Copenhagen | 20-21 May, 2027
Agentic Biopharma
Where Agents and People Work Together
Agenda
Wednesday, 27 May
Join our RTSM event to connect with industry colleagues, build expertise and drive advancements in clinical supply management. Discover more here.
Thursday, 28 May
See technological innovations that connect and create efficiency for sites, patients, and sponsors. Hear the journey of scaling end-to-end clinical development initiatives and AI to improve productivity.
Novartis is establishing a cross-Vault center of excellence. AOP Health is bringing the vision of an Industry Platform to life across Veeva Development, Quality, and Commercial Cloud. Hear their Veeva strategies and how a multi-vault approach improves collaboration and operational efficiency.
Industry leaders explore delivering value for quality in the agentic AI era. Hear how they’re navigating AI disruption to prioritize and act on the right use cases, manage risk while driving successful outcomes, and set future plans.
Learn how Merck KGaA of Darmstadt, Germany optimizes data through contextualization and cutting edge technology to drive effective use today, establish a strong foundation for AI and automation, and shape the future vision of regulatory.
Novartis and Novo Nordisk share how they are simplifying pharmacovigilance operations to increase operational efficiency and transform patient safety. Hear how they are leveraging a modern safety solution to improve data quality and enable seamless global-local collaboration.
Explore how real-time data sharing and automated workflows between Clinical Operations and Vault CRM can strengthen site relationships and speed clinical trial execution.
Learn how to manage Vault configuration and environments using DevOps principles. Review features, tools, services, and upcoming capabilities.
Learn what’s next for Veeva EDC, CDB, and eCOA. Hear upcoming enhancements and innovations including AI for study testing, programming, reporting, and transcription. An interactive Q&A follows.
Discover the latest enhancements to Veeva eTMF, CTMS, Payments, and Disclosures. Learn about upcoming features to streamline the CRA experience, site payments, and disclosure submissions. Preview future innovations in AI for Clinical Operations, automated TMF, and contract management.
Explore Vault Platform advancements to simplify implementation, customization, and ongoing management. See ways to leverage process monitor, Word-formatted outputs, action triggers, and reporting, and get a preview of upcoming Veeva AI capabilities.
Explore the roadmap and vision for Veeva QMS. See how the latest innovations streamline quality management.
Hear the roadmap and vision for Veeva LIMS. See recent highlights and upcoming features.
Veeva Training roadmap and vision for transforming learner engagement. See the latest innovations in action.
Discover key features delivered over the past year for Veeva Registrations, Submissions, Submissions Publishing, and Submissions Archive, along with highlights into this year’s roadmap. We’ll provide updates on Vault AI for Regulatory, Labeling, eCTD 4.0, Active Dossier, Global Content Plans, and other features designed to reduce data management efforts, helping biopharmas achieve end-to-end process efficiency.
Explore how a unified solution and data foundation enables data-driven decision-making and deeper patient insights. See the latest and upcoming automation capabilities and AI agents driving operational efficiency and increasing data quality.
Join Veeva’s Clinical Data product team for an interactive Q&A immediately following the roadmap.
See the latest Veeva Connections capabilities and upcoming enhancements. Discover how to streamline cross-functional business processes, improve data quality, and automate workflows.
Following the Regulatory roadmap session, join the Veeva RIM product team for Q&A. Topics include: key features from the past year, the latest in regulatory guidelines and developments, Vault AI for Regulatory, and the future roadmap.
Join our Veeva Safety product team for live roadmap Q&A.
See a demo of Veeva eSource, a new application that streamlines clinical trial data flow between sites and sponsors. Learn how it eliminates paper at the source and removes the need for SDV.
Understand key considerations for your data strategy of modern, unified digital validation. Learn how to move beyond early paperless solutions with a data-centric approach.
Learn how the Veeva Quality-RIM Connection accelerates key business processes, including using Enhanced Change Control to simplify the management of Quality Change Plans requiring regulatory approvals.
Streamline the management of pharmacovigilance agreements (PVAs) and safety data exchange agreements (SDEAs) by automating obligation oversight and distribution activities across multiple PVAs. Track partner compliance and reduce operational risk with real-time dashboards and reports.
See how the Veeva Clinical Platform improves decision-making and speeds execution of outsourced studies. Learn how to drive operational oversight with Veeva CTMS, documentation oversight with Veeva eTMF, and data oversight with Veeva CDB.
Gain insights into how Veeva Connections increases data quality, efficiency, and speed in mid-sized organizations.
