Copenhagen | 28-29 May, 2026
Powerful Community, Fresh Ideas
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
Global Head of Operational Excellence Development
Director Global Quality Systems
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.
Head of CDO Regions
Senior Vice President, Clinical Strategy
Novartis is establishing a cross-Vault center of excellence. AOP Health is bringing the vision of an Industry Platform to life across ³Ô¹Ï±¬ÁÏ Development, Quality, and Commercial Cloud. Hear their ³Ô¹Ï±¬ÁÏ strategies and how a multi-vault approach improves collaboration and operational efficiency.
Vice President Digital, Data & IT
Head, Development NxV CoE
DDIT NxV CoE Head
Sr Director, Development Cloud Strategy
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.
Head of Global Quality Services
Head of Quality Performance Transformation and Support to Operations
Senior Director, Quality Strategy, Europe
President, ³Ô¹Ï±¬ÁÏ Quality Cloud
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.
Head, RQS Operations
VP, Regulatory Strategy
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.
Director, Safety Operations Centre of Expertise & PV Technology
Head of Technology, Patient Safety & Pharmacovigilance
Global Head Pharmacovigilance Transformation
VP Safety – Europe
Explore how real-time data sharing and automated workflows between Clinical Operations and Vault CRM can strengthen site relationships and speed clinical trial execution.
Director, North American Solution Consulting, ³Ô¹Ï±¬ÁÏ Connections & Process Excellence
Learn how to manage Vault configuration and environments using DevOps principles. Review features, tools, services, and upcoming capabilities.
Technical Consultant, EDEx
Principal Product Expert, Vault Platform
Learn what’s next for ³Ô¹Ï±¬ÁÏ EDC, CDB, and eCOA. Hear upcoming enhancements and innovations including AI for study testing, programming, reporting, and transcription. An interactive Q&A follows.
General Manager, eCOA
Chief Technology Officer, Clinical Data
Discover the latest enhancements to ³Ô¹Ï±¬ÁÏ 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.
Senior Product Manager, ³Ô¹Ï±¬ÁÏ eTMF
Sr. Product Manager, Clinical Operations
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 ³Ô¹Ï±¬ÁÏ AI capabilities.
SVP, Vault AI and Vault Platform
Explore the roadmap and vision for ³Ô¹Ï±¬ÁÏ QMS. See how the latest innovations streamline quality management.
Senior Director of Product Management, ³Ô¹Ï±¬ÁÏ QMS
Hear the roadmap and vision for ³Ô¹Ï±¬ÁÏ LIMS. See recent highlights and upcoming features.
Director, Product Management, LIMS
³Ô¹Ï±¬ÁÏ Training roadmap and vision for transforming learner engagement. See the latest innovations in action.
Senior Product Manager
Discover key features delivered over the past year for ³Ô¹Ï±¬ÁÏ 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.
VP Product Management, RIM
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.
VP Product Management, ³Ô¹Ï±¬ÁÏ Safety
Join ³Ô¹Ï±¬ÁÏ’s Clinical Data product team for an interactive Q&A immediately following the roadmap.
General Manager, eCOA
Chief Technology Officer, Clinical Data
See the latest ³Ô¹Ï±¬ÁÏ Connections capabilities and upcoming enhancements. Discover how to streamline cross-functional business processes, improve data quality, and automate workflows.
Sr. Director, Development Cloud Strategy
Following the Regulatory roadmap session, join the ³Ô¹Ï±¬ÁÏ 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.
VP Product Management, RIM
Senior Product Manager, Registrations
Senior Product Manager – RIM Connections
Product Manager, Submissions & RIM MedTech
Join our ³Ô¹Ï±¬ÁÏ Safety product team for live roadmap Q&A.
VP Product Management, ³Ô¹Ï±¬ÁÏ Safety
Director Product Management
VP Product, ³Ô¹Ï±¬ÁÏ Safety
Principal Product Manager, ³Ô¹Ï±¬ÁÏ AI
See a demo of ³Ô¹Ï±¬ÁÏ 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.
Manager, EU Clinical Solution Consulting
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.
Senior Manager, Validation Management Strategy
Solution Consultant, Quality
Learn how the ³Ô¹Ï±¬ÁÏ Quality-RIM Connection accelerates key business processes, including using Enhanced Change Control to simplify the management of Quality Change Plans requiring regulatory approvals.
Senior Product Manager – RIM Connections
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.
