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Le Palais des Congrès

Apr 13, 2015 9:00 AM - Apr 15, 2015 5:30 PM

2, Place de la porte Maillot, F-75017 Paris, France

27th Annual EuroMeeting

REGULATORY EVIDENCE STANDARDS: ARE WE MAXIMISING VALUE GENERATION?

Session Chair(s)

Hans-Georg  Eichler, MD, MSc

Hans-Georg Eichler, MD, MSc

Consulting Physician

Austrian Association of Social Security Bodies, Austria

Good pharmaceutical regulation creates value, poor regulation destroys value. This basic rule goes for public health value as well as for economic value. The current business model of the bio-pharmaceutical industry is predicated on robust regulation. Without regulation, there would be no drug development as we know it, and sponsors would not be able to claim public health value for their innovative products. Yet, regulation that produces no or only limited net health benefit may stifle innovation, disincentivise investors in R&D, and, most importantly, delay or deny patients access to beneficial treatments. Focussing on diabetes drugs as an illustrative example, this session will address how we can best find a level of evidence standards that maximises both public health and economic value.

Speaker(s)

Andre  Broekmans

Panel Discussion

Andre Broekmans

TI Pharma, Netherlands

Director, Escher

Jean-Luc  Harousseau

Panel Discussion

Jean-Luc Harousseau

Haute Authorite de Sante, France

President

Yann  Le Cam, MBA

Panel Discussion

Yann Le Cam, MBA

Eurordis-Rare Diseases Europe, France

Chief Executive Officer

Tomas  Salmonson, DrMed, PhD

Panel Discussion

Tomas Salmonson, DrMed, PhD

Critical Path Institute, United States

Partner

Alan  Morrison, PhD

Panel Discussion

Alan Morrison, PhD

MSD, United Kingdom

Vice President Regulatory Affairs Intl

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