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18th DIA Japan Annual Meeting 2021
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アジェンダ
Events_Day 1
- — KY00: A New Society and Healthcare Ahead of the Digital Revolution
- — LS01: New Challenges for Non-Visited Collecting and Providing Information for Proper Use with Digital Transformation (Part 1: Collecting Safety Information)
- — LS02: Utilization of Asian Clinical Trial Network
- — LS03: 5 Industry Group Joint Session:New Options in Clinical Trial Operation Model?DCT & Remote Utilization (Part 1)
- — LS04: Formulation of Development Strategy Documents and the Role of Development Strategy Planners in the Development of Pharmaceutical Products
- — LS05: New Challenges for Non-Visited Collecting and Providing Information for Proper Use with Digital Transformation (Part 2: Providing Information for Proper Use)
- — LS06: Dive into Asia!- Asian Collaboration in Clinical Trials
- — LS07: 5 Industry Group Joint Session:New Options in Clinical Trial Operation Model? DCT & Remote Utilization (Part 2)
- — LS08: How is Your Preparation for the New Challenges, Young Guys
- — LS09: Practical Risk-based Approach to Data Integrity in Decentralized Clinical Trials
- — LS10: Digital Transformation of Drug Information -For Utilization in All Japan
- — LS11: Future Vision for Database Use
- — ST00: Current Status of Clinical Development for Depression. -Issues, Lesson Learns, Solutions-
- — LS12: How should We Collaborate Together to Enhance Model-Informed Drug Development?
- — LS13: Let's Think Together about Patient Engagement from the Research Stage of Drug Discovery
- — SS01: Utilization of Registry Data for Regulatory Application - Implementation as External Control Arm, Post-Marketing Efficacy Assessment -
- — OS01: Big expectation for International Harmonization by ICH Q12 Implementation
- — OS02: For Medical Affairs activities based on Patient Centricity
Events_Day 2
- — LS14: Global Oncology Development - Aiming to Be A Game Changer
- — LS15: Transformation of Regulatory interaction: Challenge by Accumulus Synergy
- — LS16: Toward Informed Consent Form (ICF) Common Template
- — LS17: Learning from COVID Experience: "Value created from Dialogue" and Talking about Drug Development Program Management
- — LS18: Guiding RWE Utilization for Regulatory Decision Making in US, EU and Japan
- — LS19: Valued Globalization under Healthcare New Era with Complexity and Unceratinty
- — LS20: MPS Development in Japan and Efforts toward Regulatory Acceptance
- — SS02: Preparations for Unexpected Infections from the COVID- 19 Pandemic:Rapid Development and Supply of Vaccines and Drugs for Patients
- — LS21: Consider Information Provision from the Patient's Perspective (1) Information Provision with a View to Health Literacy
- — LS22: Ways to Reduce Hurdles for Clinical Trial Participation by Conducting Good Participatory Practice Workshop Part 1
- — LS23: Increased Value to Patients and Healthcare Communities with Digital Therapeutics (DTx)
- — LS24: For Successful Launch of ICH M11: Current Situation and Looking Forward of Content Management for Electronically Structured Clinical Documents
- — LS25: East Asia Townhall
- — LS26: Ways to Reduce Hurdles for Clinical Trial Participation by Conducting Good Participatory Practice Workshop Part 2
- — LS27: Consider Information Provision from the Patient's Perspective (2) Information Provision with a View to Patient Journey
- — LS28: Issues in Handling of Cartagena Type 1 Use Regulations for Simultaneous International Development of Gene Therapy Drugs
- — LS29: Capacity Building in Asia
- — LS30: Paradigm Shift of Clinical Trial Site Costs ~Effort to Address the Diversifying Changes in Clinical Trial Design~
- — LS31: New System of Clinical Notification for Complexed Clinical Trials
- — LS32: Innovative e-labeling Initiatives in the World and Discussion on Next Steps for e-labeling in Japan
- — DA01: Current and Future Status of Drug Development in Japan, the US, and Europe under COVID-19 Pandemic
- — LS33: Win-Win Collaboration between Industries and Academia: Preparing SOP (Tentative)
- — OS03: Expedited Approval Systems to Accelerate Patient Access to Innovative Drugs in Japan and the US
- — OS04: Cross Industorial Human Resource Development for Innovators and Influencers
Events_Day 3
- — LS34: Impact of COVID-19 on US Clinical Studies Conducted by Japan-Based Pharmaceutical Companies
- — LS35: The Application of Computer Simulation to Medical Device: The Outcome of PMDA Science Board in the Fifth Term
- — LS36: Patient Engagement - Recent Practices and Future Enhancement in Japan
- — LS37: Paradigm Shift towards Electronic Package Insert -Current Status and Issues after the Revision of the Pharmaceutical Affairs Law-
- — DA02: Current and Future Status of Drug Development in Japan, the US, and Europe under COVID-19 Pandemic
- — LS38: Initiatives of Intelligent Automation Process in PV Activities Overview and Opportunities in the Future
- — LS39: Utilization method of electronic data submitted for J-NDA filing
- — LS40: Can the Reliability of Clinical Trials be Assured Remotely?
- — LS41: Data Distribution: Feasibility of EHR Data Interoperatiliby with EDC/CDMS
- — LS42: Data Visualization; New Innovative Solution in Drug Development
- — LS43: Experience of Implementation of De-Centralized Clinical Trial in Japan
- — LS44: FutureEexpectation on Information Delivery of Parmaceuticals and the Challenges: Lessons Learned at COVID-19 Vaccine
- — LS45: Risk-Based Quality Management (RBQM) in the E8 (R1) Era
- — LS46: Expectations and Challenges in Clinical Trials Incorporating Telemedicine from the Perspective of Clinical Trial Site and Patient
- — LS47: Make the Unexpected within the Expected! Can Your Organization Act without Hassle in the Event of an Unexpected Crisis?
- — LS48: Our New Challenges and New Solutions - Discuss Our Hot Topics for Our Future-
- — DA03: PMDA Town Hall
- — LS49: Change the Unexpected into the Expected ! Will Your Team Progress without Panic When a Crisis Occurs?
- — LS50: Transformation and Innovation in Drug Development with Environmental Changes Induced by COVID-19
- — OS05: Embracing Digital Opportunities to Engage Publication Readers including Patients