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WEBINAR

From PICO to Estimand: Navigating the Maze of Evidence Generation in EU HTA

WEDNESDAY 9TH AUGUST 2023 · 11:00 AM BST

You can register for a later version of this webinar (5pm BST) for our US audience here.

There’s a pressing need to align regulatory approval and market access processes, and the new EU HTA process introduces complexities and increased analytical requirements. By involving market access experts and Statisticians from the outset of trial design, we can increase the chances of successful reimbursement and access.

In this webinar, Marius Sieverding, Data Scientist, Veramed will share his insights on how best to collaborate in an evolving submission landscape from a Statistical and Clinical perspective. During the Q&A session, Marius will be joined by Arthur Allignol, Senior Principal Statistician, Daiichi Sankyo, a member of the PSI HTA special interest group, who will provide a unique perspective from the view of the sponsor.

Register today.

AGENDA

  • Understanding the PICO and Estimand Frameworks
  • Unveiling the Nuances of EU HTA Process
    • Addressing the implications of upcoming changes in EU HTA legislation
  • The key differences and challenges in translating between PICO and Estimand frameworks
    • Strategies to mitigate the consequences of misspecification
  • Enhancing Collaboration for Optimal Evidence Generation
    • How best to align objectives between regulatory and market access teams
  • Q&A Session

The presenters

Marius Sieverding

Data Scientist, Veramed

Marius is a Senior Biostatistician II in the Evidence and Value Generation (EVG) group at Veramed. He has a background in statistical programming, epidemiology and biostatistics. In the past he has helped deliver health-related studies as a Lead Programmer and as a Project Manager before moving more to the field of Statistics. He is an active member of PHUSE, PSI, and ISPOR and is interested in new methods and developments related to statistical programming, HTA and using RWD for evidence generation. He has supported HTA submissions in Germany, the UK and other EU countries.

Arthur Allignol

Senior Principal Statistician, Daiichi Sankyo

Arthur Allignol is currently a HTA and medical affairs statistician at Daiichi Sankyo and is actively involved in the PSI/EFSPI HTA Special Interest Group. Before joining Daiichi Sankyo, he worked as Real-World Data Scientist at Merck Healthcare KGaA and in academia, specializing in observational studies and complex event-history analysis. Arthur Allignol obtained his PhD in biostatistics at the university of Freiburg in 2013.

Meet Veramed

Veramed is a pioneering CRO redefining intelligent healthcare decision-making through end-to-end biometrics. We bring together people, innovation, and technology together with world-class governance to accelerate evidence generation and advance patient health. With skilled statisticians and programmers uniquely matched and scaled to client needs, we produce exceptional deliverables swiftly using a blend of skill, rigorous governance, and automation to optimize the speed and success of clinical research from design to submission and beyond.

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