CTD NeeS eCTD compilation & submission of registration files
Journey to a pharmaceutical manufacturing site
4.11 (75 reviews)
1 114
students
40 mins
content
Oct 2021
last update
FREE
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What you will learn
Journey to a pharmaceutical manufacturing site
Definition of Regulatory Affairs
Role of Regulatory Affairs
CTD /eCTD History
Advantages of CTD
Risks associated with poor 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"
Prepare submissions to regulatory authorities in all territores where the CTD/NeeS/eCTD formats are mandatory, recommended or accepted
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4354806
udemy ID
18/10/2021
course created date
20/12/2021
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