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: 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 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: Dossier 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
- P.1, P.3, P.4 92 minutes
- P.2 76 minutes
- P.5, Summary tables for impurities, P.6, P.7, P.8 153 minutes
- 3.2.R & A 23 minutes
- Bioequivalence studies overview 168 minutes
- Questionnaire Section 2 - 5
- Section 6: Regulatory submission to US
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- Types of US applications 55 minutes
- Patents, ANDA submissions 180 minutes
- ANDA lifecycle 87 minutes
- Section 7: Regulatory submission to Europe
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- Eu introduction, 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 8: Regulatory submission to emerging markets
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- Introduction to Emerging markets 110 minutes
- ACTD submission 65 minutes
- Latin America submission 120 minutes
- Section 9: Regulatory submission to India
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- Regulatory submissions to India 115 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