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Structured Benefit-Risk Assessment Across the Product Lifecycle: Practical Considerations.

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  • 11 Global Patient Safety & Labeling, Amgen, Inc, Thousand Oaks, CA, USA.

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Summary

Implementing a structured benefit-risk assessment (SBRA) framework improves medicinal product lifecycle management. This approach enhances decision-making transparency, consistency, and communication of the product benefit-risk profile.

Keywords:
European Medicines Agency (EMA)US Food and Drug Administration (FDA)benefit-risk frameworkmedicinal productrisk management planstructured benefit-risk assessment

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Area of Science:

  • Pharmacovigilance
  • Regulatory Science
  • Pharmaceutical Management

Background:

  • Benefit-risk assessment is crucial throughout a medicinal product's lifecycle.
  • Structured approaches enhance transparency and consistency in decision-making.
  • Limited practical guidance exists on organizational integration of these processes.

Purpose of the Study:

  • To describe the organizational integration of a lifecycle approach to structured benefit-risk assessment (SBRA) within a biopharmaceutical company.
  • To identify key implementation challenges and best practices.

Main Methods:

  • Case study approach detailing organizational integration.
  • Description of implementation issues, best practices, and lessons learned.

Main Results:

  • Successful implementation requires an SBRA framework, a core approach with templates, standard operating procedures, and cross-functional training.
  • Challenges include team adoption of SBRA methods (value trees, effects tables) and applying the framework to diverse products.

Conclusions:

  • Systematic benefit-risk evaluations are an emerging best practice for product lifecycle management.
  • The SBRA approach improved assessment consistency, quality, conciseness, and strategic value.
  • Increased transparency and harmonization in communicating the product benefit-risk profile were observed.