CURRICULUM VITAE NAME: Milen Nikolaev Vrabevski, MD DATE/PLACE OF BIRTH: 23 December 1968, Varna, Bulgaria CONTACT DETAILS: South Side Business Centre 38, Maystor Aleksi Rilets Str., 5th fl. Res. Distr. Manastirski Livadi - West 1618 Sofia, Bulgaria Phone: +359 2 921 1000 Fax: +359 2 921 1001 e-mail: milen.vrabevski@comac-medical.com www.comac-medical.com EDUCATION & TRAINING: 1987 Graduated the English Language School, Varna, Bulgaria 1987 1989 Navy Air Force regular service - Radio Connections Specialist 1989 1995 Graduated the Medical University, Varna - Qualified MD 1996 GCP Training for ClinTrials Research Ltd. Maidenhead, London 1996 Selling Skills Training for Medical Representatives - Pharmacia & Upjohn, Sofia 1997 CRA Training for PAREXEL International / Searle G.D., US - Caesarea, Israel 1998 CRA Training for LCC/TMC, UK - Leuven Coordinating Center HQ, Belgium 1998 CRA Training for The Medicines Company, UK - Prague, Czech Republic Page 1 of 5
Sep 1999 CRA Training for The Medicines Company Amsterdam, Netherlands. May 2000 GCP Training Course and Seminar GCP in Bulgaria - Borovetz, Bulgaria May 2000 CRA Training for The Medicines Company, UK - Athens, Greece Mar 2001 CRA Training Course for PAREXEL International Warsaw, Poland Sep 2001 Certificate of Appreciation from North England Research Institute, USA Oct 2001 Certificate of Recognition from National Heart Lung and Blood Institute of the USA (NIH) Jan 2002 Training Certificate for Administration, Management and SOPs - Atus-Group, France Feb 2002 DIA Training Auditing of Trials and Systems - London, UK Feb 2002 DIA Workshop The Future of Clinical Trials in Europe - Paris, France Mar 2002 DIA Euro Meeting - Basel, CH Apr 2002 GCP Training Course by Prof. N. Bakracheva, Chair of Bulgarian MoH Specialized Committee For Approval of Conducting Clinical Trials, Sofia, Bulgaria Jun 2002 ACRP Annual Euro Meeting Amsterdam, Netherlands Jun 2002 DIA World Annual Meeting Chicago, USA Sept 2002 EFGCP Forum Discussion on the Commission proposals, regarding the Implementing of Directive 2001/20/EC - Brussels, Belgium Oct 2002 Speaker at DIA Workshop on Clinical Trials in Russia and Eastern Europe Nov 2002 ISOQOL World Annual Meeting Orlando, FL, USA Dec 2002 RA and EC members International Meeting as a member of EFGCP, Ethics Working Party Mar 2003 DIA Euro Meeting Rome, Italy Apr 2003 Speaker at ACRP Annual Meeting Philadelphia, PA, USA May 2003 Co-Chair and Speaker at DIA Conference Clinical Trials in Central and Eastern Europe Sofia, Bulgaria Jun 2003 Co-Chair of First National Ethics Committee Members Training: Workshop on the Development of Ethical Review in Bulgaria Establishing Best Practices in Conjunction with National, EU and International Guidance co-organized by EFGCP and Association for GCP and Clinical Research Development in Bulgaria Jun 2003 Speaker at 39 th DIA Annual Meeting - San Antonio, TX, USA Sep 2003 Speaker at SMi conference Outsourcing Drug Development - Hatton, London, UK Sep 2003 Speaker at Conducting Clinical Trials in EU Accession, and Candidate Member States conference - Warsaw, Poland Dec 2003 Workshop lecturer at EMEA/EFGCP Workshop Ethics in Clinical Development from Legislation to Implementation - London, UK Apr 2004 Speaker at the UK Clinical Research Institute conference New Horizons in International Clinical Research - Harrogate, UK Page 2 of 5
May 2004 Speaker and Programme Co-chair of the Implementation of the EU Directive on GCP in Bulgaria Seminar, co-organized by Association for GCP and Clinical Research Development in Bulgaria & EFGCP May 2004 Training - How to Achieve Compliance for Conducting Clinical Trials within the Scope of Current EU Regulations Jun 2004 PAREXEL WSOP Training Nov 2004 Chairperson at Clinical Investigators Seminar Ethical and Regulatory Aspects of GCP in Investigators Practices, co-organized by Association for GCP and Clinical Research Development in Bulgaria & EFGCP May 2005 Preparing for FDA s inspection. Notice on paediatric research. New trends in clinical research phase 0 studies. BA/BE studies. Advertising and promotion in clinical research training by Borislav Borissov, MD, Prescriptia LLC Jun 2005 Clinical research & Monitoring