Tone Agasøster

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.