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    Global Pharma Drug Regulatory Affairs course

    BY
    Udemy

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    Mode

    Online

    Fees

    ₹ 449 2799

    Quick Facts

    particular details
    Medium of instructions English
    Mode of learning Self study
    Mode of Delivery Video and Text Based

    Course and certificate fees

    Fees information
    ₹ 449  ₹2,799
    certificate availability

    Yes

    certificate providing authority

    Udemy

    The syllabus

    Course Introduction and overview

    • Course Overview
    • Course Contents
    • Career Opportunities in Regulatory Affairs
    • Introduction and Objective of Course
    • Common Websites and Usage
    • ICH Guidelines
    • Literature Survey
    • General Quiz

    Drug Master File

    • Drug Master File
    • Difference between DMFs and Applications
    • Submission of DMF
    • Drug Master File Quiz

    Common Technical Documents

    • Module - 1 Administrative (Region Specific)
    • Module - 2 (Summary & Overview)
    • Module -3 (Quality) Drug Substance
    • Module -3 (Quality) Drug product
    • Module -3 (Quality) Drug product
    • Module -3 (Quality) Drug product
    • Stability Study
    • Module 4 (Non-Clinical Study)
    • Module 5 Clinical Safety reports Part - I
    • Module 5 Clinical Safety reports Part - II
    • eCTD Structure
    • Basic Demonstration of eCTD Software & eValidator
    • Quiz for eCTD & CTD Modules

    New Drug Approval (NDA) & Abreviated new drug application (ANDA)

    • New Drug Application (NDA)
    • (New Drug Approval) NDA Part - II
    • Abreviated New Drug Application (ANDA)

    Congratulations & Thank you

    • Congratulations & Thank you

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