July 17, 2025 3PM CEST
The European pharmaceutical landscape presents complex challenges in meeting Post-Authorization Safety Study (PASS) obligations and Health Technology Assessment (HTA) requirements. Successfully navigating these evolving regulations, especially with the implementation of the EU HTA Regulation, is crucial for sustained market access and demonstrating ongoing product value.
Designed for pharmaceutical professionals, this webinar will navigate the intricacies of post-authorization evidence generation in Europe. We will discuss how OM1 Aspen’s automated, technology-first approach and deep expertise in real-world evidence (RWE) can empower you to:
- Master EU PASS and HTA Landscapes: Gain clarity on navigating the current European regulatory environment and understand how to design and execute robust non-interventional studies.
- Optimize Evidence Generation: Learn how automated data collection can significantly reduce study costs and site burden while delivering high-quality, research-grade data suitable for regulatory submissions.
- Leverage AI for Enhanced Insights: Extract crucial data from unstructured text and address missing information to provide deeper insights into patient journeys and treatment outcomes.
- Strengthen Your Market Access Strategy: Effectively demonstrate long-term safety, effectiveness, and value to European HTA bodies and payers, supporting successful reimbursement and market access.
This webinar will be valuable for professionals in Medical Affairs, Clinical Development, HEOR, and Market Access who are responsible for post-authorization activities, evidence generation in Europe, and navigating European PASS and HTA requirements.
Key Takeaways:
- Actionable strategies for addressing European PASS and HTA obligations.
- How data automation streamlines non-interventional studies.
- The impact of AI in generating robust RWE for European submissions.
- Building a compelling value story for European payers and regulatory authorities.
Speaker:
- Ombretta Palucci
Vice President and Head of Operations, OM1 Europe