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 course 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.