The three CTD Guidance documents applicable to Conventional biotherapeutic products, Biotechnological/biological (Biotech) products and Blood products have been ...
Health Canada is pleased to announce the finalization of the Guidance Document: Creation of the Canadian Module 1 Backbone as a result of a 30 day consultation period. This document replaces the 2004 ...
he course is designed to introduce requirements, process, and techniques for preparing successful and high quality registration dossiers for regulatory submissions.