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Session 1: Overview of Existing Evidence Gaps and Misalignments Across Regulatory and Reimbursement Ecosystem – Implications for Patient Access
Session Chair(s)
Mira Pavlovic, DrMed, MD, MS
HTA Expert /Director/HTA Professor
NDA Advisory Services, Medicines Development and Training (MDT) Services, France
The session will set a scene by providing a high level critique of the current state of affairs in the regulatory and reimbursement ecosystem, by focusing on evidence gaps and effectiveness of communication between various players. The session will point out the most pressing issues that are amenable to solution, and discuss the implications of those issues for patient access.
Speaker(s)
Evolution of Policies and Standards for Handling the Evidence for Decision Making – Selected “Hot Topics” to Set the Scene
Michael Berntgen, PhD
European Medicines Agency, Netherlands
Head of Scientific Evidence Generation
Existing Gaps In the Use of Evidence Across Regulatory And Reimbursement Agencies, Misalignment Of Standards And Practices And Their Implications For Patient Access
Niklas Hedberg, MPharm
Dental and Pharmaceutical Benefits Agency, TLV, Sweden
HTACG Co-Chair & Chief Pharmacist
Reimagining the Use of Evidence across Regulatory and Reimbursement Continuum – What are the Promising Ways Forward?
Edith Frénoy, MA, MSc
MSD Europe Inc., Belgium
Director, European Public Policy – Strategic EU Advocacy Lead
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