Agenda

Day 1 Nov 11, 2018

9:30 AM — 12:00 PM

Student Session

1:30 PM — 1:45 PM

Welcome

2:15 PM — 3:00 PM

Keynote Address 1

3:30 PM — 4:15 PM

Keynote Address 2

4:15 PM — 5:45 PM

[DIAmond Session 1] New Challenges for Innovation - ICMRA Innovation Project -

Day 2 Nov 12, 2018

9:00 AM — 10:30 AM

[V1-S1] The Experience of Global Phase 1 Study (Japan/US) –Oncology Area-

9:00 AM — 10:30 AM

[V2-S1] Changes Required for Risk Minimization Materials

9:00 AM — 10:30 AM

[V3-S1] Utilize Know-How and Experiences of Medicine/Device Development Obtained through Investigator Initiated Clinical Trials for Forthcoming Japan Venture Promotion

9:00 AM — 10:30 AM

[V4-S1] Overview of Cancer Genome Precision Medicine in Medical Practice - Oncology Panels and CDxs -

9:00 AM — 10:30 AM

[V5-S1] Call for Abstract Session

9:00 AM — 10:30 AM

[V6-S1] Challenges and Issues to Product Development for Gene Therapy

9:00 AM — 10:30 AM

[V7-S1] Implementing Quality Management System (QMS) in Your Trials and Understanding the Purpose and Concept

9:00 AM — 10:30 AM

[V8-S1] Target Product Profile - Better Way to Build Up R&D Management Plan [Call for Abstract Session]

11:00 AM — 12:30 PM

[V1-S2] Recent Trend of Pharmaceutical Regulation in the World

11:00 AM — 12:30 PM

[V2-S2] Current Activity on Utilization of Patient Registry Data

11:00 AM — 12:30 PM

[V3-S2] Technical and Operational Know-How for Conducting Clinical Studies under Limited Manpower

11:00 AM — 12:30 PM

[V4-S2] How to Read and Future Prospects for PMDA Review Reports

11:00 AM — 12:30 PM

[V5-S2] Oligonucleotide Therapeutics as Next Generation of New Medicine - Regulatory & Quality Considerations

11:00 AM — 12:30 PM

[V6-S2] Think about the Exit Strategy in Drug Discovery Processes of Academia

11:00 AM — 12:30 PM

[V7-S2] Use and Application of Real World Data/Evidence Based on Next Generation Medical Infrastructure Act

11:00 AM — 12:30 PM

[V8-S2] The Latest Regulatory Trend and Counter Measures for Data Integrity

2:00 PM — 3:30 PM

[V1-S3] Current Situation and Future Perspectives of Risk Based Monitoring

2:00 PM — 3:30 PM

[V2-S3] The Sakigake Designation System: Challenges and Points for Improvement

2:00 PM — 3:30 PM

[V3-S3] TransCelerate: Innovation through Collaboration

2:00 PM — 3:30 PM

[V4-S3] New Methods to Clinical Evaluation of Anticancer Drugs in the Era of Immune Oncology Therapy

2:00 PM — 3:30 PM

[V5-S3] New Pharmaceutical Technical Innovation - Continuous Manufacturing and its Driving Forces

2:00 PM — 3:30 PM

[V6-S3] Patient Empowerment: Status Update of Patient Participation Support Program

2:00 PM — 3:30 PM

[V7-S3] Various Initiatives after Marketing of Regenerative Medical Products

2:00 PM — 3:30 PM

[V8-S3] Let’s Discuss How Our Values Are Related to Life and Work!

4:00 PM — 5:30 PM

[V1-S4] How Can We Define and Manage Quality Goals for Clinical Trials Using a Quality Tolerance Limit (QTL) Approach?

4:00 PM — 5:30 PM

[V2-S4] Further Perspective of Development of Medicines for RD / Pediatric

4:00 PM — 5:30 PM

[V3-S4] Future Perspectives of Effective Drug Interaction Evaluation - Comparison among Japan, US and EU Regulatory Documents -

4:00 PM — 5:30 PM

[V4-S4] It’s Time to Think About Compliance to Deliver Value Added Medical Information - Current and Ideal Situation of Medical Iformation Provision

4:00 PM — 5:30 PM

[V5-S4] What ICH E17 Would Bring to Global Drug Development

4:00 PM — 5:30 PM

[V6-S4] New Drug Development Approaches to Realize Precision Medicine (Registry Study, Platform Trial)

4:00 PM — 5:30 PM

[V7-S4] Future of e-Labeling in Japan

4:00 PM — 5:30 PM

[V8-S4] Leader of You! Are You OK For Your Motivation? How About Your Team Member? Let’s Get Together and Dialogue How We Maintenance Motivation!

Day 3 Nov 13, 2018

9:00 AM — 10:30 AM

[V1-S5] What Information and Communication Do Patients Want in Clinical Trials? How We Can Provide Them? (Part 1)

9:00 AM — 10:30 AM

[V2-S5] Efforts to Raise Drug Literacy - How Should We Take Care It in Citizens Themselves Learn about Drugs - (Part1)

9:00 AM — 10:30 AM

[V3-S5] Chance and Challenge to Maximize Product Value - Key Findings from Collaboration Between Medicine Development Division and Medical Affairs Division -

9:00 AM — 10:30 AM

[V4-S5] New Developments on Microbiome Research

9:00 AM — 10:30 AM

[V5-S5] Responses Against the Global Threat of Antimicrobial Resistance

9:00 AM — 10:30 AM

[V6-S5] Various Issues Related to HTA -Looking at on a Micro and Macro Scale-

9:00 AM — 10:30 AM

[V7-S5] Pharmacovigilance Activities in Japan, the USA, and Europe - How to Utilize Real World Data -

9:00 AM — 10:30 AM

[V8-S5] Improving Clinical Operation and Data Quality - eSource Is Transforming Clinical Trials -

11:00 AM — 12:30 PM

[V1-S6] What Information and Communication Do Patients Want in Clinical Trials? How We Can Provide Them? (Part 2)

11:00 AM — 12:30 PM

[V2-S6] Efforts to Raise Drug Literacy - How Should We Take Care It in Citizens Themselves Learn about Drugs - (Part 2)

11:00 AM — 12:30 PM

[V3-S6] The Near Future of Clinical Operation - ICT Leading Virtual Clinical Trial -

11:00 AM — 12:30 PM

[V4-S6] Possibility of AI for Future New Drug Evaluation and Review Process

11:00 AM — 12:30 PM

[V5-S6] The Latest Trend of Vaccine Policy, Regulatory Regulation in Japan, the United States and Europe

11:00 AM — 12:30 PM

[V6-S6] Evidence Generation under Japan’s New Clinical Trials Act

11:00 AM — 12:30 PM

[V7-S6] Paradigm Shift in Pharmacovigilance Activities - How to Conceptualize Research Questions -

11:00 AM — 12:30 PM

[V8-S6] Approaches to Implement Revision for New Format Labeling and Discussion How to Provide Information by Other Materials

2:00 PM — 3:30 PM

[DIAmond Session 2] Innovative Clinical Trials: A Painting of the Future

4:00 PM — 5:30 PM

[DIAmond Session 3] PMDA Town Hall

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15th DIA Japan Annual Meeting 2018

Agenda

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