Livre Blanc
Seal of Approval: Accelerating Regulatory Success with RWE
When evidence innovation meets regulatory necessity
Sep 30, 2020

In this white paper, we will examine trends in the pre-approval use of RWE by the FDA and EMA, its impact on approval timelines and explore the opportunities this creates for pharmaceutical companies in accelerating regulatory success.

For additional IQVIA perspectives on Real World Insights, please read Natural History Studies for Rare Diseases: Development Strategies for External Comparator Arms Leveraging Real World Insights which explores essential principles for defining the right strategy for natural history studies and how to design such studies in a way that the data can be used as an external comparator to augment future regulatory filings and payer submissions.

Natural History Studies for Rare Diseases

For additional IQVIA perspectives on Real World Insights, please read Natural History Studies for Rare Diseases: Development Strategies for External Comparator Arms Leveraging Real World Insights, which explores essential principles for defining the right strategy for natural history studies and how to design such studies in a way that the data can be used as an external comparator to augment future regulatory filings and payer submissions.
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