Agenda

Day 1 Nov 13, 2016

9:30 AM — 12:30 PM

[Student Session] Global Development and Benefit and Risk Assessment of Drugs

2:15 PM — 3:15 PM

Keynote Address 1

3:45 PM — 4:45 PM

Keynote Address 2

4:45 PM — 5:45 PM

Special Discussion

Day 2 Nov 14, 2016

9:00 AM — 10:30 AM

DIAmond Session: Patient-Engaged Drug Development in Japan, US, and Europe

11:00 AM — 12:30 PM

[V1-S1] Update on ICH E18: Impact on Genomic Sampling and Management of Genomic Data in Clinical Trials

11:00 AM — 12:30 PM

[V2-S1] What is a Good Medical Communication?

11:00 AM — 12:30 PM

[V3-S1] Expectations for ICH Q12

11:00 AM — 12:30 PM

[V4-S1] The Latest Topics over Development of Regenerative Medicine

11:00 AM — 12:30 PM

[V5-S1] Effective Leadership in West and East Asia Hybrid New Drug Development Teams

11:00 AM — 12:30 PM

[V6-S1] What is Needed for Further Promotion of Drug Discovery and Development from Academia?

11:00 AM — 12:30 PM

[V7-S1] The Trial Introduction of HTA in Japan - Latest Trends

2:00 PM — 3:30 PM

[V1-S2] Future of Clinical Development Strategy in Asia after ICH E17 Guideline Implementation

2:00 PM — 3:30 PM

[V2-S2] Continuous Manufacturing

2:00 PM — 3:30 PM

[V3-S2] How to Build and Execute a Robust and Effective Clinical Quality Management System for the Upcoming ICH E6 Revision

2:00 PM — 3:30 PM

[V4-S2] Sustainable Human Resource Development of Biostatisticians in Japan

2:00 PM — 3:30 PM

[V5-S2] How to Provide Drug Information from a Standpoint of a Patient (Part 1)

2:00 PM — 3:30 PM

[V6-S2] Drug Discovery and Development through Rare/Intractable Disease Research

2:00 PM — 3:30 PM

[V7-S2] Life-Long Epidemiology

4:00 PM — 5:30 PM

[V1-S3] What is the Goal of Patient-Engaged Drug Development?

4:00 PM — 5:30 PM

[V2-S3] Medical Affairs Activities from the Viewpoint of the Stakeholder

4:00 PM — 5:30 PM

[V3-S3] Towards the Implementation of M8 Guideline "eCTD Ver.4"

4:00 PM — 5:30 PM

[V4-S3] Integrity of Clinical Trials in Japan - Get to the Root of the Problems and Prevent a Recurrence

4:00 PM — 5:30 PM

[V5-S3] How to Provide Drug Information from a Standpoint of a Patient (Part 2)

4:00 PM — 5:30 PM

[V6-S3] Evidence Base and Health Care Infrastructure Supporting the Oldest of the Old in a Rapidly Aging Society

4:00 PM — 5:30 PM

[V7-S3] Efficient Utilization of Disease Registry Data in Drug Development

Day 3 Nov 15, 2016

9:00 AM — 10:30 AM

[V1-S4] What Roles should MA Division be in Charge of? - To Be the Bridge between Development and Academia as Well as Clinical Practice

9:00 AM — 10:30 AM

[V2-S4] For the Success of the Global/Asia MRCT

9:00 AM — 10:30 AM

[V3-S4] Call for Abstract Session

9:00 AM — 10:30 AM

[V4-S4] Practice of Project Management Process on Clinical Research Activities Planned and Conducted by Medical Institutes

9:00 AM — 10:30 AM

[V5-S4] Recent Efforts for Realizing Personalized Medicine by Industry, Government and Academia

9:00 AM — 10:30 AM

[V6-S4] Introduction of eTMF in Japan

9:00 AM — 10:30 AM

[V7-S4] Introduction to Database Study I - Introduction

11:00 AM — 12:30 PM

[V1-S5] Package Inserts after the Amendment of Entry Procedures in Japan: What Actually Changes from the Point of View of Patients and Global Stakeholders?

11:00 AM — 12:30 PM

[V2-S5] Think "Quality" of Clinical Trial - Quality by Design for Improvement of Quality Management Method

11:00 AM — 12:30 PM

[V3-S5] Trend and Challenges of GCP Inspection by Overseas Regulatory Authorities

11:00 AM — 12:30 PM

[V4-S5] Development of Disease-Modifying Drugs for Alzheimer’s Disease (AD); Utilizing the Use of Biomarkers

11:00 AM — 12:30 PM

[V5-S5] Educational Session: Comparison of Review Processes by PMDA/FDA/EMA - For Successful Global Simultaneous Submission

11:00 AM — 12:30 PM

[V6-S5] Utilization of Modeling & Simulation in Drug Development - From Trial Design to Decision Making

11:00 AM — 12:30 PM

[V7-S5] Introduction to database study II - Example for RMP

2:00 PM — 3:30 PM

[V1-S6] What Drug Information do Patients and Their Families Really Want?

2:00 PM — 3:30 PM

[V2-S6] Patient-Oriented Evolution on Biosimilars: Challenges in Regulatory Science, R&D and Medical Practice

2:00 PM — 3:30 PM

[V3-S6] Patient Recruitment in Japan - Now and Future

2:00 PM — 3:30 PM

[V4-S6] The Challenges and Future Expectations of Postmarketing Registry System for New Medical Devices in Cooperation with Industry/PMDA/Academia

2:00 PM — 3:30 PM

[V5-S6] Motivation Management for Project Team - Who Are You? Where Will You Go?

2:00 PM — 3:30 PM

[V6-S6] Impact to NDA Preparation and Approval Review by Initiation of the Submitted Electronic Data

2:00 PM — 3:30 PM

[V7-S6] Mighty Epidemiology!

4:00 PM — 5:30 PM

PMDA Townhall

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13th DIA Japan Annual Meeting 2016

Agenda

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