Евгений Рогов

Evgenii (Eugene) Rogov MD, JD, PhD, MSc, MRQA

DOB: September 9, 1974

KEY QUALIFICATIONS

Skills and Expertise

·        Experienced more than 18 years and in the preclinical and clinical trials areas

·        Quality Assurance auditor with over 12 years’ expertise of Medicine and Medical Devices Regulatory activities

·        Conducted more than 280 successful GCP/GLP inspections and audits, including: Sponsors, CROs, Clinical Sites (including Bioequivalence and Early Phase Units), Preclinical Facilities, Pharmacy Depots, Analytical Labs etc.). EMA/FDA/WHO inspection participant.

·        Over 20 years’ experience in the pharmaceutical development industry, in the preclinical and clinical trials areas

·        Trained by EMA/FDA in GCP inspections and OECD/PMDA in GLP inspections

·        Proven ability to deliver effective training including GCP, GLP and QA for Investigators/Sponsors/CROs

Certification, Licensing and Qualifications

·        Languages: Russian (native), English (Upper Intermediate)

·        MSc (Pharm. Med.), Hibernia College, Dublin, Ireland

·        6-month Research Ethics Fellowship, University of Washington School of Medicine, USA

·        PhD (Public Health and Healthcare Management), Russian State Medical University

·        JD (Civil Law), Moscow State University

·        MD (General Practice), Russian State Medical University

·        Over 20 scientific publications

Professional Experience

Independent GCP/GLP Auditor/Consultant, 2016 – present time

·        Independent GCP/GLP auditor

·        Provision of QA advice and support

·        Provision of GCP/GLP training

Local Ethics Committee, Best Clinical Practice LLC, Saint-Petersburg, 2016 – present time

Chairman

Nonresident GCP/GLP Inspector for Federal Service on Surveillance in Healthcare of Russia (Roszdravnadzor), 2016 – 2021

Nonresident GLP OECD Inspector for Federal Service on Accreditation of Russia (RosAccreditation), 2012-2019

State Institute of Medicines and GxP, Ministry of Industry and Trade of Russia, (MINPROMTORG), Moscow, 2016 - 2017

Head of GCP/GLP Educational Division

Federal Service for Accreditation of Russia (RusAccreditation), Moscow, 2013 – present time

Non-resident GLP OECD Inspector

Western Institutional Review Board (WIRB), Olympia, WA, USA, 2008 - present

Board Member, International Consultant

Federal Service on Surveillance in Healthcare of Russia (Roszdravnadzor), Moscow, 2009 - 2016

Deputy Head, Head of Clinical Trials Control Department

Federal Ethics Committee for Clinical Trials Review, Federal Service on Surveillance in Healthcare (Roszdravnadzor), Moscow, 2008 - 2010

Board Member

Local Ethics Committee, Russian State Medical University (RSMU), Moscow, 2001 - 2013

Clerk, Secretary, Board Member

Russian State Medical University, Moscow, Russia, 2001 - 2009

Lead Expert of Scientific Department, Head of Department of Innovations

Local and Big Pharma Companies, Russia, 2001 - 2008

CRA, Senior CRA, Lead CRA, Clinical Trials Project Manager, Freelance positions

Mirgom Pharmaceuticals Consulting, Russia, 2000 - 2001

Assistant CRA, CRA

Russian State Medical University, Russia, 1999 - 2004

Research fellow, PhD fellow

Murmansk City Hospital, Ambulance Department, Russia, 1991 – 1992, 1995, 1998

Nurse, Doctor’s Assistant, Subordinator

Other TRaINING/Experience

2018               EU GCP Inspector’s Online Training Course, EMA, London, UK

2018               GLP OECD Inspectors Training, OECD/ Russian Federal Service for Accreditation

2017               Auditing Course, RQA, Edinburgh, UK

2016, 2017   GCP Training, Yaroslavl State Medical Academy, Yaroslavl, Russia

2015               ISO 9001 principles: QA training, Certification Institute, Moscow, Russia

2015               GLP Inspectors Training, Danish Agriculture & Food Council/DANAK, Saint-Petersburg, Russia

2015               WHO National Medicines Regulatory Authority workshop, Moscow, Russia

2015               WHO sensitization workshop on Quality Management System for National Medicines Regulatory Authorities, Moscow, Russia

2014               WHO/MFDS Joint Implementation Workshop: Evaluation of biotherapeutic products, Seoul, Korea

2010 - 2014  Various EU GCP Inspectors Working Group Workshops, EMA, London, UK, Paris, France

2013              Training Course for GLP Inspectors, Standardization, Metrology & Certification Academy, Moscow, Russia

2013               OECD Training Course for GLP Inspectors, PMDA, Chiba, Japan

2010 - 2013  Series of Workshops “GCP Inspection“ (Phase I, II, III), US FDA, Moscow, Russia

2011               EU GCP Inspector’s Basic Training Course, EMA, London, UK

2010               GCP Training Course for Experienced Researchers, European Forum for Good Clinical Practice (EF GCP), Saint-Petersburg, Russia

2010               Training “Project Management for Public Authorities”, Financial Academy at the Government of the Russia, Moscow, Russia

2009 - 2010  International Fellows Program (non-complete), Research Ethics for Central and Eastern Europe (E-Education in Research Ethics), Union Graduate College Centre for Bioethics (Schenectady, NY, USA) in partnership with the Department of Medical History and Ethics of Vilnius University (Vilnius, Lithuania), NIH (Rockville Pike, MD, USA)

2009              Training Workshop “Strategic Quality Management (SQM)”, SIDCER-FERCAP, WHO-TDR Clinical Coordination and Training Center (CCTC), Thammasat University (TU), Pathumthani, Thailand

2008               Training “Protecting Study Volunteers in Research”, Office of Human Subject Protection (OHSP), University of Rochester Medical Center, Rochester, NY, USA

2008               Short Training, Northwest Association for Biomedical Research, Tacoma, WA, USA

2008               6-month International Fellows Program, Western Institutional Review Board (WIRB), University of Washington (UW), World Health Organization (WHO), Middleton Foundation, NIH, Olympia, WA, USA

2008               Surveying & Evaluating Ethical Review Practice, WHO/SIDCER, Kazan, Russia (WHO Inspection, Inspector trainee)

2006               Management Training, Highest School of Economic, Moscow, Russia

2006 - 2016  Public Healthcare Management Training, RSMU, Moscow, Russia

2002 - 2014  Series of trainings: GCP, Advanced GCP, GLP and Clinical Trials Monitoring trainings, RSMU, Clinical Research Institution, InnoPharm, GSK (Moscow), State Medical University n.a. Pavlov (Saint-Petersburg), Russia

1999 - 2004  Postgraduate residency in Public Healthcare Management, RSMU, Moscow, Russia

OTHER INFORMATION