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) & formulation dossier in ICH CTD format, and various regulatory submission procedures followed for API and drug product.
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 100 minutes
- Chromatographic terms 72 minutes
- ICH Q1A - Stability 140 minutes
- ICH Q1 B & E 90 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
- Questionnaire Section 2 - 6
- Section 7: Regulatory submission to US [API]
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- USDMF submissions 120 minutes
- USDMF communication letters 20 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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- 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 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 & Module 2 115 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
- Latin America submission 120 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
- eCTD submissions part 1 60 minutes
- eCTD submissions part 2 110 minutes
- Regulatory Inspections