Agenda

Día 1 09 oct 2022

9:00 AM — 9:30 AM

Pre Opening DIA Band

9:30 AM — 10:00 AM

Opening

9:30 AM — 12:15 PM

ST00 Designing a Clinical Trial Protocol of Lipid-lowering Agents Based on Disease Characteristics

10:15 AM — 11:15 AM

KY00 COVID-19 so Far and from Now on

11:15 AM — 12:15 PM

PC00 Drug Safety and Patients Engagement

1:15 PM — 2:30 PM

LS01 Future Directions Based on Experience Developing Drugs to Treat Novel Coronavirus Infections

1:15 PM — 2:30 PM

LS02 Quality Control in the E6(R3) Era: What Should the Quality-Control Process Emphasize?

1:15 PM — 2:30 PM

LS03 Considering Benefit-Risk Assessment in New Drug Applications

1:15 PM — 2:45 PM

SS01 Establishing an International Standard Safety Monitoring System for Preventive Vaccination (Temporaly)

3:15 PM — 4:30 PM

LS04 Present and Future of Risk-Based Approaches in Clinical Trial Operations

3:15 PM — 4:30 PM

LS05 Social Entrepreneurial Role of Academic Research and Development

3:15 PM — 4:30 PM

LS06 Challenge of Total Healthcare from Inside and Outside the Medical Industry

3:15 PM — 4:30 PM

LS07 Beyond Value Conflicts to Social Co-Creation

5:00 PM — 6:15 PM

LS08 How RWE Affects Decision Making During the COVID-19 Pandemic

5:00 PM — 6:15 PM

LS09 Innovative and Dynamic Statistical Analytics for Regulatory Submissions

5:00 PM — 6:15 PM

LS10 Introduction of Activities to Promote the Use of Data in Clinical Trials and Clinical Research and Associated Ethical Issues

5:00 PM — 6:15 PM

LS11 Model-Informed Drug Development: Application of MIDD to the Development of Novel Drugs for Treatment of COVID-19 Has Changed the World

Día 2 10 oct 2022

9:00 AM — 10:15 AM

LS12 12 Initiatives in 4 Priority Areas of DTRA for Accelerating Adoption of DCTs

9:00 AM — 10:15 AM

LS13 Transformation of Regulatory Interaction: Challenge by Accumulus Synergy 2022

9:00 AM — 10:15 AM

LS14 How to Use an Agile Approach to Drive Innovation

9:00 AM — 10:15 AM

LS15 What is So Curious about eConsent? Deep Dive into Fundamental Values

9:00 AM — 10:15 AM

LS16 Current Situation and Issues for Conducting Outcome Validation Study Prior to Post-Marketing Database Study

10:30 AM — 11:45 AM

LS17 Assuring Quality: Digital Health Technologies for Remote Data Acquisition in Clinical Trials

10:30 AM — 11:45 AM

LS18 Accelerating Pharmaceutical Approval through Asian International Collaborative Trials

10:30 AM — 11:45 AM

LS19 Agile Drug Development in the Rapidly Evolving R&D Environment

10:30 AM — 11:45 AM

LS20 Open Innovation in Drug Development in Japan: Preparations in Normal Times, Challenges, and Practices

10:30 AM — 11:45 AM

LS21 Applying Additional PV Effectively in Risk Management in Japan

12:45 PM — 2:00 PM

LS22 Using Real-World Data Based on the Next-Generation Medical Infrastructure Act

12:45 PM — 2:00 PM

LS23 Next-Generation Digital Healthcare Considering Pre-Symptomatic State, Prevention, and Well-Being (Part 1)

12:45 PM — 2:00 PM

LS24 Novel Strategy of Clinical Pharmacology in Global Clinical Development: Contribution to Worldwide Simultaneous NDA Submission and Approval

12:45 PM — 2:00 PM

LS25 Digital Transformation of Drug Information: Current Utilization Situation and Challenges in Japan

12:45 PM — 2:15 PM

SS02 Utilizing Data Obtained through Specific Clinical Trials for Pharmaceutical Approval Applications

2:30 PM — 3:45 PM

LS26 Digital Therapeutics: Strategy as SaMD (Software as a Medical Device) and Non-SaMD

2:30 PM — 3:45 PM

LS27 Data-Driven Decision Making Using Big Data and Predictive Analytics

2:30 PM — 3:45 PM

LS28 Discussion with Patients about Rare Disease Drug Development to Improve Drug Lag in Japan

2:30 PM — 3:45 PM

LS29 Has RMP Changed Post-Marketing Safety Management in Japan in the 10 Years Since it Started?

