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
Steve Guise
Roche
CIO
Come Together. Breaking Barriers to Advance Life Sciences.
9:30 CEST / 8:30 BST
Chris Moore
Veeva
President, Veeva Europe
Come Together. Breaking Barriers to Advance Life Sciences.
9:30 CEST / 8:30 BST
James Reilly
Veeva
VP, Development Cloud Strategy
Come Together. Breaking Barriers to Advance Life Sciences.
9:30 CEST / 8:30 BST
Avril England
Veeva
General Manager, Vault
Come Together. Breaking Barriers to Advance Life Sciences.
9:30 CEST / 8:30 BST
Steve Harper
Veeva
SVP Product, Sponsors, Sites and Patients
Steve is responsible for the success of Veeva’s Digital Trials product strategy – to ensure that our software is enabling a digital, connected future for Sponsors, Sites and Patients.
Come Together. Breaking Barriers to Advance Life Sciences.
9:30 CEST / 8:30 BST
Roadmap: Digital Trials Platform (starts at 13:30 CEST)
13:30 CEST / 12:30 BST
Michel Rider
GSK
VP Digital, Data, and Analytics
GSK: Scaling the Vault Clinical Platform to Accelerate R&D
11:00 CEST / 10:00 BST
Leonie Christianson
GSK
Business Lead, Vault CDMS Project
GSK: Scaling the Vault Clinical Platform to Accelerate R&D
11:00 CEST / 10:00 BST
Richard Young
Veeva
VP, Strategy, Vault CDMS
GSK: Scaling the Vault Clinical Platform to Accelerate R&D
11:00 CEST / 10:00 BST
Clinical Data: Closing Session and Q&A
16:45 CEST / 15:45 BST
Jorge Carmona Toscano
Roche
Cross Veeva Strategy Lead
Roche: Accelerating Delivery of Patient Value with Veeva’s R&D Ecosystem
11:00 CEST / 10:00 BST
Pilar Carrero
LEO Pharma A/S
VP, Global Safety
LEO Pharma: Developing a Foundation to Transform Pharmacovigilance
11:00 CEST / 10:00 BST
Sharmila Sabaratnam
Veeva
Senior Director, Vault Safety Strategy EU
LEO Pharma: Developing a Foundation to Transform Pharmacovigilance
11:00 CEST / 10:00 BST
Getting Ahead of Regulatory and Inspection Trends
12:00 CEST / 11:00 BST
Customer Panel: Building PV Outsourcing Operations for Scalability and Quality
14:15 CEST / 13:15 BST
Safety: Closing Session and Q&A
16:45 CEST / 15:45 BST
Lorna Bruce
GSK
Head of Regulatory Systems & Processes
GSK: The Path to Regulatory Transformation
11:00 CEST / 10:00 BST
Poul Henning Poulsen
Novo Nordisk
Corporate VP, Quality Systems
Novo Nordisk: Trends and Opportunities in Quality Management
11:00 CEST / 10:00 BST
Michael Jovanis
Veeva
VP, Vault Quality
Novo Nordisk: Trends and Opportunities in Quality Management
11:00 CEST / 10:00 BST
Young Shon
TFS HealthScience
EVP and CIO
Customer Panel: Laying the Foundation for Digital Clinical Trials
12:00 CEST / 11:00 BST
Sergei Ganchev
Idorsia Pharmaceuticals Ltd
CDO Process & System Lead
Customer Panel: Laying the Foundation for Digital Clinical Trials
12:00 CEST / 11:00 BST
Suah Choi
NovoNordisk
Product Owner, CTMS transformation
Customer Panel: Laying the Foundation for Digital Clinical Trials
12:00 CEST / 11:00 BST
Hugo Cervantes
Veeva
VP, Vault Clinical
Over the last 20 years Hugo has focused on increasing Clinical Development productivity through technology adoption and operating model improvements. Hugo’s career has spanned technology implementation at Phase Forward, management consulting at Accenture and Deloitte and corporate strategy at Quintiles, prior to joining Veeva in 2016.
