Learning objectives
At the end of the course, you will be able to understand & interpret the ICH Quality guidelines, CTD format, Bio-equivalence studies, regulatory submissions w.r.t API & Formulations, ANDAs, ASEAN, Europe submissions, emerging markets, CEPs, ASMFs, USDMFs, WHO, Japan, Health Canada guidance
Eligibility
B.Pharma/M.Pharma/ B.Sc/ M.Sc/ Working professionals
Syllabus
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Section 1: Indian Pharmaceutical Industry
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- Orientation session 52 minutes
- Indian Pharma industry overview
- Manufacturing process flow API 66 minutes
- Manufacturing process flow Formulations 75 minutes
- Section 2: Regulatory affairs
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- Regulatory affairs 55 minutes
- Section 3: Insight to ICH Quality guidelines & ICH M4 Q CTD format
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- ICH introduction 97 minutes
- Chromatographic terms 72 minutes
- ICH Q1A - Stability 140 minutes
- ICH Q1 B, D & E 120 min
- ICH Q2 Analytical Validation 140 minutes
- ICH Q3A Impurities in drug substances 130 minutes
- ICH Q3B Impurities in drug product 95 minutes
- ICH Q3C Residual solvents 57 minutes
- ICH Q3D Elemental impurities 106 minutes
- ICH Q6 Specifications 115 minutes
- ICH M4Q CTD format 45 minutes
- Section 4: Requirements of USFDA
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- 132 minutes
- Section 5: DMF preparation in CTD format
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- Terminology, Table of contents, S.1,S.2, APISM, ICHQ11 reference 150 minutes
- S.3, S.4, S.5 80 minutes
- S.6, S.7 36 minutes
- Section 6: Dossier preparation in CTD format
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- P.1, P.3, P.4 90 minutes
- P.2 75 minutes
- P.5, Summary tables for impurities, P.6, P.7, P.8 166 minutes
- 3.2.R & 3.2.A 24 minutes
- Bioequivalence studies overview 165 minutes
- Section 7: Regulatory submission to US [API]
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- USDMF submissions 90 minutes
- Section 8: Regulatory submission to US [formulation] & ANDA submissions
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- Types of US applications 55 minutes
- Patents, ANDA submissions 180 minutes
- ANDA lifecycle 87 minutes
- Section 9: Regulatory submission to Europe [API]
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- CEP submissions 150 minutes
- CEP submissions contd 80 minutes
- Genotoxic impurities 77 minutes
- ASMF submissions 17 minutes
- Section 10: Regulatory submission to Europe [Formulation]
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- Introduction to Eu agencies, Marketing authorization procedures 97 minutes
- Centralized procedure, National procedure, MRP & DCP 93 minutes
- Eu Patents 32 minutes
- Variations 35 minutes
- Eu Module 1 46 minutes
- Section 11: Regulatory submission to other agencies [API]
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Video session on WHO submissions uploaded. You may refer the self-explanatory PDF copies for Japan & Health Canada submissions.
- API registration with WHO 35 minutes
- Japan submissions
- Health Canada submissions
- Section 12: Regulatory submission to emerging markets [Formulation]
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- Introduction to Emerging markets 110 minutes
- ACTD submission 65 minutes
- Section 13: Regulatory submission to India [Formulation]
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- Regulatory submissions to India 115 minutes
- Section 14: Additional topics
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- Change control, Changes to DMF & ANDA 84 minutes