I drive quality improvements for clients by providing Audits and Risk Assessment services to Quality Assurance companies like SQA Services and Medpoint, as well as delivering Clinical and Regulatory Compliance Consulting services to pharmaceutical and medical device companies to detect non-compliance with laws, regulations, and management policies.

Through successfully managing Quality Assurance functions to include responsibility for ICH Good Clinical Practices, outsourced Pharmaceutical research services, and vendor selection, audit, and performance evaluation, I seamlessly enhanced the quality system to significantly reduce bottlenecks for a Russian Pharmaceutical company.

Provided MSL support in Rheumatology bioequivalence study. Participated in ICH GCP audits as a Sponsor representative. Provided a direct communication line between the investigators and Sponsor to quickly and efficiently resolve the study-related issues.

Successfully run the trial from the feasibility to the close-out visits. Main point of contact in Russia for Sponsor for all trial-related questions Provided full support for sites in accordance with ICH GCP and local regulatory requirements. Successfully passed Sponsor’s and Regulatory Authorities audits. Conducted Vendors (Drug depo facilities) audits on behalf of CR0/Sponsor NSCLC study phase IIb-III from site selection to close out. Endometrial cancer phase III from site selection to Database lock

Successfully run the trial from the feasibility to the Database lock . Main point of contact in Russia for Sponsor and CRO for all trial-related questions Provided full support for sites in accordance with ICH GCP and local regulatory requirements. Successfully passed Sponsor’s and Regulatory Authorities audits. IBD phase III study from site selection phase to Database lock

Post-Approval and Phase IV Studies Observational Study - Infectious diseases.

Performed Quality Assurance sites visits - Medical device study.

Developed Drug Safety department to provide full scale PhV service. Budget proposals on Safety services. Prepared SOPs, country-specific local working practices and trial-specific Safety Plans. Provided training on Pharmacovigilance for investigators and CRO staff. Medical liaison in resolving SAE queries. Constant update of regulatory requirements on conducting clinical trials in Russia, Ukraine, Belarus, Republic of Georgia and other non-EU countries. Close collaboration with EU-based colleagues on PhV regulatory requirements in EU countries. Developed in-house Safety reporting tracking system (SAE forms/ Regulatory submission) Reported Medwatch to FDA and other Regulatory Authorities . Took part in implementation of the ARGUS safety database. Managed PHV simultaneously in multiple trials (phase 1-3) in different countries.

Conducted site-selection, initiation, routine and close-out visits. Provided full support for sites in accordance with ICH GCP and local regulatory requirements. Successfully passed Sponsor’s and Regulatory Authorities audits. Managed sites in multinational trials in Cardiology, Neurology, Endocrinology and Oncology (phases 1-3)

I studied the inflammatory passway in patients with Cystic Fibrosis utilizing molecular biology technique.

Medicine, Doctor of Medicine

FDA, ICH GCP Clinical Investigator Training Course

Meждународная Академия Экспертизы и Оценки, Клиническая Фармакология

University of Michigan, Oncology

Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, ICH GCP

Johns Hopkins University, Clinical Research

SOFAQ , DGGF, RQA, Good Clinical Practice

British Association of Research Quality Assurance, Qality Assurance

Internal Medicine, Internship

TÜV NORD Deutschland, Lead Auditor QMS ISO 9001:2015

ACRP, Certified Clinical Research Associate

Voronezh Medical State Academy, Passed

ACRP, Certified Clinical Research Associate

Educational Commission for Foreign Medical Graduates