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Introduction to Electronic Regulatory Submissions in the eCTD Format

Price

$1,250*

Location

San Diego, California, USA

Date

20 Oct 2020 - 21 Oct 2020

Reference No: R2002399-RAP

Apply for this event

Key points about this Training Event

  • After this program, participants will be able to:
  • Understand the acronyms and terms surrounding electronic submissions
  • Break down the CTD structure using the M4 series of guidance (ICH) in preparation for eCTD
  • Identify best practices with software used to generate electronic submission content
  • Produce MS Word and PDF documents that meet FDA guidelines
  • Obtain a basic understanding of what is required to transition into submitting in the eCTD format
Event Description

Course Outline:

The deadline is fast approaching for your company to migrate to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet these new requirements, organizations need to understand both the underlying CTD structure upon which electronic submissions are built, and their options 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 guidance 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?

When:
20 - 21 October 2020

Where:
The San Diego Training and Conference Center
450 B Street, Suite 650
San Diego, CA 92101

*Cost?

RAPS Members: $1,250
Non-Members: $1,150

Applicant Requirements
  • Regulatory professionals in need of basic knowledge of the CTD format in preparation for the fast-approaching FDA electronic submission deadline
  • Professionals working in the drug, biologic or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations and submissions publishing
Reference No: R2002399-RAP
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.

Email raps@raps.org

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