Agenda

Day 1 Nov 12, 2017

9:30 AM — 12:00 PM

[Student Session] Clinical Trial Protocol Development

2:15 PM — 3:15 PM

[K1] Keynote Address 1

3:45 PM — 4:45 PM

[K2] Keynote Address 2

4:45 PM — 5:45 PM

[DIAmond Session 1] Vision of Future Drug Development in Utilizing Next-Generation Medical ICT

Day 2 Nov 13, 2017

9:00 AM — 10:30 AM

[DIAmond Session 2] To Deliver Innovative Drugs to the Patients Appropriately and Quickly – Recent Topics and Visions for Future of Regulatory Authorities among US, EU and Japan

11:00 AM — 12:30 PM

[V1-S1] To Manage Global Phase l Study - Oncology Development -

11:00 AM — 12:30 PM

[V2-S1] The Methodology of Health Technology Assessment (HTA) in Japanese

11:00 AM — 12:30 PM

[V3-S1] [Educational Session] Comparison of Post-Marketing Safety Measures among Japan, the U.S. and the EU – From the Point of View of Risk Management -

11:00 AM — 12:30 PM

[V4-S1] Let’s Think about Drug/Device Combination Use for Treatment

11:00 AM — 12:30 PM

[V5-S1] Future Steps and Challenges for Drug Development Based on National Action Plan on Antimicrobial Resistance (AMR)

11:00 AM — 12:30 PM

[V6-S1] Industry-Academia-Government Collaboration Schemes in Japan

11:00 AM — 12:30 PM

[V7-S1] Draft Regulatory Guidance for Patient Registry and the Current Situation

11:00 AM — 12:30 PM

[V8-S1] “The Negotiation” – Things You Need to Know for Your Team and Project Management

2:00 PM — 3:30 PM

[V1-S2] Raise the Curtain of “Patient Centricity” in Japan (Part I): Share and Discuss the Common Value

2:00 PM — 3:30 PM

[V2-S2] Mobile / Digital Health Data Driven Innovation for Clinical Development

2:00 PM — 3:30 PM

[V3-S2] [Educational Session] Understand the Rules and Process of the US and EU Labeling

2:00 PM — 3:30 PM

[V4-S2] Concerning the Issues of Clinical Study by Revision of the Personal Information Protection Law

2:00 PM — 3:30 PM

[V5-S2] Approaches to Enhance Appropriate Communication on Pharmaceutical Product Information

2:00 PM — 3:30 PM

[V6-S2] Paradigm Shift in Global Development Strategy - How to Utilize ICH E17 GL in New Drug Development? -

2:00 PM — 3:30 PM

[V7-S2] Patient Participation – Patient Centric Approach to Clinical Trials

2:00 PM — 3:30 PM

[V8-S2] Update on Current Status and Future Directions of Proarrhythmic Risk Assessment

4:00 PM — 5:30 PM

[V1-S3] Raise the Curtain of “Patient Centricity” in Japan (Part II): Learn by Trial and Error

4:00 PM — 5:30 PM

[V2-S3] Artificial Intelligence Leads to Realize Medical Innovation

4:00 PM — 5:30 PM

[V3-S3] What Needs to Be Done for Creating Labeling Based on the New Revision of Items to be Included?

4:00 PM — 5:30 PM

[V4-S3] What is the Role of Medical Science Liaison (MSL) as New Function of Pharmaceutical Company?

4:00 PM — 5:30 PM

[V5-S3] Approaches to Enhance Appropriate Communication on Pharmaceutical Product Information

4:00 PM — 5:30 PM

[V6-S3] The Way toward Commercialization, Regenerative Medical Products

4:00 PM — 5:30 PM

[V7-S3] Current Status on Counterfeit Medicines in Global and Issues on Japanese Market

4:00 PM — 5:30 PM

[V8-S3] Call for Abstract Session

5:45 PM — 7:00 PM

[Engage and Exchange] Special Chat Session

Day 3 Nov 14, 2017

9:00 AM — 10:30 AM

[V1-S4] The Changing Environment in the World and the Impact on the Pharmaceutical Industry

9:00 AM — 10:30 AM

[V2-S4] How to Use Statistics Correctly - Understand the Meaning of P Values and Eliminate Misuse

9:00 AM — 10:30 AM

[V3-S4] What is the New GPSP Ordinance Requirements for Post-Marketing Studies Using Healthcare Database?

9:00 AM — 10:30 AM

[V4-S4] Are the Drugs Appropriately Reaching to the Pediatrics in Needs? - Current Development Status and Future Steps of Pediatric Drugs in Japan -

9:00 AM — 10:30 AM

[V5-S4] How Do You Set in the First Step of the Project Manager Development?

9:00 AM — 10:30 AM

[V6-S4] Quality by Design; Strategically Building the Quality of Clinical Study by Pharmaceutical Company

9:00 AM — 10:30 AM

[V7-S4] More Advanced Approach of Medical Big Data - Part 1

9:00 AM — 10:30 AM

[V8-S4] Clinical Development of Biosimilar Products

11:00 AM — 12:30 PM

[V1-S5] Regulations for Conditional Accelerated Approval System and Early Access to Drug Products

11:00 AM — 12:30 PM

[V2-S5] For RMP That can be Utilized by Healthcare Professionals

11:00 AM — 12:30 PM

[V3-S5] Changing Landscape of Phase I Trials in Oncology

11:00 AM — 12:30 PM

[V4-S5] Quality by Design; Strategically Building the Quality of Clinical Study by Academia

11:00 AM — 12:30 PM

[V5-S5] What Are You Going to Do? How Will You Develop Young Staff’s Careers? How Will We Make Our Organization More Productive?

11:00 AM — 12:30 PM

[V6-S5] CRO Management for Effective Collaboration

11:00 AM — 12:30 PM

[V7-S5] More Advanced Approach of Medical Big Data - Part 2

11:00 AM — 12:30 PM

[V8-S5] Drug Development Activation in Pan-Asia Region

2:00 PM — 3:30 PM

[V1-S6] Optimal Use Guidelines (Future Direction of the System, Discussion of the NDA Review Process, and Status of Actual Medical Practice)

2:00 PM — 3:30 PM

[V2-S6] RMP in the Era of Medical Big Data

2:00 PM — 3:30 PM

[V3-S6] Drug Developments for Rare Cancer and Fraction Areas

2:00 PM — 3:30 PM

[V4-S6] How Should a Collaboration between Academia & Industry be Promoted for an Efficient Medicine/Medical Device Development

2:00 PM — 3:30 PM

[V5-S6] Quality Management and Lean Six Sigma in Clinical Trials in ARO and Pharmaceutical Companies

2:00 PM — 3:30 PM

[V6-S6] Rethinking Quality in Clinical Trials - What are Quality Tolerance Limits (QTLs) and How Should they be Adapted in Clinical Studies to Fulfill New ICH-E6 Requirement?

2:00 PM — 3:30 PM

[V7-S6] Future of Development Strategy and Lifecycle Management in Asia after ICH Q12 Guideline Implementation

2:00 PM — 3:30 PM

[V8-S6] For Providing the Most Appropriate Medicine - The Current State of Use and Development of Companion Diagnostics (Mainly on Next Generation Sequencers)

4:00 PM — 5:30 PM

PMDA Town Hall

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14th DIA Japan Annual Meeting 2017

Agenda

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