SOURCE: Xtalks


November 08, 2017 08:00 ET

Real World Evidence Across the Product Life Cycle: Regulatory and Payer Landscape, Upcoming Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - November 08, 2017) - Join experts from ICON Jane Turner, Senior Principal, Real World Evidence, and Guy Sherwin, Lead Consultant, EU Pricing and Market Access, as they discuss how real world evidence is playing a larger role across the entire product life cycle, with a focus on late phase regulatory discussions and payer decision-making.

The shift towards a value-based, patient-centric approach to health care continues to increase the need to measure the impact of biopharma products and devices in a real world setting. It's now more important than ever for sponsors to understand how real world evidence can play a role in developing a product's value story across the development continuum.

Payment models and federal reforms are increasingly focused on the real world impact of treatments and devices. Regulatory bodies are looking to real world evidence to close the gap between how a product performed in clinical trials and how a product performs in the clinical setting on a broader patient population. As the capture and connectivity of health records and data continue to move towards digitization, the ability to assess and analyse these data increases in ease and efficiency.

Innovative late phase research approaches are benefitting from this move towards digitization, at the same time as more regulatory guidance is released in both the US and EU around the use of real world evidence to support and enhance submissions and product uptake. Combined, these two activities are making a high impact on the importance of assessing and realizing a real world evidence product strategy.

The increased interest in real world evidence not only lies with regulatory bodies, however, it also stands to make a large impact on how payers may cover a product based on the real world value it brings to the patient and the market. Understanding what evidence will best support a product's value story is paramount for sponsors to ensure payers can make an informed decision about the product's impact in a real world setting.

Key Insights:

  • The broader role real world evidence is playing in decision making across the product life cycle due to technology advancements and real world data availability
  • The current EU and US regulatory landscape and guidance around use of real world evidence for enhanced regulatory submissions
  • How real world evidence can be used to support a product's value story and uptake of real world evidence as a payer decision making tool

The live broadcast takes place on Friday, November 17, 2017 at 11am EST (4pm GMT). For more information about this complimentary event visit: Real World Evidence Across the Product Life Cycle: Regulatory and Payer Landscape.


Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical and biotech companies, private and academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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