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Benchmarking Drug Safety and Pharmacovigilance

July 1, 2010

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 optimising 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 providing quantitative analysis, the report reveals top safety executives’ creative solutions to ongoing challenges and their unique perspectives on current trends.

Drug safety

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 organisations and the best structures at companies of all sizes.

Activities: Learn how several groups throughout the organisation must play an active role in the company’s pharmacovigilance activities. Metrics include activities timing and communication strategies to encourage better knowledge transfer.

Drug safety, pharmacovigilance and ROI

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 organisations.

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up to date on all agency changes, but that sometimes means working under one governing guidance while a contradictory draft guidance awaits approval.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.

To download a summary for this report click here and to purchase the full report please click here.