CTD NeeS & eCTD compilation and submission of the dossiers
Journey to CTD NeeS eCTD submissions
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1.5 hours
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Nov 2021
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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
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Related Topics
4377186
udemy ID
01/11/2021
course created date
20/12/2021
course indexed date
Angelcrc Seven
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