Customer Panel: Laying the Foundation for Digital Clinical Trials
12:00 CEST / 11:00 BST
Clinical Operations: Closing Session and Q&A
16:45 CEST / 15:45 BST
Matt Lamming
GSK
R&D Tech Senior Product Director – Clinical Development Platform
GSK: Operating Model for Agility and Maximizing Development Cloud Value
12:00 CEST / 11:00 BST
John Reilly
GSK
Head Veeva CoE
GSK: Operating Model for Agility and Maximizing Development Cloud Value
12:00 CEST / 11:00 BST
Olivier Goarnisson
Sidley Austin LLP
Counsel
Getting Ahead of Regulatory and Inspection Trends
12:00 CEST / 11:00 BST
Sharmila Sabaratnam
Veeva
Senior Director, Vault Safety Strategy EU
LEO Pharma: Developing a Foundation to Transform Pharmacovigilance
11:00 CEST / 10:00 BST
Getting Ahead of Regulatory and Inspection Trends
12:00 CEST / 11:00 BST
Customer Panel: Building PV Outsourcing Operations for Scalability and Quality
14:15 CEST / 13:15 BST
Safety: Closing Session and Q&A
16:45 CEST / 15:45 BST
Helen Donnelly
Mundipharma
Head of Regulatory Affairs Systems and Analytics
Mundipharma: Delivering Regulatory Value for Fast-Growing Pharmas through Veeva Vault RIM
12:00 CEST / 11:00 BST
Gillian Wilson
GSK
Veeva QMS Business Manager
GSK: Modernizing Global Quality Management
12:00 CEST / 11:00 BST
Amanda Piper
GSK
Senior Manager, Product Owner Veeva Quality , Audit & Risk
GSK: Modernizing Global Quality Management
12:00 CEST / 11:00 BST
Steve Harper
Veeva
SVP Product, Sponsors, Sites and Patients
Steve is responsible for the success of Veeva’s Digital Trials product strategy – to ensure that our software is enabling a digital, connected future for Sponsors, Sites and Patients.
Come Together. Breaking Barriers to Advance Life Sciences.
9:30 CEST / 8:30 BST
Roadmap: Digital Trials Platform (starts at 13:30 CEST)
13:30 CEST / 12:30 BST
Tim Davis
Veeva
VP of Strategy, MyVeeva for Patients
Most notably he was the Founder & CEO of Exco InTouch Ltd, a patient engagement and eCOA mobile application provider, which he scaled through to a successful trade sale and exit in 2016.
Tim is currently Vice President of Strategy at Veeva Systems. His primary focus is on the strategic development of MyVeeva for Patients, a patient-facing application suite.
Roadmap: Digital Trials Platform (starts at 13:30 CEST)
13:30 CEST / 12:30 BST
Nima Shah
Veeva
VP, Product Management, Vault Quality
Roadmap: Vault QMS (starts at 13:30 CEST)
13:30 CEST / 12:30 BST
Roadmap: Vault Quality Suite
15:45 CEST / 14:45 BST
Eldar Curovic
Veeva
VP, Product Management (RIM)
Roadmap: Vault Registrations (starts at 13:30 CEST)
13:30 CEST / 12:30 BST
Roadmap: Submissions, Submissions Archive, and Submissions Publishing
15:45 CEST / 14:45 BST
Doug Bain
KCR
CTO
Customer Panel: Driving Inspection Readiness for Outsourced Studies
14:15 CEST / 13:15 BST
Melissa De Swaef
argenx
Lead Clinical Operations Processes and Systems
Customer Panel: Driving Inspection Readiness for Outsourced Studies
14:15 CEST / 13:15 BST
Ruth Ruffieux
Alvotech
VP Head of Clinical Operations
Customer Panel: Driving Inspection Readiness for Outsourced Studies
14:15 CEST / 13:15 BST
Pinar Bérénice Bénet
Veeva
Sr. Director Clinical Operations, Vault
Her experience has been built on supporting life science Sponsors in implementing patient-centric and site solutions as well as designing pan-European product launch strategies across multiple therapeutic areas including oncology, Immuno-oncology, cardiovascular, gene therapies, diabetes and vaccines.
At Veeva, Pinar facilitates the digital transformation and decision making of the Sponsors and CROs across Europe.
Customer Panel: Driving Inspection Readiness for Outsourced Studies
14:15 CEST / 13:15 BST
Simone Mechler
Idorsia Pharmaceuticals Ltd.
Senior Director, Team Leader Clinical & Quality Systems
Customer Panel: Multi-Vault Governance and Release Management
14:15 CEST / 13:15 BST
Salman Saif
argenx
Senior Director, Business Systems R&D
Customer Panel: Multi-Vault Governance and Release Management
14:15 CEST / 13:15 BST
Akos Szottfried
Veeva
Global EAM Director
Since joining Veeva in 2014, Akos has been working in multiple roles including implementations, managed services and various leadership positions.
