MILEN VRABEVSKI, MDtzarsimeon.bg/wp-content/uploads/2017/03/CV-Milen-Vrabevski.pdf · Part-time...
Transcript of MILEN VRABEVSKI, MDtzarsimeon.bg/wp-content/uploads/2017/03/CV-Milen-Vrabevski.pdf · Part-time...
OCCUPATIONAL FIELD
Clinical Research, Education & Science, Pharmaceutics,
Quality of Life projects, Corporate Social Responsibility,
European Union Funding consultancy, investment
consultancy, music production & composition
(Full Service CRO/SMO, own schools & kindergartens, EU
funding/investment consultancy companies, own music
production house/recording studios, formerly – a
pharmacy chain owner)
WORK EXPERIENCE
1997 - present
Clinical Research and Development, Education & Science,
Pharmaceutics, Corporate Social Responsibility, European
Union Funding consultancy, investment consultancy, music
production & song writing, translation, Quality of Life
projects (validation)
COMAC MEDICAL Ltd.
Founder, Owner, Chief Executive
Officer (CEO), Entrepreneur, Investor
P R OF I LE
NameMilen Vrabevski, MD
Date of Birth23.12.1968
AddressSouth Side Business Centre
38 “Maystor Aleksi Rilets” Str.5th fl., 1618 Sofia, Bulgaria
Telephone+ 359 2 892 1000
Web siteswww.comac-medical.com
www.bgmf.euwww.intelligent-music.com
www.tzarsimeon.bg
MILEN VRABEVSKI, MD
EMPLOYMENT HISTORY
Dept. of Surgery - Varna District Hospital, Junior Doctor
Part-time medical translator
Part-time CRA/conducting & monitoring of clinical studies, QoL projects (validation)
Pharmacia & Upjohn, Bulgaria - Medical Representative
Owner and CEO of COMAC MEDICAL Ltd. - Full Service CRO/SMO with own
structure and activities in 21 European countries, and offices in: Sofia, Bucharest,
Belgrade, Skopje, Tuzla, Tbilisi, and Vilnius
1995 – 1996
1995 – 1996
1996 – 1997
1996 – 1997
1997 – present
PROFESSIONAL ACTIVITIES AND MEMBERSHIPS
A part of HICRONET – a professional network of small CROs
Certificate of Appreciation - North England Research Institute, USA
Certificate of Recognition - National Heart Lung and Blood Institute - USA (NIH)
Certificate of Recognition - Magic Trial
Certificate of Appreciation - MAGIC Trial
Member of Drug Information Association (DIA)
Member of Association of Clinical Research Professionals (ACRP)
Member of DIA Clinical Research Special Interest Area Community (CR SIAC)
Member of DIA CR SIAC Communications & Publications Subcommittee
Assigned to be in charge of opening an ACRP Chapter in Bulgaria
DIA Clinical Research SIAC - Core Committee Member
Certificate of Appreciation - DIA for contribution to the Clinical Research SIAC core
Committee
DIA CR SIAC Publications Subcommittee - European Leader
Certificate of Appreciation - NHLBI
EFGCP Ethics Working Party – Active Member
EFGCP Discussion on the Commission proposals, regarding the Implementing of
Directive 2001/20/EC - Brussels, Belgium
Speaker at DIA Workshop on Clinical Trials in Russia and Eastern Europe
ISOQOL World Annual Meeting – Orlando, FL, USA
Member of European Forum for GCP (EFGCP)
Speaker at ACRP Annual Meeting – Philadelphia, PA, USA
Co-Chair and Speaker at DIA Conference:
Clinical Trials in Central and Eastern Europe – Sofia, Bulgaria
DIA Chapter Task Force - Assigned to be in charge of Central and Eastern Europe
Co-Chair of First National Ethics Committee Members Training:
Speaker at 39th DIA Annual Meeting - San Antonio, TX, USA
Speaker at SMi conference Outsourcing Drug Development - London, UK
Speaker at Conducting Clinical Trials in EU Accession and Candidate Member States
conference - Warsaw, Poland
Workshop lecturer at EMEA/EFGCP Workshop:
Ethics in Clinical Development from Legislation to Implementation - London, UK
Member of the Advisory Council of the EFGCP
Speaker at the UK Clinical Research Institute conference:
New Horizons in International Clinical Research - Harrogate, UK
1999 – 2004
Sep 2001
Oct 2001
2001
2001
Jan 2002
Jan 2002
Apr 2002
Apr 2002
Jun 2002
Jun 2002
Jun 2002
Jun 2002
Aug 2002
Sep 2002
Sep 2002
Oct 2002
Nov 2002
Dec 2002
Apr 2003
May 2003
Jun 2003
Jun 2003
Jun 2003
Sep 2003
Sep 2003
Dec 2003
Feb 2004
Apr 2004
EDUCATION AND TRAINING
Seminar speaker and Program Co-chair: Implementation of the EU Directive on GCP
in Bulgaria”, co-organized by Association for Good Clinical Practice and Clinical
Research Development in Bulgaria & EFGCP
Certificate of Completion – LOGIC
Pre-IND Meeting, Food and Drug Administration Center for Drug Evaluation and
Research Division of Cardiovascular and Renal Products, Bethesda, Maryland, USA
European Co-Chair of the DIA Clinical Research SIAC
Chairperson at Clinical Investigators Seminar: Ethical and Regulatory Aspects of GCP
