Dossier preparation Module 3 [reference ICH CTD & ANDA guidance]

RA professionals play a very crucial role by giving advice to various departments for generating data for product registration & thereby helping companies in generating revenue. Product registration allows companies to market their formulation in pertinent countries for which a scientific document named as Dossier is essential. Out of 5 CTD modules of Dossier, Quality module 3 is a key module that covers data on drug substance, excipients and drug product. The discussion enclosed here will help you to understand every section of the quality module thoroughly. It also covers examples, templates & US ANDA requirements

Category: Crash Courses
Duration : Training duration: 11 hours, course would be accessible for 1 month from the date of admission

Learning objectives

Knowledge of the following topics:

3.2.S  Drug Substance: 3.2.S.1   General Information, 3.2.S.2   Manufacture, 3.2.S.3   Characterisation, 3.2.S.4   Control of Drug Substance, 3.2.S.5   Reference Standards or Materials, 3.2.S.6   Container Closure System, 3.2.S.7   Stability

3.2.P  Drug Product: 3.2.P.1   Description and Composition of the Drug Product, 3.2.P.2   Pharmaceutical Development, 3.2.P.3   Manufacture, 3.2.P.4   Control of Excipients, 3.2.P.5   Control of drug product, 3.2.P.6   Reference Standards or Materials, 3.2.P.7   Container Closure System 3.2.P.8   Stability

3.2.A Appendices, 3.2.R Regional Information, 3.3     Literature References


B.Pharm/M.Pharm/M.Sc/B.Sc/MBA/ PhD/ Working professionals from Pharma/Bio-tech industry [QC/QA/R & D/F & D/ ADL/ RA/ Patents/International business etc] & those aspiring to enhance their regulatory affairs knowledge.

Anyone willing to understand this topic can enroll


  • Section 1: Module 3 Drug substance & drug product sections
    • ICH M4Q CTD format introduction 45 minutes
    • Module 3 Drug substance sections S.1, S.2, APISM, ICHQ11 reference 150 minutes
    • Module 3 Drug substance sections S.3, S.4, S.5 80 minutes
    • Module 3 Drug substance sections S.6, S.7 36 minutes
    • Module 3 drug product sections P.1, P.3, P.4 90 minutes
    • Module 3 drug product sections P.2 75 minutes
    • Module 3 drug product sections P.5, P.6, P.7, P.8 166 minutes
    • Module 3 drug product sections 3.2.R & 3.2.A 24 minutes

Fees : 8024

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    Course Include :
  • Video
  • PDF