Customer Panel: Multi-Vault Governance and Release Management
14:15 CEST / 13:15 BST
Neelam Sidhu
Veeva
Director, R&D & Quality Customer Success
Customer Panel: Multi-Vault Governance and Release Management
14:15 CEST / 13:15 BST
Trevor Griffiths
Syneos Health
Senior Director, Clinical Data Management
Syneos: Maximizing Cycle Time Savings with Vault CDMS
14:15 CEST / 13:15 BST
Sid Mohamoodally
Veeva
Senior Director, Strategy, Vault CDMS at Veeva Systems
Syneos: Maximizing Cycle Time Savings with Vault CDMS
14:15 CEST / 13:15 BST
Martijn Van de Leur
Biomapas
Head of Global Pharmacovigilance
Customer Panel: Building PV Outsourcing Operations for Scalability and Quality
14:15 CEST / 13:15 BST
Kieran O’Donnell
Arriello
VP, Global Drug Safety
Customer Panel: Building PV Outsourcing Operations for Scalability and Quality
14:15 CEST / 13:15 BST
Antti Miikki
TFS HealthScience
Associate Director, Head of PV Operations
Customer Panel: Building PV Outsourcing Operations for Scalability and Quality
14:15 CEST / 13:15 BST
Sharmila Sabaratnam
Veeva
Senior Director, Vault Safety Strategy EU
LEO Pharma: Developing a Foundation to Transform Pharmacovigilance
11:00 CEST / 10:00 BST
Getting Ahead of Regulatory and Inspection Trends
12:00 CEST / 11:00 BST
Customer Panel: Building PV Outsourcing Operations for Scalability and Quality
14:15 CEST / 13:15 BST
Safety: Closing Session and Q&A
16:45 CEST / 15:45 BST
Tracy Kemp
Jazz Pharmaceuticals
Associate Director, IS Business Partner – Corporate Quality
Jazz Pharmaceuticals: Leveraging Vault Quality’s Scalability for Growth and Innovation
14:15 CEST / 13:15 BST
Andrea Herrmann
Merck KGaA
Senior Director, Head of Regulatory Compliance & Regulatory Information Management – GRA Operations
Customer Panel: Using IDMP to Advance Business Transformation
14:15 CEST / 13:15 BST
Emma Luke
AstraZeneca
Head, Regulatory Data Office
Customer Panel: Using IDMP to Advance Business Transformation
14:15 CEST / 13:15 BST
Olivia Maurel
Sobi
Head of Global Regulatory Affairs
Customer Panel: Using IDMP to Advance Business Transformation
14:15 CEST / 13:15 BST
Paul Attridge
Veeva
VP Regulatory Strategy, Europe
Customer Panel: Using IDMP to Advance Business Transformation
14:15 CEST / 13:15 BST
Regulatory: Closing Session and Q&A
16:45 CEST / 15:45 BST
Tom Dekker
Veeva
VP Product Management, Vault Clinical Operations
Roadmap: Vault Clinical Operations Suite
15:45 CEST / 14:45 BST
Clinical Operations: Closing Session and Q&A
16:45 CEST / 15:45 BST
Andy Han
Veeva
VP Product Management, Vault Platform
Roadmap: Vault Platform
15:45 CEST / 14:45 BST
Development Cloud: Closing Session and Q&A
16:45 CEST / 15:45 BST
Raymond Letulle
Veeva
Senior VP Products, Vault CDMS
Raymond brings over 25 years of experience to Veeva delivering enterprise and cloud-based software. He comes to Veeva from Medrio, Inc., where he spent the past several years as chief operating officer and head of product, owning the product roadmap and delivery of their cloud-based eClinical EDC and eSource products. Through his many years of experience, Raymond has developing firsthand knowledge of the best practices and challenges faced by product, engineering, marketing, and sales in delivering technology products to market.
Raymond holds a bachelor of arts degree in economics from Rice University.
