Anna Zakharova

Head of Clinical Reearch Department @ Krka

About

I'm a clinical doctor, haematologist, PhD. After 10 years of work Russian hematology research center I have switched to work in the field of clinical trials inKrka. Recent 13 years of my life are connected with investigation and registration of qualitative generics. Since 2010 I have been the head of clinical research and pharmacovigilance department. My main aims in professional field are: 1. organzation and control of preclinical, bioequivalence, pre-and post-registration clinical trials in accordance with national and EAEU legislation; 2. circumspect strategy of new products registration; 3. maintenance of effective teamwork in formed by myself Krka RF Clinical trials department.

Country

Russia

City

Moscow

Industry

Pharmaceuticals

Skill

Oncology, Regulatory Affairs, GCP, Clinical Research, Pharmacology, Regulatory Submissions, Pharmacovigilance, Pharmacokinetics, Data Analysis

Experience

Head of Clinical Reearch Department

Krka

2010-7 - Present · 16 yrs 3 mos

Moscow, Russian Federation

Coordination of project teams work at preclinical, clinical and bioequivalence studies hold for registration of KRKA products and phase IV post-registration clinical studies. Evaluation of influence of legislation changes on the field of new products registration; participation in creation of new products registration strategy taking into account made evaluation.

CRA; Project manager

Krka

2008-4 - 2010-7 · 2 yrs 4 mos

Moscow, Russian Federation

Management of clinical studies from creation of Protocol, IC and BI till coordination and check of Final report (including receiving regulatoy approval, import permission, import of samples and different kinds of monitoring visits