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Day 1 2019年11月10日 (日)

9:30 AM — 12:00 PM

Student Session: Medical Risk Communication on Diabetes Medicine: What Information Should We Share?

12:00 PM — 1:00 PM

Orientation

1:00 PM — 1:30 PM

Pre Opening

1:30 PM — 1:45 PM

Welcome

2:00 PM — 2:15 PM

Japan Inspire Awards

2:15 PM — 3:00 PM

Program Chair’s Lecture: Method of Regulatory Science Promoting Rational Medicine Initiative

3:30 PM — 4:15 PM

Keynote Address: Sitting Close to Children Bearing Life-Threatening Diseases and Their Family with Disney’s Hospitality

4:15 PM — 5:45 PM

DIAmond Session 1: What Do Patients Want for Clinical Trials and Clinical Research? What Should Stakeholders Do?

Day 2 2019年11月11日 (月)

9:00 AM — 10:30 AM

[S01]Current Status of the Application of Cancer Genomic Medicine - Present and Future of Gene panel Testing-

9:00 AM — 10:30 AM

[S02] Block Chain Technology and the Deployment to Pharmaceutical Industry

9:00 AM — 10:30 AM

[S03 ]Collaboration with WHO for Global Health

9:00 AM — 10:30 AM

[S04] Examples of Clinical QMS Introduction: Risk Analyses and Issue Management

9:00 AM — 10:30 AM

[S05] Clinical Trials Act: Experiences from the Past, the Way of the Future

9:00 AM — 10:30 AM

[S06] A Solution for Patients and Healthcare Providers: a New Trial in Pharmacovigilance

9:00 AM — 10:30 AM

[S07] Ideal Conduct and Future Perspectives for Publication by Pharmaceutical Companies

9:00 AM — 10:30 AM

[S08] Deep Dive into China Regulatory Reform from Various Perspective

9:00 AM — 10:30 AM

[S09] What is “Shared Value” Created by Collaboration Among Industry, Academia, Government and Individuals of Current and Future Generations - Going Forward to New Era of Innovation

11:00 AM — 12:30 PM

[S10] Initiatives For The Future of Digital Health: Utilizing Digitalized Product Information/Labeling for Healthcare Professionals and Patients

11:00 AM — 12:30 PM

[S11] How Will the Development and NDA Activities in Japan Change in View of the Future of AI Translation?

11:00 AM — 12:30 PM

[S12] What is Expected to MA/MSL?

11:00 AM — 12:30 PM

[S13] Challenges on Implementation of Risk Based Approach and Its Foresight

11:00 AM — 12:30 PM

[S14] Forefront of Drug Delivery System (DDS) Technology

11:00 AM — 12:30 PM

[S15] Lessens from Experiences Using MidNet for PV

11:00 AM — 12:30 PM

[S16] Promotion of Pediatric Drug Development by Industry, Government and Academia - What Has Changed, What Has Been Done and What Is Necessary for the Further Progress?

11:00 AM — 12:30 PM

[S17] Sharing Individual Participant Data (IPD) from Clinical Trials and Personal Information Protection

11:00 AM — 12:30 PM

[S18] How to Handle Conflict in the Workplace? Encourage, Engage, and Innovate with People Around You

2:00 PM — 3:30 PM

[S19] A New and Optimal Collaboration with Companies in Investigator Initiated Trials Using Government Platform

2:00 PM — 3:30 PM

[S20] Drug Information on the Pharmacokinetics Section in the Japan Package Insert Can be Evolve Furthermore Attractively?

2:00 PM — 3:30 PM

[S21] What Kind of Information Should Medical Deliver in Compliance with Promotional Activity Guideline?

