eCTD: Electronic Common Technical Document

Contact Details

  • eCTD: Electronic Common Technical Document
  • Boardroom
  • Mississauga
  • Canada
  • 18002435596

eCTD: Electronic Common Technical Document

The Electronic Common Technical Document (eCTD) format has been adapted by many regulatory agencies for submission of applications for marketing authorization. It has been found to be cheaper and more efficient especially when you are submitting thousands of pages to regulatory agencies for review. Of course it also reduces the storage space requirements. Its mandatory for certain regulatory authorities.  We don’t know when the eCTD format will be mandatory. Most likely not far from now.

The eCTD format is also used  to facilitate  the preparation of  several drug regulatory activities. Some of the considerations in submitting drug regulatory activities  include the format and the content  to be submitted. In this course partici[ants will learn the preparation and filing of drug regulatory in the eCTD format to health Canada Food and Drugs Administration (FDA)  and  European Union (EU) . the course will explore the different options applicants can use based on what they want to accomplish. we will consider the licensing of generic drugs and brand name drugs.

Participants will get a chance to to develop a model application using off the shelf tools. This eCTD course will be based on the current ICH guidelines, government guidelines  as well as the regulations that describe the required content for the markets that will be reviewed. We will  also review the regulations that define the content in  module 1  as well as the ectd architecture and the required components  for life-cycle management.

Although eCTD software varies with the vendor, we will discuss important activities associated with preparation of dossiers for submission to regulatory bodies. We will review the process of authoring documents, publishing, quality control and the submission process.

The combined in-class and  online course is available  twice a year. The Online courseFotolia_33064312_Subscription_Monthly_XXL is available through out the year.

The eCTD in-class courses will be held in Mississauga and Toronto.  You can contact us for on-site training.