ICH Project ICH Q11 Guideline Workshops ICH Q11: Development and Manufacturing of Active Pharmaceutical Ingredients (Chemicals and Biotechnology-applied Drugs / Drugs of Biological Origin)
July 13, 2011
ICH is considering the development of a high-level guideline based on a common concept (Q11) for the development and manufacturing of active pharmaceutical ingredients (APIs) for both chemicals and biotechnology-derived/biologically-derived pharmaceuticals. Progress has been slower than originally planned due to the complexity and uniqueness of the subject area (combining both chemicals and biotechnology-derived pharmaceuticals under a common concept), but we have now reached Step 2. This time, we held a Guideline Workshops on the newly developed Q11 Step 2 Guideline, including its background. Approximately 400 people from the pharmaceutical industry and other related parties attended the meeting, where a lively question-and-answer session was held.
The following is a list of the presentation materials used at the briefing.
Unauthorized copying or reproduction of any of the materials is strictly prohibited.
Date, time, and place
| Date and time | Place |
|---|---|
| August 5, 2011 (Friday) 10:00-16:55 | Tower Hall Funabori Main Hall
4-1-1 Funabori, Edogawa-ku, Tokyo |
Information, Program
Briefing Materials
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| Presentation Materials | Presentation Materials | Speakers (titles omitted) |
|---|---|---|
| Haruhiro Okuda | ||
| Session B: Overview of ICH Q11 Guideline | ||
| Example 1 | Kazunori Takagi | |
| Example 2 | Koji Takagi | |
| Title 2: Selection of starting materials and biogenic raw materials (940KB) | ||
| Example 4 | Kiyotoshi Matsumura | |
| Research Group Example | Haruhiro Okuda | |
| Title 3: Management Strategies | Tsuyoshi Ando | |
| Subject 4: Process Validation/Process Evaluation (Example 3) (980KB) | ||
| Tomonori Nakagawa | ||