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Intermediate Course for Regulatory Submissions in eCTD Format

Price

$1,550*

Location

Rockville, Maryland, USA

Date

26 Jul 2018 - 27 Jul 2018

Reference No: R1802256 - RAPS

Apply for this event

Key points about this Training Event

  • At the conclusion of this program, participants will be able to:
  • Identify best practices with software used to generate electronic submission content
  • Understand the acronyms and terms surrounding eCTD and electronic submissions
  • 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
  • Obtain an understanding of what is required to transition into submitting in the eCTD format
Event Description

Course Outline:

Effective May 5, 2018 your company is required to migrate all commercial INDs and Master Files, as well as all NDAs, ANDAs, and BLAs to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet these new requirements, organizations need to understand the processes required to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn:

  • 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 

When & Where?

When:
26 July 2018 to 27 July 2018

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

*Cost

Until 27 June 2018:
RAPS Member: $1,350
Non RAPS Member: $1,450

28 June 2018 and after:
RAPS Member: $1,450
Non RAPS Member: $1,550

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
Reference No: R1802256 - 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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