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 dossier in ICH CTD format and various regulatory submission procedures followed for drug products.
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 Formulation 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 53 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 50 minutes
- ICH Q3B Impurities in drug product 75 minutes
- ICH Q3C Residual solvents 35 minutes
- ICH Q3D Elemental impurities 55 minutes
- Mutagenic impurities 37 minutes
- Nitrosamine impurities 46 minutes
- ICH Q6 Specifications 115 minutes
- ICH M4Q CTD format 45 minutes
- Section 4: Requirements of USFDA
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- Requirements of USFDA 50 minutes
- Section 5: Dossier 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
- P.1, P.3, P.4 60 minutes
- P.2 76 minutes
- P.5, P.6 24 minutes
- P.7, P.8 27 Minutes
- 3.2.R & A 23 minutes
- Bioequivalence studies overview 168 minutes
- CTD Module 3 presentation: other dosage forms 30 minutes
- Questionnaire Section 2 - 5
- Section 6: Regulatory submission to US
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- Types of US applications 55 minutes
- Patents, ANDA submissions 187 minutes
- ANDA lifecycle 87 minutes
- Questionnaire Section 6, 7
- Section 7: Regulatory submission to Europe
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- Eu introduction, Marketing authorization procedures 73 minutes
- Centralized procedure, National procedure, MRP & DCP 88 minutes
- Eu Patents 32 minutes
- Variations 35 minutes
- Eu Module 1 & Module 2 115 minutes
- Section 8: Regulatory submission to emerging markets
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- Introduction to Emerging markets 75 minutes
- ACTD submission 50 minutes
- Latin America submission 120 minutes
- Section 9: Regulatory submission to India
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- Regulatory submissions to India 100 minutes
- Section 10: Additional topics
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- Change control, Changes to ANDA 59 minutes
- eCTD submission part 1 60 minutes
- eCTD submission part 2 110 minutes
- Regulatory Inspections
- Resume writing 28 minutes
- Video related to Vacancies 10 minutes