Agenda

Day 1 Nov 08, 2020

9:30 AM — 10:00 AM

LS01 Opening

9:30 AM — 5:30 PM

OS01 Special Session 1: Overcoming Drug-Induced Suffering

9:30 AM — 5:30 PM

OS02 Special Session 2: International Contribution to Drug Development

9:30 AM — 5:30 PM

OS02 Special Session 2: International Contribution to Drug Development_E

9:30 AM — 5:30 PM

OS03 Real World Data: Concrete Utilization Examples and Issues

9:30 AM — 5:30 PM

OS03 Real World Data: Concrete Utilization Examples and Issues_E

9:30 AM — 5:30 PM

OS04 Aiming for Further Acceleration of Gene Therapy Product Development

9:30 AM — 5:30 PM

OS05 Beyond the Artificial Intelligence (AI) Revolution: What Does the Future Hold for the Healthcare and Pharmaceutical Industries?

9:30 AM — 5:30 PM

OS06 Challenge of Incorporating Patient Perspective in Drug Development: Lessons Learned from “System of Patient Engagement inRregulatory Review” by US Food and Drug Administration/European Medicines Agency

9:30 AM — 5:30 PM

OS07 Hot Topics in Using RWD in Drug Development

9:30 AM — 5:30 PM

OS07 Hot Topics in Using RWD in Drug Development_E

9:30 AM — 5:30 PM

OS08 What’s Needed to Transform Flow of Information in Clinical Development

9:30 AM — 5:30 PM

OS08 What’s Needed to Transform Flow of Information in Clinical Development_E

9:30 AM — 5:30 PM

OS09 Applying Quality Management Principles from Engineering to Clinical Trials

9:30 AM — 5:30 PM

OS10 Considerations for Utilizing Wearable Sensors in Clinical Research

9:30 AM — 5:30 PM

OS10 Considerations for Utilizing Wearable Sensors in Clinical Research_E

9:30 AM — 5:30 PM

OS12 Changes Accelerated by Innovation: Clinical Operation & Data Management

9:30 AM — 5:30 PM

OS12 Changes Accelerated by Innovation: Clinical Operation & Data Management_E

9:30 AM — 5:30 PM

OS13 The “Where, What, and How” of Patient Needs for Clinical Trial information from the Standpoint of Individual Stakeholders: Study Participant Opinions and Study Site Updates

9:30 AM — 10:17 AM

OS14 Implementing Revision of Pharmaceutical Affairs Law: Perspectives on Current and Future eLabeling

9:30 AM — 5:30 PM

OS15 The Additional Pharmacovigilance Plan: Role in Japan

9:30 AM — 5:30 PM

OS16 What is the Quality of Real World Evidence?

9:30 AM — 5:30 PM

OS16 What is the Quality of Real World Evidence?_E

10:15 AM — 11:45 AM

LS02 Quantitative Decision Making in Drug Development

10:15 AM — 11:45 AM

LS02 Quantitative Decision Making in Drug Development_E

10:15 AM — 11:45 AM

LS03 Realization of Personalized Medicine through Reverse Translational Research

10:15 AM — 11:15 AM

SLS01 ICH 30th Anniversary: Summary of 30 Years and Future Prospects with the Role of Japan

10:15 AM — 11:15 AM

SLS01 ICH 30th Anniversary: Summary of 30 Years and Future Prospects with the Role of Japan_E

12:00 PM — 1:30 PM

LS04 What Covid-19 Has Brought to Us

12:00 PM — 2:30 PM

LS05 Student Session: Protocol Development in Oncology Clinical Trials

12:00 PM — 1:00 PM

SLS02 Next Generation Leadership for Successful Future

1:45 PM — 3:15 PM

LS06 How Do We Collaborate with Current Patients for Future Patients in Drug Development?

1:45 PM — 3:15 PM

SLS03 ICH Anniversary: Summary of 30 Years and Future Prospects in Q Ar_ea with the Role of Japan_E

1:45 PM — 3:15 PM

SLS03 ICH Anniversary: Summary of 30 Years and Future Prospects in Q Area with the Role of Japan

3:30 PM — 5:00 PM

LS07 Overcome Challenges in Complex Drug Development: Let’s Learn More About Program Management

3:30 PM — 4:30 PM

SLS04 Scientific Benefit-Risk Management and Communication for the Future

3:30 PM — 4:30 PM

SLS04 Scientific Benefit-Risk Management and Communication for the Future_E

3:30 PM — 5:00 PM

SLS05 ICH Anniversary: Summary of 30 Years and Future Prospects in S Area with Role of Japan

3:30 PM — 5:00 PM

SLS05 ICH Anniversary: Summary of 30 Years and Future Prospects in S Area with Role of Japan_E

5:15 PM — 6:15 PM

LS08 Young Professionals Exchange Networking Session

Day 2 Nov 09, 2020

9:00 AM — 10:30 AM

LS09 Driving Toward Further Operational Efficiency and Innovation in Clinical Trials

9:00 AM — 10:30 AM

LS09 Driving Toward Further Operational Efficiency and Innovation in Clinical Trials_E

9:00 AM — 10:00 AM

SLS06 New Approaches for Further Improvement in Knowledge Management

9:00 AM — 10:00 AM

SLS07 Applying “Training / Learning Innovation” to Clinical Development Projects

9:00 AM — 10:30 AM

SLS08 ICH Anniversary: Summary of 30 Years and Future Prospects in E Area with Role of Japan

9:00 AM — 10:30 AM

SLS08 ICH Anniversary: Summary of 30 Years and Future Prospects in E Area with Role of Japan_E

