[工学]Risk Management Planning.pptVIP

Risk Management PlanningIndustry Experience in Implementation Risk Management – A Sense of Déjà Vu? Overall Objectives of Risk Management Planning Benefit - Risk Optimization Optimizing Benefit Risk Risk Management Terminology A Subject of Great Confusion Risk Management Planning Understand the Terminology What Risk Management is Not ???? ……..or is it ??? Generally, Risk Management is the process of measuring, or assessing risk and then developing strategies to manage the risk. In general, the strategies employed include transferring the risk to another party, avoiding the risk, reducing the negative effect of the risk, and accepting some or all of the consequences of a particular risk. From Wikipedia, the free encyclopedia. Transatlantic Terminology – Risk Management FDA : Together, risk assessment and risk minimization form what FDA calls risk management.? Specifically, risk management is an iterative process of (1) assessing a product’s benefit-risk balance, (2) developing and implementing tools to minimize its risks while preserving its benefits, (3) evaluating tool effectiveness and reassessing the benefit-risk balance, and (4) making adjustments, as appropriate, to the risk minimization tools to further improve the benefit-risk balance. Europe : A set of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks relating to medicinal products, including the assessment of the effectiveness of those interventions Risk Management and International Harmonization International harmonization is wonderful in theory ……….but everyone is harmonizing differently Global Risk Management Planning  The Challenge of Reconciling the Differences Risk Management in Industry General Considerations Risk Management and Planning RM Planning in Industry - Critical Success Factors Safety governance – support from the top Comprehensive change management plan Defined process and roles/respons