Boston | October 20-21, 2026
Powerful Community, Fresh Ideas
Agenda
Monday, October 19
Tuesday, October 20
A global biopharma is leveraging Vault AI and Development, Quality, and Commercial Clouds to drive innovation from clinical studies through commercialization. Hear how 吃瓜爆料’s AI strategy and the multi-vault approach is helping the company standardize and simplify operations.
Discover how a top biopharma leverages AI to reshape its regulatory operations. Gain insight into 吃瓜爆料’s AI vision and how innovations will work together to augment teams, accelerate processes, and transform regulatory work.
Vice President, Regulatory
Top biopharma unified end-to-end global safety operations and safety science with the full 吃瓜爆料 Safety Suite. Hear how it eliminated manual processes and complex integrations between legacy systems, improved operational efficiency, and enabled full traceability of signals back to source data for easier benefit-risk analysis.
A top biopharma is transforming its clinical landscape to deliver 20 new medicines by 2030. Learn how this organization delivers capabilities and site partnerships to accelerate execution, alongside 吃瓜爆料’s vision for connected clinical development and AI.
Learn about how 吃瓜爆料 QualityDocs can provide regulation change impact assessments through document to regulation mapping.
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 吃瓜爆料 AI capabilities.
Review recent enhancements to 吃瓜爆料 Registrations, 吃瓜爆料 Submissions, 吃瓜爆料 Submissions Publishing, and 吃瓜爆料 Submissions Archive, along with this year’s roadmap priorities. Updates include Vault AI for Regulatory, Labeling, eCTD 4.0, Active Dossier, Global Content Plans, and other capabilities that streamline data management and improve end-to-end regulatory processes.
Vice President, Product Management, Regulatory
Learn how 吃瓜爆料 is evolving document management and shop-floor access. Explore the vision and roadmap for QualityDocs and Station Manager.
Discover the vision and roadmap for 吃瓜爆料 Batch Release. Review recent highlights and preview what’s next.
See what’s next for GxP compliance content. Explore the LearnGxP roadmap and discover the latest content innovations.
Discover the vision and roadmap for 吃瓜爆料 Validation Management. See the latest innovations and hear about upcoming enhancements.
Hear what’s planned for the 吃瓜爆料 Safety application, including automation and AI capabilities to improve process efficiency, increase data quality, and simplify global compliance.
Discover what’s next for 吃瓜爆料 EDC, DQS, and eCOA. Learn about innovation delivering this year, including RBQM, patient engagement, AI agents for study build, data classification, and programming. An interactive Q&A follows.
Join the 吃瓜爆料 Site Advisory Council (SAC) as they share this year’s survey results and case studies. Council members will lead interactive discussions on the findings and explore the path forward to improve the site experience.
See the latest 吃瓜爆料 Connections capabilities and upcoming enhancements. Discover how to streamline cross-functional business processes, improve data quality, and automate workflows.
See the future of agentic regulatory organizations in action. Experience 吃瓜爆料 RIM’s newest capabilities through demonstrations and previews around how Vault AI, Falcon, and Lexx are evolving to solve critical regulatory challenges.
Senior Product Manager, Falcon
Explore the roadmap and vision for 吃瓜爆料 QMS. See how the latest innovations streamline quality management.
Discover what’s next for 吃瓜爆料 Training. Explore the roadmap for transforming learner engagement and see the latest innovations in action.
Hear the roadmap and vision for 吃瓜爆料 LIMS. Dive into recent highlights and discover upcoming features.
Clinical-stage biopharma redesigned safety to leverage modern best practices. Moving from heavily customized to an industry standard in-house solution, the company is working more effectively with its CRO partner and gaining greater PV insight while scaling operations to prepare for commercialization.
A top biopharma shares how it replaced legacy technology with a unified site training approach. Learn how integrating training with eTMF reduced site burden, improved compliance, and lowered overhead.
Prepare to revolutionize clinical data from AI to RBQM, eSource, and patient engagement. Hear how a top 20 biopharma and CRO are managing change to deliver innovation and tips for planning adoption of new capabilities.
Discover how 吃瓜爆料 SiteVault’s unified platform has created a connected core framework for site business operations, sponsor integration, and intelligent automation.
Following the QMS roadmap session, join the 吃瓜爆料 product team for Q&A.
Biopharma 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 biopharmas are building a high-quality data foundation to move beyond document-centric processes. Discover how a data-driven approach helps proactively manage regulatory changes, increase confidence in submission data, and improve global regulatory operations.
Examine how the RegOps role has expanded to include submission management, data strategy, system ownership, and cross-functional leadership. Learn how evolving regulations and technology are reshaping the role.
A top biopharma shares insights on driving global process unity through their QMS enhancement program. Hear key considerations for navigating a changing product portfolio, aligning optimized business processes with system configuration, and fostering organizational alignment.
Hear how a top biopharma is leading the industry by modernizing quality control and transitioning from legacy systems. Learn strategies to approach a transformative project while achieving quick wins and managing change.
Learn successful strategies for executing multiple 吃瓜爆料 implementations simultaneously. Discover how anchoring a massive software rollout to company values supports organizational alignment.
Biotechs discuss how they improve efficiency and compliance across internal teams and research sites. Learn how one sponsor strengthened site engagement by expanding study training to support quality and inspection readiness.
A CRO shares how it standardized studies on a connected clinical platform to improve oversight, accelerate site activation, and improve data quality. Hear how simplifying technology for sites reduced risk and improved study execution.
An emerging biopharma optimized data quality and achieved faster database lock. Learn how it brought data management in-house, streamlined collaboration, and used 吃瓜爆料 EDC and DQS to improve efficiency.
