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Safety Risk Management: A Focus on EU RMPs and US REMS

Review the strategic and operational aspects of global risk management including key concepts, principles, and tools necessary to develop risk management programs.

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Overview

This on-demand training course is focused on the strategic and operational aspects of global safety risk management. Key concepts, principles, and tools necessary to develop risk management programs will be introduced. Participants will be exposed to the regulatory requirements in the US and European Economic Areas (EEA). Throughout the course, learners will engage in exercises to apply the knowledge gained from instructional sessions.

This on-demand training course takes an average of 8.5 hours to complete. Learners have access to the course for one year from the date of purchase.

What you will learn

    • What is risk management
    • Risk management regulations
    • Content of a US Risk Evaluation and Mitigation Strategy (REMS)
    • Content of an EU Risk Management Plan (RMP)
    • Risk minimization
    • Risk management processes
    • Development of the risk management strategy and authoring of risk management documents
    • Post-Approval requirements for RMPs and REMS
    • Preparing for risk management audits and inspections
    • Future direction of global risk management

Who should attend?

  • This program is designed for professionals involved in:

    • Risk management planning
    • Development of RMPs (Risk Management Plans) and REMS (Risk
    • Evaluation and Mitigation Strategies)
    • Drug safety and pharmacovigilance (PV)
    • Benefit-Risk assessment
    • Risk communication
    • Pharmacoepidemiology
    • Medical writing
    • Regulatory affairs, regulatory strategy
    • Medical affairs, medical information/communication
    • Pharmacovigilance quality management
    • Other disciplines that interact with or support safety and PV functions across the product lifecycle

      • Learning objectives

      • At the conclusion of this course, participants should be able to:

        • Identify the key concepts, principles, and tools used in risk management and risk minimization
        • Evaluate the current guidelines and regulations for risk management in key markets, including the EEA and US
        • Compare and contrast the EU-RMP with the US REMS and identify core elements common to both
        • Recognize the post-marketing commitments for a REMS and EU-RMP
        • Analyze the process for developing a global risk management strategy and customization based on local and regional variations

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