Agenda for Day 1 – Thursday September 10, 2026Thursday, 10 September 2026 - ET (Eastern Time, GMT-05:00)

Develop an overview of the most significant regulatory changes in 2025 and 2026 impacting clinical trials disclosure across major jurisdictions

Dive into the MHRA April 2026 changes, EU CTIS post-implementation realities, US registry evolution and emerging market requirements that affect your day-to-day operations

Gain clarity on where regulations are aligning, where they're diverging and how to prioritize compliance efforts in a fragmented global landscape

Discover how AI tools support clinical trial transparency activities including document QC, risk‑based anonymization, metadata checks, plain language summary development and content harmonization across jurisdictions

Understand where AI enhances accuracy and efficiency in disclosure workflows and where human oversight remains essential to ensure compliance, patient privacy protection and alignment with global regulatory expectations

Learn practical considerations for adopting AI responsibly including governance models, validation steps and strategies for integrating AI into existing systems without increasing site or team burden

Unlock technology-enabled approaches and frameworks to identifying and protecting commercially confidential information across clinical document submissions

Learn how organizations are streamlining CCI redaction workflows to meet tight regulatory deadlines across EU CTR, Health Canada PRCI and EMA Policy 0070

Examine practical considerations for implementing end-to-end CCI solutions while maintaining compliance

Examine the growing global expectation for returning clinical trial results and, where appropriate, individual‑level data to participants

Explore ethical, regulatory and operational considerations for returning data in a way that is accurate, understandable and actionable for patients

Share emerging best practices for designing participant‑focused result return strategies that build trust, respect contribution and support long‑term engagement

Hear directly from patients, caregivers and clinical sites about their experiences accessing and understanding clinical trial information, including what works, what doesn't and what's missing

Explore the gap between what companies create and what patients receive, understand and use when making decisions about trial participation and staying informed throughout the research process

Gain actionable insights on how to design transparency efforts that genuinely serve patient needs rather than just meeting regulatory requirements

Examine the growing regulatory and policy focus on providing clinical trial results directly to participants and how expectations are evolving across the global transparency landscape

Explore emerging developments from NIH, potential implications for future regulatory policy, and how these US initiatives compare with approaches being considered by other health authorities and research stakeholders

Assess the potential impact on sponsor disclosure programs, including governance, resource planning, and the future role of transparency teams in participant-facing communications

Explore two emerging paradigms of clinical data sharing: established voluntary sharing models and newer mandatory access frameworks, including initiatives such as European Health Data Space (EHDS) 

Examine real-world use cases that illustrate the operating models, governance frameworks, and infrastructure required to enable scalable access to clinical trial and health data 

Gain practical insights into how organizations can prepare for a hybrid future by balancing scientific collaboration, regulatory requirements, regional governance expectations, and sustainable data access pathways

Address the common organizational challenge of unclear ownership and accountability for anonymization decisions across clinical trial documents and data packages

Explore different governance models including centralized decision-making, cross-functional review committees and hybrid approaches used by leading organizations

Learn how to establish clear roles, responsibilities and escalation pathways for anonymization decisions that balance privacy protection with operational efficiency

Explore how leading organizations integrate disclosure considerations throughout the entire clinical trial lifecycle, from protocol development through results posting and archiving

Examine the operational challenges when disclosure teams are brought in too late and the downstream consequences of studies not designed with transparency in mind

Learn practical frameworks for embedding disclosure checkpoints at key study milestones to prevent compliance bottlenecks, reduce rework, and improve data quality

Technology and AI in action: Using automation and AI to reduce manual work, standardize workflows, and improve efficiency

Lessons from real implementations: Practical insights from delivered process improvement and AI initiatives that drove measurable impact

Explore challenges in ensuring consistency between clinical trial registries like ClinicalTrials.gov and peer-reviewed publications

Examine discrepancies in trial design, outcome measures, and adverse event reporting, and their impact on patient trust and secondary research

Gain insights into practical strategies for harmonizing data reporting, fostering transparency, and building credibility across clinical trial platforms