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Tokyo Big Sight

2026年10月18日 (日) 午前 9:30 - 2026年10月20日 (火) 午後 6:00

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

The 23rd DIA Japan Annual Meeting 2026

“Crossing Boundaries, Shaping a Future Beyond Imagination with Innovation.”

アジェンダ

9:00 AM — 10:40 AM

Asia-1 : Regulatory Science in Asia: Advancing Drug Development with Collaboration in Asia

9:00 AM — 10:30 AM

iPS Session : The World's First iPSC-Based Product: Journey to Commercialization and Future Outlook

9:00 AM — 10:30 AM

S01 : Utilizing DX: The Global and Japanese Status of Clinical Trial Data Concepts Pioneered by Generative AI and ICH M11

9:00 AM — 10:30 AM

S02 : Advancing Pharmacovigilance: ICSR Management, RWE Usage, and Their Combined Value for Patient Safety

9:00 AM — 10:30 AM

S03 : The Potential of Novel Partnerships to Accelerate Drug Development for Rare Diseases

9:00 AM — 10:30 AM

S04 : The Value Japan Can Contribute to Global Clinical Trials and the Role of Clinical Scientists - Clinical Science & Strategy -

9:00 AM — 10:30 AM

S05 : Reimagining Drug Development Through Virtual Experimentation: Lessons from Digital Twin Adoption in Other Industries - Clinical Innovation -

9:00 AM — 10:30 AM

S06 : Refining IC Beyond Boundaries: Dialogue on Informed Consent in Emergency Clinical Trials – Lessons from Hyperacute Stroke

11:15 AM — 12:45 PM

Asia-2a : Beyond E17 - Holistic Implementation of E5 and E17 to Lead Global Drug Development from Asia

11:15 AM — 12:45 PM

S07 : Co-Creating Patient-Centered Drug Information Through Structured Data and AI in Practice

11:15 AM — 12:45 PM

S08 : Have you looked up the blue sky? Project SOUTEN, Data-Driven Accelerated Trial Enrollment Model From Japan

11:15 AM — 12:45 PM

S09 : The Power of the DIA Community: Co-Creation of the Lifecycle for Next-Generation Drugs and Medical Devices Led by Japan

11:15 AM — 12:45 PM

S10 : ”Smart” MIDD in the ICH-M15 Era: An Industry-Government Paradigm Shift in Drug Development - Clinical Pharmacology -

11:15 AM — 12:45 PM

S11 : Regulatory Submissions and Review in the AI Era: Preparing Today for the Future of AI — Toward a Future Beyond Our Imagination - Regulatory Affairs -

11:15 AM — 12:45 PM

S12 : Evidence Requirements for Conditional and Time-Limited Approval: Statistical Evaluation of Small-Sample Regenerative Products

11:15 AM — 12:55 PM

Special Session-1 : Contributions of Japan’s Collaborative Innovation Hubs to the Drug Discovery Ecosystem

2:15 PM — 3:45 PM

Asia-2b : Transformation in Quality Management Approach for Global Clinical Trials - Strategic E6(R3) Implementation to Realize “Flexible" GCP Leveraging CTQ Factors

2:15 PM — 3:45 PM

Pitch Session

2:15 PM — 3:45 PM

S13 : Connecting Data, Opening the Future: Standardization, Integration, and AI for the Next-Generation Drug Discovery Pipeline

2:15 PM — 3:45 PM

S14 : Dialogue That Sparks Innovation: A Bridge Crossing Boundaries - Project Management -

2:15 PM — 3:45 PM

S15 : The Role of Academia and Public Private Partnerships in Accelerating Drug Development for Neurological Diseases

2:15 PM — 3:45 PM

S16 : RMP 2.0 Evolving Pharmaceutical Risk Management with the Revised PMD Act: Toward Patient-Centered Safety - Pharmacovigilance & Labeling -

2:15 PM — 3:45 PM

S17 : Medical Devices Today: Experience with RWD in Regulatory Submissions and Post-Market Surveillance - Device -

2:15 PM — 3:45 PM

Special Session-2 : Healthcare Revenue Models in the Era of Population Decline: Co Creating Innovation Through Public Private Partnerships

4:30 PM — 6:05 PM

Asia-3 : Advancing Patient-Focused Drug Development: From Clinical Trials to Real-World Medication Use

4:30 PM — 6:00 PM

Regulatory Session-1 : Delivering Innovation to Patients: Perspectives from PMDA, Startups, and Venture Capital

4:30 PM — 6:00 PM

S18 : Creating a Sustainable Digital Biomarker Ecosystem: A Future Unlocked by “New Connections” Beyond Clinical Trials

4:30 PM — 6:00 PM

S19 : Roundtable Discussion: Toward Implementation of a Single IRB

4:30 PM — 6:00 PM

S20 : Interactive Session: The Value of Continuous Thinking: Exploring the Essence of Work Shaped by Junior and Senior Professionals - Operation Team -

