RAPS - eCTD Workshops

10-13 April 2018

Updated on the latest electronic submission requirements for commercial INDs and Master Files?

Register for two great workshops in San Diego

FLYER

(Full Event Details on Flyer)

REGISTER HERE

COURSE DESCRIPTION

This April, RAPS will offer hands-on training in small group workshops on the electronic common technical document format (eCTD). Two types of workshops will be offered to those who want an interactive experience to help understand the structure and processes needed to build electronic submissions and implement operational changes.

During the Introduction Workshops (Know the Fundamentals, APR 10-11) 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

  • How to generate agency-compliant PDF files

During the Intermediate Workshops (Already Using eCTD, APR 12-13) 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

  • How to compile documents into the XML backbone of an eCTD

  • How to QC and validate an eCTD

LOCATION

New Horizons Learning Center San Diego, CA 92126

FURTHER INFORMATION

Learn more at raps.org/ectd

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