Program highlights include:

• The necessary processes to create an eCTD for an EU and FDA submission.
• A brief introduction in the eCTD basics
• Creation of a Product Master Dossier, covering the Quality-relevant part of an eCTD.
• EU Module1 - compile non-clinical and clinical studies

Learning Objectives:

At the end of this training, the participants should be able to:

• Compile a technically validated eCTD for various regions
• Maximize the reuse of compiled content
• Understand eCTD publishing and technical validation
• Understand the differences in the regional interpretations of electronic submissions
• Consider the impact of various regional interpretations of eCTD specifications and guidelines on global submissions strategy

Target Audience:

Professionals in:

• Regulatory Affairs
• Regulatory Operations
• Submission Management
• Electronic Publishing