Ensuring Patient Safety and Regulatory Compliance in an Era of Ever-Expanding Complexity



Ensuring Patient Safety and Regulatory Compliance in an Era of Ever-Expanding Complexity


There is a regulatory requirement for a pharmaceutical company to ensure global oversight for activities related to its product.

The scope of what pharmacovigilance leaders must consider has greatly increased as regulatory agencies worldwide have broadened their expectations from pharmaceutical companies. The pharmacovigilance department must know about activities beyond their direct influence, including information about product licensing, out-of-stock situations and quality control systems. This means that their activities must cover the whole life cycle of medicinal products, coordinating their efforts with clinical and medical affairs, and contacting all local affiliates.

This paper addresses the challenges posed by the expectation for global oversight of the end-to-end medicinal product life cycle, proposing some fundamental steps that should be taken by pharmacovigilance leaders.

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Elsevier's R&D Solutions for Pharmacovigilance

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Make more informed drug development decisions on safety and efficacy, risk assessments and mitigation, and study designs by providing researchers with searchable FDA/EMA drug approval documents and comparative drug safety data.
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