Day 2 – Friday, September 11, 2026 - ET (Eastern Time, GMT-05:00)
An interactive workshop designed for senior disclosure professionals and industry veterans.
Prepare for emerging regulatory landscapes including EHDS, expanding Asian markets, and evolving transparency requirements across jurisdictions
Master disclosure approaches for challenging scenarios including adaptive trials, decentralized/hybrid studies, novel modalities, and multi-sponsor collaborations
Build scalable strategies and technology roadmaps that future-proof your disclosure program as complexity and portfolio size increase
- Tom Chmielewski - Senior Director, Disclosure & Transparency, Jazz Pharmaceuticals
Fundamentals for newcomers to clinical trial transparency & disclosure.
Understand the landscape of data disclosure, key stakeholders, and why transparency matters across the clinical trial lifecycles
Navigate major regulations and requirements across FDA, EMA, MHRA, Health Canada, and other jurisdictions
Master core concepts including anonymization, redaction, plain language summaries, data sharing and common compliance pitfalls
- Rehana Blunt - Senior Manager, Clinical Trials Disclosure, Amgen
Explore how AI enhances rather than replaces medical writing expertise.
Address the reality: Why AI cannot replace strategic value, clinical judgement, and expertise that medical writers provide
Evaluate current AI tools, their appropriate applications, and where human expertise remains essential for quality and compliance
Redefine the evolving medical writer role from tactical execution to strategic oversight, with expanded skills and career opportunities in an AI-enabled environment
- Shirisha Kanthala - Director of Trial Disclosure, Incyte
- Sujata Shah - Senior Director, Medical Writing Delivery & Excellence, Moderna
Challenge the “handoff model” between regulatory writing and disclosure and examine why it creates misalignment, inefficiencies, and avoidable rework
Expose the hidden cost of disconnected teams by exploring how inconsistencies across protocols, study reports, and public disclosures arise, and how to prevent them upstream
Rethink the role of medical writers in transparency by positioning clinical team writers and disclosure specialists as a unified function with shared accountability for clear, consistent communication
- Sujata Shah - Senior Director, Medical Writing Delivery & Excellence, Moderna
- Oanh Stephan - Executive Director, Head of Global Medical Writing, Beigene
- Linda LaMarre - Director, Medical Writing, Daiichi Sankyo
Explore how leading organizations are repositioning medical writers from tactical executors to strategic partners in disclosure planning and patient communication
Examine organizational models that integrate medical writers earlier in trial planning, involve them in cross-functional decision-making, and recognize their expertise
Learn strategies for career development, professional recognition, and creating pathways for medical writers to influence transparency strategies and patient-facing communications
- Shirisha Kanthala - Director of Trial Disclosure, Incyte
- Marta Nabielec - Director of Medical Writing, Astellas Pharma
Build meaningful partnerships with patient advocacy organizations to improve disclosure material development and distribution
Learn how advocacy groups can amplify reach, provide patient input, and ensure materials meet community needs
Explore collaborative models for patient review, co-creation, and effective dissemination of trial information to patient communities
- Marina Peele - Associate Director, Clinical Trial Transparency, Cytokinetics
Understand NLM’s current expectations for registration and results reporting, including how reporting quality is evaluated, and gain insight into determinations of non-compliance made independently of NLM
Hear directly about NIH’s data return to patients initiative and how the agency is advancing transparency
Get an inside look at the ClinReg platform, NIH’s approach to modernizing clinical trial oversight and what disclosure teams need to know about its capabilities and roadmap
- Stacey Arnold - Results Team Subject Matter Expert, National Institutes of Health (NIH)
April 2026 policy changes, including new expectations for returning individual and summary‑level results to participants
How UK transparency requirements diverge from EU approaches
Clarifying sponsor vs site responsibilities in participant communications
- Clive Collett - Head of Policy and Engagement, Health Research Authority (HRA)
Updates to PRCI submission requirements
Anonymization expectations and common challenges
Timelines and format guidance
Explore the full journey of patient-facing materials from development to real-world access, including how organizations can ensure patients actually find, understand and use the information provided
Apply plain language and health literacy principles that strengthen clarity, trust and usability across diverse patient populations while supporting consistent communication throughout the trial lifecycle
Develop intentional and repeatable distribution strategies that incorporate data-driven insights, partnerships and measurable outcomes to demonstrate meaningful patient engagement
- Kimbra Edwards - Senior Director, Health Communication Services, Center for Information and Study on Clinical Research Participation (CISCRP)
Review how evolving regulatory expectations and good clinical practice standards are reshaping informed consent requirements and what this means for how sponsors design and communicate consent documents
Explore the tension between legal completeness and genuine participant comprehension and how plain language principles can bridge the gap
Determine practical approaches for designing consent processes that build meaningful trust and informed participation across trial populations
Examine how regulators are narrowing what qualifies as commercially confidential information and what this shift means for disclosure strategies
Explore the growing push from patients and stakeholders for greater openness, and how organizations can balance transparency with appropriate CCI protection
Learn practical redaction and governance best practices that ensure compliance, minimize over‑redaction, and maintain meaningful transparency
- Laura Dodd - Associate Director of Clinical Trial Transparency & Disclosure, Kura Oncology
- Whitney Graves - Director, Clinical Trial Transparency & Disclosure, Immunome
Examine the lack of harmonized anonymization standards across major jurisdictions and the practical implications for global trial sponsors managing multi-regional disclosure requirements
Compare anonymization and privacy requirements across EU (GDPR), US (HIPAA), Canada, and Asia-Pacific markets including what qualifies as personal versus confidential data by region
Learn strategies for developing adaptable anonymization approaches that balance global consistency with regional compliance requirements
- Ritama Gupta Dempsey, PhD - Associate Director, Medical Writing and Disclosure, Merck
Explore emerging trends and anticipated changes in clinical trial disclosure for 2027 and beyond, including regulatory evolution, technology advancement, and shifting stakeholder expectations
Examine open questions facing the industry such as diversity in trials without enforcement mandates, decentralized trial implications, and AI regulation acceleration
Gain forward-looking perspectives from diverse industry voices to help organizations prepare strategically for the next phase of clinical transparency
- Elizabeth Brown - Executive Director, Disclosure & Health Literacy, Merck