Objectives:

Regulatory bodies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) are increasingly recognising the value of supplementing clinical trial data with real-world evidence to improve understanding of drug performance in the healthcare setting.

Consequently, Pharma companies are increasingly including real-world studies in their evidence to:

• Understand the opportunities and best practices for involving patient partners in the generation of real-world evidence

• Explore, using case studies, the value of patient engagement in the design, delivery, analysis and communication of real-world studies

• Highlight the importance of Medical Affairs and Health Economics and Outcomes Research (HEOR) professionals in partnering with colleagues from different functions in Pharma to ensure patients are effectively engaged throughout the product lifecycle

• Discuss barriers and propose solutions to optimal patient engagement in real-world studies

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