Senior Solution Consultant and Team Lead, EU Safety
See how the ³Ô¹Ï±¬ÁÏ Clinical Platform improves decision-making and speeds execution of outsourced studies. Learn how to drive operational oversight with ³Ô¹Ï±¬ÁÏ CTMS, documentation oversight with ³Ô¹Ï±¬ÁÏ eTMF, and data oversight with ³Ô¹Ï±¬ÁÏ CDB.
Senior Solution Consultant
Gain insights into how ³Ô¹Ï±¬ÁÏ Connections increases data quality, efficiency, and speed in mid-sized organizations.
Senior Manager, Development Cloud Strategy
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.
Senior Product Expert, Vault Platform
See the latest industry best practices for cross-vault governance and how a Center of Efficiency (CoE) drives collaboration across multiple functions
Engagement Manager and Team Manager, Development Excellence, R&D Business Consulting
Sr Director, Development Cloud Strategy
Leverage Direct Data API and ³Ô¹Ï±¬ÁÏ’s open-source accelerators to build integrations with AWS, Databricks, MS Azure, and Snowflake. See how to accelerate AI and data analytics solutions.
Senior Product Expert, Vault Platform
Learn how Platform, Application, and Customer-Specific Agents drive rapid customer value and continuous innovation for quality.
Director, Quality Cloud Strategy
Learn how content intelligence can enrich and automatically classify regulatory documents with Vault?ready metadata, reducing manual effort and accelerating RIM integration post-acquisition.
Head of Technology
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.
Capability Owner Clinical Data Collection
Chief Technology Officer, Clinical Data
GSK shares its transition from fragmented, document-heavy processes to a platform-enabled model with ³Ô¹Ï±¬ÁÏ Site Connect. Learn how business-IT alignment on the ³Ô¹Ï±¬ÁÏ Clinical Platform standardizes information exchange for faster activation and predictable site performance.
Product Strategy
Senior Director, Clinical Operations Platform Excellence
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.
VP, Business Enablement & Engagement
Head Clinical Development Operations
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.
Head of Process Excellence & Change Management – R&D Digital, Data & Modelling
Data, Digital & Modelling Senior Project Manager
R&D Business Consulting Development Excellence Practice Lead EU
Engagement Manager, DevEx, R&D BC
Discover how Novo Nordisk uses ³Ô¹Ï±¬ÁÏ 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.
Product Owner
Senior Product Manager
Engagement Manager and Team Manager, Development Excellence, R&D Business Consulting
Learn how ³Ô¹Ï±¬ÁÏ is evolving document management and shop-floor access. Explore the vision and roadmap for QualityDocs and Station Manager.
Director of Product Management, QualityDocs, Station Manager, and Training
³Ô¹Ï±¬ÁÏ Validation Management vision and roadmap, including latest innovations and upcoming enhancements.
Senior Product Manager, Validation Management
Vision for the future of GxP compliance content. Review the LearnGxP roadmap and latest content innovations.
GM – ³Ô¹Ï±¬ÁÏ LearnGxP
³Ô¹Ï±¬ÁÏ Batch Release roadmap and vision. See recent highlights and upcoming features.
Senior Director, Product Management, ³Ô¹Ï±¬ÁÏ Batch Release
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 ³Ô¹Ï±¬ÁÏ’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.
Executive Director, Regulatory AI Strategy
Product Manager, ³Ô¹Ï±¬ÁÏ AI
BioNTech shares best practices for release management and scaling operations for commercialization. Explore its collaborative approach to adopting new ³Ô¹Ï±¬ÁÏ Safety capabilities is increasing efficiency and reducing case processing timelines.
Director PV Safety Systems
Team Manager, Managed Services, ³Ô¹Ï±¬ÁÏ Safety
³Ô¹Ï±¬ÁÏ 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.
Senior Solution Consultant, eCOA
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.
Head of AI & Automation
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.
SVP, Vault AI and Vault Platform
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.
VP Product, ³Ô¹Ï±¬ÁÏ Safety
Get a live demo of upcoming ³Ô¹Ï±¬ÁÏ 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.
Senior Solution Consultant
³Ô¹Ï±¬ÁÏ 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 ³Ô¹Ï±¬ÁÏ Standard Questions and reusable responses eliminate data collection and cut survey turnaround time in half.
Solution Consultant
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.
Solution Consultant, RIM
Remove data silos to enable earlier signal detection and more proactive risk management with a unified solution that seamlessly scales PV operations.
