2019 SessionsDownload Agenda
*Agenda subject to change. Check back frequently for session updates.
NNIT: Continuous Improvement through Unified RIM
With unified RIM, regulatory teams benefit from greater transparency, improved data quality, and an enhanced user experience. More importantly, they gain a platform that stays current with regulatory requirements and releases new capabilities three times per year. In this session, we’ll discuss how to transition to a unified RIM platform and leverage these release cycles to maximize your investment. For Business and IT.
Speakers: Rune Bergendorff, Director of Life Sciences Advisory and Gaurav Anand, AVP Life Sciences Application Services
AstraZeneca: Our Future Reimagined with Unified Clinical
Hear about AstraZeneca’s clinical transformation and their vision for 2021. They’ll detail their move to a unified suite, success criteria, and the considerations for a streamlined clinical landscape. For Business and IT.
Speaker: Debbie Brook, Clinical Programme Manager, Global Medicines Development (GMD) Transformation
GSK: An Agile Approach to Global Regulatory Processes
By standardizing on a common RIM platform, GSK is driving global alignment across business units. Learn how they are using an agile approach to unify regulatory processes and generate value throughout their multi-year transformation. For Business and IT.
Speaker: Richard Eddershaw, Head of Global Regulatory Operations - Pharma
GSK: Best Practices for Adopting a Modern eTMF Application
GSK streamlines study processes and drives global synergies across divisions with Vault eTMF. Learn about the drivers and business case approach to leveraging eTMF as a strategic asset within the organization. For Business and IT.
Speakers: Astrid Beriaux, Head of Trial Master File and Hélène Kermarec, TMF Business System Owner at GSK
UCB: Increasing Alignment for More Effective Partnerships
UCB has implemented a single system to manage controlled content internally and also shared with contract manufacturing organizations and other partners. Learn how UCB deployed Vault QualityDocs to over 2000 external users, streamlining collaborative processes and gaining greater control and oversight. For Business and IT.
Speakers: Olivier Melis, Quality Digital Partner and Michel Van Nyvel, Digital Partner QA
GE Healthcare: Lessons Learned from an End-to-end RIM Implementation
Hear how GE Healthcare adopted Vault Registrations, Vault Submissions, and Vault Submissions Archive. We'll explore critical elements of the planning process, streamlining cross-functional business processes, and how the team has measured success. For Business and IT.
Speaker: James Hendry, Head of Global Regulatory Operations - Pharma
Veeva Session: Vault Platform Security and Access Control Best Practices
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. For Business and IT.
Speaker: Kate Wilber, Director Product Management, Veeva Systems
Idorsia: Unifying Clinical with Vault CTMS and Vault eTMF
Idorsia discusses their learnings after a year using Vault CTMS and Vault eTMF. Hear how they improved trial execution and are leveraging a complete view across trials. For Business and IT.
Speaker: Simone Mechler, Associate Director, Clinical & Quality Systems at Idorsia Pharmaceuticals
Johnson and Johnson: Global Journey to Harmonize Controlled Content Management
Johnson and Johnson’s single instance of Vault QualityDocs was initially rapidly adopted in more than 210 locations across 60 countries. As an enterprise-wide standard, the journey now continues with onboarding of the main pharma document management community. Learn how their journey of global harmonization continues with Vault QualityDocs. For Business and IT.
Speaker: Garrett Sayers, Supply Chain Systems and Solutions Lead EMEA
BMS: Planning and Tracking Submission Content
As part of a major transformation initiative, BMS adopted Vault Registrations to improve global visibility into submission content. Hear what advice they have for a smooth deployment and continued success two years post-launch. For Business and IT.
Speakers: Lianne Wolf, Head of Regulatory Sciences Austria and Paul Attridge, Sr. Director, Vault RIM, Veeva Systems
Veeva Session: Scalable and Compliant Release Management
With a scalable and robust release management process, companies can efficiently and effectively evaluate new releases. Learn best practices on managing new Vault releases and ways to validate new capabilities. For IT.
