| A compelling public health rationale to support a business, regulatory or public policy strategy relies on a thorough understanding of the issues raised by the interaction of business, science, public health, and public policy. The Issues Management Team works closely with other Pinney Associates teams to assess and influence scientific and policy environments, both pre- and post-approval, for pharmaceuticals, biologics, and consumer healthcare products. The Issues Management Team typically helps the client by:
- Identifying, defining, assessing, prioritizing, tracking and addressing issues raised by a business, regulatory, or public policy action
- Developing compelling and considered science-based, data-driven responses and positions on the issues, and strategies to manage them
- Assessing and laying out the public health rationale, including a risk/benefit analysis
- Developing reports for internal and external use, including scientific and public health assessments of pharmaceuticals, biologics, and consumer healthcare products
This may involve:
- Collecting, reviewing, synthesizing and monitoring the scientific literature, regulatory documents and other publicly available information
- Data gathering and analysis
- Gathering expert opinion through identifying and interviewing scientific, medical, policy, and regulatory experts, and convening expert advisory panel meetings
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