Agenda
Tuesday 7 June
Wednesday 8 June
The environment in which we operate is more unpredictable than ever, and the imperative to accelerate the full product lifecycle has never been stronger. It’s time to break the barriers of the past that inhibit the future. But which roles will our teams, our technology, and our ability to collaborate play in that process? And which innovations will drive a paradigm shift?
Steve Guise (CIO, Roche Pharmaceuticals Division) joins Chris Moore, Jim Reilly, Avril England, and Steve Harper of Veeva, as we come together in Zurich to answer these questions.

CIO

President, Veeva Europe

VP, Development Cloud Strategy

General Manager, Vault

SVP Product, Sponsors, Sites and Patients
EU CTR went into effect on 31 January, 2022 to increase the efficiency and transparency of clinical trials in Europe. Join this discussion to hear about your peers’ first CTR application and CTIS experiences, as well as business process changes and Vault application adjustments being made to comply with the regulation.
Meet Veeva’s strategy lead for Veeva RTSM, Natalie Townsend, to talk about our newest product for clinical data. Ask questions about Veeva’s randomization and trial supply management capabilities and learn what Veeva is doing to improve the connections between RTSM, EDC and other applications.
The EU GMP and FDA’s cGMP guidelines require the Annual Product Quality Review (APQR) to verify the consistency and appropriateness of existing processes while identifying product and process improvement opportunities. These different reviews could put an additional burden on an already challenging data collection activity. Join this discussion to learn Veeva’s approach to APQR automation and explore future enhancements.
Modern-day learners prefer interactive training consumed in small chunks, yet reusing the initial qualification training materials for refresher training lowers engagement and learning effectiveness. Join this discussion to learn techniques to bring together training technology and content to improve refresher training.
We’ll talk about how Vault Publishing has impacted current submission processes and how associated roles will change.
Discover how GSK is accelerating trials by modernizing their clinical ecosystem and implementing the Vault Clinical Suite. Learn how their platform approach addresses a wide range of business problems and of their successes and learnings with Vault CDMS.

VP Digital, Data, and Analytics

Business Lead, Vault CDMS Project

VP, Strategy, Vault CDMS
Transformation at scale is complex and requires a holistic approach. Hear Roche’s journey to accelerate drug development with greater clinical oversight, improved end-to-end regulatory processes, and efficient quality and content management. Connecting workflows across functional areas and providing a single source of truth with Veeva Development Cloud, Roche can drive better business execution. Join this session to see their vision, lessons learned, and the benefits of seamless information flow between clinical, regulatory, and quality.

Cross Veeva Strategy Lead
Companies are reevaluating their approach to pharmacovigilance to better scale and support a global operating model. Safety is increasingly complex with distributed data ownership and multi stakeholder environment. Hear LEO Pharma’s safety vision, technology’s changing role, and how Veeva can help develop a foundation for transformation.

VP, Global Safety

Senior Director, Vault Safety Strategy EU
Discover how GSK delivered significant regulatory transformation throughout their global organization with Vault RIM. They will cover their goals, how Veeva Vault RIM changed their approach, scaling the solution across the company, and the value they delivered as a result.

Head of Regulatory Systems & Processes
Novo Nordisk shares the life sciences trends shaping their quality system landscape. Hear how they are leveraging advanced technology to meet their changing business priorities and scale for the future.

Corporate VP, Quality Systems

VP, Vault Quality
Digital transformation of clinical trials is accelerating as the industry adopts decentralized trial (DCT) methods that better connect sponsors, sites, and patients. To reap the full benefits of DCTs, core trial processes must be digitized for seamless execution and data flow across stakeholders. Join our panel to hear how Idorsia, Novo Nordisk, and TFS HealthScience have implemented Vault Clinical applications to lay the foundation for digital trials.

EVP and CIO

CDO Process & System Lead

Product Owner, CTMS transformation

VP, Vault Clinical
GSK eliminated organizational silos and shifted to an agile operating model with a Vault center of excellence (COE). Working with functional areas, the COE efficiently manages new releases and how Vaults work together – getting greater alignment internally and with Veeva. Hear how GSK is leveraging Vault, key lessons learned building a COE, and plans to maximize the Development Cloud investment.

