Regulatory Submissions, Information, and Document Management Forum

Although the eCTD AdPromo Guidance from the FDA has been out for more than two years, the majority of companies haven’t switched this process to eCTD. Commonly heard excuses are that it is complicated, expensive, and just too hard to change a process that entails hundreds of submissions a year per marketed product. This session will be an informative and fun panel discussion with seasoned experts who have made the switch to submitting AdPromo materials in eCTD format within their own companies, and lived to tell about it.