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Intermediate Course for Planning and Executing Regulatory Submissions in eCTD Format

Price

$1,350*

Location

San Diego, California, USA

Date

26 Mar 2020 - 27 Mar 2020

Reference No: R0220396-RAP

Apply for this event

Key points about this Training Event

  • Identify best practices with software used to generate electronic submission content
  • Understand how MS Word functionality can be used to reduce the need for PDF remediation to produce an FDA-compliant PDF file
  • Apply ICH and regional requirements for the content of an eCTD submission
  • Produce and review eCTDs to minimize the chance of Refusal to Review and Refuse to File (RTF) actions by FDA
Event Description

Course Outline:

How to comply with the May 2020 electronic submissions requirements
During this workshop, you will learn:

  • Which agency guidelines and technical specifications publishers need to follow and how to incorporate them into your workflow and QC
  • How to apply ICH and regional requirements to your eCTD
  • What your publishers need from you to compile documents into the XML backbone of an eCTD, and to lifecycle that application
  • How to QC and validate an eCTD
  • How metadata and study tagging files work, and how you can make them work for you and your application
  • Tips, tricks and best practices gathered from industry professionals

 You will also be provided with a brief overview of the difference between submissions to US and the Rest of the World (ROW) and give you a basic understanding how the regions differ

When & Where?

When:
26 - 27 March 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: $1,350

Applicant Requirements
  • Those with a working knowledge of the CTD format who are already preparing documents for FDA submissions
  • This workshop is beneficial for professionals working in the drug, biologic or combination products fields who are involved in the preparation of electronic submissions
Reference No: R0220396-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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