After completing medical training and obtaining my medical degree, I worked in the field of medical devices, pharmaceuticals, clinical research and analyses.
I have extensive and broad experience in conducting clinical evaluations, including literature reviews, risk management and post-market surveillance for medical devices; as well as developing, integrating and maintaining these processes as part of the quality management system in accordance with relevant legislation.
With regard to medicines, I am competent in writing, maintaining and assessing the clinical part of the CTD file, including Module sections 2.5 and 2.7 as well as Module 5.
In terms of clinical trials, I have a background in planning, conducting and monitoring clinical trials for pharmaceuticals and medical devices, including post-market clinical follow-up studies.
In addition, I have significant medical and regulatory analysis experience in medical devices and pharmaceuticals, such as developing an appropriate medical and regulatory strategy and defining product status, reference/equivalent products, key product features and so on.
I am proud to be part of the multidisciplinary STARoDub team and that my knowledge and experience contributes to the overall client outcome.