Drug Evaluation Committee Drug Evaluation Committee Symposium
Information and materials of the symposium held by the Committee on Drug Evaluation are posted here.
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Held "2025 Annual Meeting of the Drug Evaluation Committee" Drug Evaluation Committee Ecosystem - Overcoming Turbulent Times and Promoting Attractive Activities
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October 31, 2025 "Model Credibility Evaluation in Drug Development"
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Video Distribution - GCP has moved from a checklist to a "thinking" guideline. Now is the time to become a self-directed thinker! -Exploring the key to mindset through trends and specific examples of Clinical Trial 119
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Workshop "Smooth Submission of Electronic Data and Effective Utilization of CDISC Compliant Data" Presentation Material: Report on the Results of Questionnaire on "Inquiry Items for Electronic Data" and "Handling of Deviation Information and Case Acceptance/Rejection".
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June 13, 2025 "Patient Experience Information for Decision Making in Drug Development
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April 2, 2025 Workshop on "The Actual Use and Future Prospects of Open Source Software "R" in Drug Submission Processes
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February 5, 2025 Single IRB Workshop
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Event for medical institutions "Symposium on Promoting the Use of ICF Common Template: Case Studies of its Introduction in Medical Institutions" (Web-based event: Feb. 26, 2025)
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FY2024 General Meeting of the Clinical Evaluation Subcommittee, Part 2: "What Will Happen? What to do? Clinical Research and Clinical Trials in Japan -Promoting Clinical Research and Clinical Trials based on High Drug Discovery Capability and Strong International Competitiveness-".
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Briefing Session on the Alliance for Research in Southeast and East Asia (ARISE)" on April 2, 2025
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Announcement of "eCTD v4 Implementation Promotion Symposium Presentation Materials
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Briefing on "Asian Trial Network for Adverse Adverse Surveillance of Cancer (ATLAS project)" on February 25, 2025
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Lecture "QMS and its approach to implementation at medical institutions and sponsors - Basics and implementation of QMS that each individual understands:
The Importance of "Fostering a Culture of Quality" and "Demonstrating Leadership"" -
April 16, 2025 Web-based "ICH M10 Guideline Information Session" (in Japanese)
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April 20, 2024 Web-based Symposium "Promotion and Optimization of Electromagnetic Implementation: Don't miss out on the era of 100% electromagnetization! ~"
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CRC/CRA Joint Workshop in Kansai: Consistent Quality Management Connecting Medical Institutions and Clinical Trial Sponsors - Interactive Workshop for CRCs and CRAs" to be held in person on February 22, 2025.
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Information about the "Workshop for Promoting QMS Implementation - Experiencing Approaches to Organizational Issues" event for pharmaceutical companies/CROs (face-to-face: 2025/3/4)
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146th Annual Meeting of the Committee on Drug Evaluation "Patient and Public Involvement" to be considered now - For whom our activities are for
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Symposium on Pediatric Drug Development - Toward a New Era of Pediatric Drug Development" to be held on March 25, 2024
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FY2023 General Meeting of the Clinical Evaluation Subcommittee, Part 2: "ICH: The Clinical Part You Can't Ask About Now: Toward the Future"
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Recent Developments in Regulation and Review of Programmed Medical Devices and the Drug Evaluation Committee (Webinar: February 8, 2024)
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Appropriate Understanding of ICHE19 and its Introduction in Japan (Webinar: 1/30/2024)
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Lecture held on January 18, 2024
Quality by Design and Consistent Quality Management in Clinical Trials
~From the perspective of both sponsors and investigational sites" "Quality by Design and Consistent Quality Management in Clinical Trials -
Briefing on "Guidelines for Providing Information on Clinical Trials for Patients and the General Public, 3rd Edition" (held on 12/14/2023)
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The 5th Symposium on the Utilization of Medical Information Databases (Webinar: 11/8/2023)
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Symposium on "Drug Development Utilizing Patients' Voices" for patients, citizens, and pharmaceutical companies
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The 143rd Annual Meeting of the Committee on Drug Evaluation Breakthrough to Drug Lag/Loss: Toward Realization of Safe, Secure, and Well-Being Medicine and Society
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Materials for "Toward Utilization in Drug Development: Opinion Exchange Meeting between Pharmaceutical Companies and Disease Registry Holders" (held on October 2, 2023)
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Medical Information Database Mini Symposium (Webinar: Sep. 25)
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Materials for eCTD v4 Implementation Promotion Briefing Session
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Materials for "Workshop for Practitioners on Electronic Data Submission at the Time of Application" in FY2022
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The 106th Annual Meeting of the Clinical Evaluation Committee [Part 2] New Normal Clinical Trial - Optimization and Efficiency of Clinical Trial with COVID-19 as an Opportunity
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Symposium on "Current Status and Issues of Estimating Treatment Effectiveness in Clinical Development of Rare Diseases
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Mini-Seminar on Electromagnetic Compliance" on December 21, 2022
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Points to keep in mind regarding post-marketing clinical trials other than post-marketing clinical trials for reexamination and reevaluation" Information Session held on October 27, 2022
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Materials for "Symposium on Personal Information Protection in Drug Development
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Briefing on Registration of Clinical Trial Implementation Status, etc." held on April 20, 2022
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Workshop on Pediatric Drug Development" held on the web on March 29, 2022
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Clinical Trials Awareness Seminar "Let's learn about 'Drugs' and 'Clinical Trials'!
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10th Data Science (DS) Subcommittee General Meeting (Symposium) Part 1
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Workshop for Practitioners on Electronic Data Submission at the Time of Application
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105th Clinical Evaluation Subcommittee General Meeting (Part 2)-Considering the Future Pharmaceutical Industry from the Perspective of Advances in Digital Technology
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GPSP Information Session 2022" hosted by PMDA Reliability Assurance Department
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The 139th Annual Meeting of the Committee on Drug Evaluation - "Looking Back on the New Coronavirus" - Sharing Best Practices and Resolving Domestic Issues
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Symposium for pharmaceutical companies on "Drug Development Based on Patients' Voices
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Symposium on Causal Inference for Understanding ICH-E9(R1)
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The 104th Annual Meeting of the Clinical Evaluation Committee (Part 2) - Innovation and New Challenges
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Workshop for Practitioners on Electronic Data Submission at the Time of Application
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The 103rd Annual Meeting of the Clinical Evaluation Committee (Part 2) - The Near Horizon of Drug Development
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Symposium on "Network Meta-Analysis from the Basics: Overview, Case Studies and Points to Consider
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Workshop for Practitioners on Electronic Data Submission at the Time of Filing [Day 2] - CDISC Standard Compliant Data
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Workshop for Practitioners on Electronic Data Submission at the Time of Filing [Day 1] - Electronic Data in Clinical Pharmacology
