Poster Presentations
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ABSTRACTS
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Poster Presentations P.164 The Pharmacovigilance Audit S. Jolley,1 D.W. Lechner2 1 Taratec Development Corporation, Bridgewater, New Jersey, USA; 2 Sentrx, Little Falls, New Jersey, USA During high profile drug withdrawals of the past, most of the focus of the press and legal community was on the actual adverse event and the people who were injured. Today, the attention seems to be on the documentation of how and when companies learned of the increased frequency of adverse events and their response to the data. Meanwhile, international regulatory guidances on drug safety monitoring are increasing. With ICH E2E and E2C, CIOMS VI and VII, and the FDA Risk Minimization Guidance, companies may need to audit their premarketing and post-marketing safety monitoring practices to ensure they are following Good Pharmacovigilance Practices, or GPvP. A pharmacovigilance audit begins with a strong methodology that captures the key requirements of all the applicable regulatory bodies. It compares a company’s practices to an “ideal” process map that includes strategy, infrastructure, tools, execution and evaluation. The pharmacovigilance audit reviews company practices regarding the processing and follow-up of reported cases, identification of safety signals, updating of a product’s benefit/risk balance, crisis management, alignment of global pharmacovigilance SOPs between HQ and subsidiaries, and unique clinical trial safety issues such as unblinding and discontinuation due to safety reasons. From there, it inspects the detailed documentation of items such as AE data received, SOPs followed, analyses performed, thresholds met or not met, actions taken to review and triage potential signals, and subsequent label changes. Systems are an important component in a pharmacovigilance audit. Safety databases are evaluated for documentation on validation, systems life cycle development, change management, adherence to SOPs, and data integrity. A detailed report documents where GPvPs are being followed and what remedial action may be necessary. The report demonstrates that a company wants to know whether or not it is doing everything possible during development and post-marketing to protect patient safety.
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