Learning objectives
After listening to the lectures, you will gain knowledge essential to work in RA department as an associate, officer etc and will be able to face interviews confidently. This course is designed for B.Pharm, M.Sc freshers
Eligibility
Graduates and post graduates. Anyone willing to understand this topic can enroll. Students pursuing final year B.Pharmacy can also enrol
Syllabus
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Section 1: Introductory session
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- Manufacturing process flow API 60 minutes
- Manufacturing process flow-Formulation 75 minutes
- Departments in pharmaceutical industry & responsibilities
- Section 2: Regulatory affairs
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- Introduction to RA profession 2 hours 20 minutes
- Section 3: ICH & Quality guidelines
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- Overview of ICH Quality guidelines 100 minutes
- Overview of ICH quality guidelines additional notes
- Section 4: ICH M4 Q CTD format
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- ICH M4 Q CTD format 45 minutes
- Section 5: DMF preparation in CTD format
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- DMF preparation in CTD format 95 minutes
- DMF preparation in CTD format Table of contents Module 3
- Section 6: Dossier preparation in CTD format
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- CTD Module 3 Drug product part 1 1 hour 50 minutes
- CTD Module 3 Drug product part 2 50 minutes
- Dossier Module 3 Table of contents
- Bioequivalence studies overview 2 hours 30 minutes
- CTD Module 3 presentation: other dosage forms 30 minutes
- Section 7: Regulatory submission to US-API
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- USDMF submission
- Section 8: Regulatory submission to US- Formulation
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- Types of applications 45 minutes
- Paragraph certifications & Hatch Waxman Act 53 minutes
- ANDA submission modules 48 minutes
- Section 9: Regulatory submission to Europe -API
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- CEP & ASMF submission
- Section 10: Regulatory submission to Europe - Formulation
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- Introduction to Eu agencies, Marketing authorization procedures 1 hour 47 minutes
- Section 11: Regulatory submission to emerging markets
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- Introduction to emerging markets submission 75 minutes
- ACTD submissions 50 minutes
- Section 12: eCTD format
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- eCTD format & demonstration 1 hour 30 minutes
- Questions on all sections
- Resume writing 28 minutes
- Video related to Vacancies 10 minutes