ICH Project ICH S6(R1) Guideline Workshops ICH S6(R1) Guideline Workshops on Non-clinical Safety Assessment of Biopharmaceuticals
August 08, 2011
ICH S6(R1) "Non-clinical Safety Evaluation of Biotechnology-based Medicinal Products" has now been harmonized by Japan, the U.S., and the EU, and a Guideline Workshops were held on the following dates. Approximately 100 participants from not only JPMA member companies but also from a wide range of related companies 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 Location
| Date and time | Place |
|---|---|
| Friday, September 5, 2011, 13:30-16:00 | Japan Pharmaceutical Manufacturers Association |
Information and Program
Briefing Materials
| Presentations | Speakers |
|---|---|
| Japan Pharmaceutical Manufacturers Association | |
| Pharmaceuticals and Medical Devices Agency |