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Navigating Significant Safety Issues

In recent years public expectations for rapid identification and the prompt management of emerging safety issues has grown exponentially, with drug safety coming to the forefront of many consumers’ minds.

Challenges in navigating Significant Safety Issues (SSIs), Emerging Safety Issues, Standalone Signal Notifications are not new. Important new or changed risks associated with medicinal products can be a confusing world, with crossover and varying regional regulatory requirements. In general, interpretation of signal requirements varies, resulting in the potential for over-saturating regulator systems with non-urgent risks.

The TGA acts as an independent evaluator of SSIs reported by Sponsors and is able to provide Sponsors with guidance, support and action plans to continue to monitor, further evaluate, or action risks which have impact on patients or the public.

In the last 12 months, Commercial Eyes has identified over 100 potential safety concerns through internal processes and collaborated with our clients to assess and action the risk. In the last 12 months, Commercial Eyes has reported 49 SSIs received from various external sources to regulators across global jurisdictions.

Patient Safety & Risk Management is a complex and evolving science requiring a critical, risk-based pharmacological and physiological assessment with patient and public health and the center of decision making.

Alongside regulatory bodies, Sponsors continue to play an expanding role in the data mining and proportionality assessment of drug-event pairs.  Sponsors must express their professional judgement about safety issues to provide consumers and health-care professionals with up-to-date drug safety information.

Our Patient Safety & Risk Management team has over 20 GxP-trained personnel able to support in the identification and safety profiling of risks associated with medicinal products. We can assist Sponsors to plan and implement a timely response to safety issues, ensuring that patients and HCPs have up-to-date information.

For more information, please contact us at [email protected]