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Day 1 2014年11月16日 (日)

9:00 AM — 10:30 AM

#1 Basic Introduction for Non-Specialist: Drug-Drug Interaction and Summary of Change in New Japanese Drug-Drug Interaction Guideline

9:00 AM — 10:30 AM

#2 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 1

9:00 AM — 10:30 AM

#3 Action Learning for Six Sigma Analytical Tools Using Real Case Studies

9:00 AM — 10:30 AM

#4 Coaching as a Diverse Communication Tool Across Functions and Areas

9:00 AM — 10:30 AM

#5 The Basics of “Investigator Initiated Trial (IIT)” Regulation

9:20 AM — 12:30 PM

Student Session

11:00 AM — 12:30 PM

#10 HTA 2016? What are the challenges for Japan?

11:00 AM — 12:30 PM

#6 Prediction for Human Pharmacokinetics and Safety Using Systems Pharmacology

11:00 AM — 12:30 PM

#7 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 2

11:00 AM — 12:30 PM

#8 An Introduction to Adaptive Designs

11:00 AM — 12:30 PM

#9 Let’s Learn and Talk about Project Management Basics of the Clinical Study in Medical Institutes!

1:30 PM — 2:05 PM

Welcome, Opening Remarks, Global DIA Awards Presentation, and Program Instructions

2:20 PM — 3:10 PM

Keynote Speech 1

3:10 PM — 4:00 PM

Keynote Speech 2

4:30 PM — 5:45 PM

Special Session: Opening Plenary

Day 2 2014年11月17日 (月)

9:00 AM — 10:30 AM

[V1-S1] Vision for the Future: Global Simultaneous Filing to the World First Approval - Strategies for Early NDA Approval

9:00 AM — 10:30 AM

[V2-S1] Listen to What the Patient Has to Say - A Message from Patients to Those Engaged in Drug Development

9:00 AM — 10:30 AM

[V3-S1] The Dawn of Advanced Regulatory Review and Consultation

9:00 AM — 10:30 AM

[V4-S1] Points to Consider on the Biosimilar Development - Comparability Evaluation, Interchangeability, Advantage of Biosimilar Development

9:00 AM — 10:30 AM

[V5-S1] Leading Innovation with Stakeholders — the Project Meeting Management

9:00 AM — 10:30 AM

[V6-S1] Made in Academia: Seed Development Initiatives

11:00 AM — 12:30 PM

[V1-S2] Vision for the Future: Global Simultaneous Approval — Efforts and Challenge for Simultaneous Review on Each Country

11:00 AM — 12:30 PM

[V2-S2] Discussion About the Provision of Information for Patients —What is a Patient-Oriented Information from the Regulatory Agencies, Pharmaceutical Companies, and AMedical Professionals?

11:00 AM — 12:30 PM

[V3-S2] Medical Big Data Usage — Hopes and Challenges in Clinical Development and Postmarketing Safety Surveillance

11:00 AM — 12:30 PM

[V4-S2] Bridging the Gap between Bio-ventures and the Pharmaceutical Industry to Form Drug-Making Partnerships

11:00 AM — 12:30 PM

[V5-S2] Magic Bullets for Conflicts!! – Case Study of Conflict Prevention and Resolution in R&D Projects

11:00 AM — 12:30 PM

[V6-S2] ARO Activities to Facilitate Late-Phase Clinical Trials in Asia

2:00 PM — 3:30 PM

[V1-S3] Global Contribution for Clinical Development from Japan

2:00 PM — 3:30 PM

[V2-S3] How Can We Apply the Electric Health Records for Postmarketing Drug Safety in Japan?

2:00 PM — 3:30 PM

[V3-S3] Lessons Learned of Adaptive Design from Case Example

2:00 PM — 3:30 PM

[V4-S3] Innovation in Development of Orphan Drugs (1) — Status Quo of Designation Scheme and Academia

2:00 PM — 3:30 PM

[V5-S3] Brain Storming How We Can Conduct Clinical Trials - A Company-Funded Company-Lead Trial is Not Only the Way to Run a Clinical Trial

2:00 PM — 3:30 PM

[V6-S3] Management of COI in Clinical Trials and Future Perspective

4:00 PM — 5:30 PM

[V1-S4] Virtual Meeting of PMDA’s Scientific Consultation: Points to Maximize an Efficiency of the Meeting

4:00 PM — 5:30 PM

[V2-S4] What is the Benefit-risk Balance Assessment which Japan is Aiming for? - Strategy for Generation of Useful Information which Contributes to Patients

4:00 PM — 5:30 PM

[V3-S4] Innovation of Clinical Development with Maximum Use of Existing Data

4:00 PM — 5:30 PM

[V4-S4] Innovation in Development of Orphan Drugs (2) — Diversifying Type of Operation and Companies

4:00 PM — 5:30 PM

[V5-S4] Introduction to the Role of Medical Affairs for Research and Development Department

4:00 PM — 5:30 PM

[V6-S4] Application of Lean Six Sigma in DM Process Improvement in an Investigator Initiated Clinical Trial

5:45 PM — 7:00 PM

Let’s Chat! – Presented by DIA Community

Day 3 2014年11月18日 (火)

9:00 AM — 10:30 AM

[V1-S5] Commercialization of Regenerative Medical Products and Quality Assurance

9:00 AM — 10:30 AM

[V2-S5] Is the Risk Management Plan Really Effective? Part I

9:00 AM — 10:30 AM

[V3-S5] Multi-Regional Clinical Trials: Where Should it Be Headed?

9:00 AM — 10:30 AM

[V4-S5] Fostering Superior Talents involved in Drug Development and Evaluation - The Necessity of “Human Resource Development” and “People-to-people Exchange” beyond Boundaries

9:00 AM — 10:30 AM

[V5-S5] Risk-based Approach to Monitoring — Part 1: Current Status and Outlook

9:00 AM — 10:30 AM

[V6-S5] Genomic Sampling Over Generations

11:00 AM — 12:30 PM

[V1-S6] Expectation and Challenge for Regenerative Medical Products Development - What is Changed Based on the Revision of Pharmaceutical Affairs Law?

11:00 AM — 12:30 PM

[V2-S6] Is the Risk Management Plan Really Effective? Part II

11:00 AM — 12:30 PM

[V3-S6] Beyond Japan: From Asian Studies to Global Studies

11:00 AM — 12:30 PM

[V4-S6] Seeking for the Future Prosperity for Both Pharmaceutical Company and CRO

11:00 AM — 12:30 PM

[V5-S6] Risk-based Approachto Monitoring — Part 2: Implementation Status of TransCelerate Member Companies in Japan

11:00 AM — 12:30 PM

[V6-S6] New Relationship of Drugs and Medical Devices Will Open up the Future of the Health Care

1:50 PM — 2:50 PM

Special Session: Medical Contributions With A New Perspective That Transcends Boundaries

2:50 PM — 3:00 PM

Best Presenter/Student Award

3:30 PM — 6:25 PM

PMDA Town Hall

3:30 PM — 5:00 PM

Round Table: What are Expectations for “Adaptive Licensing"?

6:25 PM — 6:30 PM

Closing Remarks

11th Annual Meeting DIA Japan 2014

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