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Tokyo Big Sight

19 oct 2025 9:30 a.m. - 21 oct 2025 6:00 p.m.

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

The 22nd DIA Japan Annual Meeting 2025

Strong Ties of Japan with Asia and the World for Delivering ‘Tomorrow's Normal’ to Patients

Agenda

9:00 AM — 10:30 AM

S01 : How the Revised Declaration of Helsinki Shape the Future - Challenges in Clinical Settings/Studies/Research and Hopes

9:00 AM — 10:30 AM

S02 : Optimizing Global Drug Development from Asia - Challenges of Clinical Pharmacology Community in Japan, China, and South Korea

9:00 AM — 10:30 AM

S03 : Looking Ahead to the Future of PMS: Proposal for a Grand Design Based on Global Standards from JSCTR

9:00 AM — 10:30 AM

S04 : Discussing Critical to Quality Factors: Looking Ahead to ICH E6 (R3) Step 5

9:00 AM — 10:30 AM

S05 : Delivering Tomorrow's Normal Sense to Inbound Visitors and Patients to Japan; Considering the Future of Multilingual Support

9:00 AM — 10:30 AM

Special Session - 1 : Toward “Tomorrow’s Normal” through AI Utilization - Current Status and Challenges -

11:15 AM — 12:45 PM

S06 : Delivering Innovative Medicines Faster to Patients in Asia – From Perspective of China-Japan Collaboration in Simultaneous Global Development

11:15 AM — 12:45 PM

S07 : Global Regulatory Expansion Strategy for Orphan Drugs Already Approved in Japan: Collaborating to Pioneer Tomorrow's Normal

11:15 AM — 12:45 PM

S08 : First-in-Global, First from Japan: Current Status and Future Prospects of First-In-Human Trials in Japan

11:15 AM — 12:45 PM

S09 : Towards a Future Without Drug Lag / Drug Loss - Patients' Expectations, Industry's Goals, and Academia's Recommendations

11:15 AM — 12:45 PM

S10 : Impact of ICH E6 (R3) on GCP Inspection: from Global Perspectives

11:15 AM — 12:45 PM

S11 : Innovating the Future of Medicine and Healthcare - Strategic Initiatives by the Life Intelligence Consortium (LINC)

1:55 PM — 3:25 PM

DIAmond Session - 1 : Building a Solid Pathway to Reliance in ASEAN

1:55 PM — 3:25 PM

S12 : Transitioning to Open Source: Unlocking New Data Analysis Environments and Transforming Organizations

1:55 PM — 3:25 PM

S13 : Ecosystem Synergy: Enhancing Global Pharma Development through Data Interoperability

1:55 PM — 3:25 PM

S14 : Can RWD Address Patient Enrollment Challenges? – Toward a Future Where Effective RWD Use Is Standard in Drug Development

1:55 PM — 3:25 PM

S15 : The Road to Single IRB - Establishing a Globally Recognized Single IRB

1:55 PM — 3:25 PM

S16 : How will Post-Marketing Safety Measures Change with the Revision of the Pharmaceuticals and Medical Devices Act?

4:25 PM — 5:55 PM

S17 : Achieving a Healthier Future for Asia Through Trust and Collaboration

4:25 PM — 5:55 PM

S18 : How Virtual Reality and the Metaverse are Transforming Communication in Healthcare and Clinical Trials?

4:25 PM — 5:55 PM

S19 : The Cutting Edge of Healthcare DX in Japan and Abroad: What Future are We Aiming for?

4:25 PM — 5:55 PM

S20 : Shaping a New Era from the Frontlines: Inside-out for the Pediatric Drug Development Future

4:25 PM — 5:55 PM

S21 : Toward Tomorrow’s Norm: Patient-Driven Drug Development through Collaboration with Academia and Emerging Biopharma

4:25 PM — 5:55 PM

Special Session - 2 : The Role of Asia in Advancing Global Clinical Trials - Toward Tomorrow’s Normal for Asian Patients -

9:00 AM — 10:30 AM

DIAmond Session - 2 : The First Step Toward “Tomorrow’s Normal”: The Aspiration of Asian Patients

9:00 AM — 10:30 AM

S22 : Navigating Complexity in DCTs: Implications for Data Management and Risk-Based Quality Oversight

9:00 AM — 10:30 AM

S23 : New Normal for Patients: Future Changes Brought by the Revision of the Pharmaceutical and Medical Device Act

9:00 AM — 10:30 AM

S24 : Value Creation through Program and Project Management - For the “Tomorrow's Normal” to Patients -

9:00 AM — 10:30 AM

S25 : Exploring Exit Strategies and Challenges for dBM Development in Pharmaceutical Drug Development

9:00 AM — 10:30 AM

S26 : Advancing Neurotherapeutics: Driving Global Innovation in Treatments for Neurological Disorders

11:15 AM — 12:45 PM

S27 : Clinical Trials 2035: Innovations That will Transform the Future of Research

11:15 AM — 12:45 PM

S28 : Utilization of Patient Experience Data for Patient-Focused Drug Development

11:15 AM — 12:45 PM

S29 : Accelerating ICH M11 Implementation: International Collaboration Across Stakeholders for Innovation with the Digital Protocol

11:15 AM — 12:45 PM

S30 : Asian Collaboration in Drug development: Perspectives from Open Innovation and Corporate Venture Capital Investment

11:15 AM — 12:45 PM

S31 : Let's think New Strategies to Expand Treatment Options

11:15 AM — 12:45 PM

Special Session - 3 : China Town Hall

1:55 PM — 3:25 PM

S32 : Optimizing Clinical Trials: Rethinking the “Norms” of Clinical Operations in Japan - Past Assumptions and Future Directions

1:55 PM — 3:25 PM

S33 : Utilizing Patient Experience and Preference Information in Regulatory Decision-Making

1:55 PM — 3:25 PM

S34 : Pediatric Drug Development and Evidence Strategies in Japan in the Era of Global Clinical Trials

1:55 PM — 3:25 PM

S35 : Health Equity, Tomorrow’s Normal in Rare Diseases

1:55 PM — 3:25 PM

S36 : Towards a Unified Submission Paradigm: Enhancing Regulatory Preparedness through Collaboration and Technology

1:55 PM — 3:25 PM

S37 : Recent Phase I Cancer Trial Design and Practice

3:55 PM — 5:25 PM

DIAmond Session - 3 : PMDA Town Hall

5:25 PM — 5:55 PM

Closing

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