subject: Aarkstore Enterprise---benchmarking Drug Safety And Pharmacovigilance [print this page] Abstract Abstract
Reinforce Your Drug Safety Team
This is a one-of-a-kind study dedicated exclusively to drug safety and pharmacovigilance. Benchmarking Drug Safety and Pharmacovigilance is a data-driven guide to optimizing your company' s drug safety efforts. Designed for drug safety teams that work with clinical and post-marketed products, this study details budgets and outsourcing, structure and staffing, activities, timing, and communications. Beyond quantitative analysis, top executives reveal best practices, creative solutions to ongoing challenges, and their unique perspectives on current trends.
Leverage and maximize your resources
Drug safety is an essential function, but it is not immune to the budget cuts occurring across the industry. If companies do not fund drug safety adequately, however, they can open themselves up to risk. What' s more, drug safety teams must have the flexibility to evolve, stay on technology' s cutting edge and keep up with ever-changing safety demands.
Budgets and Outsourcing: Win more resources and defend the budget you already have, even as other groups face cuts. See how other teams balance workloads via outsourcing to gauge your own mix of in-house/outsourced tasks.
Structure and Staffing: Use our benchmarks to reinforce your thinking around group structure and tools. Identify the types of positions necessary to run the simplest of organizations and the best structures at companies of all sizes.
Activities: Learn how several groups throughout the organization must play an active role in the company' s pharmacovigilance activities. Metrics include activities timing and communication strategies to encourage better knowledge transfer.
Trumpet the value of your team
Because drug safety and pharmacovigilance are necessary functions, your team may not spend much time thinking about ROI. In fact, drug safety veterans say it is crucial to communicate successes and prove strategic value. Discover how other groups address this challenge and work to build a drug safety culture in their organizations.
Improve communication with the FDA
Drug teams must stay up to date on all agency changes, but that sometimes means working under one governing guidance while a contradictory draft guidance awaits approval. Implement best practices to resolve such confusion as you improve your company' s communication processes with regulatory agencies, including the FDA.
METRICS INTRODUCTION
Benchmarking Drug Safety and Pharmacovigilance' s three chapters include metrics detailing drug safety/pharmacovigilance budgets and outsourcing, structure and staffing, and timing of activities. In many cases throughout the report, data are broken down by company type - large, mid-size, small and biotechnology.
Chapter 1: Budgets and Outsourcing
Budget Data
Total and US-only drug safety budgets
Drug safety budget allocation
Budget centralization (dedicated budgets versus funded by various departments)
Departments that contribute to non-centralized drug safety budgets
Budget coverage (number of investigational and marketed drugs covered)
Percentage of drug safety budgets allocated to various global markets, including the US, UK, France, Spain, and Japan