Principal Product Expert, ³Ô¹Ï±¬ÁÏ Safety
Hear how ³Ô¹Ï±¬ÁÏ powers real-time release by pairing ³Ô¹Ï±¬ÁÏ Batch Release data and content aggregation with automated QC testing and continuous monitoring from ³Ô¹Ï±¬ÁÏ LIMS.
Director, Batch Release Strategy
Senior Director, Europe LIMS Strategy
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.
Global Head Digital Health and Innovation
Head Of Clinical Data Operations
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.
Vice President R&D Operations
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.
Senior Director, Regulatory Systems Operations
Senior Manager, Regulatory Platform Innovation
VQMS Director
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.
Product Manager QMS
³Ô¹Ï±¬ÁÏ Quality Vault Business Manager
Principal Product Expert, Vault Platform
Learn how argenx amplifies internal content and enhances training efficiency by using LearnGxP.
Head of Quality Training
GM – ³Ô¹Ï±¬ÁÏ LearnGxP
Explore how ³Ô¹Ï±¬ÁÏ Quality Cloud streamlines CDMO-sponsor collaboration. See how a transparent, tech-enabled partnership reduces friction and creates value for both companies.
Global Quality Systems Manager
QMS Program lead
Quality Digital Manager
Senior Director, Quality Strategy, Europe
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.
Vice President Global Quality
Discuss challenges and strategies with industry peers and ³Ô¹Ï±¬ÁÏ for moving beyond manual QC processes and legacy tech toward a more resilient, digitized lab.
Senior Director, Europe LIMS Strategy
Senior Director, LIMS Strategy
Learn how MSD and Sandoz define success for regulatory transformation, secure leadership alignment, and tailor strategies to accelerate operational outcomes.
Executive Director, Regulatory Innovation and Information Management
Vice President, Regulatory Business Consulting, Europe
Global Head Regulatory Operations
VP, Regulatory Strategy
Discover how large and small biopharmas have implemented submissions publishing to accelerate submissions and optimize delivery.
Regulatory Affairs Specialist
Associate Director, Head of Regulatory Operations
Director Regulatory Strategy
Information and Regulatory Affairs Manager
Senior Submissions Manager
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.
Director Patient Safety/QPPV
Department Manager, Global Safety
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.
Principal Solution Consultant
Discover the latest enhancements to ³Ô¹Ï±¬ÁÏ 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 ³Ô¹Ï±¬ÁÏ OpenData Clinical for accurate, compliant data about investigators and sites.
Senior Product Manager
Senior Product Manager
Learn how to build custom AI agents in Vault Platform. See how custom agents enable business process automation with ³Ô¹Ï±¬ÁÏ AI.
Senior Manager, Solution Consulting, ³Ô¹Ï±¬ÁÏ 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.
Engagement Manager, DevEx, R&D BC
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 ³Ô¹Ï±¬ÁÏ capabilities and AI.
Principal Product Owner
Senior Product Owner
Sr. Director, Development Cloud Strategy
Global Content Plans streamline the assembly and dispatch of core documents. See how this accelerates time to submission and approval of multi-market changes.
Product Manager, Submissions & RIM MedTech
The new Clinical Operations-CDB connection automates protocol deviation processing and delivers real-time KRIs and QTLs to ³Ô¹Ï±¬ÁÏ CTMS. Replace manual data transfers and static risk assessments with programmatic RBQM metrics for faster resolution and real-time oversight.
Principal Solution Consultant
Extend and customize your document processes using Document Type Triggers in Vault Java SDK.
Senior Product Expert, Vault Platform
Learn how automating transfer of protocol deviation data with the Clinical Operations-EDC Connection centralizes issue management for improved visibility and faster resolution.
Director of Product Management, ClinOps
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.
Engagement Manager
Principal Consultant
Harmonize PSMF content and improve real-time QPPV oversight to stay inspection-ready. Easily manage multiple local PSMFs and adhere to regional requirements.
Senior Solution Consultant and Team Lead, EU Safety
Friday, 29 May
Hear how biopharmas of all sizes leverage ³Ô¹Ï±¬ÁÏ 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.
Director, Digital Product
Head Clinical Data Management
Senior Implementation Manager
Boehringer Ingelheim and Roche share how they are tailoring their operating models to accelerate payments to research sites. Learn how they are using ³Ô¹Ï±¬ÁÏ Payments and the ³Ô¹Ï±¬ÁÏ Clinical Platform to help increase speed, visibility, and accuracy.
Product Manager ¨C One Medicine Platform Clinical
Head of Emerging Markets, CDO Regions
Head of Product Site & Investigator Engagement
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.
