ICH Project ICH Q11 guideline information session ICH Q11: Development and Manufacturing of Active Pharmaceutical Ingredients (Chemicals and Biotechnology-applied Drugs/Biologically-derived Pharmaceuticals)
Jul 13, 2011
ICH is considering the development of a high-level guideline based on a common concept for the development and manufacturing of active pharmaceutical ingredients (API) for both chemicals and biotechnology-derived/biologically-derived pharmaceuticals (Q11). 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, a briefing on the newly developed Q11 Step 2 Guideline, including its background, was held. 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 | Location |
|---|---|
| Friday, August 5, 2011, 10:00-16:55 | Tower Hall Funabori Main Hall
4-1-1 Funabori, Edogawa-ku, Tokyo |
Information and Program
Briefing Materials
Horizontal scrolling is available
| Briefing Materials | Presentation materials | Speakers (titles omitted) |
|---|---|---|
|
Haruhiro Okuda |
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Session B: Overview of ICH Q11 Guideline |
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Session 1：History of the development of manufacturing processes（802KB) |
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Example 1 |
Kazunori Takagi |
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Example 2 |
Koji Takagi |
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Presentation 2: Selection of starting materials and biogenic raw materials (940KB) |
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Example 4 |
Kiyotoshi Matsumura |
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Research Group Exemplification |
Haruhiro Okuda |
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Exemplification 3: Management Strategies |
Tsuyoshi Ando |
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Presentation 4: Process validation/process evaluation (example 3) (980KB) |
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Tomonori Nakagawa |
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For inquiries, please contact
ICH Secretariat of the Pharmaceutical Manufacturers' Association of Japan
- Phone
- 03-3241-0326
The End