2:30 PM — 4:00 PM

SS03 Preparing for the Next Pandemic and Improving Public and Patient Understanding of Product Information: 2030 at the Global Level and What to Think Now

4:30 PM — 6:00 PM

DA01 Power of Information - Change in Healthcare DX Innovation and High Quality Healthcare in Digital Health Age"

4:30 PM — 5:45 PM

LS30 Future Digital Labeling in Japan and Europe

4:30 PM — 5:45 PM

LS31 Team Building for Innovation: How to Foster Psychological Safety

4:30 PM — 5:45 PM

LS32 Current Status and Prospects for the Future of Decentralized Clinical Trials Utilizing Medical Institution Collaboration

4:30 PM — 5:45 PM

LS33 Usefulness and Challenges of Telemedicine in Clinical Practice and Trials

Día 3 11 oct 2022

9:00 AM — 10:15 AM

LS34 Generating and Utilizing RWE from RWD: From Dreams to Realization

9:00 AM — 10:15 AM

LS35 Company-Provided Information and Patients' Health Literacy: Gaps and Solutions

9:00 AM — 10:15 AM

LS36 Fireside Chat: How to Create an Environment for Easy Clinical Trial Participation

9:00 AM — 10:15 AM

LS37 Delivering Truly Valuable Drug Information for Clinical Practice in the New Normal

9:00 AM — 10:15 AM

LS38 What Systems/Infrastructure Can Be Used for Pediatric Drug Development?

10:30 AM — 11:45 AM

LS39 Implementing Data Sharing in a Time of Pandemic

10:30 AM — 11:45 AM

LS40 Promoting DX (Digital Transformation) in Risk Communication to Patients

10:30 AM — 11:45 AM

LS41 Clinical Trial Ambassadors: Empower Patients with Knowledge

10:30 AM — 11:45 AM

LS42 Academia-Industry Collaboration to Promote Clinical Research Utilizing Real-World Data

10:30 AM — 11:45 AM

LS43 Current Compliance and Utilization Status and Issues for Human-Derived Data

12:45 PM — 2:00 PM

LS44 Challenges for the Future Realized by Digital Biomarkers

12:45 PM — 2:00 PM

LS45 CMC-related topics-will be released as soon as details are decided-

12:45 PM — 2:00 PM

LS45 Toward ICF Common Template Implementation as All Japan

12:45 PM — 2:00 PM

LS46 Advancing Risk Communication in Pregnancy through Utilizing Registry Data

12:45 PM — 2:00 PM

LS47 New Normal of Creating Program Value Creation in Healthcare

12:45 PM — 2:15 PM

SS04 The Future of Drug Development: Past, Current, and Future

2:30 PM — 4:00 PM

DA02 New Style of Clinical Trial with Innovative Tools

2:30 PM — 3:45 PM

LS48 Availability of Structured Data for Clinical Study Protocols after Implementing ICH M11

2:30 PM — 3:45 PM

LS49 Introduction for DIA Japan Community

2:30 PM — 3:45 PM

LS50 Considerations for Providing Reliable Pharmaceutical Information and the Perspective of Information Recipients

2:30 PM — 3:45 PM

LS51 Next-Generation Digital Healthcare Considering Pre-Symptomatic State, Prevention, and Well-Being (Part 2)

4:30 PM — 6:00 PM

DA03 PMDA Town Hall

4:30 PM — 5:45 PM

LS52 Breaking the Document Paradigm and Digitizing Clinical Study Start-Up

4:30 PM — 5:45 PM

LS53 Application of RWD to Clinical Development: Discussion with Industry, Regulatory, and Academia Through Hypothetical Case Studies

4:30 PM — 5:45 PM

LS54 Branding! Let's Design Our Own Lives in the New Healthcare Era

4:30 PM — 5:45 PM

LS55 Patient-Public Involvement in the Clinical Study: Findings from Simulated Clinical Study Workshops

6:15 PM — 6:45 PM

Closing

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19th DIA Japan Annual Meeting 2022

Agenda

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