aggregate safety reports - Orbit by Feith

Periodic Reporting

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

March 30, 2023

Periodic Reporting

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

March 11, 2022

The Orbit Blog

From Reactive to Proactive: The Evolution of Aggregate Safety Reporting

Helping organizations move away from reactive Aggregate Safety Reporting

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