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Congress Center Basel

Apr 17, 2018 2:00 PM - Apr 19, 2018 11:00 PM

Messeplatz 21 , CH-4021 Basel , SWITZERLAND

DIA EUROPE 2018

Evidence Generation in Medicines Development for Rare Patient Populations: Challenges and Opportunities

Session Chair(s)

Michelle  Rohrer, PhD

Michelle Rohrer, PhD

Senior Vice President, Global Head of Product Development Regulatory and Policy

Genentech, A Member of the Roche Group, United States

Tomas  Salmonson, DrMed, PhD

Tomas Salmonson, DrMed, PhD

Partner

Critical Path Institute, United States

This session will focus on challenges and opportunities on pre- and post-authorisation evidence generation in rare patient populations, as identified by patients, regulators, HTA bodies and industry. The discussion will center around the following topics: choice of control, endpoints (biomarkers, clinical outcomes, PROs), therapeutic indication, post authorisation evidence generation/ registries. Following a brief description of key challenges in four topic rounds the panel will bring in perspectives based on concrete cases and examples and discuss on opportunities and solutions. The session will touch but not focus on real world data and as such complement other sessions on that theme.

Speaker(s)

Robert  Hemmings, MSc

Panel Discussion

Robert Hemmings, MSc

Critical Path Institute, United States

Partner

Niklas  Hedberg, MPharm

Panel Discussion

Niklas Hedberg, MPharm

Dental and Pharmaceutical Benefits Agency, TLV, Sweden

HTACG Co-Chair & Chief Pharmacist

Dimitrios  Athanasiou, MBA

Panel Discussion

Dimitrios Athanasiou, MBA

WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS, Greece

Patient Advocate

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