Preparation for ICH-Brussels Begins

Rockville, MD (Sept. 17)-In November, representatives to the International Conference on Harmonization will meet in Brussels, Belgium, to discuss several international cooperation initiatives, including ICH Q10: Pharmaceutical Quality System and ICH Q8R: Pharmaceutical Development. In preparation, the US Food and Drug Administration is holding a public meeting to provide information and receive comments to take to the ICH meeting, according to a Sept. 16 Federal Register notice.

At last week’s 2008 PDA/FDA Joint Regulatory Conference in Washington, DC, FDA Office of Compliance Deputy Director Joe Famulare speculated that ICH Q8R: Pharmaceutical Development may be finalized in Brussels. Q8R will provide more clarity on quality by design and specifically “design space.” In addition, the Implementation Working Group for ICH Q10, which is in Step 5 of the harmonization process, is expected to discuss next steps in Brussels.

The public meeting will be held Oct. 21 from 3 pm-5:30 pm at 5600 Fishers Lane, 3rd floor, Conference Rooms D and E, Rockville, MD. Contact Tammie Jo Bell in the Office of the Commissioner at [email protected] to register.