Drug Evaluation Committee Drug Evaluation Committee Symposium

Information of "Workshop on the Implementation of the Clinical Trial Ecosystem Declaration 2025" -Convincing Clinical Trial Operations through Dialogue and Review of Japan's Unique Operations with CTQ as a Common Language

FY2025 Assembly of the Clinical Evaluation Committee, Part 1: "Let's Increase AI Literacy - AI Applications in the Medical and Pharmaceutical Industries"

The video clips of the symposium "Covariate Adjustment for Improving Statistical Efficiency in Randomized Controlled Trials" are now available for viewing.

Symposium on Pediatric Drug Development to be held on March 17, 2026
Symposium on Pediatric Drug Development "Envisioning the Future of Pediatric Drug Development: Challenges in the New Era Brought about by the Revision of the Pharmaceutical Affairs Agency Law

Assembly of the Drug Evaluation Committee for 2025 - The Drug Evaluation Committee Ecosystem - Overcoming Turbulent Times and Promoting Attractive Activities

October 31, 2025 "Model Credibility Evaluation in Drug Development

Video Distribution - GCP has moved from a checklist to a "thinking" guideline. Now is the time to become an independent thinker! -Exploring the key to mindset through trends and specific examples of Clinical Trial 119.

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".

June 13, 2025 "What is Useful Patient Experience Information for Decision Making in Drug Development?

April 2, 2025 Workshop "The Actual Use of Open Source Software "R" in Approval Application Work and Future Prospects"

February 5, 2025 Single IRB Workshop

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)

FY2024 Assembly 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-".

Briefing Session on the Alliance for Research in Southeast and East Asia (ARISE)" on April 2, 2025

Announcement of "eCTD v4 Implementation Promotion Symposium Presentation Materials

Briefing on "Asian Trial Network for Adaptive Tumor and Lung Cancer Study (ATLAS project)" held on February 25, 2025

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 Workshops

April 20, 2024 Web-based Symposium "Promotion and Optimization of Electromagnetic Implementation: Don't miss out on the era of 100% electromagnetization! ~"

CRC/CRA Joint Workshop in Kansai: Consistent Quality Management Linking Medical Institutions and Clinical Trial Sponsors - Interactive Workshop for CRCs and CRAs" to be held in person on February 22, 2025

Information on the "Workshop for Promoting QMS Implementation: Experiencing the Approaches to Organizational Issues" Event for Pharmaceutical Companies/CROs (Face-to-Face: March 4, 2025)

146th Assembly of Drug Evaluation Committee: Thinking Now about "Patient and Public Involvement" - For Whom We Work

March 25, 2024 "Symposium on Pediatric Drug Development - Toward a New Era of Pediatric Drug Development" to be held on March 25, 2024

2023 Assembly of the Clinical Evaluation Subcommittee, Part 2: "ICH: Clinical Edition: Toward the Future

The Latest Regulatory and Review Developments for Programmed Medical Devices and the Drug Evaluation Committee's Initiatives (Webinar: Feb. 8, 2024)

Toward Proper Understanding and Domestic Introduction of ICHE19 (Webinar: 1/30/2024)

Lecture 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 December 14, 2023)

The 5th Symposium on the Utilization of Medical Information Databases (Webinar: 11/8/2023)

Symposium on "Drug Development Utilizing Patients' Voices" for patients, citizens, and pharmaceutical companies

The 143rd Assembly of the Drug Evaluation Committee Breakthrough to Drug Lag/Loss: Toward Realization of Safe, Secure, and Well-Being Medicine and Society

Materials for "Toward Utilization in Drug Development: Opinion Exchange Meeting between Pharmaceutical Companies and Disease Registry Holders" (held on October 2, 2023)

Medical Information Database Mini Symposium (Webinar: Sep. 25)

Materials for eCTD v4 Implementation Promotion Briefing Session

Materials for "Workshop for Practitioners on Electronic Data Submission at the Time of Application" in FY2022

The 106th Assembly of the Clinical Evaluation Committee [Part 2] New Normal Clinical Trial: Optimization and Efficiency of Clinical Trial with COVID-19 as an Opportunity

Symposium on "Current Status and Issues of Estimating Treatment Effectiveness in Clinical Development of Rare Diseases

Mini-Seminar on Electromagnetic Compliance" on December 21, 2022

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

Materials for "Symposium on Personal Information Protection in Drug Development

Briefing on Registration of Clinical Trial Implementation Status, etc." held on April 20, 2022

Workshop on Pediatric Drug Development" held on the web on March 29, 2022

Clinical Trials Awareness Seminar "Let's learn about 'Drugs' and 'Clinical Trials'!

The 10th Data Science (DS) Subcommittee Assembly (Symposium) Part 1

Workshop for Practitioners on Electronic Data Submission at the Time of Application

105th Clinical Evaluation Subcommittee Assembly (Part 2)-Considering the Future Pharmaceutical Industry from the Perspective of Advances in Digital Technology

GPSP Information Session 2022" hosted by PMDA Reliability Assurance Department

The 139th Assembly of Drug Evaluation Committee - "Looking Back on the New Coronavirus" - Sharing Best Practices and Resolving Domestic Issues

Symposium for pharmaceutical companies on "Drug Development Based on Patients' Voices

Symposium on Causal Inference for Understanding ICH-E9(R1)

104th Assembly of the Clinical Evaluation Section (Part 2) - Innovation and New Challenges

Workshop for Practitioners on Electronic Data Submission at the Time of Application

The 103rd Assembly of the Clinical Evaluation Committee (Part 2) - Discussing the Near Future of Drug Development

Symposium on "Network Meta-Analysis from the Basics: Overview, Case Studies and Points to Consider

Workshop for Practitioners on Electronic Data Submission at the Time of Application [Day 2] - CDISC Standard Compliant Data

Workshop for Practitioners on Electronic Data Submission at the Time of Filing [Day 1] - Electronic Data in Clinical Pharmacology