Journey to CTD NeeS eCTD submissions
What you’ll be taught
Definition of Regulatory Affairs
Position of Regulatory Affairs
CTD /eCTD Historical past
Benefits of CTD
Authority’s Pathway of Registration File
CTD Triangle
CTD, NeeS & eCTD definition
Variations between submission varieties CTD “Frequent Technical Paperwork” / NeeS “Non-eCTD digital Submissions” / eCTD “digital Frequent Technical Paperwork”
Group of CTD (Module 1, 2, 3, 4, & 5)
Standards of file preparation.
Module 1 “Regional Administrative Info”
Module 2 “Abstract / Overview Module”
Module 3 “High quality” – CMC “Chemistry, Manufacturing & Controls” particulars
Module 4 “Non-Scientific Research”
Module 5 “Scientific Research”
Overcoming challenges in m1 compilation
Description
CTD “Frequent Technical Paperwork” is the obligatory format for regulatory submissions worldwide.
This course explains the rationale for the CTD, NeeS & eCTD. Additionally, supplies detailed steering on its construction and format.
A number of MENA authorities had carried out eCTD/NeeS or CTD as a submission format for pharmaceutical merchandise. Nearly World authorities (Ministries of well being) have carried out CTD submission as a regular guideline for registration of merchandise.
All pharmaceutical firms are searching for new world markets’ alternatives by means of exportation of their drug merchandise. As exportation promote the pharmaceutical subject and encourage the investments within the pharmaceutical business. In an effort to achieve export, all firms must be accustomed to the implementation of the unified world registration system which known as CTD, in addition to ought to know learn how to put together their pharmaceutical/organic registration recordsdata to be complying to the worldwide unified registration system.
Contributors finishing this course ought to be capable of:
* Put together submissions to regulatory authorities in all international locations or areas the place the CTD/NeeS/eCTD codecs are obligatory, advisable or accepted.
* Perceive the variations between CTD, NeeS & eCTD.
Define
1. Position of regulatory affairs.
2. Definition and distinction between CTD, NeeS & eCTD.
3. CTD/eCTD historical past.
4. Group of CTD (Module 1, 2, 3, 4, & 5)
5. Standards of file preparation.
Content material
Introduction
Journey to CTD NeeS eCTD submissions 2
Journey to CTD NeeS eCTD submissions 3
Journey to CTD NeeS eCTD submissions 4
Journey to CTD / NeeS / eCTD submissions 4
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