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    • US Regulatory Strategy for Biologics and Pharmaceutical Drugs

    US Regulatory Strategy for Biologics & Pharmaceutical Drugs

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    Udemy

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    Mode

    Online

    Fees

    ₹ 499 1799

    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
    ₹ 499  ₹1,799
    certificate availability

    Yes

    certificate providing authority

    Udemy

    The syllabus

    Section 1: Welcome & Introduction

    • Welcome
    • Drug Development Overview
    • FDA History and Organizational Structure
    • The Regulatory Affairs Professional in the Biopharma Industry
    • Lecture 5: Section 1 Summary

    Section 2: Pre-Investigational New Drug (Pre-IND) - Preclinical Development

    • Introduction to the Course Drug
    • Basics of Regulatory Intelligence and Developing a Strategy
    • Planning Nonclinical Studies with the Investigational New Drug
    • Manufacturing Considerations for the Investigational New Drug
    • Preparing the IND for FDA Submission
    • Section 2 Summary

    Section 3: Investigational New Drug (IND) - Clinical Development

    • Is It Safe-to-Proceed?
    • Clinical Development Strategy: Regulatory Paths & Programs
    • IND Management
    • Phase 1 & EOP1: Clinical Pharmacology
    • Phase 2 & EOP2: Proof-of-Concept and Pediatrics
    • Phase 3: Pivotal and Confirmatory Studies
    • Section 3 Summary

    Section 4: New Drug Application - Getting A Drug Approved

    • Preparing the NDA/BLA for FDA Submission
    • The NDA/BLA Review Process and Getting FDA Approved

    Section 5: Post-Approval - Marketed Drug

    • Post-Marketing Maintenance & Label Expansion

    Section 6: Course Wrap-Up

    • Course Wrap-Up

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