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: Manufacturing process flow API & Formulation
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- Orientation session 52 minutes
- Manufacturing process flow API 60 minutes
- Manufacturing process flow Formulations 75 minutes
- Section 2: Regulatory affairs
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- Regulatory affairs 2 hours 20 minutes
- Section 3: Insight to ICH Quality guidelines & ICH M4 Q CTD format
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- ICH introduction 160 minutes
- ICH Q1A - Stability 140 minutes
- ICH Q1 B & E 90 min
- ICH Q2 Analytical Validation 140 minutes
- ICH Q3A Impurities in drug substances 50 minutes
- ICH Q3B Impurities in drug product 75 minutes
- ICH Q3C Residual solvents 35 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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- 148 minutes
- Section 5: DMF preparation in CTD format
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- Module 3 Drug substance Table of contents, S.1 to S.6 120 minutes
- Module 3 Drug substance S.7 15 minutes
- Section 6: Dossier preparation in CTD format
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- P.1, P.3, P.4 60 minutes
- P.2 75 minutes
- P.5, P.6 24 minutes
- P.7, P.8 27 Minutes
- 3.2.R & 3.2.A 24 minutes
- Bioequivalence studies overview 165 minutes
- CTD Module 3 presentation: other dosage forms 30 minutes
- Questionnaire Section 2 - 6
- Section 7: Regulatory submission to US [API]
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- USDMF submissions 105 minutes
- USDMF closure, changes 30 minutes
- Questionnaire Section 7 - 10
- Section 8: Regulatory submission to US [formulation] & ANDA submissions
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- Types of US applications 55 minutes
- Patents, ANDA submissions 187 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, suspension, withdrawal, closure 140 minutes
- CEP: revision & renewal 35 minutes
- Genotoxic impurities 77 minutes
- ASMF submissions 25 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 75 minutes
- ACTD submission 50 minutes
- Latin America submission 120 minutes
- Section 13: Regulatory submission to India [Formulation]
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- Regulatory submissions to India 100 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
- Video related to Vacancies 10 minutes