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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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