Journey to CTD NeeS eCTD submissions
What you will learn
Definition of Regulatory Affairs
Role of Regulatory Affairs
CTD /eCTD History
Advantages of CTD
Authority’s Pathway of Registration Dossier
CTD Triangle
CTD, NeeS & eCTD definition
Differences between submission forms CTD “Common Technical Documents” / NeeS “Non-eCTD electronic Submissions” / eCTD “electronic Common Technical Documents”
Organization of CTD (Module 1, 2, 3, 4, & 5)
Criteria of dossier preparation.
Module 1 “Regional Administrative Information”
Module 2 “Summary / Overview Module”
Module 3 “Quality” – CMC “Chemistry, Manufacturing & Controls” details
Module 4 “Non-Clinical Study”
Module 5 “Clinical Study”
Overcoming challenges in m1 compilation
Description
CTD “Common Technical Documents” is the mandatory format for regulatory submissions worldwide.
This course explains the rationale for the CTD, NeeS & eCTD. Also, provides detailed guidance on its structure and format.
Several MENA authorities had implemented eCTD/NeeS or CTD as a submission format for pharmaceutical products. Almost Global authorities (Ministries of health) have implemented CTD submission as a standard guideline for registration of products.
All pharmaceutical companies are looking for new global markets’ opportunities through exportation of their drug products. As exportation promote the pharmaceutical field and encourage the investments in the pharmaceutical industry. In order to succeed in export, all companies should be familiar with the implementation of the unified global registration system which is called CTD, as well as should know how to prepare their pharmaceutical/biological registration files to be complying to the global unified registration system.
Participants completing this course should be able to:
* Prepare submissions to regulatory authorities in all countries or regions where the CTD/NeeS/eCTD formats are mandatory, recommended or accepted.
* Understand the differences between CTD, NeeS & eCTD.
Outline
1. Role of regulatory affairs.
2. Definition and difference between CTD, NeeS & eCTD.
3. CTD/eCTD history.
4. Organization of CTD (Module 1, 2, 3, 4, & 5)
5. Criteria of dossier preparation.
Content