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Achieving Launch Access and Value: Common Pitfalls of Integrated Evidence Plans (IEPs)
In the past, product approval meant demonstrating safety and efficacy to regulatory bodies in discrete countries—with a placebo comparator. Today companies must anticipate a changing reimbursement, adoption, and policy environment. The need to make population-based decision-makers aware of the value the new product brings while tailoring evidence to the specific requirements of an increasingly diverse and more sophisticated set of audiences has never been more important. New product development requires keen attention to planning and coordination across many internal functions to ensure efficiency and success. The creation of a formal IEP is essential to meet these goals. Changes over time in the methods through which products are approved and launched also require new approaches to Integrated Evidence Planning. Embracing those key IEP considerations will position companies and their products for success in this evolving landscape.
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