Sponsor uses ”Presentation of Safety Risks” Framework for training and improving how to categorize safety risks

Featured Solution: Presentation of Safety Risks Across the Lifecycle (PoRTL) Framework

Background

“A large pharmaceutical company has used the ‘Presentation of Safety Risks Across the Lifecycle (PoRTL) Framework’ to train entry-level safety physicians to familiarize them with key pharmacovigilance guidances and aid them in presenting risks for products. In a discussion about the Framework and its practical applications, the safety physicians provided feedback on its use and impact. Below is a summary of their responses.

The Framework provides the following benefits:

• Facilitates internal consistency and harmonization across teams on presenting safety risks and provides more efficient decision making.

• The ability to delineate these terms and use them appropriately at an early stage further helps us categorize the risks when they occur.
• It enables the Safety Team to provide evidence-based justification for each risk proposed in reference safety information.
• It has provided us with considerations on the appropriate characterization and categorization of safety concerns and risks, including factors influencing what should be made an important risk.
• Serves as a trigger for consistent and uniform characterization of risks that are captured in our reference safety information which will further support patient safety.
• It helps make risks clearer to patients when the presentation of risks is clarified.
• Efficient decision-making also helps us get needed medications to patients faster.”

[Sponsor Company]