Roadmap: Vault CDMS
15:45 CEST / 14:45 BST
Clinical Data: Closing Session and Q&A
16:45 CEST / 15:45 BST
Marius Mortensen
Veeva
VP Product Management, Vault Safety
Roadmap: Vault Safety Suite
15:45 CEST / 14:45 BST
Safety: Closing Session and Q&A
16:45 CEST / 15:45 BST
Nima Shah
Veeva
VP, Product Management, Vault Quality
Roadmap: Vault QMS (starts at 13:30 CEST)
13:30 CEST / 12:30 BST
Roadmap: Vault Quality Suite
15:45 CEST / 14:45 BST
Eldar Curovic
Veeva
VP, Product Management (RIM)
Roadmap: Vault Registrations (starts at 13:30 CEST)
13:30 CEST / 12:30 BST
Roadmap: Submissions, Submissions Archive, and Submissions Publishing
15:45 CEST / 14:45 BST
Hugo Cervantes
Veeva
VP, Vault Clinical
Over the last 20 years Hugo has focused on increasing Clinical Development productivity through technology adoption and operating model improvements. Hugo’s career has spanned technology implementation at Phase Forward, management consulting at Accenture and Deloitte and corporate strategy at Quintiles, prior to joining Veeva in 2016.
Customer Panel: Laying the Foundation for Digital Clinical Trials
12:00 CEST / 11:00 BST
Clinical Operations: Closing Session and Q&A
16:45 CEST / 15:45 BST
Tom Dekker
Veeva
VP Product Management, Vault Clinical Operations
Roadmap: Vault Clinical Operations Suite
15:45 CEST / 14:45 BST
Clinical Operations: Closing Session and Q&A
16:45 CEST / 15:45 BST
Richard Young
Veeva
VP, Strategy, Vault CDMS
GSK: Scaling the Vault Clinical Platform to Accelerate R&D
11:00 CEST / 10:00 BST
Clinical Data: Closing Session and Q&A
16:45 CEST / 15:45 BST
Raymond Letulle
Veeva
Senior VP Products, Vault CDMS
Raymond brings over 25 years of experience to Veeva delivering enterprise and cloud-based software. He comes to Veeva from Medrio, Inc., where he spent the past several years as chief operating officer and head of product, owning the product roadmap and delivery of their cloud-based eClinical EDC and eSource products. Through his many years of experience, Raymond has developing firsthand knowledge of the best practices and challenges faced by product, engineering, marketing, and sales in delivering technology products to market.
Raymond holds a bachelor of arts degree in economics from Rice University.
Roadmap: Vault CDMS
15:45 CEST / 14:45 BST
Clinical Data: Closing Session and Q&A
16:45 CEST / 15:45 BST
Nathan Chestney-Stagg
Veeva
VP Strategy R&D
NCS is a recognised thought leader in the Life Sciences industry with deep experience in Implementing industry leading solutions in the areas of cloud computing, from CRM to Medical to most recently heading up R&D strategy in Europe.
Development Cloud: Closing Session and Q&A
16:45 CEST / 15:45 BST
Andy Han
Veeva
VP Product Management, Vault Platform
Roadmap: Vault Platform
15:45 CEST / 14:45 BST
Development Cloud: Closing Session and Q&A
16:45 CEST / 15:45 BST
Sharmila Sabaratnam
Veeva
Senior Director, Vault Safety Strategy EU
LEO Pharma: Developing a Foundation to Transform Pharmacovigilance
11:00 CEST / 10:00 BST
Getting Ahead of Regulatory and Inspection Trends
12:00 CEST / 11:00 BST
Customer Panel: Building PV Outsourcing Operations for Scalability and Quality
14:15 CEST / 13:15 BST
Safety: Closing Session and Q&A
16:45 CEST / 15:45 BST
Marius Mortensen
Veeva
VP Product Management, Vault Safety
Roadmap: Vault Safety Suite
15:45 CEST / 14:45 BST
Safety: Closing Session and Q&A
16:45 CEST / 15:45 BST
Robert Gaertner
Veeva
Senior Director Strategy Vault Quality
Quality: Closing Session and Q&A
16:45 CEST / 15:45 BST
Robert Weisz
Veeva
Director, Quality Strategy Europe
Quality: Closing Session and Q&A
16:45 CEST / 15:45 BST
Sofía Lange
Veeva
Strategy Director, Vault Quality & Manufacturing
Sofía´s background is Biochemist with a major in Biotechnology. Sofía has been working more than 14 years in Pharmaceutical Quality Management & Manufacturing focusing in continuous improvement. Sofia brings a broad successful experience in handling GMP Licenses with MoH across the globe (Argentina, Brazil, Chile, Germany, Russia, Singapore, USA-FDA/DEA) being herself a certified ISO 9001, ISO14000 and IRCA Pharmaceutical GMP Lead Auditor.
