Learning objectives
After listening to the lectures, you will gain knowledge essential to work in RA department and will be able to face interviews confidently.
You will learn interpretation and implementation of relevant regulatory guidelines, preparation of API Drug Master File (DMF) and various regulatory submission procedures followed for APIs.
Eligibility
B.Sc/ M.Sc/ B.Pharma/M.Pharma/ Working professionals
Syllabus
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Section 1: Indian pharmaceutical industry
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- Orientation session 52 minutes
- Manufacturing process flow API 66 minutes
- Manufacturing process flow Formulation 75 minutes
- Indian pharma industry overview
- Section 2: Regulatory affairs
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- Regulatory Affairs 53 minutes
- Section 3: Insight to ICH Quality guidelines & ICH M4 Q CTD format
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- ICH introduction 100 minutes
- Chromatographic terms 75 minutes
- ICH Q1A - Stability 140 minutes
- ICH Q1 B & E 90 minutes
- ICH Q2 Analytical Validation 137 minutes
- ICH Q3A Impurities in drug substances 130 minutes
- ICH Q3B Impurities in drug product 94 minutes
- ICH Q3C Residual solvents 55 minutes
- ICH Q3D Elemental impurities 105 minutes
- ICH Q6 Specifications 115 minutes
- ICH M4Q CTD format 45 minutes
- Section 4: Requirements of USFDA
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- Requirements of USFDA 133 minutes
- Section 5: DMF preparation in CTD format
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- Terminology, Table of contents, S.1,S.2, APISM, ICHQ11 reference 133 minutes
- S.3, S.4, S.5 80 mins
- S.6, S.7 35 minutes
- Questionnaire Section 2 - 5
- Section 6: Regulatory submission to US
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- USDMF submissions 120 minutes
- USDMF communication letters 20 minutes
- Section 7: Regulatory submission to Europe
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- EDQM, CEP, Application form, QOS, Evaluation, approval, certification database, validity, inspections 150 minutes
- CEP: Suspension, withdrawal, closure, revision & renewal 80 minutes
- Genotoxic impurities 77 minutes
- ASMF submissions 17 minutes
- Section 8: Regulatory submission to other agencies
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Video session on WHO submissions uploaded. You may refer the self-explanatory PDF notes for Japan & Health Canada submissions.
- API registration with WHO 35 minutes
- Japan submissions
- Health Canada submissions
- Section 9: Additional topics
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- Change control, Changes to DMF 53 minutes
- eCTD submission part 1 60 minutes
- eCTD submission part 2 110 minutes
- Regulatory Inspections