Regulatory Aspects of MIDD from a European Perspective

Kristin Karlsson has been employed as a pharmacometrician/ pharmacokinetic assessor at the Swedish Medical Products Agency since February 2016. In her role as a senior assessor, she has been involved in assessing questions related to modelling and simulation in various procedures such as initial marketing authorization applications, new indication pediatrics, and scientific advice. Kristin is the vice-chair of the newly formed EMA Methodology Working Party, and was the chair of the former Modelling and Simulation Working Party 2018-2022. Kristin is also the regulatory chair of the ICH M15 informal working group (Model Informed Drug Development), and a previous member of the ICH E11A expert working group (Pediatric extrapolation). June 2022 – March 2023, Kristin was the Swedish delegate of the EMA Pediatric Committee (PDCO).  

Kristin Karlsson has been part of the pharmacometric community for almost 20 years and has experience with modelling and simulation within regulatory agencies, academic research and within the pharmaceutical industry. Kristin Karlsson has an MSc in Chemical Engineering and earned a PhD in Pharmacometrics at Uppsala University, Sweden. During her PhD studies and academic career, Kristin worked on methodology and application of non-linear mixed effects modelling and clinical trial simulations.