After completing a higher medical education and obtaining a medical doctor degree, I have been working in the field of medical devices, medicinal products, clinical trials and analytics.
I have a broad experience with performing clinical evaluation including literature search, risk management and post-market surveillance for medical devices, as well as with developing, cointegrating and maintaining of these processes as a part of a quality management system in compliance with relevant legislation.
With respect to medicinal products, I’m skilled in writing, updating and reviewing of the clinical part of CTD dossier, including sections 2.5, 2.7 of Module 2 and Module 5.
Concerning clinical trials, I have a background in planning, conducting and monitoring of clinical trials for medicinal products and medical devices, including post-market clinical follow-up studies.
Besides that, I have a significant medical and regulatory analytics experience related to medical devices and medicinal products, such as developing appropriate medical and regulatory strategy, defining the status of the products, reference/equivalent products, key product characteristics etc.
I am proud to be a part of the multidisciplinary STARoDub team contributing my knowledge and experience to overall result for the benefit of our customers.