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Why so Persitently Unruly?

Given how vital the practice is to international regulatory compliance and to keeping products safely on the market, it may be expected that global life sciences firms would have the production and management of patient-facing materials efficiently coordinated so that accuracy and speed to market were taken for granted. Nothing could be further from reality.

Undoubtedly, the global labelling management burden in life sciences has soared in recent years. Companies’ R&D ambitions are growing, businesses are expanding into more markets, and regulators are steadily strengthening safety requirements to protect patients from harm. Each time the benefit/risk profile or safety factors change, or as regional or local regulatory agencies update their standards, international biopharmaceutical firms must react swiftly with accurate, compliant labelling for all affected markets. If they fail to do so, they risk delays to shipping or even to keeping their product registrations on the market, with implications for sales, revenues, and reputation.

Given that all of these market conditions are set to intensify rather than diminish, finding a solution sooner is now a priority. Balancing market opportunity, risk, and cost is becoming increasingly tough to do, so it is unsurprising that organisations are keen to bring the situation under control. As the frequency of changes increases − due to ever-growing product complexity, heightened pharmacovigilance, and new regulatory specifications – the demand soars exponentially.

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Agnes Cwienczek is a Senior Life Sciences Consultant at AMPLEXOR with a remit that includes the provision of business process and data management expertise in the areas of regulatory information management, document management, and submission management. Prior to joining AMPLEXOR, she worked at Merck in its Global Regulatory and Quality Assurance department. Agnes received her Master’s degree in Information Management from the University of Koblenz-Landau, Germany.
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Anges Cwienczek
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