Tone Agasøster

Norwegian Medicines Agency

Dr Tone Agasøster works at the Norwegian Medicines Agency as an assessor of quality dossiers for MA applications and clinical trials (synthetic substances and finished products). She is a pharmacist by education, and has a PhD (from 1994) in development of automated HPLC methods for determination of some antibacterial drugs in fish using dialysis for on-line sample preparation. She started in the position at the Norwegian Medicines Agency in 1998, and has been the assessor of many centralised applications. She has been a member of the Quality Working Party since 1999, and the respective Core Team since its introduction in 2012. She is QWPs observer in EDQMs Expert Group 7 on antibiotics, and is QWPs/ECs representative in ICH Q2 Analytical Validation (revision)/Q14 Analytical Procedure Development. She is also involved in EMA drafting groups.