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Benchmarking Drug Safety and Pharmacovigilance
Cutting Edge Information, March 2010, Pages: 155
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up to date on all agency changes, but that sometimes means working under one governing guidance while a contradictory draft guidance awaits approval.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,
It’s clear to pharmaceutical and biotechnology executives that drug safety teams are vital to protecting patients and keeping drugs on the market. Some high-profile examples of poor drug safety efforts over the past decade and even some more recently in 2010, have prompted the pharma industry to invest more in drug safety. Beyond changes to investments and added resources, companies are beginning to regard drug safety in more strategic terms.
Benchmarking Drug Safety and Pharmacovigilance provides best practices for pharmaceutical and biotechnology teams to structure their drug safety teams, develop pharmacovigilance strategies, allocate budgets and headcounts appropriately, and learn when to initiate critical pharmacovigilance activities. Explore real-company strategies and metrics for companies’ drug safety and pharmacovigilance teams:
- Learn what it means to develop a strategic drug safety team: Many drug company executives view drug safety as a required function or as nothing more than a cost center. This study uncovers best practices that top-notch drug safety and pharmacovigilance teams have in place to deliver strategic impact.
- Optimize your drug safety team: Several factors affect the size and structure of drug safety and pharmacovigilance teams. This study shows how to align your team, assign responsibility for investigational and post- market products, determine the most appropriate activities to outsource, and understand how to choose among drug safety vendors.
- Prove the drug safety team’s value: Performance measurement for pharmacovigilance activities are few and far between. So how does a drug safety team demonstrate its impact to the bottom line? This study showcases best practices to measure and prove the value of a strategic drug safety team.
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