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    Drug Development and Pharmaceutical R&D Business Framework

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    Udemy

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    Mode

    Online

    Fees

    ₹ 499 1999

    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  ₹1,999
    certificate availability

    Yes

    certificate providing authority

    Udemy

    The syllabus

    Introduction to Drug Discovery & Development

    • Introduction
    • Drug Development in a Nutshell
    • Knowledge Check on Drug Discovery
    • Drug Discovery
    • The R&D Pipeline & Portfolio Management: An Introduction
    • Investigations in the drug development phase

    Development Phases (Highlights)

    • Pre-Clinical (Phase 0)
    • What are Clinical Trials?
    • Phase I
    • Phase II
    • Phase III
    • Registration & Launch
    • Phase IV (Post-Launch)
    • Knowledge check on drug development phases

    The R&D organisation

    • The R&D Organisation
    • The CMC Function
    • The Clinical Function
    • The Non-Clinical Safety Function
    • The Regulatory Affairs Function
    • Project Management Functions
    • Knowledge check on the R&D Organisation

    Project Management Framework and Governance

    • The Project Team
    • Project Management Framework
    • Global Drug Development Plan & The Target Product Profile (TPP)
    • Project Milestones: Overview of milestone types and Phase Milestones
    • Project Deliverables
    • Project Decision Points and Project Governance
    • Knowledge check on Project Management Framework and Governance

    Information Systems, Numericals and Reporting

    • IT Landscape and Information Flow
    • Project Reporting
    • Function Reporting
    • Portfolio Reporting, Performance Indicators and Benchmarking

    Conclusion

    • Summary of Learnings & The future of pharmaceutical companies
    • Course Assets/ Downloads
    • Acknowledgements

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