Natalya Makeeva

More than 20 years ago Natalya started her career in clinical trials as Data management specialist at little local Clinical Research Organization. Continuing her professional journey, Natalya obtained experience of work both in little local and big global pharmaceutical companies and CROs, including Pfizer, Astra Zeneca, Merck Serono, PPD, Nearmedic. In Natalya`s career history there are different positions held within clinical trials area: in the frames of Data Management – since 2003, Clinical Monitoring – since 2006, Project Management – since 2009, Trainings – since 2012, Quality Assurance – since 2015. Besides, Natalya is a member of international Research Quality Association since 2019 and international certificate of Quality Management Systems Lead Auditor holder. Natalya has experience of conducting the audits in GCP, GDP, GxP and GVP areas. She conducted clinical trials audits (including Trial Master Files and Investigational Study Files audits) on the base of CROs and investigational sites as well as CRO, logistics companies, laboratories (clinical and bio-analytical) and phase I and bio-equivalence units audits. She will be happy to help you in case you need to conduct an audit in Russian Federation, Kazakhstan, Georgia and Armenia. The audits can be performed in Russian and/or English languages.