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Attributing Value to Innovation: Which Evidence is Needed to Satisfy Different Decision-Making Methodologies?
Session Chair(s)
Michael Berntgen, PhD
Head of Scientific Evidence Generation
European Medicines Agency, Netherlands
Introducing innovative medicines into healthcare systems requires several decisions on the value of the product. How should underlying methodologies evolve in order to allow decision-making on clinical evidence for new therapeutic approaches?
Learning Objective : Translate requirements into evidence generation plans; identify similarities and differences in decision making; rate the strength of available clinical evidence to meet evidence requirements
Speaker(s)
Evidence and gaps across decision making on innovation
Hubert Leufkens, PharmD, PhD
Utrecht University, Netherlands
Emeritus Professor of Pharmaceutical Policy and Regulatory Science
Reviewing oncology product in new lights – a regulatory perspective
Sinan Bardakci Sarac, MD
Danish Medicines Agency, Denmark
Senior Medical Officer
Challenges of “Early Access” Approvals for HTA Bodies
Anna Nachtnebel, DrMed, MS
Dachverband der Sozialversicherungsträger, Austria
Senior HTA Expert, Medicine, Public Health
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