skills training by Jo Burmester, UK June 2005 Bulgarian Regulation in Clinical Research and Drug Safety. GCP in Bulgaria training by Dr. Emil Hristov, Executive director of BDA (Bulgarian Drug Agency) Aug 2005 Clinical Trials Design. Clinical Trial for Bioequivalence Assessment - training by Assoc. Prof. Ivanka Atanassova, Bulgarian Drug Agency Aug 2005 PAREXEL WSOP Training Nov 2005 Chairperson of Clinical Investigators Seminar Ethical and Regulatory Aspects of GCP in Investigators Practices by Association for GCP and Clinical Research Development - Scopje, Macedonia Nov 2005 Programme Committee Member for DIA 2007 Euro Meeting Vienna, Austria Nov 2006 Co-chair of the DIA conference The Changing World of Clinical Trials - Basel, Switzerland Jun 2006 Speaker at 42 nd DIA Annual Meeting, Philadelphia, USA Oct 2006 Co-Chair of the DIA Regulatory Seminar In-depth Review of Current Registration Procedures in the EU and Impact of New Medicines Legislation - Sofia, Bulgaria Oct 2006 Speaker at the SMi conference Conducting Clinical Trials in Europe - London, UK Mar 2007 Programme Committee Member, Clinical Research Track Chair and Session Chair at the 19 th Annual DIA Euro Meeting Vienna, Austria May 2007 Speaker at Yaku-Kon Meeting, (annual meeting of European-based Japanese Pharmaceutical Companies) - London, UK Oct 2007 Programme Advisor at the DIA Clinical Forum Madrid, Spain Jul 2008 Speaker at the National Round Table The Future of Bulgaria s Cultural Heritage - V. Tarnovo, Bulgaria Page 3 of 5
Nov 2008 Feb 2009 Lecturer at START UP 2008 Bulgarian Forum for Starting Enterpreneurs at the University of National and World Economy Sofia, Bulgaria Co-Chair of the First Educational Workshop in Eastern Europe CDISC European Educational Roadshow, co-organized by Association for GCP and Clinical Research Development & Clinical Data Interchange Standards Consortium (CDISC) - Sofia/Bulgaria EMPLOYMENT HISTORY: 1989 1995 Member of the Academic Council at Medical University, Varna 1995 1996 Dept. of Surgery - Varna District Hospital, Junior Doctor 1995 1996 Part-time medical translator 1996 1997 Part-time CRA/conducting & monitoring of clinical studies 1996 1997 Pharmacia&Upjohn, Bulgaria - Medical Representative 1997 Present Owner and of - Full Service CRO with offices in Bulgaria, Romania, Serbia, Macedonia and Lithuania: www.comac-medical.com Jan 2002 Member of Drug Information Association (DIA) Jan 2002 Member of Association of Clinical Research Professionals (ACRP) Apr 2002 Member of DIA Clinical Research Special Interest Area Community (CR SIAC) Apr 2002 Member of DIA CR SIAC Communications & Publications Subcommittee Apr 2002 Founder and Chairman of Association for GCP and Clinical Research Development Jun 2002 Assigned to be in charge of opening an ACRP Chapter in Bulgaria Jun 2002 DIA Clinical Research SIAC - Core Committee Member Jun 2002 DIA CR SIAC Publications Subcommittee - European Leader Sep 2002 Member of European Forum for GCP (EFGCP) Sep 2002 EFGCP Ethics Working Party Active Member Jun 2003 DIA Chapter Task Force - Assigned to be in charge of Central and Eastern Europe Feb 2004 Member of the Advisory Council of the EFGCP Jan 2005 Pre-IND Meeting, Food and Drug Administration Center for Drug Evaluation and Research Division of Cardiovascular and Renal Products, Bethesda, Maryland, USA Sep 2005 European Co-Chair of the DIA Clinical Research SIAC May 2006 Member of the DIA Advisory Council Europe (ACE) Mar 2007 Citizens for European Development of Bulgaria (GERB) nominee for Member of European Parliament Jun 2007 Session Chairperson of (DIA) 43rd Annual Meeting, Atlanta, USA Page 4 of 5
Oct 2007 Citizens for European Development of Bulgaria (GERB) nominee for Member of Sofia Municipal Council Dec 2007 Founder and Chairman of Bulgarian Memory Foundation www.bgmf.eu Oct 2008 Association Enterpreneurs GERB - member of National Executive Council. LANGUAGES: Bulgarian - mother tongue English - fluent, read, written and spoken Russian - fluent, read, written and spoken French basic level COMPUTER SKILLS: Windows XP, MS Office, MS Word for Windows, MS Excel, MS Power Point Signed: Milen Vrabevski, MD Date: May, 2010 Sofia, Bulgaria Page 5 of 5