Speakers: Neelam Sidhu, Manager, Customer Success Manager, Europe, Veeva Systems and Akos Szottfried, Practice Manager, Managed Services, Veeva Systems
Veeva Session: Evaluating the Tangible Benefits of Vault Clinical Suite
Based on real-world scenarios and Veeva’s value engineering model, learn how to identify areas for process improvement, key performance indicators, and the value realised from streamlining end-to-end clinical trial processes. For Business and IT.
Speakers: Michael Burton, Director, Value Engineering & James Reilly, VP, Vault Clinical, Veeva Systems
Veeva Session: Accelerating Implementations with Vault Quality Essentials
Vault Quality Essentials is a new Veeva services offering that delivers streamlined content management and quality processes tailored to the needs of small and medium-sized businesses. Hear how the Vault Quality applications can be deployed in weeks not months leveraging best practices in the Essentials package. For Business and IT.
Speaker: Robert Weisz, Practice Manager, Veeva Systems
UCB: Unifying Submission Content Development
UCB streamlined their business processes and unified submission content development across regulatory, clinical, and quality. Join this session to hear more about what challenges they faced, how they leverage Vault in their end-to-end labelling process improvements, and what plans they have for the future. For Business and IT.
Speaker: Mark Morris, Director, Regulatory Knowledge Management
Veeva Session: Best Practices for Vault Lifecycles and Workflows
Vault lifecycles and workflows are critical to supporting regulated processes. Hear case studies on key business challenges and how Vault was configured to solve them. We'll cover objects and documents, and take a first look at the new multi-document workflow. For business and IT.
Speakers: Kate Wilber, Director Product Management, and Charles Bonnefoy, Practice Director, Veeva Systems
Valiance: Applying Agile Principles to Veeva Vault Migrations
A successful migration requires flawless planning and execution. Hear about recent experiences, best practices, and lessons learned from migrating from legacy systems to Veeva Vault. For business and IT.
Speaker: Paul Crean, Director – Delivery Services - Europe
LEO: Journey Towards a Unified Development Application Platform
Get first-hand insights and recommendations for adopting Vault Development Cloud across R&D. LEO Pharma discusses the journey from ideation, to obtaining executive approvals, and proof of concepts that led to a unified platform programme. For business and IT.
Speakers: Mika Välilä, Senior Director, Digital Business Platforms and Anders Helmø Larsen, Business Relationship Manager
Novo Nordisk: Simplifying Quality Content Management in a Complex World
Novo Nordisk is leveraging Vault QualityDocs to simplify controlled content management across multiple departments and regions, and increase operational efficiencies. Hear how they are moving 50.000 users from a 20 year-old, fragmented, on premise system landscape to a single, modern solution – eliminating IT risks and gaining greater business value. For business and IT.
Speakers: Sune Mouritzen, Project Director and Stine Adrian Møller, Programme Director
Panel Discussion: SOPs of the Future - Reimagining Procedural Instructions
Standard operating procedures are critically important to defining processes, establishing quality controls, and sustaining GxP compliance. However, with the complexity of today's working environments traditional multi-page SOPs may not be the most effective approach for managing, delivering, and consuming information. Join our panel discussion as we reimagine SOPs leveraging modern technologies. For business.
Speakers: Heike Roeder, VP, Corporate Quality – Head Process & Knowledge Management, Bayer
Olivier Melis, Quality Digital Partner, UCB
Sune Mouritzen, Project Director, Novo Nordisk
Stine Adrian Møller, Programme Director, Novo Nordisk
Sophie Wehenkel, Manager, PwC Germany
Garrett Sayers, Supply Chain Systems and Solutions Lead EMEA, Johnson & Johnson
Robert Gaertner, Director Strategy, Vault Quality, Veeva Systems
Horizon Therapeutics: Streamlining Quality Management in an Outsourced Business Model
With a unified solution to manage quality content and key QMS processes such as deviations and CAPAs, and change control, quality teams at Horizon Therapeutics get a deeper understanding of quality events and how they are related. We will discuss potential insights gained for key quality processes and how to maximize impact to the business. For business and IT.
