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19th DIA Japan Annual Meeting 2022
Agenda
Day 1
- — Pre Opening DIA Band
- — Opening
- — ST00 Designing a Clinical Trial Protocol of Lipid-lowering Agents Based on Disease Characteristics
- — KY00 COVID-19 so Far and from Now on
- — PC00 Drug Safety and Patients Engagement
- — LS01 Future Directions Based on Experience Developing Drugs to Treat Novel Coronavirus Infections
- — LS02 Quality Control in the E6(R3) Era: What Should the Quality-Control Process Emphasize?
- — LS03 Considering Benefit-Risk Assessment in New Drug Applications
- — SS01 Establishing an International Standard Safety Monitoring System for Preventive Vaccination (Temporaly)
- — LS04 Present and Future of Risk-Based Approaches in Clinical Trial Operations
- — LS05 Social Entrepreneurial Role of Academic Research and Development
- — LS06 Challenge of Total Healthcare from Inside and Outside the Medical Industry
- — LS07 Beyond Value Conflicts to Social Co-Creation
- — LS08 How RWE Affects Decision Making During the COVID-19 Pandemic
- — LS09 Innovative and Dynamic Statistical Analytics for Regulatory Submissions
- — LS10 Introduction of Activities to Promote the Use of Data in Clinical Trials and Clinical Research and Associated Ethical Issues
- — LS11 Model-Informed Drug Development: Application of MIDD to the Development of Novel Drugs for Treatment of COVID-19 Has Changed the World
Day 2
- — LS12 12 Initiatives in 4 Priority Areas of DTRA for Accelerating Adoption of DCTs
- — LS13 Transformation of Regulatory Interaction: Challenge by Accumulus Synergy 2022
- — LS14 How to Use an Agile Approach to Drive Innovation
- — LS15 What is So Curious about eConsent? Deep Dive into Fundamental Values
- — LS16 Current Situation and Issues for Conducting Outcome Validation Study Prior to Post-Marketing Database Study
- — LS17 Assuring Quality: Digital Health Technologies for Remote Data Acquisition in Clinical Trials
- — LS18 Accelerating Pharmaceutical Approval through Asian International Collaborative Trials
- — LS19 Agile Drug Development in the Rapidly Evolving R&D Environment
- — LS20 Open Innovation in Drug Development in Japan: Preparations in Normal Times, Challenges, and Practices
- — LS21 Applying Additional PV Effectively in Risk Management in Japan
- — LS22 Using Real-World Data Based on the Next-Generation Medical Infrastructure Act
- — LS23 Next-Generation Digital Healthcare Considering Pre-Symptomatic State, Prevention, and Well-Being (Part 1)
- — LS24 Novel Strategy of Clinical Pharmacology in Global Clinical Development: Contribution to Worldwide Simultaneous NDA Submission and Approval
- — LS25 Digital Transformation of Drug Information: Current Utilization Situation and Challenges in Japan
- — SS02 Utilizing Data Obtained through Specific Clinical Trials for Pharmaceutical Approval Applications
- — LS26 Digital Therapeutics: Strategy as SaMD (Software as a Medical Device) and Non-SaMD
- — LS27 Data-Driven Decision Making Using Big Data and Predictive Analytics
- — LS28 Discussion with Patients about Rare Disease Drug Development to Improve Drug Lag in Japan
- — LS29 Has RMP Changed Post-Marketing Safety Management in Japan in the 10 Years Since it Started?
- — 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
- — DA01 Power of Information - Change in Healthcare DX Innovation and High Quality Healthcare in Digital Health Age"
- — LS30 Future Digital Labeling in Japan and Europe
- — LS31 Team Building for Innovation: How to Foster Psychological Safety
- — LS32 Current Status and Prospects for the Future of Decentralized Clinical Trials Utilizing Medical Institution Collaboration
- — LS33 Usefulness and Challenges of Telemedicine in Clinical Practice and Trials
Day 3
- — LS34 Generating and Utilizing RWE from RWD: From Dreams to Realization
- — LS35 Company-Provided Information and Patients' Health Literacy: Gaps and Solutions
- — LS36 Fireside Chat: How to Create an Environment for Easy Clinical Trial Participation
- — LS37 Delivering Truly Valuable Drug Information for Clinical Practice in the New Normal
- — LS38 What Systems/Infrastructure Can Be Used for Pediatric Drug Development?
- — LS39 Implementing Data Sharing in a Time of Pandemic
- — LS40 Promoting DX (Digital Transformation) in Risk Communication to Patients
- — LS41 Clinical Trial Ambassadors: Empower Patients with Knowledge
- — LS42 Academia-Industry Collaboration to Promote Clinical Research Utilizing Real-World Data
- — LS43 Current Compliance and Utilization Status and Issues for Human-Derived Data
- — LS44 Challenges for the Future Realized by Digital Biomarkers
- — LS45 CMC-related topics-will be released as soon as details are decided-
- — LS45 Toward ICF Common Template Implementation as All Japan
- — LS46 Advancing Risk Communication in Pregnancy through Utilizing Registry Data
- — LS47 New Normal of Creating Program Value Creation in Healthcare
- — SS04 The Future of Drug Development: Past, Current, and Future
- — DA02 New Style of Clinical Trial with Innovative Tools
- — LS48 Availability of Structured Data for Clinical Study Protocols after Implementing ICH M11
- — LS49 Introduction for DIA Japan Community
- — LS50 Considerations for Providing Reliable Pharmaceutical Information and the Perspective of Information Recipients
- — LS51 Next-Generation Digital Healthcare Considering Pre-Symptomatic State, Prevention, and Well-Being (Part 2)
- — DA03 PMDA Town Hall
- — LS52 Breaking the Document Paradigm and Digitizing Clinical Study Start-Up
- — LS53 Application of RWD to Clinical Development: Discussion with Industry, Regulatory, and Academia Through Hypothetical Case Studies
- — LS54 Branding! Let's Design Our Own Lives in the New Healthcare Era
- — LS55 Patient-Public Involvement in the Clinical Study: Findings from Simulated Clinical Study Workshops
- — Closing