Get a look into open-source tools that increase administrator and developer productivity. Built with Vault API and an intuitive user interface, easily modify configurations, execute queries, clean up sandboxes, and more.
See the latest industry best practices for cross-vault governance and how a Center of Efficiency (CoE) drives collaboration across multiple functions
Leverage Direct Data API and Veeva’s open-source accelerators to build integrations with AWS, Databricks, MS Azure, and Snowflake. See how to accelerate AI and data analytics solutions.
Learn how Platform, Application, and Customer-Specific Agents drive rapid customer value and continuous innovation for quality.
Learn how content intelligence can enrich and automatically classify regulatory documents with Vault‑ready metadata, reducing manual effort and accelerating RIM integration post-acquisition.
Hear the vision to revolutionize clinical data with automated data workflows, risk-based strategies, and AI innovation. Boehringer Ingelheim shares why now and early lessons on its journey from complexity to efficiency. Discuss how to manage change under pressure and apply disruptive processes without disrupting people.
GSK shares its transition from fragmented, document-heavy processes to a platform-enabled model with Veeva Site Connect. Learn how business-IT alignment on the Veeva Clinical Platform standardizes information exchange for faster activation and predictable site performance.
Parexel and Idorsia share approaches to strengthening oversight in outsourced trials. Hear how Parexel automates data exchange with CTMS Transfer to increase visibility and reduce manual administrative burden for both CROs and sponsors. Idorsia will share steps taken and plans to maintain sponsor oversight in alignment with ICH E6(R3) regulations.
Hear how Chiesi R&D and Quality functions are implementing 8 applications and 7 connections across Development and Quality Clouds in a 24-month timeframe. The Chiesi team will share insights into their decision-making, operating model, change management, and digital redesign for processes.
Discover how Novo Nordisk uses Veeva Process Monitor to analyze and optimize their business processes. This session will demonstrate how to visualize process flows, identify bottlenecks, and easily track process KPIs like cycle time.
Learn how Veeva is evolving document management and shop-floor access. Explore the vision and roadmap for QualityDocs and Station Manager.
Veeva Validation Management vision and roadmap, including latest innovations and upcoming enhancements.
Vision for the future of GxP compliance content. Review the LearnGxP roadmap and latest content innovations.
Veeva Batch Release roadmap and vision. See recent highlights and upcoming features.
Discover how AI is poised to redefine the regulatory operating model, as AI agents complete labor intensive tasks as well as assist humans in critical decision making in an agentic regulatory organization. We will share Veeva’s strategy to support this evolution, our near term roadmap, and the long term vision. The session will close with a preview demo of Vault AI for regulatory scenarios.
BioNTech shares best practices for release management and scaling operations for commercialization. Explore its collaborative approach to adopting new Veeva Safety capabilities is increasing efficiency and reducing case processing timelines.
Veeva eCOA enables sites to own real-time data change requests with built-in regulatory compliance and complete audit trails. Preview key updates that automate the data change request process and eliminate paper for EU and ICH E6(R3) compliance.
AI agents can maintain consistency across core clinical study documents. See how AI can enforce alignment between related documents, reduce the hand-off friction that drives rework across months of revision, and support authoring from a structured study definition. Learn how to reduce document rework, shorten review cycles, and lower the risk of documentation inconsistencies identified during inspection.
Understand how Vault AI, AI in the Vault Platform, enables businesses to scale AI adoption within the same environment that manages data and documents. Explore Vault AI agent use cases across clinical, regulatory, safety, and quality.
Reduce case processing time with rules-based automation and generative AI agents. Easily measure key case processing metrics to identify bottlenecks, monitor quality, and optimize PV resource allocation.
Get a live demo of upcoming Veeva EDC innovations, simplifying medical imaging and file attachments. Learn how masking tools reduce PHI and PII risk in DICOM images and how file attachment capabilities remove the need for custom solutions or third-party storage.
Veeva Study Startup streamlines site selection by consolidating workflows into a single process, accelerating timelines up to 33%. See the complete selection lifecycle from interest survey to eCDA execution, and learn how Veeva Standard Questions and reusable responses eliminate data collection and cut survey turnaround time in half.
Learn how to facilitate accurate batch release and product lifecycle management with Active Dossier by maintaining a list of current documents for a product in multiple markets.
Remove data silos to enable earlier signal detection and more proactive risk management with a unified solution that seamlessly scales PV operations.
Hear how Veeva powers real-time release by pairing Veeva Batch Release data and content aggregation with automated QC testing and continuous monitoring from Veeva LIMS.
