variation management by shortening the timeline from event creation to implementation.

Seth Taylor Veeva
Director, Vault Connections

See how the Veeva Development Cloud streamlines end-to-end business processes by connecting clinical, quality, regulatory, and safety.

Jeff Steward Veeva
Manager, Solution Consulting, Vault RIM & Vault Safety

Learn how Vault CDMS will change, and why, over the next 12 months, from meeting customer requests, to expanding Vault Connections, and launching Veeva CDB.

Drew Garty Veeva
Chief Technology Officer, Vault CDMS
Richard Young Veeva
VP, Strategy, Vault CDMS

Watch how Process Navigator enhancements simplify and accelerate document navigation and access.

Gerome Yabut Veeva
Associate Product Manager

See how you can easily manage the entire complaint lifecycle, including triaging, investigating, and CAPA in Vault QMS.

David Mishler Veeva
Director, Vault Quality
Matt Kopecky Veeva
Manager, Solutions Consulting, Vault Quality

October 14, 2021
One day to learn from the best in life sciences

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