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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Drug Safety eLearning Program (all six modules!)
The Drug Safety eLearning Program provides the knowledge you need, from regulations and requirements through pre-market review and post-market monitoring. This online comprehensive program includes six self-paced modules that have been designed using the latest instructional strategies including microlearning and gamification to improve retention and make learning convenient for busy professionals.
Each module is broken down in to bite-sized chunks of information that can typically be consumed in 5-10 minutes increments, preventing cognitive overload and improving learning outcomes. Learners have access to the eLearning modules 24 hours a day, 7 days a week for one full year, and are mobile compatible making it easy to learn on the go! Continuing education credits are available for all modules.