Course of Common Technical Document

By Dr.Heba Uncategorized
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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.”

 

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What Will You Learn?

  • By studying CTD, you'll acquire the necessary knowledge and skills to navigate the complex landscape of regulatory affairs, ensuring compliance with global standards and contributing to the successful development and approval of pharmaceutical products.

Course Content

GRA – CTD

  • Session 1 of CTD
    01:23:25
  • Session 4 CTD-part 1
    28:35
  • session 4 CTD part 2
    39:10
  • Session 5 of CTD
    01:42:08
  • Session 6 of CTD
    01:47:14
  • Session 2 of CTD
    01:35:20
  • Session 3 of CTD
    01:37:04

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