| Greetings!
The upcoming AAPS Pharma workshop builds on the foundation of Level II and takes participants deeper into the realities of preparing New Drug Submissions (NDS) in CTD and eCTD formats for Health Canada. It focuses on what actually drives successful submissions - from advanced dossier structuring and lifecycle management to responding effectively to Health Canada inquiries and reconsideration requests. The session also offers detailed guidance on Module 1 (Administrative and Product Information) and practical insights into handling post-market compliance with precision.
Designed for professionals who already work in regulatory affairs or quality assurance, this workshop bridges experience with execution. Participants will gain clarity on Health Canada’s Module 1 and ICH Modules 2–5, and learn how to manage eCTD submissions using the Common Electronic Submissions Gateway (CESG). The discussion will also cover verification standards, media and email submissions, and what regulators actually look for when reviewing a dossier.
By the end of the session, attendees will walk away with a stronger understanding of how to verify transactions for compliance, manage complex submissions with confidence, and apply proven best practices to strengthen every Health Canada filing. | 
No comments:
Post a Comment