In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts in European regulation and evidence of new medicines:
Steffen Thirstrup: Chief Medical Officer at European Medicines Agency.
Richard Bergstrom: Head of Policy at IQVIA.

They compare regulatory benefit-risk decisions with HTA’s comparative effectiveness and economics, unpack the role of conditional versus accelerated approvals, debate surrogate endpoints versus overall survival, and explore how real-world evidence, patient experience data, and joint scientific advice can make adaptive approaches workable across Europe, including through the European Health Data Space and joint clinical assessments.

Key Topics

Regulatory Versus HTA: Benefit-risk focus, added benefit comparisons, joint clinical assessments.

Conditional Approvals: Surrogate endpoints, confirmatory commitments, withdrawal, or label narrowing.

Endpoints & Outcomes: Overall survival pressure, validated biomarkers, patient experience relevance.

Real-world Evidence: Registries and randomized rollout, data quality limits, outcomes-based contracting lessons.

Adaptive Pathways & Data Space: Early joint advice, platform and sandbox tools, European Health Data Space.

Opinions expressed are those of the speakers.

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/?utm_source=chatgpt.com">Duane Schulthess</a> speaks with two experts in European regulation and evidence of new medicines:
<ul>
<li><a href="https://www.linkedin.com/in/steffen-thirstrup/">Steffen Thirstrup</a>: Chief Medical Officer at <a href="https://www.linkedin.com/company/european-medicines-agency/">European Medicines Agency</a>.</li>
<li><a href="https://www.linkedin.com/in/richard-bergstrom-62ab07198/">Richard Bergstrom</a>: Head of Policy at <a href="https://www.linkedin.com/company/iqvia/">IQVIA</a>.</li>
</ul>
They compare regulatory benefit-risk decisions with HTA&rsquo;s comparative effectiveness and economics, unpack the role of conditional versus accelerated approvals, debate surrogate endpoints versus overall survival, and explore how real-world evidence, patient experience data, and joint scientific advice can make adaptive approaches workable across Europe, including through the European Health Data Space and joint clinical assessments.
Key Topics 
<ul>
<li>Regulatory Versus HTA:&nbsp;Benefit-risk focus, added benefit comparisons, joint clinical assessments. </li>
<li>Conditional Approvals: Surrogate endpoints, confirmatory commitments, withdrawal, or label narrowing. </li>
<li>Endpoints &amp; Outcomes:&nbsp;Overall survival pressure, validated biomarkers, patient experience relevance. </li>
<li>Real-world Evidence:&nbsp;Registries and randomized rollout, data quality limits, outcomes-based contracting lessons. </li>
<li>Adaptive Pathways &amp; Data Space: Early joint advice, platform and sandbox tools, European Health Data Space.</li>
</ul>
Opinions expressed are those of the speakers.

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess, Managing Director of Vital Tran…

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