Emma Hansson, Ph.D.

Senior Director, Regulatory Affairs

Portrait-of-Emma-Hansson_Pharmetheus

Bio

  • Joined Pharmetheus in 2016, actively working in client projects, serving as Regulatory Affairs Consultant
  • Expertise includes regulatory strategy, pharmacometrics and clinical pharmacology, in therapeutic areas such as oncology, endocrinology, and infectious diseases
  • Previously worked as Pharmacokinetics and Pharmacometrics Assessor at the Swedish Medical Products Agency, where she evaluated marketing authorization applications with a focus on clinical pharmacology and pharmacometrics
  • M.Sc. in Pharmacy (2006) and Ph.D. in Pharmaceutical Biosciences (2012) from Uppsala University, Sweden
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Pharmetheus affiliated publications

A structured approach to pharmacometric covariate modelling: why the estimand is the first decision and the method the secondUsage and regulatory acceptance of PBPK models in paediatric drug applications: a review of EMA and FDA public assessment reportsA structured approach to pharmacometric covariate modelling: why the estimand is the first decision and the method the secondLarge Language Model-Supported Data Collation: Addressing Accuracy and ReproducibilityReference-corrected VPCs: addressing model evaluation challenges with real-world data and adaptive designsModel-informed pediatric drug development for clevidipineA workflow for evaluating and optimizing the designs of paediatric studiesRituximab PK and PD evaluation based on a study in diffuse large B-cell lymphoma: influence of tumor size on PK and assessment of PK similarityRituximab pharmacokinetic and pharmacokinetic–pharmacodynamic evaluation based on a study in diffuse large B-cell lymphoma: Influence of tumor size on pharmacokinetic and assessment of pharmacokinetic similarityImeglimin Population Pharmacokinetics and Dose Adjustment Predictions for Renal Impairment in Japanese and Western Patients with Type 2 DiabetesPopulation Pharmacokinetic Modelling and Simulation of Imeglimin in Type 2 Diabetes Patients to Support Dose Recommendations to Patients with Renal Impairment