Complimentary Training – Paper Publishing The Right Way
This training was conducted on October 3rd, 2014 at 1 PM Eastern. This training includes ~25 minutes of training followed by ~5 minutes for Q&A.
While the FDA strongly recommends electronic publishing in the eCTD format, some sponsors still wish to submit with paper. Paper publishing has a number of specific formatting and ‘linking’ requirements that many regulatory personnel are unaware of. This training will cover all the structure and formatting requirements for a CTD based paper submission to the FDA.
This training is important to any sponsor who does not wish to convert to eCTD publishing at this time.