Module 12 2019

ICH Specifications Specifications define: • XML structure • File Formats •

Hypertext Linking and Bookmarks

Checksums

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• Allowed characters in folder and file naming • Folder and File Naming Conventions • PDF version • Fonts used: Times New Roman, Arial, and Courier • Font size • Page Orientation • Headers and Footers

The Organisation for Professionals in Regulatory Affairs

Slide 24