Come together. Breaking barriers
to advance life sciences.

Zurich • 8 June, 2022
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Agenda

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Tuesday 7 June


17:00 CEST
16:00 BST
Registration Opens

19:00 CEST
18:00 BST
Welcome Reception

Wednesday 8 June


Connect
08:00 CEST
07:00 BST
Registration, Networking

Opening Keynote
09:30 CEST
08:30 BST

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.

Steve Guise Roche
CIO
Chris Moore Veeva
President, Veeva Europe
James Reilly Veeva
VP, Development Cloud Strategy
Avril England Veeva
General Manager, Vault
Steve Harper Veeva
SVP Product, Sponsors, Sites and Patients

Connect
10:20 CEST
09:20 BST
Networking and Refreshments

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.


Sessions
11:00 CEST
10:00 BST

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.

Michel Rider GSK
VP Digital, Data, and Analytics
Leonie Christianson GSK
Business Lead, Vault CDMS Project
Richard Young Veeva
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.

Jorge Carmona Toscano Roche
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.

Pilar Carrero LEO Pharma A/S
VP, Global Safety
Sharmila Sabaratnam Veeva
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.

Lorna Bruce GSK
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.

Poul Henning Poulsen Novo Nordisk
Corporate VP, Quality Systems
Michael Jovanis Veeva
VP, Vault Quality

Sessions
12:00 CEST
11:00 BST

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.

Young Shon TFS HealthScience
EVP and CIO
Sergei Ganchev Idorsia Pharmaceuticals Ltd
CDO Process & System Lead
Suah Choi NovoNordisk
Product Owner, CTMS transformation
Hugo Cervantes Veeva
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.

Matt Lamming GSK
R&D Tech Senior Product Director – Clinical Development Platform
John Reilly GSK
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.

Olivier Goarnisson Sidley Austin LLP
Counsel
Sharmila Sabaratnam Veeva
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.

Helen Donnelly Mundipharma
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.

Gillian Wilson GSK
Veeva QMS Business Manager
Amanda Piper GSK
Senior Manager, Product Owner Veeva Quality , Audit & Risk

Connect
12:45 CEST
11:45 BST
Networking, Lunch, and Sessions

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.

Steve Harper Veeva
SVP Product, Sponsors, Sites and Patients
Tim Davis Veeva
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.

Nima Shah Veeva
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.

Eldar Curovic Veeva
VP, Product Management (RIM)

Sessions
14:15 CEST
13:15 BST

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.

Doug Bain KCR
CTO
Melissa De Swaef argenx
Lead Clinical Operations Processes and Systems
Ruth Ruffieux Alvotech
VP Head of Clinical Operations
Pinar Bérénice Bénet Veeva
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.

Simone Mechler Idorsia Pharmaceuticals Ltd.
Senior Director, Team Leader Clinical & Quality Systems
Salman Saif argenx
Senior Director, Business Systems R&D
Akos Szottfried Veeva
Global EAM Director
Neelam Sidhu Veeva
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.

Trevor Griffiths Syneos Health
Senior Director, Clinical Data Management
Sid Mohamoodally Veeva
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.

Martijn Van de Leur Biomapas
Head of Global Pharmacovigilance
Kieran O’Donnell Arriello
VP, Global Drug Safety
Antti Miikki TFS HealthScience
Associate Director, Head of PV Operations
Sharmila Sabaratnam Veeva
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.

Tracy Kemp Jazz Pharmaceuticals
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.

Andrea Herrmann Merck KGaA
Senior Director, Head of Regulatory Compliance & Regulatory Information Management – GRA Operations
Emma Luke AstraZeneca
Head, Regulatory Data Office
Olivia Maurel Sobi
Head of Global Regulatory Affairs
Paul Attridge Veeva
VP Regulatory Strategy, Europe

Connect
15:00 CEST
14:00 BST
Networking and Refreshments

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.


Sessions
15:45 CEST
14:45 BST

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.

Tom Dekker Veeva
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.

Andy Han Veeva
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.

Raymond Letulle Veeva
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.

Marius Mortensen Veeva
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.

Nima Shah Veeva
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.

Eldar Curovic Veeva
VP, Product Management (RIM)

Zone Close
16:45 CEST
15:45 BST

Join our strategy and product leaders for a brief recap of the day’s sessions and get your final questions answered.

Hugo Cervantes Veeva
VP, Vault Clinical
Tom Dekker Veeva
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.

Richard Young Veeva
VP, Strategy, Vault CDMS
Raymond Letulle Veeva
Senior VP Products, Vault CDMS

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

Nathan Chestney-Stagg Veeva
VP Strategy R&D
Andy Han Veeva
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.

Sharmila Sabaratnam Veeva
Senior Director, Vault Safety Strategy EU
Marius Mortensen Veeva
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.

Robert Gaertner Veeva
Senior Director Strategy Vault Quality
Robert Weisz Veeva
Director, Quality Strategy Europe
Sofía Lange Veeva
Strategy Director, Vault Quality & Manufacturing

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

Paul Attridge Veeva
VP Regulatory Strategy, Europe

18:15 CEST
17:15 BST
Evening Dinner at Giardino Verde