All statisticians in the Pharmaceutical Industry will be impacted by the new EU HTA regulation. Activities around HTA submissions will happen earlier than currently, in parallel to the regulatory approval process for marketing authorization. There will be an increased scope of evidence for the joint clinical assessment to fulfill the needs of all EU member …
Future implications of EU HTA and how Next Gen get involved Read More »
End of last year, a congressional report about the approval of an Alzheimer drug by the FDA was published. It critiques both the FDA and the sponsor company Biogen. Reuters and many other major news organisations reported about it. Today, I interviewed Anja Schiel about this topic. We talked about the background of Alzheimer and …
If you’re a statistician working in a regulatory setting, you’re probably familiar with estimands as a way to frame the clinical question of interest. But what’s the role of estimands beyond regulatory approval, in a Health Technology Assessment setting? That question is especially important these days where the framework for pan-European HTA is taking shape. …
Are you a statistician, data scientist, or healthcare specialist looking for the perfect conference to attend? The Effective Statistician Conference 2023 is an exciting opportunity for statisticians, health care specialists, and data scientists to come together and learn from industry experts, exchange ideas, share breakthrough advancements in statistics, collaborate with peers, and stay ahead of the …
The first conference of The Effective Statistician Read More »
As a statistician, have you ever wondered—why are statistical analyses for HTA dossiers differ from those in regulatory dossiers? Aren’t they both just benefit-risk assessments? In this podcast, we review some of the history and background of how HTA and regulatory decision making have common sources of information, but different utility functions for how they …
What is EU HTA and why should statisticians care? Read More »
Are you curious about aggregate safety assessment planning? Whether you’re an experienced statistician or just starting out in the field, your work increasingly demands that you apply principles of aggregate safety assessment planning. With an ever-changing and advancing landscape filled with data and technology advancements, it is essential to stay current on this topic. In …
What is the ASAP and what you should know about it Read More »