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Selecting and Managing Outsourced Safety Providers

Selecting and Managing Outsourced Safety Providers

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.

Featured Topics
  • The Current and Future Landscape of Pharmacovigilance
  • Defining a Safety Program's Needs
  • Outsourced Safety Providers
  • Transfer of Responsibilities
  • Offshoring and Outsourcing
  • Risks and Issues
  • Developing an Outsourced Safety Program
  • Internal Assessment
  • Planning a Business Outsourcing Model
  • Successful Selection of an Outsourced Provider
  • The Sponsor and Contract Service Provider Relationship
  • Safety Outsourcing Provider Management
  • Pharmacovigilance Inspection Programs
  • Inspections in US, EU, and UK
  • Inspection Findings
  • Review

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