PGD Regulatory Affairs [Formulation]

The installment facility is available for fee payment.

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

Learning objectives

At the end of the course, you will be able to understand & interpret the ICH Quality guidelines,  CTD format, regulatory submissions w.r.t Formulations, ANDAs, ASEAN, Europe submissions, submissions emerging markets 

Eligibility

B.Pharma/M.Pharma/ B.Sc/ M.Sc/ 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 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: Dossier 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
    • P.1, P.3, P.4 92 minutes
    • P.2 76 minutes
    • P.5, Summary tables for impurities, P.6, P.7, P.8 153 minutes
    • 3.2.R & A 23 minutes
    • Bioequivalence studies overview 168 minutes

  • Section 6: Regulatory submission to US
    • Types of US applications 55 minutes
    • Patents, ANDA submissions 180 minutes
    • ANDA lifecycle 87 minutes

  • Section 7: 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 46 minutes

  • Section 8: Regulatory submission to emerging markets
    • Introduction to Emerging markets 110 minutes
    • ACTD submission 65 minutes

  • Section 9: Regulatory submission to India
    • Regulatory submissions to India 115 minutes

  • Section 10: Additional topics
    • Change control, Changes to ANDA 59 minutes

Fees : 28320

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    Course Include :
  • Video
  • Audio
  • PPT
  • PDF
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