Learning objectives
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Eligibility
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Syllabus
Section 1: Manufacturing process flow API & Formulation - Orientation session 52 minutes
- Manufacturing Process Flow API 66 minutes
- Manufacturing Process Flow Formulation 75 minutes
- Section 2: Regulatory affairs
- Regulatory affairs 2 hours 20 minutes
- Section 3:
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- Section 4: Insight to ICH Quality guidelines & ICH M4 Q CTD format
- 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 50 minutes
- ICH Q3B Impurities in drug product 94 minutes
- ICH Q3C Residual solvents 35 minutes
- ICH Q3D Elemental impurities 105 minutes
- ICH Q6 Specifications 115 minutes
- ICH M4Q CTD format 45 minutes
- Section 5: Requirements of USFDA
- Requirements of USFDA 148 minutes
- Section 6: Dossier preparation in CTD format
- 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 7: Regulatory submission to US
- Types of US applications 55 minutes
- Patents, ANDA submissions 187 minutes
- ANDA lifecycle 87 minutes
- Questionnaire Section 6, 7
- Section 8: Regulatory submission to Europe
- 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 9: Regulatory submission to emerging markets
- Introduction to Emerging markets 110 minutes
- ACTD submission 65 minutes
- Latin America submission 120 minutes
- Section 10: Regulatory submission to India
- Regulatory submissions to India 115 minutes
- Section 11: Additional topics
- Change control, Changes to ANDA 59 minutes
- eCTD submission part 1 60 minutes
- eCTD submission part 2 110 minutes
- Regulatory Inspections
- Video related to Vacancies 10 minutes