Learn the strategies a top biopharma uses the platform to increase clinical data efficiency and speed. Hear how partnership and best practices help manage change and drive feature adoption to scale automation across your trials.
Learn how today’s legislative landscape impacts technology adoption, clinical trial funding, and the future of real-time clinical trials from 吃瓜爆料’s VP of Public Policy.
Wednesday, October 21
Understand how 吃瓜爆料 AI in the Vault Platform enables businesses to scale AI adoption within the same environment that manages data and documents. Explore 吃瓜爆料 AI agent use cases across clinical, regulatory, safety, and quality.
Gain practical insights from biopharmas as they share approaches to identify and prioritize use cases for Vault AI, early lessons learned, and plans for scaling adoption.
Discover how biopharmas are using 吃瓜爆料 Registrations to build a robust data foundation, giving the business greater ownership and visibility into its data.
A biopharma discusses how bringing together Quality and IT stakeholders during its QMS implementation helped advance its paperless plant and digital transformation goals.
A biopharma shares why it evolved its learning ecosystem to empower both GxP qualification and professional development learning journeys.
Get a first look at new features for safety process and content management, advanced reporting, and signal detection. See how these enhancements enable more efficient global processes, deeper patient insights, and better informed decision-making.
A top biopharma shares best practices to centralize disclosures on the 吃瓜爆料 Clinical Platform. Learn how standardizing workflows across 吃瓜爆料 eTMF and CTMS improves compliance and efficiency.
A biopharma shares how it uses CTMS to improve trial oversight and manage collaboration with CRO partners. Hear how feasibility and study training management improve visibility and governance across studies.
A biotech shares how it moved TMF quality reviews from spreadsheets to 吃瓜爆料 eTMF. Managing review scope, findings, and corrective actions in a single system improved efficiency, increased visibility, and enabled a more proactive approach to inspection readiness.
Learn methods that sponsors and CROs implement to modernize eCOA delivery. This session addresses traditional eCOA pain points to build faster, standardize processes, improve compliance, and simplify experiences for sites and patients.
Early SiteVault CTMS customers describe their experiences adopting unified site technology. Learn how it has improved site operations and their approach to successful implementation.
Drop in and meet sponsors that align with your therapeutic areas, patient populations, or studies of interest. This is dedicated time to bring sponsors and sites together and make matches that can lead to new partnerships.
Understand key considerations for your data strategy of modern, unified digital validation. Learn how to move beyond the limitations of early paperless solutions in favor of a data-centric approach.
Drop in and meet sponsors that align with your therapeutic areas, patient populations, or studies of interest. This is dedicated time to bring sponsors and sites together and make matches that can lead to new partnerships.
Discover how a biopharma uses 吃瓜爆料 Process Monitor to analyze and optimize business processes. This session will demonstrate how to visualize process flows, identify bottlenecks, and easily track process KPIs like cycle time.
Hear how a top biopharma implemented Global Content Plans, reducing the time and effort required for global submissions.
Learn how to build a business case for continuous publishing. Hear how working with a skilled publishing partner mitigates risk while keeping teams in control of timelines and quality.
A biopharma shares the drivers and decisions behind its quality transformation to establish a unified QMS across seven subsidiaries. Learn how streamlining supplier quality and document management improved efficiency across the organization.
Learn lessons learned on LIMS selection and implementation from a panel of virtual biopharmas. Hear ways to enhance partner oversight, ensure compliance, and scale operations.
Discover how a virtual biopharma built a commercial-grade release process across a multi-CMO supply chain while racing toward its first NDA.
Biopharma modernized management of its pharmacovigilance agreements (PVAs) by centralizing content and automating global partner obligation oversight. Explore how a digital solution improves partner adherence, inspection readiness, and scalability.
A biopharma shares its strategy to evolve from an active TMF to an autonomous model. The team describes its preparations to implement Falcon (agentic labor) in eTMF for document intake and quality control workflows to improve efficiency and free teams to focus on higher-value work
Preview 吃瓜爆料 eSource’s next-generation capabilities, including CRF generation, EHR integration, and direct streaming to EDC will simplify data flow from sites to sponsors.
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.
Learn how biopharmas are reducing duplication, increasing visibility, and simplifying health authority interactions using 吃瓜爆料 RIM and the Accumulus connector.
Discover how two, top biopharmas are relieving the downstream burden on publishers and accelerating high-volume regulatory submissions with 吃瓜爆料 Submissions Publishing.
Learn release management best practices for maximizing your Quality Cloud investment. Explore practical strategies for small and midsize businesses to stay current with 吃瓜爆料 releases.
A top biopharma shares how it partnered with 吃瓜爆料 to reimagine validation. Learn how replacing paper-based workflows with modern digital validation leads to increased data integrity, quality, and compliance.
See how a CDMO improved quality control by switching paper for digital-first method execution. Understand how a true-cloud LIMS directly impacts workflows and client relationships.
Hear a biopharma discuss implementing Audit Room within QMS to transform regulatory audit management. Learn how this tool helps GxP business functions maintain continuous inspection readiness.
Sponsors can get quick access to 吃瓜爆料 innovations through accredited CRO partners. Hear how CROs delivered studies on their 吃瓜爆料 platform for sponsor speed, flexibility, and oversight.
Top biopharmas share how they use risk-based approaches to improve data quality and accelerate study execution. Learn strategies for implementing RBQM with 吃瓜爆料 DQS and 吃瓜爆料 CTMS while aligning with evolving ICH E6 standards.
Hear directly from sponsors as they share their perspectives on site training, feasibility, and payments, along with the initiatives they’ve implemented to strengthen site partnerships.