This course provides an overview of the trends in outsourcing safety functions to contract service providers and examines the reasons for outsourced safety programs. A review of the types of contract service providers, including full-service, partial-service, niche/safety only, business process outsourcing (BPOs), and knowledge process outsourcing (KPOs), will be presented. Beginning with an internal assessment and analysis of pharmacovigilance tasks, an outsourcing business plan will be described followed by the vetting and ultimate selection of the outsourced pharmacovigilance partner. Best practices for management of pharmacovigilance service providers, including governance, will also be discussed. Finally, inspections of outsourced safety service providers, including regulatory authority expectations for pharmacovigilance agreements between sponsors/marketing authorization holders and contract service providers, will be presented.

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