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Intermediate Course for Regulatory Submissions in eCTD Format

Price

$1,250*

Location

Rockville, Maryland, USA

Date

14 Nov 2019 - 15 Nov 2019

Reference No: R1907368

Apply for this event

Key points about this Training Event

  • Identify best practices with software used to generate electronic submission content
  • Understand the acronyms and terms surrounding eCTD and electronic submissions
  • Obtain an understanding of what is required to transition into submitting in the eCTD format
Event Description

Course Outline:

If you are currently preparing CTD submissions for the FDA and are familiar with the CTD structure, but need to learn how to comply with the May 2018 electronic submission requirements.

  • How to comply with the May 2018 electronic submissions requirements
  • Which agency guidelines and technical specifications publishers need to follow 
  • How to apply ICH and regional requirements to your eCTD
  • How to compile documents into the XML backbone of an eCTD, and lifecycle that application 
  • How to QC and validate an eCTD 
  • How metadata and study tagging files work 
  • Tips, tricks and best practices gathered from industry professionals 
  • How convert from a paper application to an eCTD 
  • How the new Module 1 (version 3.3) can be used for regulatory submissions 
  • What CTD readiness really means 
  • We will also provide a brief overview of the difference between submissions to US and Rest of the World (ROW), and give you a basic understanding how the regions differ.

When & Where?

When:
14 Nov - 15 Nov 2019

Where:
The University at Shady Grove
9630 Gudelsky Drive
Rockville
Maryland, USA
20850-3481

*Cost?

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

Applicant Requirements
  • Professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions particularly medical writers, regulatory operations, and submissions publishing.
  • Those involved in medical writing, regulatory operations, and submissions publishing.
Reference No: R1907368
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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