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Benchmarking Drug Safety and Pharmacovigilance
Benchmarking Drug Safety and Pharmacovigilance
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
Navi Mumbai,
Maharashtra,
India
(prbd.net)
30/10/2010
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.
Sample Content
The following excerpt is found in Chapter 2, "Structure and Staffing." The full report discusses in-house drug safety team responsibilities for companies of different types.
Small companies show the largest variation when delegating drug safety responsibilities. This finding illustrates the many different corporate structures that are found across small companies. Figure 2.14 (data shown in full report) shows that 57% of small companies' drug safety teams work with both investigational and post-marketed drugs. Drug safety teams at 29% of small companies work exclusively on investigational products - the highest among the different company size categories. For many small companies, investigational compounds are the only drugs in their portfolios. Perhaps when these investigational drugs reach the post-marketing stage, the pharmacovigilance will be done using the same drug safety group. That is the logical evolution of the drug safety team as a product progresses through its lifecycle.
This excerpt is taken from Chapter 1, "Budgets and Outsourcing." The full report contains real-company strategies and insights concerning budget
Budgeting Process
As stated earlier, even drug safety departments are not immune to the across-the-board cost-cutting trend that has emerged throughout the pharmaceutical industry. With this in mind, Cutting Edge Information examines some drug safety teams' budgeting processes, as well as the methods that many teams use to justify the return on investment for drug safety activities.
Companies Included in Report
Abbott Laboratories
Bausch and Lomb
Cerexa
ClinQuest Inc.
Cubist Pharmaceuticals
Drug Safety Alliance (DSA)
Elan
Ferring Pharmaceuticals
Genzyme
GlaxoSmithKline
InterMune Pharmaceuticals
Isis Pharmaceuticals
Jazz Pharmaceuticals
Johnson & Johnson
Labopharm
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