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Keep shoppingRegulatory affairs CTD course
91 students
Regulatory affairs CTD course
CTD file preparation and reviewing tips
Created byMoshira Abbas Elmazahy
Last updated 5/2024
Arabic
What you'll learn
- Each trainee will be able to to prepare a registration file of pharmaceutical product according to a CTD format
- Learn details about DMF, COS, CEP, LOA
- Know ICH guidelines concerning to preparation of CTD file.
- Know Cmc chemistry manufacturing and control
- Submit CTD file to different regulatory authorities upon their request.
- Prepare a registration file according to the CTD format from module 1 to module 5 in accurate, precise & saving time manner.
- * Prepare acceptable CTD file to support export purpose.
- Cooperate with different departments involved in preparing CTD file.
- Review the CTD file before the submission of file to the authority and reply to any comments or requirements of different authorities.
Explore related topics
Course content
7 sections • 39 lectures • 8h 43m total length
Requirements
- No required tools
Description
Section 1
-Regulatory affairs profesion
-organization of different departments in pharmaceutical industry
-Introduction to Common Technical Document (CTD)
-Background on ICH guidance and CTD
-Basic structure of CTD (module 1-5)
-Module I (Regional)-
Administrative information
-Details of module 1 to GCC Module
-Workshop
Section 2
-Module III Quality (Drug Product)
CMC(chemical manufacturing control)
-Description and composition
-Pharmaceutical development
-manufacture
-Control of excipients
-Control of drug product
-workshop
Section 3
The rest of quality module (Module 3 product)
-Reference standard, SDS, COA
-container closure system primary and secondary packaging materials
-Stability study
-Appendices & Regional information from Uganda and GCC
*Workshop
Section 4
-Module III Quality (Drug substance)
-Details information about DMF of
active substance and its contents
according to CTD format
-details about COS, LOA
-General information of API
-Manufacture
-Characterization
-Control of drug substance
-Reference standard
-Container closure system
-Stability study
*Workshop
Section 5
-Module IV(Non clinical study reports)
-Module V (Clinical study reports)
*Brief information about
Bioequivalence and pharmacovigilance
*Workshop
Section 6
-Module II(Summary)
-How can you prepare brief summary for each module
(1,3,4&5)
-How can you fill the application of quality overall summary
(QOS), quality information summary (QIS)
-Brief summary eCTD
-How can you prepare a CTD file
Who this course is for:
- Fresh graduate pharmacists
- Fresh graduate veterinary
- Experienced pharm
- Fresh graduate chemist
- *pharmacist, chemist& veterinary who are working in pharmaceuticals industries
- Quality assurance
- *pharmacist, chemist& veterinary who are working in pharmaceuticals industries such as (regulatory affairs, R&D, quality control, quality assurance & planning sector) and those intended to be professional in regulatory affairs field
- R & D
- Quality control
- Export regulatory affairs who want to register aregister the pharmaceutical products according to a CTD format not only in Egypt but also in different countries such as GCC , African countries to support the export which achieve the national goal