Join an industry panel to learn their methods and results from modernizing eCOA delivery. This session highlights practical strategies to build faster, simplify processes, and accelerate timelines across organizations.
Recordati shares its clinical implementation journey in a heavily outsourced setting. Discover how sponsor ownership establishes oversight of data, documents, and operations to accelerate trial execution and improve CRO collaboration.
GSK streamlines end-to-end quality and regulatory processes with the Quality-RIM Connection. Hear key strategies and realized efficiencies, including how a connected approach speeds up regulatory assessments and ensures compliance.
Learn how Haleon creates an impactful user experience leveraging help sections and controls. See walkthroughs of action layouts, working in multiple Vaults, intelligent flash reporting, search enhancements, keyboard shortcuts, and more.
Learn how argenx amplifies internal content and enhances training efficiency by using LearnGxP.
Explore how Veeva Quality Cloud streamlines CDMO-sponsor collaboration. See how a transparent, tech-enabled partnership reduces friction and creates value for both companies.
Hear from a growing biopharma that evolved its quality culture, shifting from process improvement to a predictive approach. Learn why unifying on a single platform helps anticipate risks and make smarter decisions.
Discuss challenges and strategies with industry peers and Veeva for moving beyond manual QC processes and legacy tech toward a more resilient, digitized lab.
Learn how MSD and Sandoz define success for regulatory transformation, secure leadership alignment, and tailor strategies to accelerate operational outcomes.
Discover how large and small biopharmas have implemented submissions publishing to accelerate submissions and optimize delivery.
Camurus and Orifarm improved efficiency and oversight by bringing safety solutions in-house. Discover proven approaches for sustaining operational excellence with a lean team, strategies for increasing CRO oversight, and practical ways to enable agility for your organization.
Automate serious adverse event (SAE) data transfer with the Safety-EDC Connection. Gain real-time visibility into case promotion and follow-ups, reduce manual effort, and replace manual reconciliation with a connected data foundation.
Discover the latest enhancements to Veeva Study Startup, Site Connect, and Study Training. Learn about upcoming features that simplify training and increase visibility for sites and sponsors. Preview recent improvements and future innovation in Veeva OpenData Clinical for accurate, compliant data about investigators and sites.
Learn how to build custom AI agents in Vault Platform. See how custom agents enable business process automation with Veeva AI.
Understand platform operating models and end-to-end value realization. See how DevEx (business consulting) team partners with you to bring platform ways of working across processes, connections, and governance.
Join GSK for a discussion on how to efficiently manage large-scale migrations of data and documents to facilitate asset integration (M&A) and CRO collaboration with the help of Veeva capabilities and AI.
Global Content Plans streamline the assembly and dispatch of core documents. See how this accelerates time to submission and approval of multi-market changes.
The new Clinical Operations-CDB connection automates protocol deviation processing and delivers real-time KRIs and QTLs to Veeva CTMS. Replace manual data transfers and static risk assessments with programmatic RBQM metrics for faster resolution and real-time oversight.
Extend and customize your document processes using Document Type Triggers in Vault Java SDK.
Learn how automating transfer of protocol deviation data with the Clinical Operations-EDC Connection centralizes issue management for improved visibility and faster resolution.
Learn how to accelerate validation and streamline the toolchain required for the ERP lifecycle management in the GxP regulated industries. See a practical example of digital SAP validation, and a perspective on how to integrate with SAP Cloud ALM.
Harmonize PSMF content and improve real-time QPPV oversight to stay inspection-ready. Easily manage multiple local PSMFs and adhere to regional requirements.
Friday, 29 May
Hear how biopharmas of all sizes leverage Veeva EDC and CDB to gain full ownership of their data and scale efficiency. From early implementation to global expansion, these leaders share strategies to maintain oversight, automate manual reconciliation, and sustain operational momentum long after the initial go-live.
Boehringer Ingelheim and Roche share how they are tailoring their operating models to accelerate payments to research sites. Learn how they are using Veeva Payments and the Veeva Clinical Platform to help increase speed, visibility, and accuracy.
Hear how Genmab’s technology transformation supports rapid growth amid company and asset acquisitions. Learn how an efficient, scalable technology foundation enables operational oversight during portfolio expansion in a heavily outsourced model.
Hear how Idorsia has leveraged the Vault Platform to drive organizational agility, navigate strategic transformation, and maintain a strong foundation for future growth.
