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Clinical Research Experts

Elena Gorelova

Manager, Quality Assurance/Quality Control
Clinical Research
Accell Clinical Research
Ukraine

Biography

Ms. Gorelova is a Saint Petersburg State Technological Institute graduate with a Master’s Degree in Biotechnology Engineering. Starting in 2001 Elena has spent over 10 years working for one of the largest Russian pharmaceutical manufacturers in the quality control department. She provided oversight of raw materials quality assurance process, all stages of the manufacturing process, and final quality control of manufactured products for both liquid and solid drug forms. By 2012 Ms. Gorelova has moved through the ranks from the role of a QA Engineer to the Head of Quality Assurance Department at her firm, and in these capacities, she participated in the establishment of a Quality Management System (QMS) and QMS essential documentation. In 2012 Ms. Gorelova joined Accell Clinical Research team as the Quality Control and Quality Assurance Manager. Elena has made a significant professional contribution to Accell Clinical Research and has successfully guided the company through more than 16 external audits and inspections in 5 years. Under her leadership, the clinical sites used by Accell have passed regulatory inspections from EMA and Russian Roszdravnadzor with no significant findings.

Research Interest

Biotechnology Engineering, Quality Managemnet

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