Understanding the transition to the eCTD format in-person.  

In-person eCTD Training Workshops


Staying on top of submission requirements from the US Food and Drug Administration can be complicated. The transition to electronic has also made things more complex. Companies are slowly uncovering several burdens as they transition to the electronic common technical document (eCTD) format. Stay in the loop by signing up for the latest information about next upcoming eCTD training and other RAPS professional development programs.
 

2019 Dates Coming Soon 


If you are not prepared, you can easily cost your company time and money.

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

Objectives of In-Person Workshop:

  • To understand the common submission intake process with CTD structure
  • Stay aligned with best practices that will lead to successful electronic regulatory applications
  • In-depth discussion followed by a lab practice for real world application
 

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.

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.

 Training participants can receive RAC Credits.


2019 Dates Coming Soon 

Stay in the loop by signing up for the latest information about next upcoming eCTD training and other RAPS professional development programs.