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Value, Access and Regulatory Strategy Workshop

Session 6: Use of Real-World Evidence to Support Access

Session Chair(s)

Katarzyna  Kolasa, PhD

Katarzyna Kolasa, PhD

  • Professor of Health Economics, Head of Dept. of Health Economics and Health Mgmt
  • Kozminski University, Poland

How to get a full insight into the unmet medical needs and create a meaningful research & development (R&D) program as well as a credible value proposition? What makes a successful pricing & reimbursement (P&R) story in the era of the growing healthcare budget constraints? In the session, we will discuss whether the growing opportunities of real world data (RWD) can ease these challenges. In the era of digitalization of healthcare and burst of patient’s stories sharing on social media, more and more new types of RWD are becoming available. The question is how to leverage on them in a credible and robust manner in order to develop new RWD driven R&D and P&R decision making processes.

Panel Discussion with Q&A

Following questions will be addressed:

  • How Can RWD Uncover Real Unmet Medical Needs in R&D Process?
  • Shall We Rethink RWD in the Era of Health's Digitalization?
  • Can We Move from RWD to Real World Decision Making?
  • How to Redefine RWD to Ensure Its Usability for R&D and P&R Decision Making Processes?


François  Meyer, MD

RWE and the European Network for Health Technology Assessment

François Meyer, MD

  • Advisor to the President, International Affairs
  • French National Authority for Health (HAS), France
Radek  Wasiak, PhD, MA

How Can Real-world Data (RWD) Uncover Real Unmet Medical Needs in R&D Process

Radek Wasiak, PhD, MA

  • Chief Data Officer and Head of Europe
  • Cytel, Singapore
Vladimir  Zah, PhD

4 W Behind RWE (Real World Evidence)

Vladimir Zah, PhD

  • Chief Executive Officer
  • ZRx Outcomes Research Inc., Canada
Michael  Schroter, PhD, MBA

Use of RWD to Enable Value Based Pricing

Michael Schroter, PhD, MBA

  • Founding Partner
  • Viopas, Switzerland
Stephane  Regnier, PhD

Can Advanced Predictive Analytics Using Real World Data Support Reimbursement Decisions?

Stephane Regnier, PhD

  • Head of HEOR Excellence, Global Patient Access
  • Novartis Pharmaceuticals, Switzerland