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home > ebr > winter 2001 > periodic safety update reports help assure pharmacovigilance in an era of unprecedented change
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European Biopharmaceutical Review

Periodic Safety Update Reports Help Assure Pharmacovigilance in an Era of Unprecedented Change

The demands that stakeholders are placing on drug safety units can only be met through a structured approach to radically improve effectiveness and efficiency. Periodic safety update reports (PSURs) are effective stimuli for proactive pharmacovigilance, but they need to be produced at an even rate and with guaranteed consistency in both format and content. As the volumes of safety data continue to increase, firms that accept the status quo will restrict the ability to deliver accurate and timely safety data to patients, physicians and agencies.


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By Chris Holmes, Principal of Pharmaceuticals Europe, and Glen Potvin, Managing Consultant, at World Class International Chris Holmes became a Business Consultant for World Class International in 1993, and has successfully led and managed global projects to simplify, control and improve business processes. This has produced significant improvements in business performance and has created a stable infrastructure for international pharmaceutical clients. Chris has been responsible for developing the successful Business Process Transformation methodology within World Class International, and his current role is Principal of Pharmaceuticals Europe.

Glen Potvin is a Managing Consultant and is involved with pharmaceutical companies across the US and Europe. He has responsibility for projects in areas such as new product introduction, process transformation, supply chain management, activity-based cost management, continuous improvement facilitation, benchmarking, and customer satisfaction management.
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Chris Holmes
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Glen Potvin
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