Explore recent enhancements to Vault Reporting and Dashboards, including Aggregate Formulas, which simplify advanced data summarization. Plus, get an early look at the high-impact features coming on the near-term roadmap.
Sobi shares how it is preparing to modernize its release process with Veeva Batch Release. Learn about jurisdictional control and how it transforms release decision-making from a manual burden to a strategic advantage.
UCB shares how it uses Veeva Validation Management to unify compliance and streamline global operations. Learn how replacing fragmented, paper-heavy workflows with a data-centric tool accelerates project timelines while ensuring inspection readiness and data integrity.
Novo Nordisk explains how to prioritize AI solutions that address universal problems for quality. Learn ways to start, scale, and measure AI adoption and deliver value to the broadest possible user base.
Alfasigma and CSL will share their approach data management and learn techniques that help ensure data integrity and optimize submissions of critical data to Health Authorities.
Unlock the full potential of Veeva RIM with a unified data foundation and a vision to leverage AI agents. Through a pragmatic, phased approach, mAbxience demonstrates how Veeva RIM, data integrity, process transformation, and AI-driven tools can drive regulatory process efficiency.
OM Pharma streamlined pharmacovigilance agreement (PVA) management by centralizing content and automating global partner obligation oversight. Discover how transitioning from manual spreadsheets and emails to a unified, digital solution improves partner adherence, increases operational efficiency, and simplifies compliance.
Automating data flow across clinical applications accelerates data-driven processes. See how Veeva Connections, including a preview of the Clinical Operations-CDB Connection, syncs Veeva EDC, Veeva CDB, and Veeva CTMS, cutting protocol deviation processing time from weeks to hours.
Modernize and simplify site-facing workflows with Veeva Study Startup, Site Connect, and Study Training. This includes capabilities to generate FDA Form 1572s, assign digital training ahead of visits, and automate safety letter distribution and acknowledgment — reducing sites’ burden and improving their compliance from start-up to closeout.
Hear how cross-vault process optimization unlocks real value in organizations by streamlining end-to-end processes. See a live demonstration on accelerated submission document collection across RIM Submissions, QualityDocs, and eTMF.
Learn about document rendition enhancements and best practices for more efficient document migrations.
Learn how to perform regulation change impact assessments through document-to-regulation mapping. Link content directly to requirements to automatically identify impacted areas and trigger assessment workflows the moment regulations change.
Learn how Veeva RIM publishes a eCTD 4.0 submission using Veeva Submissions Publishing and preview eCTD 4.0 forward compatibility – all within the same processes used today, without any add-ons.
De-risk your migration to Veeva Vault with best practices for data mapping and validation. Discover how Automation Toolkits reduce manual effort across global implementations and empower teams to work at scale.
Preview Veeva eSource to eliminate paper at the source and reduce the need for SDV. See how Veeva Clinical Connections reduce end-to-end effort and the roadmap to further automate workflows, including protocol deviations. Hear directly from Princess Maxima, the largest pediatric cancer center in Europe, on requirements for a successful eSource solution for sites.
Learn how Amgen accelerates trial execution with standardized, connected training on the Veeva Clinical Platform. Discover how unifying clinical operations with Veeva Study Training supports ICH E6(R3) compliance while reducing site burden.
Lundbeck details the governance and operational steps to centralize eTMF content from CRO partners and acquired studies, including mid-Phase III trials. Get practical insights and risk mitigation approaches for Vault-to-Vault transfers while maintaining study continuity.
IT leaders share how they are streamlining processes across clinical, regulatory, safety, and quality. They’ll share lessons learned from their implementations, discuss fostering effective IT-business partnerships, and how to measure ROI.
Discover how a clinical stage biotech has reshaped how they work with CROs and improved control, data quality, and oversight by bringing in-house and connecting clinical, regulatory, and safety systems in-house and connecting them. Gain insights into their decision making, the phased approach they adopted and the lessons learned.
AstraZeneca shares how it partnered with Veeva to reimagine validation. Learn how replacing paper-based workflows with modern digital validation leads to increased data integrity, quality, and compliance.
Learn how Aenova is unifying quality management at its sites to provide a seamless customer experience. Discover how a single digital foundation builds trust through transparency and operational excellence.
Hear how digital batch release has evolved from a regulatory uncertainty into a proven operational standard through the lens of a Qualified Person. Discover best practices for modernizing this process within the context of European regulations and standards.
Hear insights on navigating a Vault-to-Vault migration including data governance, process alignment, and technical considerations to enable effective change management and long-term RIM value.
