Optimise Your Regulatory & HTA Submissions with a Comprehensive Health Economic

Presented by

Michael Cook, Principal, Epidemiology

About this talk

Optimise Your Regulatory & HTA Submissions with a Comprehensive Health Economic & Epidemiologic Evidence Strategy Regulators and payers have placed new demands on industry to provide health economic and epidemiologic evidence, in addition to clinical trials data, to demonstrate the value and safety of a new product. A comprehensive evidence strategy, when created early in the clinical development program, is a key component of successful regulatory and HTA submission planning. Planning for regulatory and HTA submissions requires strategic foresight into what regulators and payers will consider most influential in their respective reviews. An important step is to identify the health economic and epidemiology evidence that needs to be collected during the clinical development program, and what evidence may already exist. An early landscape assessment can identify evidence sources that may already exist in the published literature. It is also important to define the aspirational value message for the investigational product in terms of unmet medical need, clinical value, human value, or economic value. By aligning the health economic and epidemiologic evidence strategy with the aspirational value message, the relevance of each piece of evidence becomes clear. Speakers: Michael Cook, Principal, Epidemiology & Dhvani Shah, Lead Health Economist

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BioPharma companies and Medical Devices manufacturers face growing operational, regulatory and economic challenges when it comes to developing their drug or device. ICON provides analysis and key insights on these challenges, with practical advice and recommendations.