Quality: Closing Session and Q&A
16:45 CEST / 15:45 BST
Paul Attridge
Veeva
VP Regulatory Strategy, Europe
Customer Panel: Using IDMP to Advance Business Transformation
14:15 CEST / 13:15 BST
Regulatory: Closing Session and Q&A
16:45 CEST / 15:45 BST
Steve Guise
Roche
CIO
Come Together. Breaking Barriers to Advance Life Sciences.
9:30 CEST / 8:30 BST
Chris Moore
Veeva
President, Veeva Europe
Come Together. Breaking Barriers to Advance Life Sciences.
9:30 CEST / 8:30 BST
James Reilly
Veeva
VP, Development Cloud Strategy
Come Together. Breaking Barriers to Advance Life Sciences.
9:30 CEST / 8:30 BST
Avril England
Veeva
General Manager, Vault
Come Together. Breaking Barriers to Advance Life Sciences.
9:30 CEST / 8:30 BST
Steve Harper
Veeva
SVP Product, Sponsors, Sites and Patients
Steve is responsible for the success of Veeva’s Digital Trials product strategy – to ensure that our software is enabling a digital, connected future for Sponsors, Sites and Patients.
Come Together. Breaking Barriers to Advance Life Sciences.
9:30 CEST / 8:30 BST
Roadmap: Digital Trials Platform (starts at 13:30 CEST)
13:30 CEST / 12:30 BST
Michel Rider
GSK
VP Digital, Data, and Analytics
GSK: Scaling the Vault Clinical Platform to Accelerate R&D
11:00 CEST / 10:00 BST
Leonie Christianson
GSK
Business Lead, Vault CDMS Project
GSK: Scaling the Vault Clinical Platform to Accelerate R&D
11:00 CEST / 10:00 BST
Richard Young
Veeva
VP, Strategy, Vault CDMS
GSK: Scaling the Vault Clinical Platform to Accelerate R&D
11:00 CEST / 10:00 BST
Clinical Data: Closing Session and Q&A
16:45 CEST / 15:45 BST
Simone Mechler
Idorsia Pharmaceuticals Ltd.
Senior Director, Team Leader Clinical & Quality Systems
Customer Panel: Multi-Vault Governance and Release Management
14:15 CEST / 13:15 BST
Salman Saif
argenx
Senior Director, Business Systems R&D
Customer Panel: Multi-Vault Governance and Release Management
14:15 CEST / 13:15 BST
Akos Szottfried
Veeva
Global EAM Director
Since joining Veeva in 2014, Akos has been working in multiple roles including implementations, managed services and various leadership positions.
Customer Panel: Multi-Vault Governance and Release Management
14:15 CEST / 13:15 BST
Neelam Sidhu
Veeva
Director, R&D & Quality Customer Success
Customer Panel: Multi-Vault Governance and Release Management
14:15 CEST / 13:15 BST
Pilar Carrero
LEO Pharma A/S
VP, Global Safety
LEO Pharma: Developing a Foundation to Transform Pharmacovigilance
11:00 CEST / 10:00 BST
Sharmila Sabaratnam
Veeva
Senior Director, Vault Safety Strategy EU
LEO Pharma: Developing a Foundation to Transform Pharmacovigilance
11:00 CEST / 10:00 BST
Getting Ahead of Regulatory and Inspection Trends
12:00 CEST / 11:00 BST
Customer Panel: Building PV Outsourcing Operations for Scalability and Quality
14:15 CEST / 13:15 BST
Safety: Closing Session and Q&A
16:45 CEST / 15:45 BST
Poul Henning Poulsen
Novo Nordisk
Corporate VP, Quality Systems
Novo Nordisk: Trends and Opportunities in Quality Management
11:00 CEST / 10:00 BST
Michael Jovanis
Veeva
VP, Vault Quality
Novo Nordisk: Trends and Opportunities in Quality Management
11:00 CEST / 10:00 BST
Helen Donnelly
Mundipharma
Head of Regulatory Affairs Systems and Analytics
Mundipharma: Delivering Regulatory Value for Fast-Growing Pharmas through Veeva Vault RIM
12:00 CEST / 11:00 BST
Marius Mortensen
Veeva
VP Product Management, Vault Safety
Roadmap: Vault Safety Suite
15:45 CEST / 14:45 BST
Safety: Closing Session and Q&A
16:45 CEST / 15:45 BST