Location: Moscow, Russia Contact phone: +7 909 158 45 92 E-mail: mikhail@abramovich.biz Place of birth: Moscow, Russia Nationality: Russian Languages: Russian (native), English (fluent), Esperanto (advanced), French (basic)
· ICH-GCP and Russian regulations in clinical trials, medical writing, organization of clinical trials (study set-up, start-up meeting, monitoring, study termination, project management), medical statistics, logistics and customs clearance of study products; · business development and marketing of medical products; · registration of medical products; · management of representative offices (start-up and licensing, legal, finances, HR, provider management); · surgical and therapeutic gynecology.
Since Jun 2007 Job Title: Head of Office Responsibility: Office set-up, administration and management, line management, project management and coordination of phase I-IV multi-national clinical trials, registration of medical products Company: Harrison Clinical Research Deutschland GmbH (Germany), Representative Office Moscow, Russia
Jul 2001 – Jul 2010 Job Title: Head of Office Responsibility: Office set-up, administration and management, line management, project management and coordination of phase II-IV clinical trials Company: Health Research Services Ltd. (UK), Representative Office Moscow, Russia Mar 1996 – Jul 2001 Job Title: Head of Scientific Research Department Responsibility: Coordination of multi-national clinical trials, marketing and business development support, line management Company: Dr. W. Schwabe / Deutsche Homöopathie-Union (Germany), Representative Office Moscow, Russia Jan 1995 – Feb 1996 Job Title: Head of Medical Representatives Department Responsibility: Organization and supervision of medical representatives work, line management Company: Madaus GmbH (Germany), Representative Office Moscow, Russia Sep 1989 – Feb 1996 Job Title: Physician Responsibility: Patient treatment as surgical gynecologists Institution: Municipal Clinical Hospital № 64, Moscow, Russia
Date of Medical License: Jun 1987 Sep 1987 – Aug 1989 Clinical Fellowship in Obstetrics/Gynecology, Peoples Friendship University, Moscow, Russia Final qualification: Obstetrician/gynaecologist (Qualification Certificate) Sep 1981 – Jun 1987 Moscow Medical Stomatological Institute (Department of General Medicine), Moscow, Russia Final qualification: Medical Doctor (Diploma with honours)
· 2011 – ICH-GCP Refreshing Course "AOP Pharma" (Austria), Moscow, Russia · 2010 – Line Management "Harrison Clinical Research", Munich, Germany · 2010 – ICH-GCP Refreshing Course "Harrison Clinical Research", Munich, Germany · 2010 – New Russian Law on Medications Turnover and New Patients Insurance Regulations Ministry of Health of Russia and "ROSNO" insurance company · 2010 – Clinical Studies in Ukraine State Pharmacology Committee, Kiev, Ukraine · 2010 – GMP Services Training "Harrison Clinical Research", Munich, Germany · 2010 – Time Management: Flexible Methods “Time Management Company”, Moscow, Russia · 2010 – SVEN (global company database) Training: How to Generate Experience Reports "Harrison Clinical Research", Munich, Germany · 2009 – TrialWorks (study database) Training "Harrison Clinical Research", Munich, Germany · 2008 – COCA (cost calculation software) Upgrade Training "Harrison Clinical Research", Munich, Germany · 2008 – HCR CEE Managers Training "Harrison Clinical Research", Munich, Germany · 2008 – Phase I Studies "Novartis" (Switzerland), Moscow, Russia · 2008 – HCR Project Manager Training "Harrison Clinical Research", Brussels, Belgium · 2007 – HCR Introductory Training and SVEN (global company database) Training "European Center for Clinical Research Training", Brussels, Belgium · 2007 – COCA (cost calculation software) Introductory Training "Harrison Clinical Research", Munich, Germany · 2007 – HCR CRA Training & Workshop "Harrison Clinical Research", Munich, Germany · 2007 – Time Management "European Center for Clinical Research Training", Munich, Germany · 2007 – Project Management Workshop "European Center for Clinical Research Training", Munich, Germany · 2007 – Introduction to HCR Central Databases "European Center for Clinical Research Training", Moscow, Russia · 2006 – Clinical Trials of Medical Products in Germany “Akademie fur Fortbildung”, St. Leon-Rot, Germany · 2006 – ICH-GCP: a Refreshing Training Course “Akademie fur Fortbildung”, St. Leon-Rot, Germany · 2006 – GCP for Monitors, Auditors and Pharmaceutical Industry Specialists “Center of Pharmaceutical Education”, Moscow, Russia · 2005 – HRS Standard Operating Procedures “Health Research Services Ltd.”, St. Leon-Rot, Germany · 2004 – GCP for Investigators, Moscow “Innopharm”, Moscow, Russia · 2004 – ICRF: Principles and Procedures “Zenetar” Ltd. (UK), Moscow, Russia · 2004 – Standard Operating Procedures “Zenetar” Ltd. (UK), Moscow, Russia · 2003 – Validation of PC systems; 21 CFR part 11 "ClinResearch" (Germany), Moscow, Russia · 2003 – Drug Registration in Russia Ministry of Health, Moscow, Russia · 2002 – Auditing course “BARQA”, Cambridge, UK · 2002 – GCP auditing: a practical approach “BARQA”, Cambridge, UK · 2001 – RDE in clinical trials “DHU”, Moscow, Russia · 2000 – Statistical thinking for clinical trials “Parexel”, Moscow, Russia · 2000 – Drug Registration in Russia Ministry of Health, Moscow, Russia · 1999 – Practical aspects of clinical trials “Innopharm”, Smolensk, Russia · 1997 – Introduction in Homeopathy “DHU”, Karlsruhe, Germany · 1997 – Clinical Trials According to GCP Standard State Pharmacological Committee, Moscow, Russia · 1996 – Good Clinical Practice “DHU”, Karlsruhe, Germany · 1995 – Postrgraduate training in Gynecology Municipal Healthcare Administration, Moscow, Russia · 1994 – Acupuncture 2-nd Moscow State Medical Institute, Moscow, Russia · 1992 – Laparoscopy Municipal Clinical Hospital No. 36, Moscow, Russia
In total 9 publications.
Computer literate: advanced user Driving License: class B, since 1995