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The TransCelerate “Interpretation of Pharmacovigilance Guidances and Regulations” (IGR PV) Initiative designed a framework (entitled “A Framework on the Presentation of Safety Risks Throughout the Product Lifecycle”) outlining regulatory requirements and considerations for presenting risks in key required safety-related regulatory documents throughout the lifecycle.
This framework was developed based on specific health authority (HA) guidance documents applicable throughout the product lifecycle to support safety documents such as:
• Investigator’s Brochure (IB)
• Development Safety Update Report (DSUR)
• Periodic Safety Update Report (PSUR)/Periodic Benefit-Risk Evaluation Report (PBRER)
• Risk Management Plan (RMP).
The information was synthesized into a framework to review the key definitions of risk, provide clarity, and assist with how to handle presenting risks across the lifecycle to meet health authority requirements. Considerations are also offered to help pharmaceutical companies develop approaches for presenting risk through the lifecycle and across relevant safety documents, given differing regulatory requirements over a product’s lifecycle. This framework supports a transparent approach to presenting risks and provides a starting point for collaboration between industry and health authorities to protect and improve the health of trial subjects, patients, and the public.
This session will share key findings that the framework synthesized and discuss practical use cases, such as how it can be used to upskill and educate safety professionals within biopharma organizations. By leveraging this framework, participants will be able to incorporate these key findings and considerations into their organizations and better operationalize the presentation of safety information in key documents.