PGD Regulatory Affairs [API & Formulation]

The installment facility is available for fee payment.

Category: Postgraduate Courses
Duration : Self paced, recommended to complete in 6 months
108 Students Enrolled

Learning objectives

At the end of the course, you will be able to understand & interpret the ICH Quality guidelines, CTD format, Bio-equivalence studies, regulatory submissions w.r.t API & Formulations, ANDAs, ASEAN, Europe submissions, emerging markets, CEPs, ASMFs, USDMFs, WHO, Japan, Health Canada guidance

Eligibility

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

Syllabus

  • Section 1: Indian Pharmaceutical Industry
    • Orientation session 52 minutes
    • Indian Pharma industry overview
    • Manufacturing process flow API 66 minutes
    • Manufacturing process flow Formulations 75 minutes

  • Section 2: Regulatory affairs
    • Regulatory affairs 55 minutes

  • Section 3: Insight to ICH Quality guidelines & ICH M4 Q CTD format
    • ICH introduction 97 minutes
    • Chromatographic terms 72 minutes
    • ICH Q1A - Stability 140 minutes
    • ICH Q1 B, D & E 120 min
    • ICH Q2 Analytical Validation 140 minutes
    • ICH Q3A Impurities in drug substances 130 minutes
    • ICH Q3B Impurities in drug product 95 minutes
    • ICH Q3C Residual solvents 57 minutes
    • ICH Q3D Elemental impurities 106 minutes
    • ICH Q6 Specifications 115 minutes
    • ICH M4Q CTD format 45 minutes

  • Section 4: Requirements of USFDA
    • 132 minutes

  • Section 5: DMF preparation in CTD format
    • Terminology, Table of contents, S.1,S.2, APISM, ICHQ11 reference 150 minutes
    • S.3, S.4, S.5 80 minutes
    • S.6, S.7 36 minutes

  • Section 6: Dossier preparation in CTD format
    • P.1, P.3, P.4 90 minutes
    • P.2 75 minutes
    • P.5, Summary tables for impurities, P.6, P.7, P.8 166 minutes
    • 3.2.R & 3.2.A 24 minutes
    • Bioequivalence studies overview 165 minutes

  • Section 7: Regulatory submission to US [API]
    • USDMF submissions 90 minutes

  • Section 8: Regulatory submission to US [formulation] & ANDA submissions
    • Types of US applications 55 minutes
    • Patents, ANDA submissions 180 minutes
    • ANDA lifecycle 87 minutes

  • Section 9: Regulatory submission to Europe [API]
    • CEP submissions 150 minutes
    • CEP submissions contd 80 minutes
    • Genotoxic impurities 77 minutes
    • ASMF submissions 17 minutes

  • Section 10: Regulatory submission to Europe [Formulation]
    • Introduction to Eu agencies, 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 11: Regulatory submission to other agencies [API]
  • Video session on WHO submissions uploaded. You may refer the self-explanatory PDF copies for Japan & Health Canada submissions. 

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

  • Section 12: Regulatory submission to emerging markets [Formulation]
    • Introduction to Emerging markets 110 minutes
    • ACTD submission 65 minutes

  • Section 13: Regulatory submission to India [Formulation]
    • Regulatory submissions to India 115 minutes

  • Section 14: Additional topics
    • Change control, Changes to DMF & ANDA 84 minutes

Fees : 35400

Enroll Now
    Course Include :
  • Video
  • Audio
  • PPT
  • PDF
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