Course of Common Technical Document
About Course
“I am excited to inform you that, throughout this course, I will guide you through an in-depth exploration of the intricacies of both CTD and eCTD. By the end of our journey together, you will have a comprehensive understanding of the details, structure, and importance of these vital documents in the pharmaceutical and regulatory landscape.”
“The Common Technical Document, often abbreviated as CTD, serves as a universally recognized and standardized format for compiling the essential documentation necessary for the registration of pharmaceutical products. Within its comprehensive structure, the CTD meticulously encapsulates intricate details regarding a drug’s quality, safety, and efficacy. This document is ingeniously organized into modules, each thoughtfully designed to address various facets of the drug’s developmental journey. From the nuanced insights into chemistry and manufacturing processes to the comprehensive clinical data, the CTD is an indispensable tool in the pharmaceutical regulatory arena.”
Course Content
GRA – CTD
Session 1 of CTD
01:23:25Session 4 CTD-part 1
28:35session 4 CTD part 2
39:10Session 5 of CTD
01:42:08Session 6 of CTD
01:47:14Session 2 of CTD
01:35:20Session 3 of CTD
01:37:04