Ms Klara Salinger

 Position Research Officer
 Org Unit Adelaide Health Technology Assessment
 Email klara.salinger@adelaide.edu.au
 Telephone +61 8 8313 6131
 Location Floor/Room WS9086.08 ,  Adelaide Health and Medical Sciences ,   North Terrace
  • Biography/ Background

    Ms. Salinger is responsible for critically appraising evidence of health technologies for purposes of systematic reviews and for evaluation of medical device submissions to the Therapeutic Goods Administration.

    Regulatory Assessment of Medical Devices

    Ms. Salinger is responsible for the evaluation of evidence for safety and performance of medical devices provided in applications (application audits and conformity assessments) submitted to the Therapeutic Goods Administration. Evaluations involve synthesis and critical appraisal of clinical data; published studies; post-marketing studies; pharmacovigilance and registry data; risk-analysis and management; and information provided to health professionals and consumers. Common indications for assessed devices include: orthopaedics; ophthalmology and cardiology. 

    Additional expertise

    • Research documentation audits
    • Data management planning
    • Record archiving
    • Documentation writing (e.g. SOPs) and form design

     

  • Qualifications

    University Qualifications

    Master in Public Heath, University of Adelaide (2014)

    Bachelor of Biotechnology (Honours), Flinders University (2011)

    Professional Training

    Applied GCP (Good Clinical Practice) Training for Investigational Sites and Sponsor Representatives E6(R2), ARCS Australia (2017)

  • Publications

    Selected Contracted Reports

    Newton S, Salinger K, Pridham L, Parsons T, Merlin T. Assessment of extended half-life clotting factor concentrates. 2017. Australian Haemophilia Centre Directors’ Organisation. Melbourne Victoria

    Morona J, Mittal R, Newton S, Salinger K, Carter DA, Schubert C, Merlin T. MSAC 1435 Part A, Assessment Report. 2017. Commonwealth of Australia, Canberra

    Conference Posters

    Salinger K, Stapledon R, Brigham M. South Australian post-migration screening programs for new migrants. 2015. Poster presentation. 5th Conference of The International Union Against TB and Lung Disease Asia Pacific Region 2015. Sydney, 31 August - 2 September 2015.

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Entry last updated: Thursday, 9 Aug 2018

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