Special Learning Series
Learning and Dialogue for YORIAILab Members and Clinical Trial Ambassador
If you are not a YORIAILab member and wish to access recordings and materials from the special seminar, please apply for membership ➡️ (annual membership fee starts from 1,000 yen).
Regarding the Handling of Recordings and Materials
Special Learning Series
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Access to the lecture recording is available for six months from the seminar date . This is limited to YORIAILab members and clinical trial ambassadors .
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If you are able to view the lecture recordings, there will be a "Watch Lecture Recording" button in the information section for each session.
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Access to the presentation materials is limited to YORIAILab members and clinical trial ambassadors . If you are not a member and wish to receive the materials, please contact us individually.
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If you reuse any or all of the lecture recordings and materials after they have been made publicly available, please be sure to clearly indicate the URL of the source recording . Thank you for your understanding and cooperation.
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Clinical Trial Lay Summary
Completed on July 9, 2025
Instructor: Nobutaka Yagi
PPI JAPAN "Guide to Creating a Ray Summary" ➡️
Good Lay Summary Practice (English) ➡️
U.S. Food and Drug Administration (FDA) Guidance Series on Patient-Centered Drug Development
US FDA Patient-Focused Drug Development Guidance Series
Guidance 1 & 2: Patient Experience Data
Completed on April 11th and 18th, 2025.
Instructor: Nobutaka Yagi
Patient-Focused Drug Development (Patient-Centered Drug Development) Guidance Documents and Glossary (English, FDA website) ➡️
Standards for Conducting Clinical Trials of Pharmaceuticals, Revised 3rd Edition
ICH-E6 (ICH-GCP) R3
Completed on January 30th and February 14th, 2025.
Instructor: Kotone Matsuyama
ICH-E6 R3 Principles・Annex 1【Step 4】(English, PMDA website)➡️
Annex 2 [Step 3] (English, PMDA website) ➡️
PMDA's explanatory document for Annex 2 (PMDA website) ➡️
Helsinki Declaration 2024 Revision and Helsinki Statement
Declaration of Helsinki & Helsinki Statement
Completed on November 21, 2024. Instructor: Kotone Matsuyama
Completed on November 27, 2024. Instructor: Chieko Kurihara
Declaration of Helsinki, revised 2024
(English, World Medical Association website ➡️ / Japanese, Japan Medical Association website ➡️)
Helsinki Statement (English, Japanese, Arabic) ➡️