Agendas

Day 1 2015年11月15日 (日)

9:30 AM — 12:00 PM

Student Session

2:15 PM — 2:55 PM

KEYNOTE SPEECH 1

2:55 PM — 3:35 PM

KEYNOTE SPEECH 2

4:05 PM — 4:45 PM

KEYNOTE SPEECH 3

Day 2 2015年11月16日 (月)

9:00 AM — 10:30 AM

[V2-S1] Network Meta-Analysis: New Analytical Approaches in HTA and Drug Development - Introduction of methodology and its application

9:00 AM — 10:30 AM

[V3-S1] New Era of Benefit-Risk Balance Evaluation - Will Risk Information Keep Increasing? - (Part 1)

9:00 AM — 10:30 AM

[V4-S1] Use of Human Organ/Tissue for New Drug Development

9:00 AM — 10:30 AM

[V5-S1] Introduction of Project Management Basic Process on Clinical Research Activities Planned and Conducted by Medical Institutes

9:00 AM — 10:30 AM

[V6-S1] The Difference between Pharmaceuticals and Medical Devices

9:00 AM — 10:30 AM

[V7-S1] Call for Abstract Session

10:00 AM — 12:30 PM

[V1-S1-S2] What Can Japan Do for Global Medicine Development?

11:00 AM — 12:30 PM

[V2-S2] ICH E14: Update on Current Status and Future Directions of Cardiac Safety Assessment

11:00 AM — 12:30 PM

[V3-S2] New Era of Benefit-Risk Balance Evaluation - Will Risk Information Keep Increasing? - (Part 2)

11:00 AM — 12:30 PM

[V4-S2] Intellectual Property Strategies about Medical Technologies and Products in the Future - Let’s Think about Effective Intellectual Property Strategies to Grow Seeds of New Technologies through Cooperation by Industry, Government, and Academia

11:00 AM — 12:30 PM

[V5-S2] Leading Innovation Leveraged by a Project Leadership

11:00 AM — 12:30 PM

[V6-S2] Contributions of Statistics and Behavior Observation to Drug and Medical Device Development

11:00 AM — 12:30 PM

[V7-S2] How to Succeed in “The Personalized Medicine Business”

2:00 PM — 3:30 PM

[V1-S3] For Enhancement of Industry-Government-Academia Collaboration in Japan (Part 1)

2:00 PM — 3:30 PM

[V2-S3] Promoting Clinical Development for Patients with Rare Diseases - Patient Focused Drug Development in Japan

2:00 PM — 3:30 PM

[V3-S3] Implication of Medical Big Data Usage – Applicability and Challenges in Clinical Development

2:00 PM — 3:30 PM

[V4-S3] The Next Generation Drug Development for Personalized Health Care

2:00 PM — 3:30 PM

[V5-S3] Fostering Further Collaboration between PMDA, Company and academia with Efficient “Project Management” in Drug Development

2:00 PM — 3:30 PM

[V6-S3] Tips for Better Drug Development Strategy in Asia - Let's Give Honest Opinions

2:00 PM — 3:30 PM

[V7-S3] Let’s Think about Selecting Adverse Reactions for Labeling and How to Describe Their Frequency

4:00 PM — 5:30 PM

[V1-S4] For Enhancement of Industry-Government-Academia Collaboration in Japan (Part 2)

4:00 PM — 5:30 PM

[V2-S4] What Drug Information Do Patients and Their Families Really Want?

4:00 PM — 5:30 PM

[V3-S4] Global Direction of Safety Assessment with Pharmaco-Epidemiology

4:00 PM — 5:30 PM

[V4-S4] Future Perspective of Personalized Medicines in Oncology Disease Area - Can You Imagine How NGS Technology is Being Expanded in Japan? -

4:00 PM — 5:30 PM

[V5-S4] Career-Building for Entry-Level and Mid-Level R&D Personnel

4:00 PM — 5:30 PM

[V6-S4] HTA in Japan – What Should Pharmaceutical Companies Do?

4:00 PM — 5:30 PM

[V7-S4] Future of the Pharmacovigilance from Development to Commercial – Where is the Spirit of ICH E2E Guideline in Japan?

5:45 PM — 7:00 PM

Special Chat Session

Day 3 2015年11月17日 (火)

9:00 AM — 10:30 AM

[V1-S5] Future Drug Development with Multi-Regional Clinical Trials (MRCT) Based on ICH E17 Guideline

9:00 AM — 10:30 AM

[V2-S5] Present Condition of Regulation for Regenerative Medical Products in Japan

9:00 AM — 10:30 AM

[V3-S5] Risk Communication in EU, US and Japan - Goals and Objectives of Various Tools including Labeling - (Part 1)

9:00 AM — 10:30 AM

[V4-S5] CRO Outsourcing Model – History and Future Outlook – Sponsor’s & CRO’s Perspective

9:00 AM — 10:30 AM

[V5-S5] With the Aim of Developing Pediatric Drugs Being Triggered by Japan

9:00 AM — 10:30 AM

[V6-S5] The Future of Electronic Data Submission in Japan - Strategy for CDISC Correspondence

9:00 AM — 10:30 AM

[V7-S5] To Fight Against Superbugs - Future Development of Antibacterial Drugs Surrounding Drug-Resistant Pathogens

11:00 AM — 12:30 PM

[V1-S6] Patient-Focused Medical Affairs Roles and Activities - Beyond the Pill with Patient Support Programs

11:00 AM — 12:30 PM

[V2-S6] Perspectives for Development of Regenerative Medical Products in PMD Act

11:00 AM — 12:30 PM

[V3-S6] Risk Communication in EU, US and Japan - Goals and Objectives of Various Tools including Labeling - (Part 2)

11:00 AM — 12:30 PM

[V4-S6] ICH E9 (R1): Discussion on the Appropriate Estimands for Clinical Trials

11:00 AM — 12:30 PM

[V5-S6] Industrial Development and Growth Strategy for Biosimilars - From the Viewpoint of the Acceleratation of Biosimilars Use

11:00 AM — 12:30 PM

[V6-S6] Towards ICH E6 Revision - Think about How Quality Management System (QMS) Can be Introduced in Clinical Trials

11:00 AM — 12:30 PM

[V7-S6] Rethinking Vaccine Policy-Making in an Era of Vaccine Hesitancy

2:00 PM — 3:30 PM

ROUND TABLE: Let’s Hear from AROs and R&D Heads - Towards New Medicine Development

4:00 PM — 5:30 PM

PMDA Town Hall

12th Annual Meeting DIA Japan 2015

Agendas

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