ICH Leaders Meet

November 13, 2008
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The Steering Committee and Expert Working Groups of the International Conference on Harmonization are meeting this week in Brussels to discuss current harmonization efforts.

Brussels, Belgium (Nov. 13)-The Steering Committee and Expert Working Groups of the International Conference on Harmonization are meeting this week in Brussels to discuss current harmonization efforts.

ICH Q8R Pharmaceutical Development is expected to be finalized. Q8R will provide more clarity on quality by design and specifically “design space.” In addition, the Implementation Working Group for ICH Q10 Pharmaceutical Quality System, which is in Step 5 of the harmonization process, is discussing next steps.

Also this week in Brussels, ICH is holding a meeting for the public to provide information on recent developments at ICH in the context of globalization and international cooperation. Pharmaceutical Technology will report on the outcome of these meetings in next week’s ePT.

In related news, the Clinical Data Interchange Standards Consortium (CDISC) is working to harmonize information technology standards for clinical research and electronic health records. CDISC met with the Health Information Technology Standards Panel on Monday to encourage a global solution.