Phase 2 Part B and Phase 3

The files and instructions needed to conduct the second portion (Part B) of Phase 2 of ETICS III  – the review/analysis portion, and Phase 3 (adding one more sequence) – are now available.

If you are a vendor of a tool for the review/validation/importing of eCTD sequences, you can participate in Part B.  Regulatory authorities are invited to participate as well.

If you are a vendor of a tool for the building of eCTDs, you can participate in Phase 3. The instruction spreadsheets for each region contain instructions for both phases. Each regional 7-zip file is organized in a similar manner. If you do not have a tool for extracting 7-zip files, you may download this open source free tool: http://7-zip.org/

Download the 7-zip files for each of the 3 regions in the study below:

CA: Click here to download.

EU: Click here to download.

US: Click here to download.   <<< Note – Phase 3 instructions were corrected October 12, 2012

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