eCTD Training

Get hands-on experience in a small group training led by industry experts and learn to prepare successful electronic submissions.


San-Diego

Intermediate Course for Regulatory Submissions in eCTD Format

San Diego, CA
19-20 October 2017

Frankfurt

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

Frankfurt, GER
6-7 November 2017

Effective 5 May 2017 your company must migrate all NDAs, ANDAs and BLAs to electronic-only regulatory submissions based on the required ICH eCTD format. To ensure you have successfully met these new requirements, you need to understand the processes required to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications.


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. FDA’s May 2018 deadline mandates you comply with the new requirements. This course will help you understand the processes needed to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications.

Learn:

  • How to QC and validate an eCTD
  • How metadata and study tagging files work
  • How to convert from a paper application to an eCTD
  • How to apply ICH and regional requirements to your eCTD
  • Tips, tricks and best practices gathered from industry professionals
  • How the new Module 1 (version 3.3) can be used for regulatory submissions
  • Which agency guidelines and technical specifications publishers need to follow
  • How to compile documents into the XML backbone of an eCTD and lifecycle that application
Plus, get an overview of the difference between submissions to US and Rest of the World (ROW) and give you a basic understanding how the regions differ.







Learn:

  • How to QC and validate an eCTD
  • How to create a baseline submission
  • How to apply lean authoring principles
  • How to set up gateways with authorities
  • What Module 1 documents need to be added
  • How to convert from a paper application to an eCTD
  • How quick eCTDs can be exchanged with the authorities
  • Tips, tricks and best practices gathered from industry professionals
Also, get an overview of the difference between submissions to US, EU, Canada and Switzerland that will help you understand how to prepare for each.











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