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Introduction to Electronic Regulatory Submissions in the eCTD Format

Price

$1,450*

Location

San Diego, California, USA

Date

13 Nov 2018 - 14 Nov 2018

Reference No: R1802269 - 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?
13 November 2018 - 14 November 2018

Where?
New Horizons Learning Center   
7480 Miramar Drive  
San Diego, CA 92126

*Cost?

Until 15 October 2018:
RAPS Member: $1,250.00
Non RAPS Member: $1,350.00

16 October 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: R1802269 - 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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