Katja Rudell, PhD

Katja Rudell, PhD

Katja Rudell, PhD

Director Clinical Outcomes Assessments (COA)

Katja is the COA Team Lead based in the London Office. She provides strategic and scientific guidance on robust design, implementation and dissemination of patient-centric projects to support market access but also throughout the product lifecycle. Katja has developed 20 COA instruments and engaged with regulatory agencies on the implementation of PRO information on around 40 compounds

Katja has worked across various therapeutic areas including oncology (Lung and Kidney), neuroscience (including AD & MCI), nicotine addiction, rare disease (haemophilia and immunoglobulins, short bowel and HAE), ophthalmology, analgesics and respiratory conditions.  

Katja has been a cross-industry lead for several cross- industry consortia as well as current ISPOR COA special interest group lead. She has been conducting qualitative interviews, focus groups, feasibility and scoping activities, quantitative research, survey development, review, selection and implementation of COA, submission of COA section of study documents for regulatory purposes (protocols, statistical analyses report and end of study reports). Her main motivation is to develop assessments that best capture patient experiences and will allow access to better medications. She speaks fluent German.

Work Experience

Prior to joining Parexel, Katja worked as a COA specialist for AstraZeneca, Pfizer as well as a patient service manager for Shire for the UK/ IRE Region. She has been an academic health psychologist at the University of Kent and is currently holding an Honorary Research Fellowship at the Department of Psychiatry with Sir Kam Bhui.

Education

Katja holds a PhD in Psychology as applied to Medicine from Queen May, Barts’ and the London Medical School, University of London, UK, MSc in Health Psychology, University College London and BSc in Psychology from Royal Holloway, University of London.

We are always available for a conversation.

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