4:30 PM — 6:00 PM

S21 : Real-World Applications of Generative AI: Practical Implementation and Considerations in Drug Development - Statistics -

4:30 PM — 6:00 PM

S22 : Modernizing Clinical Trials with Pragmatic Elements: Regulatory and Sponsor Perspectives from Japan and Beyond

4:30 PM — 6:00 PM

S23 : Do Unmet Needs Persist Despite Advances in Treatment and Diagnosis? Bridging the Gap with RWD and AI - Medical Affairs -

4:30 PM — 6:00 PM

Sponsord Seminar : From Discovery to Submission: Operationalizing Next-Gen AI and Agentic Workflows in Drug R&D

7:00 PM — 8:45 PM

Special Chatting Session

9:00 AM — 10:30 AM

DIAmond Session-1 : From Japan to the World: Bringing Next-Generation Treatments to Patients

9:00 AM — 10:30 AM

Regulatory Session-2 : China Town Hall

9:00 AM — 10:30 AM

S24 : Reframing Vulnerability: Toward Inclusion of Pregnant and Lactating Women in Clinical Research through ICH E21 - Bioethics -

9:00 AM — 10:30 AM

S25 : Can Patient-First Care Survive Drug Lag? Finding the Right Balance Between Universal Healthcare and Innovation - HEOR+ -

9:00 AM — 10:30 AM

S26 : Bringing Your "?" to Everyone: The PEC 120 Million Dialogue Session

9:00 AM — 10:30 AM

S27 : Rebooting PMS: Redefining PMS in Light of RMP Formalization and Evolving Development

9:00 AM — 10:30 AM

S28 : The Practice of Patient Preference Study and Its Value as Evidence: Connecting the Patient's Voice to Decision-Making

9:00 AM — 10:30 AM

S29 : Estimand in Medicinal Product Information: Challenges and Perspectives from Development to Post-Marketing ?Medical Communications?

11:15 AM — 12:45 PM

DIAmond Session-2 : Advancing Next-Generation Medical Research Beyond Gravity — Microgravity as a Transformative Frontier —

11:15 AM — 12:45 PM

S30 : Evolving Review Collaboration Among ICH Founders: Combining Regulatory and Global Development Experiences for Patient Benefit

11:15 AM — 12:45 PM

S31 : The Frontier of Evidence Generation through Clinical Trial Data×RWD: Data Ecosystems Shaping RWD/RWE and Japan's Place - Clinical Data Management -

11:15 AM — 12:45 PM

S32 : Dialogue Between Regulators and Startups: PMDA and AMED Public Support Programs and the Reality for Founders - Open Innovation -

11:15 AM — 12:45 PM

S33 : Creating a Collaborative Communication Platform to Support Clinical Trials in Accordance with ICH E6 (R3) - Lean Six Sigma & Healthcare Process Excellence -

11:15 AM — 12:45 PM

S34 : ”Reach” Before Recruitment: Rethinking Clinical Trial Information Flow: Perspectives from Patients, Industry, and Regulators -Clinical Operations & Monitoring -

11:15 AM — 12:45 PM

S35 : Healthcare DX 2030: Unlocking the Next Moves in Vaccines, Medicine, and Real-World Data from Vaccination Digitalization

11:15 AM — 12:45 PM

S36 : Implementing Go/No-Go Decision-Making in Drug Development and Healthcare Ecosystems Across Sectors

2:15 PM — 3:45 PM

DIAmond Session-3 : Driving Drug Discovery Innovation with AI

2:15 PM — 3:45 PM

Media Session : Addressing Information Asymmetry Between Patients and Healthcare Stakeholders in Drug Development

2:15 PM — 3:45 PM

S37 : New Insights, Strategies and Practices to Optimize Protocol Data Collection

2:15 PM — 3:45 PM

S38 : Risk Communication: Today and Tomorrow: The Emerging Convergence of Behavioral Science and Digital/AI Innovation

2:15 PM — 3:45 PM

S39 : Assessing Real-World Data Relevance and Reliability for Regulatory Submission Across Stakeholder Views

2:15 PM — 3:45 PM

S40 : Final Outputs Don't Tell the Whole Story: Walking Through Design Processes in Routine PV and Post-Marketing Database Studies - Life Cycle Management -

2:15 PM — 3:45 PM

S41 : Adaptive Trials for Better Decision-Making (Tentative)

2:15 PM — 3:45 PM

S42 : Reflecting on the Integration of Regulatory Requirements for Clinical Trials in Japan: Focusing on Interventional Research

4:30 PM — 6:00 PM

DIAmond Session-4 : PMDA Town Hall

6:00 PM — 6:30 PM

CLOSING

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