Risk Identification and Evaluation. As part of TRACER, risk information will be solicited from four key sources: (i) Copy Approval Teams; (ii) U.S. Pharma’s Monitoring Control Center of Excellence (CCoE); (iii) Deputy Compliance Officers (DCOs); and (iv) Legal department personnel. Based on inputs from these sources, a relative risk ranking report will be produced for all GSK Products (Risk Evaluation Report). The Risk Evaluation Report will be presented to the leadership team of each U.S. Pharma commercial business unit (Leadership Team) and the U.S. Pharma Commercial Leadership Team (CLT) along with recommendations regarding which products may require enhanced risk mitigation plans. The Risk Evaluation Report will also be used by the CCoE to inform the risk- based selection of products as required by the Field Force Monitoring Program described in CIA Section III.L.
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Sources: Corporate Integrity Agreement, Corporate Integrity Agreement, Corporate Integrity Agreement