Speaker: Jacintha O'Reilly, Associate Director, Quality Systems
Norgine: The Role of RIM Innovation in Regulatory Transformation
Join this session to hear Norgine discuss how RIM innovation has allowed them to streamline processes, better manage resources, and monitor change events by setting effectiveness checks and metrics. For business.
Speakers: Segren Bernard, Associate Director, Regulatory Information Management and Jade Knight, Partner Services Manager
Veeva Session: Enabling Data-Driven Decisions with Vault Reporting and Dashboards
Make informed decisions with visibility into operational processes, application usage, and other management KPIs. See how to use reports and dashboards to determine information such as cycle times, overdue processes, and user access. We’ll also explore what’s coming on the product roadmap. For business and IT.
Speakers: Kate Wilber, Director Product Management and Adam Kohegyi, Consultant, Clinical Operation, EU R&D Services, Veeva Systems
Roadmap and Vision: Vault QMS
See Vault QMS in action and learn about recent and upcoming enhancements. Hear how Veeva is streamlining quality management and enabling greater insights. For business and IT.
Speakers: Joby George, Senior Product Manager, Vault Quality, and Sandeep Chopra, VP Product Management, Vault Quality, Veeva Systems
Roadmap & Vision: Vault Registrations
See how Vault Registrations can help you manage global complexity through bundling and splitting submissions and a new affiliate home page. Also, learn about recent progress in xEVMPD support as well as our plans for future IDMP capabilities. For business and IT.
Speakers: Kate Wilber, Director, Product Management, and Uri Reich, VP Product Management, RIM, Veeva Systems
Roadmap and Vision: Clinical Operations - Vault CTMS, Vault eTMF, and Vault Study Startup
Learn about key enhancements for the clinical operations suite of applications including Vault CTMS, Vault eTMF, Vault Study Startup, and the Veeva Clinical Network. For business and IT.
Speakers: Lauren Garson, Senior Director, Clinical Strategy, Tom Dekker, Senior Product Manager, and Steve Harper, VP Product Management, Clinical Operations, Veeva Systems
Roadmap and Vision: Vault QualityDocs, Vault Training, Vault Station Manager
With a unified quality suite that includes blended learning assignments and a tablet application for the manufacturing floor, companies can make compliance easier. We’ll review key enhancements from the last year, and take a look at the upcoming roadmap for a preview of what's to come. For business and IT.
Speakers: Joby George, Senior Product Manager, Vault Quality, and Sandeep Chopra, VP Product Management, Vault Quality, Veeva Systems
Roadmap & Vision: Vault Submissions, Vault Submissions Archive, and Vault Submissions Publishing
Learn about key Vault Submissions enhancements such as report-level content plans and advances in document linking and navigation. We'll also preview the Vault Submissions, Vault Submissions Archive, and Vault Submissions Publishing roadmaps including improvements for submission content plans, import and export of submissions, and future support for additional regional eCTD and validation criteria. For business and IT.
Speaker: Uri Reich, VP Product Management, RIM, Veeva Systems
Veeva Session: Managing Vault Environments with Vault Tools
Understand available tools and best practices for managing Vault environments to save time and reduce risk. Hear about approaches and tools used to streamline implementation, testing, and compliance. We’ll also demonstrate features such as sandbox Vaults, datasets in configuration migration and reporting, and explore the roadmap for Vault environment management tools. For IT.
Speakers: Andy Han, VP Technology, and John Tanner, Senior Product Manager, Veeva Systems
Accenture: The Beating Heart of a Living Business
Large scale change management is not a core competence for most clinical operations teams. Accenture provides advice from their experience managing global transformation programs. For business and IT.
Speaker: Andrew Finlayson, Health Experiences Lead UK&I