R&D Tech Senior Product Director – Clinical Development Platform

Head Veeva CoE
Hear what is keeping heads of safety, EU QPPVs, and corporate compliance officers up at night. Sharing experiences with global pharma companies and regulators, we’ll discuss challenges on evolving PV regulations, oversight, overlapping GxP requirements, managing diverse portfolios, and inspection trends. Hear how GDPR, increasing data requirements, and cloud technology are driving new approaches to global safety database, safety data exchange, and content management to improve oversight and compliance.

Counsel

Senior Director, Vault Safety Strategy EU
Mundipharma recently completed its implementation of Vault RIM. They will share some of the benefits they have discovered through simplifying and streamlining their regulatory processes, as well as the best practices they learned on the way.

Head of Regulatory Affairs Systems and Analytics
Gain insights from GSK’s quality modernization journey to increase agility and compliance. Learn from their experience and approach to implementation and data migration as they moved from a legacy on-premises system to a modern cloud platform across the enterprise.

Veeva QMS Business Manager

Senior Manager, Product Owner Veeva Quality , Audit & Risk
Join our services team to discuss Veeva’s enablement program for Vault EDC. Get your questions answered about validation, training, and certification programs. Plus, talk with fellow customers about release management and adopting new features.
We’ll discuss ways to migrate data and integrate with Vault, sharing best practices and customer use cases.
Come share your challenges managing PSMFs and hear ways you can leverage Vault SafetyDocs to easily meet regional requirements, gain oversight, and improve inspection readiness.
The Veeva Digital Trials platform connects sponsors, CROs, sites, and patients for seamless process execution and data flow across all stakeholders. This roadmap session will detail Veeva’s plans to streamline study execution for sites and sponsors, making trial participation easier for patients.

SVP Product, Sponsors, Sites and Patients

VP of Strategy, MyVeeva for Patients
Get a demo of External Notifications, APQR 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
Join us for lunch, networking, and get a sneak peek at what is upcoming in Vault RIM Registrations, such as IDMP Viewer and Label Process Automation.

VP, Product Management (RIM)
Biopharmaceutical companies argenx and Alvotech and CRO KCR share how they successfully drive inspection readiness. Learn how to select an appropriate eTMF operating model, define new processes, and enhance oversight and collaboration with study partners.

CTO

Lead Clinical Operations Processes and Systems

VP Head of Clinical Operations

Sr. Director Clinical Operations, Vault
With an effective governance model, companies can efficiently evaluate and validate new capabilities from each release across multiple Vault applications. We’ll discuss different governance models and release management best practices including risk-based approach to validation.

Senior Director, Team Leader Clinical & Quality Systems

Senior Director, Business Systems R&D

Global EAM Director

Director, R&D & Quality Customer Success
Syneos recently led a successful CDMS adoption program and reduced EDC setup times by up to 50%. Learn from their experience using Agile Design build techniques, including advice on standards and form designs. Plus, gain early insights into aggregating and cleaning multiple data sources with Veeva CDB.

Senior Director, Clinical Data Management

Senior Director, Strategy, Vault CDMS at Veeva Systems
Outsourcing operations are incorporating technology to improve scalability and quality and easily meet local regulatory requirements. Service providers share their PV strategy, ways of leveraging Vault Safety for greater automation and control, and approaches to support increasing industry demand.

Head of Global Pharmacovigilance

VP, Global Drug Safety

Associate Director, Head of PV Operations

Senior Director, Vault Safety Strategy EU
Jazz Pharmaceuticals will share how they leveraged Vault Quality following a major acquisition, to accelerate growth and drive innovation. Learn from their approach to integrating two quality systems and how they have matured their platform approach to enable growth and scalability.

Associate Director, IS Business Partner – Corporate Quality
Our panelists discuss how they are using IDMP to drive greater operational excellence and efficiency across their businesses. Learn about the challenges, solutions, and benefits they’ve seen from the new standards and how they have approached the change process within their respective organizations.

