Agenda

Day 1 Nov 05, 2023

9:30 AM — 12:45 PM

#SC01: Life Cycle Management

9:30 AM — 12:45 PM

#SC02: Medical Affairs

9:30 AM — 12:45 PM

#SC03: DIA Regulatory Communication Training

9:30 AM — 12:45 PM

Student Session : Appropriateness of Placebo-Controlled Trials ?Consider Ethical Issues and Patient Consideration from Multiple Perspectives?

12:55 PM — 1:35 PM

Orientation

1:45 PM — 2:15 PM

Opening

2:15 PM — 2:45 PM

PROGRAM CHAIR : Management of Pharmaceutical R&D in the New Era ~Society 5.0~ with Integrating Knowledge and Skills that Transcend Time and Space (Japanese)

2:15 PM — 2:45 PM

Program Chair Session : Management of Pharmaceutical R&D in the New Era ~Society 5.0~ with Integrating Knowledge and Skills that Transcend Time and Space

3:00 PM — 4:00 PM

Keynote-1 : Futuristic vision for disease prediction and prevention at ultra-early stages -Moonshot Research & Development Program-

5:00 PM — 6:00 PM

Keynote-2 : Regulatory Innovation in Oncology Drug Development

5:00 PM — 6:00 PM

KEYNOTE-2 :Regulatory Innovation in Oncology Drug Development (Japanese)

5:00 PM — 6:30 PM

S01 : Think about the Medical DX Reiwa Vision 2030 and Future Drug Information

5:00 PM — 6:30 PM

S02 : Cutting Edge Series - Future Life with Connected Technologies - from Food and FemTech Perspectives

5:00 PM — 6:30 PM

S03 : Open Science accelerated by COVID-19, followed by Evidence Generation in the Era of Artificial Intelligence and Digital Transformation

5:00 PM — 6:30 PM

S04 : Introduction to Project Management for Beginner: What is a Project?

Day 2 Nov 06, 2023

9:30 AM — 11:00 AM

S05 : CDM: Basis for ALL Clinical Research Collaborations

9:30 AM — 11:00 AM

S06 : "Let's Dialogue about the Future of Treatment Development for Rare Cancers -Steps Toward Unmet Needs-"

9:30 AM — 11:00 AM

S07 : Your Life Data for Good Sake? :How to Deploy Wearable Devices

9:30 AM — 11:00 AM

S08 : Patient Centric Informed Consent - How We can Design IC Process and Empower Participants.

9:30 AM — 11:00 AM

Special Session-1 : Orphan Drug Development Update - Issues and Measures for Global Cooperation –

11:15 AM — 12:45 PM

DIAmond Session-1 : China Town Hall

11:15 AM — 12:45 PM

S09 : FDA and PMDA Update: Oncology Drug Development and Regulation

11:15 AM — 12:45 PM

S10 : What's the Neighborhood Do? A Quality Strategy for All Stakeholders

11:15 AM — 12:45 PM

S11 : Challenges and Transforming Interactive Communication in Drug Development Using Open Source Software

11:15 AM — 12:45 PM

S12 : Fundamental Question of Trial Participation - What are the Ethical Issues in Clinical Trials? Let's Talk about it Together

1:45 PM — 3:15 PM

S13 : The Direction of Review of Regenerative Medical Products ? From the Experiences of 10 Years and the Future ?

1:45 PM — 3:15 PM

S14 : Toward Society 5.0: What We should do/can do Now for Delivery and/or Access to Correct Medical Information

1:45 PM — 3:15 PM

S15 : Data Integrity from Electronic Health Record (EHR) to EDC from the View of Medical Practice and Clinical Trial

1:45 PM — 3:15 PM

S16 : Hints for Utilization of Real World Data in Drug Development -Maximization of RWD Utilization Value Corresponding to the Issue to be Solved-

1:45 PM — 3:15 PM

Special Session-2 : Consider the Future of the Pharmaceutical Industry. ~What value can DIA Create?

4:15 PM — 5:45 PM

S17 : Field-Based Reconsideration of Protocol Design

4:15 PM — 5:45 PM

S18 : We've Come This Far! Implementation of Automation of Safety and Regulatory Authority Initiatives

4:15 PM — 5:45 PM

S19 : How We Drive the Changes; a Change Framework with Psychological Safety

4:15 PM — 5:45 PM

S20 : Next Generation Medical Infrastructure Act Revision Promotes Utilization of Medical Information

4:15 PM — 5:45 PM

Special Session-3 : Consider the Future of the Pharmaceutical Industry. ~What value can DIA Create?

6:00 PM — 7:30 PM

Special Chatting Session

Day 3 Nov 07, 2023

9:30 AM — 11:00 AM

S21 : Exploring IRBs with a Global Twist!

9:30 AM — 11:00 AM

S22 : Beyond ICH M11-How will the Digitalization of Protocol Data Transform Drug Development? - Future Perspective -

9:30 AM — 11:00 AM

S22 : Beyond ICH M11-How will the Digitalization of Protocol Data Transform Drug Development? ~Future Perspective~

9:30 AM — 11:00 AM

S23 : What are the Challenges of Medical Technology Development and Innovation Assessment in the New Healthcare Era?

9:30 AM — 11:00 AM

S24 : What Industry, Government, and Academia should do to Accelerate Drug Development in the Field of Neurological Diseases

9:30 AM — 11:00 AM

S25 : Let's Dialogue about Drug Development Research in the Era of Super Smart Society in Collaboration with Academia, Government, Industry, and Public

11:15 AM — 12:45 PM

DIAmond Session-2 : Modernizing Clinical Research Globally: A Multi-Stakeholder Discussion Focused on Accelerating Innovation & Improving Patient Experiences

11:15 AM — 12:45 PM

S26 : Beyond ICH M11-How will Drug Development Change? ~ Issues in Japan

11:15 AM — 12:45 PM

S27 : Discussion with Patients for Development of Rare Diseases ~For Improve Drug Loss in Japan~

11:15 AM — 12:45 PM

S28 : Paradigm Shift in Oncology Drug Development ~ Challenging Dose Optimization with Clinical Pharmacology Approach ~

11:15 AM — 12:45 PM

S29 : "How can People Evolve and Adapt in the Era of Society 5.0? - Let's Chat about our Value in Healthcare Platform-"

1:45 PM — 3:15 PM

S30 : Pharmaceutical Company’s Initiatives and Challenges in Health Literacy & Statistical Literacy

1:45 PM — 3:15 PM

S31 : Full Remote DCT Implementation in Clinical Trials for Cancer Patients

1:45 PM — 3:15 PM

S32 : Reboot Patient Engagement for GCP Renovation

1:45 PM — 3:15 PM

S33 : Developing Talent in the Society 5.0 Era: Who are the Critical R&D Personnel for Open Innovation?

1:45 PM — 3:15 PM

S34 : How should be Reguratory Document for Innovative Drug Development and Effective Drug Application Review in Society 5.0 Era?

4:15 PM — 5:45 PM

DIAmond Session-3 : PMDA Town Hall Meeting

4:15 PM — 5:45 PM

S35 : Incorporate Patient's ‘ Voice ’ into Clinical Trials with dBM

4:15 PM — 5:45 PM

S36 : Society 5.0 in the Healthcare Domain Aimed for with the Supercomputer "Fugaku"

4:15 PM — 5:45 PM

S37 : Challenges and the Future Ahead for Sharing and Integrating Medical Data

4:15 PM — 5:45 PM

S38 : Real World of Clinical Pharmacology in Global Drug Development

6:00 PM — 6:30 PM

Closing

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20th DIA Japan Annual Meeting 2023

Agenda

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