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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
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
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
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,
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
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
Anyone can create a data visualization but not everyone can create a data visualization that is effectively communicating the data – and this is what we should aim for. Done wrong they leave the audience confused. In this episode, I’ve gathered up six problems around creating data visualisations, so you
A few days from today, it will be Christmas already and I am sure you are very thrilled to get ready for Christmas! And it’s almost time for another year and as the New Year brings a lot of challenges, I am excited to share with you my plans and projects for
Do you want to be a more effective statistician?Do you have what it takes to be an effective leader in your organisation? Many people think that strong leadership skills are something that statisticians don’t have. However, as a statistician, you definitely have a lot to offer an organization. Statisticians often
What are the advantages of being active on LinkedIn? How can you find the right career opportunity on this social site? How can increasing your network attract more opportunities? What kind of content should you post? In today’s episode, I am talking about my favorite social media platform, LinkedIn. LinkedIn
Why is it important for a statistician to take the culture of the first mover advantage on a more personal level? How do the first-mover advantages help the personal and professional growth of a statistician? What does it take to be the first mover? How does being the first mover
How could differences between countries affect the elements that are included in statistical research? How could studies with such a diverse sample from different countries be managed to create a more dependable reference for statistical studies? How do differences of the quality of care that the target population receives impact