Leveraging post-marketing regulatory requirements to drive commercial value
While long-term surveillance and ongoing studies are inevitable for certain products and approvals via accelerated pathways, this regulatory requirement also represents an opportunity to substantiate product value.
In partnership with Endpoints News, Parexel’s regulatory, access, and real-world research experts delivered a webinar focusing on value creation through an integrated evidence approach to post-marketing regulatory requirements.
Topics include:
- Regulatory expectations and acceptability during clinical development, marketing application and post-marketing stages
- Best practices for real-world evidence generation in the context of long-term population surveillance
- Strategies for generating evidence on long-term effectiveness to support product value
- How this approach can support reimbursement and value-based pricing models
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