Special Seminar for YORIAILab members
& Clinical Trial Ambassadors
Learning and dialogue between YORIAILab members and Clinical Trial Ambassadors
If you are not a member of YORIAILab and would like to participate in the seminar, please apply for membership ( click here to apply for membership ).
If you have any questions, please contact us at the following email address. Contact: YORIAILab Office ✉ info@yoriailab.com
📢About viewing and handling of recordings
Access to the recording will be limited to YORIAILab members and Clinical Trial Ambassadors for six months from the seminar date .
In accordance with YORIAILab's regulations for lecture recordings, in order to allow many people to use lecture recordings for learning purposes, in principle, they will be made available to the general public six months after the seminar date (with the consent of the seminar instructor, only the lecture portion will be made available [excluding Q&A and discussion portions]).
If you wish to make secondary use of all or part of a lecture recording after it has been made public , please be sure to indicate the URL of the recording . Thank you for your understanding and cooperation.
US FDA Patient-Focused Drug Development Guidance Series
U.S. Food and Drug Administration "Patient-Centered Drug Development" Guidance Series
Guidance 1 & 2 Patient Experience Data
1st session: April 11, 2025 (Friday )
2nd session: Friday, April 18, 2025, 19:00-20: 30 (can be extended up to 21:00)
Lecturer: Nobutaka Yagi
Guidance 3 & 4 Clinical Outcome Assessment
1st: 📅Currently being adjusted
2nd: 📅Currently being adjusted
Lecturer: Nobutaka Yagi
Patient-Focused Drug Development
Click here for the FDA website
Each guidance document and glossary are available for download.
ICH-E6 (ICH-GCP) R3
Standards for Clinical Trials of Pharmaceuticals: 3rd Revised Edition - Challenges in Implementation
1st session: January 30, 2025 (Thursday )
2nd session: February 14th, 2025 (Friday )
Lecturer: Kotone Matsuyama
ICH-E6 R3
Principles Annex 1 [Step 4 ] (English, available for download on PMDA website)
Principles [Step 4] (Japanese translation by DeepL) is here
Annex 2 [Step 3] (English, PMDA website, downloadable) is here
PMDA's Annex 2 explanatory document (available for download on PMDA website) is here
The 2024 Revision of the Declaration of Helsinki and the Declaration of Helsinki
The 2024 Declaration of Helsinki & Helsinki Statement
1st session: Thursday, November 21, 2024
Lecturer: Kotone Matsuyama
2nd session: November 27, 2024 (Wednesday )
Lecturer: Chieko Kurihara
Declaration of Helsinki (Revised 2024)
English (World Medical Association website , downloadable)
Japanese (downloadable from the Japan Medical Association website)
Helsinki Statement
English version (file opens) is here
Japanese version (file opens) is here