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Don't Get Behind on Electronic Submission Requirements for Commercial INDs and Master Files

In-person eCTD Training Workshops

24–27 March 2020
San Diego Training and Conference Center 
450 B St Ste 650
San Diego, CA 92101-8091


  REGISTER FOR INTRODUCTION     REGISTER FOR INTERMEDIATE
 

Effective May 5, 2020 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, and options available, to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications.

To successfully meet the new eCTD requirements, RAPS offers in-person training workshops.

Introduction to Regulatory Submissions in eCTD Format will cover:

  • 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 guidance 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

Who Should Attend:

These workshops are beneficial for 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. There are no prerequisites and you do not have to be a RAPS member to participate.

  REGISTER FOR INTRODUCTION
24–25 March 2020
San diego, ca
 REGISTER FOR INTERMEDIATE
26–27 march 2020
san diego, ca


Which workshop should I take?

Both. To fully understand use of the eCTD format and the regulatory authority’s Common Electronic Submissions Gateway (CESG), it is best to take both the introduction and intermediate course. FDA and other leading regulatory authorities can adjust or make requirements changes at anytime.

Workshop attendees can earn up to 18 RAC credits; the Introduction to Electronic Regulatory Submissions in eCTD Format is worth 8 RAC credits and the Intermediate Course on Planning and Executing Submissions in eCTD Format is worth 10 RAC credits.

Already have a handle on submission requirements?

The Intermediate Course on Planning and Executing Regulatory Submissions in eCTD Format will cover:

  • How to comply with the May 2020 electronic submissions requirements
  • 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
  • How to convert from a paper application to an eCTD
  • How the new Module 1 (version 3.3) can be used for regulatory submissions
  • How to generate and use an effective planner
  • What CTD readiness really means