Learn how to optimise submissions with a comprehensive health economic and epidemiological evidence strategy
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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.
Key insights include:
- The different types of health economic and epidemiologic evidence that can be used optimise the success of regulatory and HTA submissions
- The typical timeframes for generating each piece of evidence
- How to address challenging HTA submission scenarios
Michael Cook, MSc, MSPH, PhD
Dr. Cook has 15 years of pharmaceutical company experience holding positions of increasing responsibility at Merck, Pfizer and Shire. His area of methodological expertise is in the analysis of large health care databases to conduct real world evidence (RWE) studies.
Dhvani Shah, MS
Lead Health Economist
Dhvani Shah has over 8 years of experience in HEOR, and has led numerous evidence generation activities to demonstrate and communicate product value. At ICON, She is responsible for preparing HEOR research and value strategies, developing economic models for HTA submissions and conducting literature reviews and evidence synthesis activities.
- Health Economics & Outcomes Research (HEOR)
- Market Access
- Medical Affairs
- Regulatory Affairs
- Pharmacovigilance & Risk Management
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