Back to Agendas
REGULATORY EVIDENCE STANDARDS: ARE WE MAXIMISING VALUE GENERATION?
Session Chair(s)
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)
Panel Discussion
Andre Broekmans
TI Pharma, Netherlands
Director, Escher
Panel Discussion
Jean-Luc Harousseau
Haute Authorite de Sante, France
President
Panel Discussion
Yann Le Cam, MBA
Eurordis-Rare Diseases Europe, France
Chief Executive Officer
Panel Discussion
Tomas Salmonson, DrMed, PhD
Critical Path Institute, United States
Partner
Panel Discussion
Alan Morrison, PhD
MSD, United Kingdom
Vice President Regulatory Affairs Intl
Have an account?