Emma Hansson, Ph.D.

Senior Consultant, 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

Simplifying the Communication of Covariate Effects from Pharmacometric Models – The Role of Unconditional Covariate EffectsThe evolving role of in vitro – in vivo correlation in Model-Informed Drug Development: A multi-stakeholder perspectiveModel-Informed Drug Development in Small PopulationsRegulatory Aspects of Sex-Related Differences in Drug Development: Past, Present, and FutureA 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 ImpairmentCaplacizumab Model-Based Dosing Recommendations in Pediatric Patients With Acquired Thrombotic Thrombocytopenic Purpura [2]Caplacizumab Dosing Rational in aTTP Patients Supported by Mechanism Based PKPD Modelling