Learning objectives
At the end of the course, you will be able to understand & interpret the ICH Quality guidelines, CTD format, regulatory submissions w.r.t Formulations, ANDAs, ASEAN, Europe submissions, submissions emerging markets
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 97 minutes
- Chromatographic terms 75 minutes
- ICH Q1A - Stability 140 minutes
- ICH Q1 B, D & E 117 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
- 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 46 minutes
- Section 8: Regulatory submission to emerging markets
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- Introduction to Emerging markets 110 minutes
- ACTD submission 65 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