PGD Regulatory Affairs [API & Formulation]

The installment facility is available for fee payment.

Category: Postgraduate Courses
Duration : Self paced, recommended to complete in 4 months

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

  • Section 1: Introductory session
    • Indian pharma industry
    • Manufacturing process flow API 66 minutes
    • Manufacturing process flow-Formulation 75 minutes
    • Departments in pharmaceutical industry & responsibilities

  • Section 2: Regulatory affairs
    • Introduction to RA profession 55 minutes

  • Section 3: ICH & Quality guidelines
    • Overview of ICH Quality guidelines 103 minutes
    • Overview of ICH quality guidelines additional notes

  • Section 4: ICH M4 Q CTD format
    • ICH M4 Q CTD format 45 minutes

  • Section 5: DMF preparation in CTD format
    • DMF preparation in CTD format 95 minutes
    • DMF preparation in CTD format Table of contents Module 3
    • DMF preparation in CTD format Table of contents

  • Section 6: Dossier preparation in CTD format
    • CTD Module 3 Drug product part 1 1 hour 50 minutes
    • CTD Module 3 Drug product part 2 50 minutes
    • Bioequivalence studies overview 2 hours 30 minutes

  • Section 7: Regulatory submission to US-API
    • USDMF submission 1 hour 20 minutes

  • Section 8: Regulatory submission to US- Formulation
    • Types of applications 45 minutes
    • Paragraph certifications & Hatch Waxman Act 53 minutes
    • ANDA submission modules 48 minutes

  • Section 9: Regulatory submission to Europe -API
    • CEP & ASMF submission 2 hours 30 minutes

  • Section 10: Regulatory submission to Europe - Formulation
    • Introduction to Eu agencies, Marketing authorization procedures 1 hour 47 minutes

  • Section 11: Regulatory submission to emerging markets
    • Introduction to emerging markets submission 1 hour 30 minutes
    • ACTD submissions 67 minutes

  • Section 12: eCTD format
    • eCTD format & demonstration 1 hour 30 minutes
    • Questions on all sections

Fees : 15340

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    Course Include :
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