Rose Keeling
26 March 2025
Completing the Quality/CMC module of the CTD
12-hour
Understanding the Key aspects of the CTD Global Dossier, Understanding and reviewing the drug substance sections of the CTD dossier, Examining the drug product sections of the dossier, Understanding the reviewer’s perspective – The CTD equation and importance of development pharmaceutics, Understanding source documents, Change control and global roll out
Andrew Willis
RK
Issued to
Rose Keeling
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Credential Verification
Issue date: March 26, 2025
ID: 36713f18-5406-4a25-9c6d-bcfbbf7e06cd
Type
Course
Level
Professional
Format
Online
Duration
2 days
Price
Paid
Description
The holder of this certificate has attended the course "Completing the Quality/CMC Module of the CTD".
This training course examines the FDA and EMA regulatory requirements for both pharmaceuticals and biotech. It will give you the confidence to identify, compile and submit the correct information in the quality module. Once completed you will have a comprehensive understanding of key areas such as CMC regulatory strategy, building the pharmaceutical sections, creating the drug product sections, and creating the Quality Overall Summary (QOS).
Skills
Regulatory Affairs
Common Technical Document
CMC Regulatory Affairs
Earning Criteria
Participation
Attended the live online course held by Educo Life Sciences.
Watching
Or watched the recorded materials for the course held by Educo.