Senior Director, Head of Regulatory Compliance & Regulatory Information Management – GRA Operations

Head, Regulatory Data Office

Head of Global Regulatory Affairs

VP Regulatory Strategy, Europe
Meet speakers from the earlier panel, Driving Inspection Readiness for Outsourced Studies, and members of Veeva’s strategy team to continue the discussion about inspection readiness and sponsor-CRO collaboration. Learn how to select, evolve, and optimize your eTMF operating model.
Machine learning algorithms present an attractive technology for improving the efficiency of many resource-intensive data management processes. Join speakers from GSK and CluePoints as they discuss the results of prototype deep learning algorithms trained on historical trial data to automate and significantly improve the processes for medical coding and detecting data anomalies.
Join peers to discuss pharmacovigilance reporting challenges and hear ways a unified solution, incorporating gateways and content management, streamlines the process.
The EU GMP and FDA’s cGMP guidelines require the Annual Product Quality Review (APQR) to verify the consistency and appropriateness of existing processes while identifying product and process improvement opportunities. These different reviews could put an additional burden on an already challenging data collection activity. Join this discussion to learn Veeva’s approach to APQR automation and explore future enhancements.
Modern-day learners prefer interactive training consumed in small chunks, yet reusing the initial qualification training materials for refresher training lowers engagement and learning effectiveness. Join this discussion to learn techniques to bring together training technology and content to improve refresher training.
We’ll take a look at a concrete plan for IDMP preparation and share experiences in an open forum.
Hear our vision and roadmap for the Vault Clinical Operations Suite. We’ll share our plans to help clinical teams streamline processes with email ingestion, comply with EU CTR regulations, proactively manage study risks, enable efficient data exchange between sponsors and CROs, and more.

VP Product Management, Vault Clinical Operations
Join us as we explore what’s new with Vault Platform and how your organization can leverage upcoming capabilities. We’ll look ahead at scalability, improving release and sandbox management, workflow and reporting enhancements, and simplifying API for easier integrations.

VP Product Management, Vault Platform
Hear about upcoming innovations and enhancements in Vault EDC and CDB, including orchestration and automation within study builds, an innovative user experience for lesion identification and RECIST assessments for oncology trials, and automated data quality checks. We’ll wrap up with a peek into Veeva’s strategy and roadmap for digital trials.

Senior VP Products, Vault CDMS
Hear from the Product team about the Vault Safety Suite roadmap and key areas we will be focusing on. We will highlight our approach to touchless case processing for EMA and MHRA. We’ll also share how we’re reducing the burden to stay current with regulations such as EDQM.

VP Product Management, Vault Safety
Learn about Veeva’s vision for Vault Quality Suite and upcoming new products and features. Also, get a demo of recent enhancements in Vault QualityDocs, Vault Station Manager, and Vault Training applications.

VP, Product Management, Vault Quality
This session will cover forthcoming features for Vault RIM Submissions, Submissions Archive, and Submissions Publishing and the meaningful improvements that they will deliver for submissions processes. Topics will include the new Submissions Wizard, the Table of Contents Editor, and a preview of the New Submissions Archive Viewer.

VP, Product Management (RIM)
Join our strategy and product leaders for a brief recap of the day’s sessions and get your final questions answered.

VP, Vault Clinical

VP Product Management, Vault 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.

VP, Strategy, Vault CDMS

Senior VP Products, Vault CDMS
Join us for a brief recap of the day’s sessions and get a final chance to ask questions.

VP Strategy R&D

VP Product Management, Vault Platform
Join our strategy and product leaders for a brief recap of the day’s sessions and get a final chance to ask questions.

Senior Director, Vault Safety Strategy EU

VP Product Management, Vault Safety
Join quality leaders across strategy, product, and services for a brief recap of the day’s sessions and Q&A.

Senior Director Strategy Vault Quality

Director, Quality Strategy Europe

Strategy Director, Vault Quality & Manufacturing
Join us for a brief recap of the day’s sessions and get a final chance to ask questions.

VP Regulatory Strategy, Europe