
What North American and APAC sponsors need to know about EU Joint Clinical Assessment — and why EMA approval doesn't guarantee reimbursement.

Mia Malmenäs is a Senior Principal at ICON plc and an evidence-generation strategist with more than 25 years of experience across the pharmaceutical and CRO sectors. Her expertise includes evidence-generation planning, real-world evidence, observational research, evidence synthesis, health economics, and statistical methodology. She co-led ISPOR’s Medication Adherence and Persistence Special Interest Group for six years and was recognized with the ISPOR Distinguished Service Award. She holds BSc and MSc degrees in Biostatistics and an Executive MBA from Stockholm University.