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Periodic Reporting
Mary Coleman

From Reactive to Proactive: The Evolution of Aggregate Safety Reporting

Introduction Aggregate safety reporting is an essential component of drug safety, enabling the identification and management of safety concerns related to a product. It is also an extremely resource intensive, complex, and never-ending exercise that requires significant coordination by various teams. Failing to deliver on these activities could have serious consequences for patients, pharmaceutical, and

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March 30, 2023
Periodic Reporting
Mary Coleman

Helping organizations move away from reactive Aggregate Safety Reporting

The Challenge The regulatory demands of guidance, PV Legislation, and local Health Authority requests are ever-increasing. With that, so too is your global Aggregate Safety Reporting workload. The logistical challenge of responsibilities and safety commitments are time-consuming efforts that without consistent management, can be ineffective, costly, and even detrimental to patient safety. Complexity Teams must

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March 11, 2022
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