Vice President, Enterprise Digital Solutions
Vice President Site Management and Feasibility
Hear how Idorsia has leveraged the Vault Platform to drive organizational agility, navigate strategic transformation, and maintain a strong foundation for future growth.
Vice President, Head Scientific & Quality Systems
Associate Director, ³Ô¹Ï±¬ÁÏ R&D Competence Center Lead
VP, R&D and Quality Strategy
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.
Senior Director of Product Management, Vault Platform
Sobi shares how it is preparing to modernize its release process with ³Ô¹Ï±¬ÁÏ Batch Release. Learn about jurisdictional control and how it transforms release decision-making from a manual burden to a strategic advantage.
Director Global Quality Systems
UCB shares how it uses ³Ô¹Ï±¬ÁÏ 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.
Head of IT Compliance Solutions
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.
Director
Director, Quality Cloud Strategy
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.
GRA Data Standards and Excellence Lead
Manager, Regulatory Digital
Principal, Regulatory Business Consulting, Europe
Unlock the full potential of ³Ô¹Ï±¬ÁÏ RIM with a unified data foundation and a vision to leverage AI agents. Through a pragmatic, phased approach, mAbxience demonstrates how ³Ô¹Ï±¬ÁÏ RIM, data integrity, process transformation, and AI-driven tools can drive regulatory process efficiency.
Head of Regulatory Operations
Regulatory Operations
Systems Administrator & Regulatory Operations Manager
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.
Drug Safety Operations Manager
Automating data flow across clinical applications accelerates data-driven processes. See how ³Ô¹Ï±¬ÁÏ Connections, including a preview of the Clinical Operations-CDB Connection, syncs ³Ô¹Ï±¬ÁÏ EDC, ³Ô¹Ï±¬ÁÏ CDB, and ³Ô¹Ï±¬ÁÏ CTMS, cutting protocol deviation processing time from weeks to hours.
Principal Solution Consultant
Modernize and simplify site-facing workflows with ³Ô¹Ï±¬ÁÏ 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 ¡ª reducing sites¡¯ burden and improving their compliance from start-up to closeout.
Solution Consultant
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.
Engagement Manager, Development Excellence, R&D Business Consulting
Director, North American Solution Consulting, ³Ô¹Ï±¬ÁÏ Connections & Process Excellence
Learn about document rendition enhancements and best practices for more efficient document migrations.
Principal Product Expert, Vault Platform
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.
Strategy Director, Quality SMB, EU
Solution Consultant, Quality
Learn how ³Ô¹Ï±¬ÁÏ RIM publishes a eCTD 4.0 submission using ³Ô¹Ï±¬ÁÏ Submissions Publishing and preview eCTD 4.0 forward compatibility – all within the same processes used today, without any add-ons.
Solution Consultant, Regulatory
De-risk your migration to ³Ô¹Ï±¬ÁÏ 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.
Partner, ³Ô¹Ï±¬ÁÏ Practice Lead
Preview ³Ô¹Ï±¬ÁÏ eSource to eliminate paper at the source and reduce the need for SDV. See how ³Ô¹Ï±¬ÁÏ 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.
Senior Director, Clinical Data Strategy
Team Lead, Clinical Data Provisioning and Interim Manager, Data Intelligence
Learn how Amgen accelerates trial execution with standardized, connected training on the ³Ô¹Ï±¬ÁÏ Clinical Platform. Discover how unifying clinical operations with ³Ô¹Ï±¬ÁÏ Study Training supports ICH E6(R3) compliance while reducing site burden.
Development Operations Innovation Director
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.
Senior Specialist
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.
Partner, Life Sciences
Sr Director, Development Cloud Strategy
Business Systems Lead
Head of RQS System Strategy and Digital Excellence
Senior Director
Vice President, Head Scientific & Quality Systems
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.
Head of Digital and IT
R&D Digital Platforms Lead
AstraZeneca shares how it partnered with ³Ô¹Ï±¬ÁÏ to reimagine validation. Learn how replacing paper-based workflows with modern digital validation leads to increased data integrity, quality, and compliance.
Director, IT – Business Partner, Quality Systems
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.
Vice President Quality System Excellence
Division Head
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.
Qualified Person
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.
Senior Director Regulatory Operations and Systems
ERV Change, Comms and Training Lead
Principal, Regulatory Business Consulting, Europe
Sobi will share how they stay current with evolving ³Ô¹Ï±¬ÁÏ RIM capabilities. Leave with practical ways to operationalize process and feature updates.
