Drug Evaluation Committee Drug Evaluation Committee Symposium

Workshop to be held on April 16, 2026: “What Is a ‘Lay Summary’ That Answers ‘What I Want to Know’?—Let’s Think About It Together from the Perspectives of Patients, Regulators, and Practitioners!”

“FY 2026 Joint Assembly of the Drug Evaluation Committee and the Regulatory Affairs Committee” Held

We have released the presentation materials and video from the symposium “Covariate Adjustment for Improving Statistical Efficiency in Randomized Controlled Trials.”

Industry Workshop on Implementing the “Clinical Trial Ecosystem Industry Declaration 2025” Held

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 and Medical Devices Act”

Announcement: Presentation Materials for the “Asian eCTD / Gateway System Information Symposium” Now Available

Announcement of the “Workshop on Implementing the 2025 Clinical Trial Ecosystem Industry Declaration” – Using CTQ as a Common Language, Reviewing Japan’s Unique Operational Practices, and Fostering Dialogue to Achieve Consensus-Based Clinical Trial Operations –

FY2025 Clinical Evaluation Subcommittee Assembly, Part 1: “Enhancing AI Literacy—Utilizing AI in the Healthcare and Pharmaceutical Industries”

“FY 2025 Assembly of the Drug Evaluation Committee” Held: Drug Evaluation Committee Ecosystem — Overcoming Turbulent Times to Promote Engaging Activities—

October 31, 2025: “Model Credibility Assessment in Drug Development”

Video Stream – GCP: From Checklists to a “Mindset” Framework. Now Is the Time to Become a Critical Thinker! ~Exploring the Keys to the Right Mindset Through Trends and Specific Examples from Clinical Trial 119~

Workshop: “Smooth Submission of Electronic Regulatory Data and Effective Utilization of CDISC-Compliant Data” Presentation Materials: Report on Survey Results Regarding “Inquiries Concerning Electronic Regulatory Data” and “Handling of Deviations and Case Acceptance/Rejection”

Held on June 13, 2025: “What Constitutes Patient Experience Information Useful for Decision-Making in Drug Development”

April 2, 2025: Workshop “Current Status and Future Prospects of Using the Open-Source Software ‘R’ in Approval Application Processes”

February 5, 2025: Single IRB Workshop

Event for Medical Institutions: “Symposium on Promoting the Use of the ICF Common Template: Case Studies of Implementation at Medical Institutions” (Online: February 26, 2025)

FY2024 Clinical Evaluation Subcommittee Assembly, Part 2: “What Lies Ahead? What Should We Do? Clinical Research and Clinical Trials in Japan—Promoting Clinical Research and Clinical Trials Based on Strong Drug Discovery Capabilities and International Competitiveness”

April 2, 2025: “Information Session on the Southeast Asia–East Asia International Collaborative Clinical Research Alliance (ARISE)”

Announcement: “eCTD v4 Implementation Promotion Symposium Presentation Materials” Now Available

February 25, 2025: “Asia Cancer Clinical Trials Network (ATLAS Project) Information Session”

January 23, 2025: Lecture “QMS in Medical Institutions and Clinical Trial Sponsors and Approaches to Its Implementation—The Basics of QMS and Implementation That Everyone Can Understand:
The Importance of ‘Fostering a Culture of Quality’ and ‘Exercising Leadership’—”

April 16, 2025: Online “ICH M10 Guideline Workshops”

April 20, 2024 (Online) Symposium: “Promoting the Adoption and Optimization of Electrification—Don’t Get Left Behind in the Era of 100% Electrification!”

Announcement of the “Joint CRC/CRA Workshop in Kansai: Consistent Quality Management Connecting Medical Institutions and Sponsors—An Interactive Workshop for CRCs and CRAs” (In-person: February 22, 2025)

Event Announcement for Pharmaceutical Companies and CROs: “Workshop on Promoting QMS Implementation—Experience Hands-On Approaches to Organizational Challenges” (In-Person: March 4, 2025)

146th Assembly of the Drug Evaluation Committee: “Patient and Public Involvement”—A Timely Discussion ~For Whom Do We Work?~

“Symposium on Pediatric Drug Development—Toward a New Era in Pediatric Drug Development” to be held on March 25, 2024

FY2023 Clinical Evaluation Subcommittee Assembly, Part 2: “ICH Basics You Can’t Ask About Now—Clinical Edition: Looking Toward the Future”

Program: Latest Trends in Medical Device Regulation and Review, and the Drug Evaluation Committee’s Initiatives (Online: February 8, 2024)

Toward a Proper Understanding of ICHE19 and Its Domestic Implementation (Online: January 30, 2024)

Lecture Held on January 18, 2024:
“Quality by Design in Clinical Trials and Consistent Quality Management”
~From the Perspectives of Both Sponsors and Investigator Sites~

Information Session on the “Guidelines for Providing Information on Clinical Trials to Patients and the General Public, 3rd Edition” (Held on December 14, 2023)

The 5th Symposium on the Utilization of Medical Information Databases (Online: November 8, 2023)

“Drug Development Incorporating Patient Voices” Symposium for Patients, Citizens, and Pharmaceutical Companies

143rd Assembly of the Drug Evaluation Committee: Breakthrough to Address Drug Lag/Loss—Toward Realizing Safe, Secure, and Well-Being-Oriented Healthcare and Society—

Presentation Materials for “Toward Utilization in Drug Development: Exchange of Views Between Pharmaceutical Companies and Disease Registry Operators” (Held October 2, 2023)

Medical Information Database Mini-Symposium (Online: September 25)

eCTD v4 Implementation Promotion Briefing Materials

FY2022 “Workshop for Practitioners on Electronic Data Submission at the Time of Application” Materials

106th Assembly of the Clinical Evaluation Subcommittee [Part 2] Clinical Trials in the “New Normal” — Streamlining and Optimizing Clinical Trials in the Wake of COVID-19

Symposium: “Current Status and Challenges in Estimating Therapeutic Efficacy in Clinical Development for Rare Diseases”

“Mini-Seminar on Digital Transformation” Held on December 21, 2022

Briefing Session on “Points to Note Regarding Post-Marketing Clinical Trials Other Than Those Related to Re-examination and Re-evaluation” (Held October 27, 2022)

Materials from the “Symposium on Personal Information Protection in Pharmaceutical Development”

“Briefing Session on the Registration of Clinical Trial Status and Other Information” (Held April 20, 2022)

March 29, Reiwa 4 (Online) “Workshop on Pediatric Drug Development”

Clinical Trial Awareness Seminar: “Let’s Learn About ‘Medicines’ and ‘Clinical Trials’!”

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

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

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

“GPSP Briefing 2022” Hosted by the PMDA Quality Assurance Department

139th Assembly of the Drug Evaluation Committee – “Reflecting on the Novel Coronavirus” ~ Sharing Best Practices and Addressing Domestic Challenges ~ –

"Drug Development Incorporating Patient Voices" Symposium for Pharmaceutical Companies

Symposium on Causal Inference to Aid Understanding of ICH-E9(R1)

104th Assembly of the Clinical Evaluation Subcommittee (Part 2) – Innovation and New Challenges

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

103rd Assembly of the Clinical Evaluation Subcommittee (Part 2) – Discussing the Near Future of Drug Development

“Learning Network Meta-Analysis from the Basics: Overview, Case Studies, and Key Considerations” Symposium

Workshop for Practitioners on Electronic Data Submission at the Time of Application [Day 2] – Data Compliant with CDISC Standards –

Workshop for Practitioners on Electronic Data Submission at the Time of Application [Day 1] — Electronic Data in the Field of Clinical Pharmacology —