A Quality Management System for Pharmacovigilance Activities
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A QUALITY MANAGEMENT SYSTEM FOR PHARMACOVIGILANCE ACTIVITIES JACQUELINE SAYERS,B S c (HoNs), MBA, PHD Global Head of Quality and Training. Pharma Development Biometrics. Pharmacovigilance-Processing Center, Roche Products Ltd., Herts, United Kingdom
DAPHNESELF,B S c (HoNs), PHD Safety Quality Assurance Head, Clinical Safety and Regulatory Coordination, Novartis Horsham Research Center, W. Sussex, United Kingdom
Pharmacovigilance is an area of drug development that is increasingly found in the regulatory spotlight. As a result, companies need to have confidence in the quality and the accuracy of the data being used in the benefit-risk assessments of their products. Roche Products and Novartis have both introduced quality management systems into their pharmacovigilance operations. This paper discusses why such functions are considered necessary and the activities they carry out. Key Words: Pharmacovigilance; Safety; Quality
INTRODUCTION IN RECENT YEARS COMMERCIAL pressure has forced pharmaceutical companies to shorten drug development timelines in order to bring products to market as quickly as possible. In addition, regulatory authorities have also moved toward faster review times with an increased emphasis or assumption that postmarketing surveillance will be done to pick up any “rare” events. For example, a New Drug Application containing 4000 patients is unlikely to pick up an event that occurs at a rate of 1 in 5000. As a result, the need for an accurate and comprehensive pharmacovigilance system to monitor benefit-risk profiles throughout the clinical trial
Reprint address: Jacqueline Sayers, Global Head of Quality and Training, Pharma Development Biometrics, Pharmacovigilance-Processing Center, Roche Products Ltd., 40 Broadwater Road, Welwyn Garden City, Heas, UK.
phase and postmarketing has increased in prominence. (Definitions are provided in the appendix.) Such a system has to fulfill several functions: Collect and collate adverse event (AE) reports from clinical trials, 0 Collect and collate AE reports spontaneously reported by consumers or health professionals, 0 Collect and collate AE reports from literature sources and regulatory authorities, Assess the seriousness and expectedness of the reports, 0 Enter the data onto a suitable central database, 0 Provide a medical evaluation of the report, *Provide an analysis of similar events for expedited reports, and 0 Ensure that reporting timelines for expedited reports are met. 0
The specific organizational structures used to carry out these functions vary between
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companies. In general however, data will be collected in local countries by clinical research staff (from clinical trials) and by drug safety/surveillance staff (spontaneous reports). Reports will then be forwarded to some form of “processing center.” Commonly, a com
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