Head of Regulatory Business Operations
Learn how Amgen uses the Accumulus connector with ³Ô¹Ï±¬ÁÏ RIM to seamlessly move health authority questions data to and from Accumulus and ³Ô¹Ï±¬ÁÏ RIM.
Senior Director – Government Strategy
Associate Vice President, Digital Transformation/E2E Regulatory Content Automation Lead
Chief Product & Technology Officer
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.
Head of Safety Data and Systems
Director, Global Patient Safety Operations
Director, Head of Safety Technology
Director, Head of Global Safety Operations
Discover how the eCOA design studio and pre-built instrument library facilitate sub-4-week builds and rapid mid-study changes.
Senior Solution Consultant
New ³Ô¹Ï±¬ÁÏ Payments capabilities streamline site contracting and fee management. See how the Fee Schedule Builder improves study start-up processes and reduces administrative burden.
Sr. Product Manager, Clinical Operations
Use ³Ô¹Ï±¬ÁÏ 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.
Senior Solution Consultant
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.
Principal Product Manager, ³Ô¹Ï±¬ÁÏ Platform, R&D Tech and ³Ô¹Ï±¬ÁÏ Centre of Excellence
R&D Practice Leader EMEA
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.
Senior Product Manager
Discover how embedded test execution, control charts, and review by exception help teams release products faster.
Senior Director, Europe LIMS Strategy
Director, Product Management, LIMS
Process Monitor helps you identify and diagnose process bottlenecks and optimization opportunities using live ³Ô¹Ï±¬ÁÏ RIM data. Learn how process analysis and event-level data visualization turns opaque workflows into measurable performance metrics.
Solution Consultant
Principal, Regulatory Business Consulting, Europe
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 ³Ô¹Ï±¬ÁÏ Connections.
VP Product, ³Ô¹Ï±¬ÁÏ Safety
We conclude ³Ô¹Ï±¬ÁÏ 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.
Senior Patient Partnering Manager / CEO
Eliminate manual data reconciliation and spreadsheets with ³Ô¹Ï±¬ÁÏ 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.
Senior Solution Consultant
³Ô¹Ï±¬ÁÏ 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.
Senior Product Manager, Clinical Operations
Discover how the ³Ô¹Ï±¬ÁÏ Safety-RIM Connection can increase downstream business process efficiency, including case processing, product quality complaints, and adverse event document intake highlighting.
Senior Product Manager – RIM Connections
Discover the new Clinical Data AI Agents¡ª including listing, local lab, and testing¡ª that simplify complex data tasks. Improve data quality and drive operational efficiency for data managers and clinical programmers.
Manager, EU Clinical Solution Consulting
Director, Product Expert, Clinical
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.
Principal Product Expert, Vault Platform
The Quality-Safety Connection automates intake by sharing product quality complaint and adverse event (AEs) data across ³Ô¹Ï±¬ÁÏ QMS and ³Ô¹Ï±¬ÁÏ Safety.
Engagement Manager, Development Excellence, R&D Business Consulting
Director, North American Solution Consulting, ³Ô¹Ï±¬ÁÏ Connections & Process Excellence
See how quality teams can view key process metrics, visualize processes, and detect bottlenecks early.
Principal Product Expert, Vault Platform
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 ³Ô¹Ï±¬ÁÏ 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.
Director, TMF Strategy
Senior Product Manager, ³Ô¹Ï±¬ÁÏ eTMF
CTMS is a CRA¡¯s most powerful tool for driving trial success and site engagement. Join ³Ô¹Ï±¬ÁÏ 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 ³Ô¹Ï±¬ÁÏ CTMS enhancements to streamline site monitoring and improve the CRA experience.
Senior Director, Clinical Strategy
Principal Product Expert
Join the ³Ô¹Ï±¬ÁÏ product team for an in-depth discussion and feedback session about ³Ô¹Ï±¬ÁÏ RIM Connections. Connections sync data and business processes with ³Ô¹Ï±¬ÁÏ Clinical, Quality, Safety, PromoMats, and Medical.
Senior Product Manager – RIM Connections
Connect with your peers and the ³Ô¹Ï±¬ÁÏ product team for an in-depth discussion and feedback session about Active Dossier, Global and Submission Content Plans, and Publishing.
Product Manager, Submissions & RIM MedTech
Connect with your peers and the ³Ô¹Ï±¬ÁÏ product team for an in depth discussion and feedback session about IDMP data management and PMS submission.
Senior Product Manager, Registrations