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Radisson Blu

Oct 25, 2017 8:00 AM - Oct 26, 2017 3:30 PM

Steinentorstrasse 25, 4001 Basel, Switzerland

Value, Access and Regulatory Strategy Workshop

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Session 1: Different Perspectives on Unmet Medical Need

Session Chair(s)

Claudine Sapède, PharmD

Claudine Sapède, PharmD

Director, Global HTA Policy, NOVARTIS INTERNATIONAL, Switzerland

Addressing unmet medical need is a key criterion for medicine prioritization and for a molecule to qualify for accelerated regulatory review processes. Yet, there is not a common definition of the term and the interpretations may also vary between stakeholder groups (regulators, HTA bodies/payers, patients, medicine developers…). To what extend and how is unmet medical need considered in reimbursement decision-making? Could we make progress and advance these questions? This is what will be explored in this session.

Speaker(s)

François Houyez

A Patient’s Perspective

François Houyez

Treatment Information and Access Director, Health Policy Advisor, European Organisation for Rare Diseases (EURORDIS), France

Michael Berntgen, PhD

A Regulator’s Perspective

Michael Berntgen, PhD

Head of Scientific Evidence Generation, European Medicines Agency, Netherlands

Antje Behring, PharmD, PhD

An HTA Body’s Perspective

Antje Behring, PharmD, PhD

Head, Early Benefit Assessment, Pharmaceuticals Department, Federal Joint Committee (G-BA), Germany

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