PGD Regulatory Affairs [API]

The installment facility is available for fee payment.

Category: Postgraduate Courses
Duration : Self paced, Recommended to complete in 6 months
13 Students Enrolled

Learning objectives

Understand & interpret the ICH Quality guidelines,  CTD format, regulatory submissions w.r.t API - CEPs, ASMFs, USDMFs, WHO, Japan, Health Canada submissions

Eligibility

B.Sc/ M.Sc/ B.Pharma/M.Pharma/ Working professionals 

Syllabus

  • Section 1: Indian pharmaceutical industry
    • Orientation session 52 minutes
    • Manufacturing process flow API 66 minutes
    • Manufacturing process flow Formulation 75 minutes
    • Indian pharma industry overview

  • Section 2: Regulatory affairs
    • Regulatory Affairs 53 minutes

  • Section 3: Insight to ICH Quality guidelines & ICH M4 Q CTD format
    • 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
    • Requirements of USFDA 133 minutes

  • Section 5: DMF preparation in CTD format
    • 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

  • Section 6: Regulatory submission to US
    • USDMF submissions 90 minutes

  • Section 7: Regulatory submission to Europe
    • CEP submissions 150 minutes
    • CEP submissions contd 80 minutes
    • Genotoxic impurities 77 minutes
    • ASMF submissions 17 minutes

  • Section 8: Regulatory submission to other agencies
  • Video session on WHO submissions uploaded. You may refer the self-explanatory PDF notes for Japan & Health Canada submissions. 

    • API registration with WHO 35 minutes
    • Japan submissions
    • Health Canada submissions

  • Section 9: Additional topics
    • Change control, Changes to DMF 53 minutes

Fees : 23600

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    Course Include :
  • Video
  • Audio
  • PPT
  • PDF
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