Ms Klara Salinger
|Org Unit||Adelaide Health Technology Assessment|
|Telephone||+61 8 8313 6131|
Adelaide Health and Medical Sciences
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.
- Research documentation audits
- Data management planning
- Record archiving
- Documentation writing (e.g. SOPs) and form design
Master in Public Heath, University of Adelaide (2014)
Bachelor of Biotechnology (Honours), Flinders University (2011)
Applied GCP (Good Clinical Practice) Training for Investigational Sites and Sponsor Representatives E6(R2), ARCS Australia (2017)
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
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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