10:45 AM — 12:15 PM

LS10 ICH M11: Clinical Electronic Structured Harmonized Protocol

10:45 AM — 12:15 PM

LS11 Keynote Address: Patient-Focused Drug Development

10:45 AM — 12:15 PM

LS11 Keynote Address: Patient-Focused Drug Development_E

10:45 AM — 11:45 AM

SLS09 How Do Quality Risk Management and Risk-Based Monitoring Work Together? Gaps Between Ideal and Actual Experience During COVID-19

10:45 AM — 11:45 AM

SLS10 Status and Challenges of Regulatory Decision Making in Development Using Model Informed Drug Development

10:45 AM — 11:45 AM

SLSx09

12:45 PM — 2:15 PM

LS12 Creating an Insightful Patient Journey Map On-Site: Let’s look at and Feel The Patients’ Voice Together and Think about What We Can Do! (part 1)

12:45 PM — 2:15 PM

LS13 Let’s Broaden Young Peoples’ Horizons from the Multidisciplinary Perspective

12:45 PM — 1:45 PM

SLS11 How Can industry Play a Role through Publications to Elevate Patient Voice?

12:45 PM — 1:45 PM

SLS11 How Can industry Play a Role through Publications to Elevate Patient Voice?_E

12:45 PM — 2:15 PM

SLS12 ICH Anniversary: Summary of 30 years and Future Prospects in M Area with Role of Japan

12:45 PM — 2:15 PM

SLS12 ICH Anniversary: Summary of 30 years and Future Prospects in M Area with Role of Japan_E

12:45 PM — 2:15 PM

SLS13 Impact of Patient Engagement Initiatives in Clinical Trial Design and Execution_E

2:15 PM — 2:30 PM

LS14 Creating an Insightful Patient Journey Map On-Site: Let’s look at and feel the patients’ voice together and think about what we can do! (part 2)

2:30 PM — 4:00 PM

LS15 Career Development in the New Healthcare Era

2:30 PM — 4:00 PM

LS16 Current Status and Future of Digital Therapeutics (DTx): How DTx Are Developed and Penetrate Medical Care

2:30 PM — 3:30 PM

SLS13 Impact of Patient Engagement Initiatives in Clinical Trial Design and Execution

4:15 PM — 5:15 PM

SLS14 WHAT’S NEW? Risk Communication and Pharmaceutical Information in the Digital Era in Japan, Europe, and the US

4:15 PM — 5:15 PM

SLS14 WHAT’S NEW? Risk Communication and Pharmaceutical Information in the Digital Era in Japan, Europe, and the US_E

4:15 PM — 5:15 PM

SLS15 Digital Transformation of Medical Information in Japan from Development to Post-Marketing

4:15 PM — 5:15 PM

SLS16

4:15 PM — 5:15 PM

SLS17 Current Status of Drug Development and Current Challenges for Clinical Trials and Regulations in China

5:30 PM — 8:00 PM

LS17 Special Chat Session

Day 3 Nov 10, 2020

9:00 AM — 10:30 AM

LS18 Global Oncology Development – 2nd

9:00 AM — 10:30 AM

LS19 Data Reliability and Quality for Post-Marketing Database Study

9:00 AM — 10:00 AM

SLS18 Joining Global Advanced Clinical Trials: Japan’s Perspective and the Kobe Initiative

9:00 AM — 10:00 AM

SLS19 Innovative Engagement: Talk with External Expert in Medical Affairs Activity

10:45 AM — 12:15 PM

LS20 New Phase in Combatting Antimicrobial Resistance (AMR)

10:45 AM — 11:45 AM

SLS20 Opportunity for International Harmonization of Implementing Early Access to Pharmaceuticals

10:45 AM — 11:45 AM

SLS20 Opportunity for International Harmonization of Implementing Early Access to Pharmaceuticals_E

10:45 AM — 11:45 AM

SLS21 “Where, What, and How” of Clinical Trial Information Required by Patients: Disclosure of Investigator Site Name and Clinical Trial Results

10:45 AM — 11:45 AM

SLS22 Patient-Centric Approach to Clinical Research: Challenges to Improving Efficiency and Quality

12:45 PM — 2:15 PM

LS21 Clinical Trial Innovation: Learning from Case Study and Accelerating Adaptation in Japan

12:45 PM — 1:45 PM

SLS23 How to Promote Use of Centralized IRB in Clinical Trials

12:45 PM — 1:45 PM

SLS23 How to Promote Use of Centralized IRB in Clinical Trials_E

12:45 PM — 1:45 PM

SLS24 “Rule of Rules” for Development Tool Qualification

2:30 PM — 4:00 PM

LS22 Real Operations in Regenerative Medicine Product Clinical Trials

2:30 PM — 4:00 PM

LS23 DIAmond Session 2: PMDA Town Hall

2:30 PM — 4:00 PM

LS23 DIAmond Session 2: PMDA Town Hall_E

2:30 PM — 4:00 PM

LS24 Utilization of “Pharmaceuticals for Specific Use” for Pediatric Drug Development

2:30 PM — 3:30 PM

SLS26 Operational Innovation in Medical Affairs for Improved Patient Outcomes

4:15 PM — 5:15 PM

SLS27 DIAmond Session 3: Beyond Innovation – What is Future Healthcare?

4:15 PM — 5:15 PM

SLS28 Recent Advances in Pharmacovigilance: Machine Learning and Statistical Pattern Discovery Case Studies from Around the World

4:15 PM — 5:15 PM

SLS28 Recent Advances in Pharmacovigilance: Machine Learning and Statistical Pattern Discovery Case Studies from Around the World_E

4:15 PM — 5:15 PM

SLS29 Improving Sponsor Clinical Trial Processes by Utilizing the Voice of Clinical Study Sites

5:15 PM — 5:30 PM

LS25 Closing Remarks

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17th DIA Japan Annual Meeting 2020

Agenda

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