Sobi will share how they stay current with evolving Veeva RIM capabilities. Leave with practical ways to operationalize process and feature updates.
Learn how Amgen uses the Accumulus connector with Veeva RIM to seamlessly move health authority questions data to and from Accumulus and Veeva RIM.
Ferring and LEO Pharma are scaling PV operations with a global safety solution to support strategic growth. Explore how they are streamlining end-to-end processes, increasing efficiency, and seamlessly incorporating affiliates and partners.
Discover how the eCOA design studio and pre-built instrument library facilitate sub-4-week builds and rapid mid-study changes.
New Veeva Payments capabilities streamline site contracting and fee management. See how the Fee Schedule Builder improves study start-up processes and reduces administrative burden.
Use Veeva Study Training to simplify training and improve compliance for internal and external users. See a new feature that enables you to grant clinical system access automatically to users who have completed the requisite training.
See how Knowledge Navigator assist end users by delivering fast, role‑based, and governed answers across SOPs, policies, learning systems, how‑to guides, and users access management databases. It boosts productivity, accelerates system adoption, and empowers end users to execute with confidence and ease in a regulated enterprise.
Large language models are now part of translation in regulated environments. We explore how to manage associated risks and how a hybrid approach combining AI with structured, validated content, quality estimation for risk-based routing, and human oversight, can ensure quality, traceability, and compliance.
Discover how embedded test execution, control charts, and review by exception help teams release products faster.
Process Monitor helps you identify and diagnose process bottlenecks and optimization opportunities using live Veeva RIM data. Learn how process analysis and event-level data visualization turns opaque workflows into measurable performance metrics.
Manage growing adverse event (AE) volume from diverse sources with automation. See how to collect post-marketing AEs in a structured manner with customizable web forms and seamlessly automate AE intake from medical, clinical, and quality with Veeva Connections.
We conclude Veeva Summit with the human reason innovation matters. Danielle Drachmann – senior researcher, clinical trial participant, and mother of three – lives at the intersection of clinical research and rare disease. From this deeply personal vantage point, she challenges patient centricity and introduces Return on Engagement (ROE), a more meaningful path to partnership – and a faster route to successful clinical trial outcomes.
Eliminate manual data reconciliation and spreadsheets with Veeva CDB. See a live demo of dynamic query text, auto checks, the vendor query workflow, and more. Learn how to embed data values directly into queries, and use the query metrics dashboard to optimize cleaning strategies.
Veeva Disclosures streamlines EU CTR compliance by automating CTIS submissions for Clinical Trial Agreements. Discover upcoming functionality and recent enhancements to simplify disclosure preparation, including reviewer comments and CTMS data synchronization.
Discover how the Veeva Safety-RIM Connection can increase downstream business process efficiency, including case processing, product quality complaints, and adverse event document intake highlighting.
Discover the new Clinical Data AI Agents— including listing, local lab, and testing— that simplify complex data tasks. Improve data quality and drive operational efficiency for data managers and clinical programmers.
Get a sneak peek at the updated Document Viewer that simplifies end user experience, and learn how the Document Readiness Panel can streamline content preparation.
The Quality-Safety Connection automates intake by sharing product quality complaint and adverse event (AEs) data across Veeva QMS and Veeva Safety.
See how quality teams can view key process metrics, visualize processes, and detect bottlenecks early.
Customer-only deep dive on the technical infrastructure, governance, and operational shifts required for upcoming AI roadmap releases. Discuss process, training, cost considerations, and the importance of taking a long-term adoption approach.
Join fellow Veeva eTMF customers in an interactive discussion sharing perspectives on the future of TMF operations. Explore practical insights for preparing your organizations for AI adoption and aligning risk-based strategies for increased operational efficiency.
CTMS is a CRA’s most powerful tool for driving trial success and site engagement. Join Veeva CTMS customers for a collaborative session to bridge the gap between user pain points and the product roadmap. We’ll discuss your feedback and preview upcoming Veeva CTMS enhancements to streamline site monitoring and improve the CRA experience.
Join the Veeva product team for an in-depth discussion and feedback session about Veeva RIM Connections. Connections sync data and business processes with Veeva Clinical, Quality, Safety, PromoMats, and Medical.
Connect with your peers and the Veeva product team for an in-depth discussion and feedback session about Active Dossier, Global and Submission Content Plans, and Publishing.
Connect with your peers and the Veeva product team for an in depth discussion and feedback session about IDMP data management and PMS submission.