Agenda

Day 1 Nov 06, 2013

9:00 AM — 10:45 AM

#1: Point to Consider: Safety Content of Company Core Data Sheet Prepared by Western Companies

9:00 AM — 10:45 AM

#2: A New Project Manager: Team Management – What is needed to build effective project team?

9:00 AM — 10:45 AM

#3: Action Learning for Six Sigma Analytical Tools by Real Case Study ~ (Japanese Language Only)

9:00 AM — 12:45 PM

Student Session: Global Clinical Development and Benefit-risk Assessment ~ (Japanese Language Only)

11:00 AM — 12:45 PM

#4: HTA in practice in Europe - What are the challenges for Japan?

11:00 AM — 12:45 PM

#5: Fundamental Knowledge of Project Risk Management for Medicinal Product Development

11:00 AM — 12:45 PM

#6: Control Strategy for Drug Substance Based on ICH M7 and Q11

2:00 PM — 2:20 PM

Welcome

2:20 PM — 2:40 PM

Award Presentation

2:40 PM — 3:10 PM

Opening Remarks: The Role of Universities to Educate Students for Developing the Field of Therapeutic Medicine

3:40 PM — 4:30 PM

Keynote Speech 1: What ARO can do for Innovative Drug Development

4:30 PM — 5:20 PM

Keynote Speech 2: History and Future of ICH

Day 2 Nov 07, 2013

9:00 AM — 10:30 AM

Session 1 / Venue 1: Drug Development thorough Collaboration with ARO and Future - Part 1

9:00 AM — 10:30 AM

Session 1 / Venue 2: Risk-based Approach to Monitoring

9:00 AM — 10:30 AM

Session 1 / Venue 3: New Initiative at the International Community ~ (English Language Only)

9:00 AM — 10:30 AM

Session 1 / Venue 4: Multiregional Drug Development ~ (English Language Only)

9:00 AM — 10:30 AM

Session 1 / Venue 5: Application of Coaching and Development for Project Team Building

9:00 AM — 10:30 AM

Session 1 / Venue 6: Recommendations for Developing Postmarketing Surveys and Clinical Investigations Using SS-MIX Standardized Storage

11:00 AM — 12:30 PM

Session 2 / Venue 1: Drug Development thorough Collaboration with ARO and Future Prospects - Part 2

11:00 AM — 12:30 PM

Session 2 / Venue 2: What is going on after J-RMP Implementation?

11:00 AM — 12:30 PM

Session 2 / Venue 3: Asia Town Hall

11:00 AM — 12:30 PM

Session 2 / Venue 4: Effective Consultation Strategy in the Global Development Based on Consultation Examples of Japan and Other Regions

11:00 AM — 12:30 PM

Session 2 / Venue 5: Effective Collaboration and Recent Trend of Project Leader and Project Manager ~ (English Language Only)

11:00 AM — 12:30 PM

Session 2 / Venue 6: Drug Evaluation with Small Clinical Trials

2:00 PM — 3:30 PM

Session 3 / Venue 1: Globalization of ICH Guidelines ~ (English Language Only)

2:00 PM — 3:30 PM

Session 3 / Venue 2: Current Status and Perspectives for the Development of Companion Diagnostics and Personalized Medicine - Part 1

2:00 PM — 3:30 PM

Session 3 / Venue 3: Implementation of and Innovative Labeling Hub in Asia including Japan and Integration with Global Model Point of View

2:00 PM — 3:30 PM

Session 3 / Venue 4: Regulation, Development, and Future of Biosimilars

2:00 PM — 3:30 PM

Session 3 / Venue 5: Virtual Meeting of PMDA’s Scientific Consultation: Points to Maximize an Efficiency of the Meeting ~ (Japanese Language Only)

2:00 PM — 3:30 PM

Session 3 / Venue 6: Now, Let’s have a Direct Discussion with Patients for the Drug Discovery and Development

4:00 PM — 5:30 PM

Session 4 / Venue 1: The Future of ICH ~ (English Language Only)

4:00 PM — 5:30 PM

Session 4 / Venue 2: Current Status and Perspectives for the Development of Companion Diagnostics and Personalized Medicine - Part 2

4:00 PM — 5:30 PM

Session 4 / Venue 3: Past, current and future of Benefit Risk Balance assessment-Where we are and where we will be

4:00 PM — 5:30 PM

Session 4 / Venue 4: Issues to be Addressed from the Result of Metrics Analyses - Maximizing Japan's Strength

4:00 PM — 5:30 PM

Session 4 / Venue 5: Development of Regenerative Medicinal Products

4:00 PM — 5:30 PM

Session 4 / Venue 6: Frontline of the Development of Medical Devices

5:30 PM — 7:00 PM

Special Talk Session: Let’s Chat over a Glass of Wine! ~ (Japanese Language Only)

Day 3 Nov 08, 2013

9:00 AM — 10:30 AM

Session 5 / Venue 1: Team Medical Care and Ethics

9:00 AM — 10:30 AM

Session 5 / Venue 2: Adaptive Licensing ~ (English Language only)

9:00 AM — 10:30 AM

Session 5 / Venue 3: Regulatory Communication – What will be occurred by implementation of Key Action Date to the review process?

9:00 AM — 10:30 AM

Session 5 / Venue 4: Toward Utilization of CDISC Standards at J-NDA Submission - Part 1

9:00 AM — 10:30 AM

Session 5 / Venue 5: Current and Future: Medical Affairs and Medical Scientific Liaison (MSL)

9:00 AM — 10:30 AM

Session 5 / Venue 6: Pharmacopoeia and Biologics

11:00 AM — 12:30 PM

Session 6 / Venue 1: Current Situation of Early and Exploratory Clinical Studies as one of the Leading Countries with Drug Development

11:00 AM — 12:30 PM

Session 6 / Venue 2: Global Simultaneous Submission - Lessons Learned and Overcoming Next Challenges

11:00 AM — 12:30 PM

Session 6 / Venue 3: How to keep a Good Drug with Positive B/R Balance for a Long Period after Approval

11:00 AM — 12:30 PM

Session 6 / Venue 4: Toward Utilization of CDISC Standards at J-NDA Submission - Part 2

11:00 AM — 12:30 PM

Session 6 / Venue 5: Drug Supply in the Disaster or Emergency

11:00 AM — 12:30 PM

Session 6 / Venue 6: Deploying Lean Six Sigma in your Organization - Problem Solving Approaches in Research and Development

12:30 PM — 2:00 PM

Luncheon Session: Protecting our Innovative Medicines: The Biopharmaceutical Industry’s Collaboration Against Doping Abuse in Sports ~ (Japanese Language Only)

2:00 PM — 2:20 PM

Special Speech: Messages for the 10th Memorial Round Table Future Drug Development and Regulatory Science

2:20 PM — 3:50 PM

Round Table 1: Drug Development in the Future

4:10 PM — 5:40 PM

Round Table 2: Japanese ARO Model

5:40 PM — 5:50 PM

Best Presenter Award

5:50 PM — 6:00 PM

Closing Remarks

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10th Annual Meeting DIA Japan 2013

Agenda

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