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Introduction to Electronic Regulatory Submissions in the eCTD Format

Price

$1,450*

Location

Rockville, Maryland, USA

Date

24 Jul 2018 - 25 Jul 2018

Reference No: R1802255 - RAPS

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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?

When:
24 July 2018 - 25 July 2018

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

*Cost?

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.

Email raps@raps.org

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