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