Risk Mitigation Plans. Risk Mitigation Plans (RMPs) will be completed annually for all GSK Products. All RMPs will outline standard risk mitigation activities that will be performed and tracked for each GSK Product, regardless of the product’s relative risk ranking (Standard RMPs). Standard risk mitigation activities will consist of the monitoring activities to be conducted for each GSK Product in the upcoming year, such as monitoring of speaker programs, speaker training, advisory boards, sampling, verbatim reviews, medical information requests and ride-alongs with sales personnel. Based on the Risk Evaluation Report, products may be selected for Enhanced RMPs by either (or both) the Leadership Teams and the CLT. These RMPs will include enhanced risk mitigation activities, in addition to the standard activities (Enhanced RMPs). Enhanced RMPs will consist of activities tailored to the risks identified during the risk ranking process. For example, such activities may include increased compliance messaging from Leadership Teams, modifications to or limitations of promotional programs, or enhanced training requirements. All RMPs (whether Standard or Enhanced) will be developed by brand teams, in consultation with their respective DCOs and the CCoE, on an annual basis. Each RMP will specify the: (i) risk monitoring activities; (ii) metrics by which monitoring activities and results will be evaluated and/or measured; (iii) risk mitigation action items, if necessary; (iv) metrics by which risk mitigation activities and results will be evaluated and/or measured; (v) responsible individual(s); and (vi) expected date(s) of monitoring and/or action item completion. The RMPs will be reviewed and approved by the respective business unit Leadership Teams.
Appears in 4 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement, Corporate Integrity Agreement
Risk Mitigation Plans. Risk Mitigation Plans (RMPs) will be completed annually for all GSK Baxano Surgical Government Reimbursed Products. All RMPs will outline standard risk mitigation activities that will be performed and tracked for each GSK Baxano Surgical Government Reimbursed Product, regardless of the product’s relative risk ranking (Standard RMPs). Standard risk mitigation activities will consist of the monitoring activities to be conducted for each GSK Baxano Surgical Government Reimbursed Product in the upcoming year, such as ride-alongs with sales personnel, sampling, verbatim reviews, monitoring of speaker programs, speaker training, advisory boards, sampling, verbatim reviews, and medical information requests and ride-alongs with sales personnelrequests. Based on the Risk Evaluation Report, products Government Reimbursed Products may be selected for Enhanced RMPs by either (the Compliance Committee or both) the Leadership Teams and the CLTCompliance Officer. These RMPs will include enhanced risk mitigation activities, in addition to the standard activities (Enhanced RMPs). Enhanced RMPs will consist of activities tailored to the risks identified during the risk ranking process. For example, such activities may include increased compliance messaging from Leadership Teamsmessaging, modifications to or limitations of promotional programs, or enhanced training requirements. All RMPs (whether Standard or Enhanced) will be developed jointly by brand teams, in consultation with their respective DCOs the Compliance Officer and the CCoE, applicable department on an annual basis. Each RMP will specify the: (i) risk monitoring activities; (ii) metrics by which risk monitoring activities and results will be evaluated and/or measured; (iii) risk mitigation action items, if necessary; (iv) metrics by which risk mitigation activities and results will be evaluated and/or measured; (v) responsible individual(s); and (vi) expected date(s) of monitoring and/or action item completion. The RMPs will be reviewed and approved by the respective business unit Leadership Teams.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Baxano Surgical, Inc.)
Risk Mitigation Plans. Risk Mitigation Plans (RMPs) will be completed annually for all GSK Par Relevant Government Reimbursed Products. All RMPs will outline standard risk mitigation activities that will be performed and tracked for each GSK Par Relevant Government Reimbursed Product, regardless of the product’s relative risk ranking (Standard RMPs). Standard risk mitigation activities will consist of the monitoring activities to be conducted for each GSK Par Relevant Government Reimbursed Product in the upcoming year, such as ride-alongs with sales personnel, sampling, verbatim reviews, monitoring of speaker programs, speaker training, advisory boards, sampling, verbatim reviews, and medical information requests and ride-alongs with sales personnelrequests. Based on the Risk Evaluation Report, products Relevant Government Reimbursed Products may be selected for Enhanced RMPs by either (the Compliance Committee or both) the Leadership Teams and the CLTCompliance Officer. These RMPs will include enhanced risk mitigation activities, in addition to the standard activities (Enhanced RMPs). Enhanced RMPs will consist of activities tailored to the risks identified during the risk ranking process. For example, such activities may include increased compliance messaging from Leadership Teamsmessaging, modifications to or limitations of promotional programs, or enhanced training requirements. All RMPs (whether Standard or Enhanced) will be developed jointly by brand teams, in consultation with their respective DCOs the Compliance Officer and the CCoE, applicable department on an annual basis. Each RMP will specify the: (i) risk monitoring activities; (ii) metrics by which risk monitoring activities and results will be evaluated and/or measured; (iii) risk mitigation action items, if necessary; (iv) metrics by which risk mitigation activities and results will be evaluated and/or measured; (v) responsible individual(s); and (vi) expected date(s) of monitoring and/or action item completion. The RMPs will be reviewed and approved by the respective business unit Leadership Teams.;
Appears in 1 contract
Samples: Corporate Integrity Agreement