2:00 PM — 3:30 PM

[S22] Enabling More Efficient Clinical Studies through TransCelerate Solutions

2:00 PM — 3:30 PM

[S23] What Patient Registries Bring to Rare Disease Medicine Development

2:00 PM — 3:30 PM

[S24] Have You Already Had a Labeling with New Format? How to Read New Format of Labeling and Impact for Implementation on Medical Practice

2:00 PM — 3:30 PM

[S25] Let’s Talk a Lot About What Future Shape of Ideal Collaboration to Promote Life Science Field Is

2:00 PM — 3:30 PM

[S26] eSource in Clinical Trials -Global/Japan Use Cases-

2:00 PM — 3:30 PM

[S27] How About the Courage to Take a Further Step for Young People?

4:00 PM — 5:30 PM

[S28] Global Oncology Development - Be a Game Changer in Oncology Development -

4:00 PM — 5:30 PM

[S29] Leveraging Physiological Pharmacokinetic (PBPK) Analysis for Development After Issuing Official Guidance the Potential Impacts of PBPK Analysis on Japan Submission

4:00 PM — 5:30 PM

[S30] lCH E9 (R1): Understand Estimand. Let’s Discuss the Impact on the Design of Clinical Trials

4:00 PM — 5:30 PM

[S31] Do you manage quality of the clinical trial for whom ? - What We Can Do for Patients -

4:00 PM — 5:30 PM

[S32] The Basics of Health Technology Assessment - From Clinical Trials to Pricing -

4:00 PM — 5:30 PM

[S33] Practice of Post-Introduction of New Consultation System of Labeling for Revision

4:00 PM — 5:30 PM

[S34] The Present and Future of Utilization of AI and Digital Technology in Medicine Development and Healthcare Services -To Deliver Rational Medicine-

4:00 PM — 5:30 PM

[S35] The Appropriate Use of Drugs in Asia Countries, Especially Elder Patients

4:00 PM — 5:30 PM

[S36] Bringing Japanese Technology to the World! Ideal Way of Life Science Innovation in the Era of Peace, Considered by Industry, Government and Academia

5:45 PM — 7:00 PM

Special Chatt Session

Day 3 2019年11月12日 (火)

9:00 AM — 10:30 AM

[S37] The Future of Medical Big Data Based on the Next Generation Medical Infrastructure Act

9:00 AM — 10:30 AM

[S38] Regenerative Medical Products - Learn from the Latest Approved Products -

9:00 AM — 10:30 AM

[S39] Utilization of RWD for the Clinical Trial Design and New Drug Application

9:00 AM — 10:30 AM

[S40] Consider How to Provide Patient-Sought Drug Information

9:00 AM — 10:30 AM

[S41] The Dawn of Program Management: Beyond Project Management

9:00 AM — 10:30 AM

[S42] Think About Informed Consent from a Patient’s Perspective – What Can We Do to Promote Proper Understanding of Clinical Trials and PatientFriendly Clinical Trials?

9:00 AM — 10:30 AM

[S43] Virtual Clinical Trials: Roadmap for Implementation in Japan

11:00 AM — 12:30 PM

[S44] Innovative Drug Development: Is the Placebo Arm Really Necessary?

11:00 AM — 12:30 PM

[S45] Gene Therapy – Learn from the Cases

11:00 AM — 12:30 PM

[S46] Establishing Real-World-Evidence in Japan, from the Perspective of Database Utilization

11:00 AM — 12:30 PM

[S47] Toward to Development of Comprehensive and Reliable Drug Information System for Consumers and Patients

11:00 AM — 12:30 PM

[S48] How Should We Set Up Our R&D Strategy and Target Product Profile? Key Learning from Real Cases

11:00 AM — 12:30 PM

[S49] Forefront of Patient Technology in Clinical Trials

11:00 AM — 12:30 PM

[S50] The Latest Cases and Further Perspective of Early Approval System in Japan

2:00 PM — 3:30 PM

DIAmond Session 2: Rational Medicine for Patients

4:00 PM — 5:30 PM

DIAmond Session 3: PMDA Town Hall

5:30 PM — 5:40 PM

Closing

16th DIA Japan Annual Meeting 2019

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