Drug Evaluation Committee April 16, 2025 Web-based "ICH M10 Guideline Information Session" (in Japanese)

Jan 31, 2025

ICH M10 Guideline "Guidelines for Method Validation and Analysis of Drug Concentrations in Biological Samples" was issued as a notice on December 4, 2024 and has reached Step 5.
In order to promote understanding of this guideline, we have decided to hold an ICH M10 guideline briefing session.

Statement of Opinion

Date and Time

Wednesday, April 16, 2025, 14:00-16:00
Method of the event

Webinar format using Cisco Webex (no pre-registration required)
Program
  1. 1.
    Briefing notes and opening remarks
  2. 2.
    Overview of ICH M10 Guidelines
  3. 3.
    Answers to preliminary questions
  4. 4.
    Closing Remarks

Please refer to the following for details on the briefing session, how to participate, and how to submit questions in advance. We sincerely look forward to your participation.

PMDA Link: https://www.pmda.go.jp/int-activities/symposia/0153.html

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