Intermediate Course for DMF/ASMF/Module 3 Submissions in eCTD Format

If you are currently preparing and maintaining paper ASMFs and DMFs and/or Module 3 in eCTD for the EU, US, Canada and/or Switzerland and have to use the eCTD format, this course is for you.

The FDA’s May 2018 deadline mandates that you comply with the new requirements. The use of eCTD is already mandatory for all for centralised procedure human ASMF submissions from 1 July 2016. To successfully meet these requirements, organizations need to understand the processes needed to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications.

During this workshop, you will learn:

• How structured and transparent the eCTD lifecycle of an ASMF/DMF can be, for
  • EU (including an Applicant’s and Restricted Part)
  • US
  • Canada
  • Switzerland (including an Applicant’s and Restricted Part)
• What Module 1 documents need to be added
• What the routing is of questions and responses
• How structured and transparent the Module 32S and 32P for an applicant are
• How easy eCTDs can be created and maintained
• How to set up gateways with authorities
• How quick eCTDs can be exchanged with the authorities
• How to create a baseline submission
• How to apply lean authoring principles
• How to QC and validate an eCTD
• Tips, tricks and best practices gathered from industry professionals
• Converting from a paper application to an eCTD
• What CTD readiness really means

We will also provide an overview of the difference between submissions to US, EU, Canada and Switzerland and help you understand how to prepare for each.

Join us for this intense two-day, hands-on compilation training that will answer your submission questions and help you get on a direct path to compliance.