Back to previous page

Introduction to Electronic Regulatory Submissions in the eCTD Format




Rockville, Maryland, USA


24 Jul 2018 - 25 Jul 2018

Reference No: R1802255 - RAPS

Apply for this event
Event Description

Course Outline:

To understand the underlying CTD structure upon which electronic submissions are built, and suggestions for implementing operational changes that will lead to successful electronic regulatory applications.

During this workshop, you will learn:

  • Different submission types
  • Which applications need to be submitted electronically
  • How to understand and follow the CTD structure
  • How to use the M4 series of guidances and granularity to generate compliant submissions
  • Agency-compliant PDF files and how to generate them
  • Which agency guidelines and technical specifications publishers need to follow
  • What tools are required to electronically submit your applications

When & Where?

24 July 2018 - 25 July 2018

US Pharmacopeial Convention
12601 Twinbrook Pkwy
Rockville, Maryland, USA, 20852-1717


Until 25 June 2018:
RAPS Member: $1,250.00
Non RAPS Member: $1,350.00

26 June 2018 and after:
RAPS Member: $1,350
Non RAPS Member; $1,450

Applicant Requirements
  • Organisations who need to understand the underlying CTD structure upon which electronic submissions are built
Reference No: R1802255 - RAPS
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.


Come and join our community!

We are ready and waiting for you

This site uses cookies. By continuing to browse the site, you are agreeing to our use of cookies.

Read more or Hide this message