An International Conference on Harmonization expert working group met in Brussels last week to discuss Q8(R1) Pharmaceutical Development, the annex to Q8. The addendum document, which provides greater detail on design space, including examples and approaches to take, has moved through the consultation period. According to sources, the guideline is now ready for Step 4 of the ICH process (i.e., or adoption by the three regions’ regulatory bodies and representatives-US, EU, and Japan).

Also meeting in Brussels last week was the implementation working group for the quality guidelines: Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Quality Pharmaceutical System. The group discussed items that needed further clarification, including  knowledge management, real-time release testing, and control strategy. The group also discussed training issues and plans for the next six months.

The next implementation working group meeting will take place in June 2009 in Yokohama, Japan.