in Investigators’ Practices, co-organized by Association for GCP and Clinical Research
Program Committee Member for DIA 2007 Euro Meeting – Vienna, Austria
Member of the DIA Advisory Council Europe (ACE)
Speaker at 42nd DIA Annual Meeting, Philadelphia, USA
Speaker at the SMi conference “Conducting Clinical Trials in Europe” - London, UK
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
Co-chair of DIA conference: “The Changing World of Clinical Trials” - Basel,
Switzerland
Program Committee Member, Clinical Research Track Chair and Session Chair at the
19th Annual DIA Euro Meeting – Vienna, Austria
Speaker at “Yaku-Kon” Meeting, (annual meeting of European-based Japanese
Pharmaceutical Companies) - London, UK
Session Chairperson of (DIA) 43rd Annual Meeting, Atlanta, USA
Program Advisor at the DIA Clinical Forum Madrid, Spain
Co-Chair of the First 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
Certificate of Achievement - Rocket AF
“Comac Medical” receives award in the annual competition “IT project of 2016”
May 2004
Jul 2004
Jan 2005
Sep 2005
Nov 2005
May 2006
Jun 2006
Oct 2006
Oct 2006
Oct 2006
Nov 2006
Mar 2007
May 2007
Jun 2007
Oct 2007
Feb 2009
Sep 2010
Feb 2017
Graduated the English Language School, Varna, Bulgaria
Navy Air Force regular service – Radio/Telegraph Operator
Graduated the Medical University, Varna - Qualified MD
Certificate of Attendance - Orientation to Clinical Monitoring Training Course,
Maidenhead, England
International GCP and CRA trainings and seminars for PAREXEL, ClinTrials Research
Ltd, The Medicines Company, Pharmacia etc.
GCP Training for ClinTrials Research Ltd. – Maidenhead, London
Selling Skills Training for Medical Representatives - Pharmacia & Upjohn, Sofia
CRA Training for PAREXEL International / Searle G.D., US - Caesarea, Israel
CRA Training for LCC/TMC, UK - Leuven Coordinating Center HQ, Belgium
CRA Training for The Medicines Company, UK - Prague, Czech Republic
CRA Training for The Medicines Company – Amsterdam, Netherlands
GCP Training Course and Seminar “GCP in Bulgaria” - Borovetz, Bulgaria
CRA Training for The Medicines Company, UK - Athens, Greece
CRA Training Course for PAREXEL International – Warsaw, Poland
1987
1987 – 1989
1989 – 1995
Aug 1996
1996 – 2000
1996
1996
1997
1998
1998
Sep 1999
May 2000
May 2000
Mar 2001
PROFESSIONAL ACTIVITIES AND MEMBERSHIPS
Certificate of Appreciation from North England Research Institute, USA
Certificate of Recognition from National Heart Lung and Blood Institute of the USA
(NIH)
Training Certificate for Administration, Management and SOPs - Atus-Group, France
DIA Training “Auditing of Trials and Systems” - London, UK
DIA Workshop “The Future of Clinical Trials in Europe” - Paris, France
Certificate of Attendance - DIA Educational Seminar on Practical GCP Compliance
Auditing of Trials and Systems, London
DIA Euro Meeting - Basel, CH
GCP Training Course by Prof. N. Bakracheva, Chair of Bulgarian MoH Specialized
Committee For Approval of Conducting Clinical Trials, Sofia, Bulgaria
ACRP Annual Euro Meeting – Amsterdam, Netherlands
DIA World Annual Meeting – Chicago, USA
EFGCP Forum Discussion on the Commission proposals, regarding the Implementing
of Directive 2001/20/EC - Brussels, Belgium
Speaker at DIA Workshop on Clinical Trials in Russia and Eastern Europe
ISOQOL World Annual Meeting – Orlando, FL, USA
RA and EC members International Meeting as a member of EFGCP, Ethics Working
Party
DIA Euro Meeting – Rome, Italy
Speaker at ACRP Annual Meeting – Philadelphia, PA, USA
Co-Chair and Speaker at DIA Conference “Clinical Trials in Central and Eastern Europe”
– Sofia, Bulgaria
Certificate of Attendance - DIA Workshop on Clinical Trials in Central and Eastern
Europe. Sofia
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
Speaker at 39th DIA Annual Meeting - San Antonio, TX, USA
Speaker at SMi conference “Outsourcing Drug Development” - Hatton, London, UK
Speaker at Conducting Clinical Trials in EU Accession, and Candidate Member States
conference - Warsaw, Poland
Certificate of Attendance - Outsourcing of Drug Development
Certificate of Attendance - Clinical Trials in EU Accession & Candidate States (2005),
London
Workshop lecturer at EMEA/EFGCP Workshop “Ethics in Clinical Development from
Legislation to Implementation” - London, UK
Speaker at the UK Clinical Research Institute conference “New Horizons in International
Clinical Research” - Harrogate, UK
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
DIA Training: How to Achieve Compliance for Conducting Clinical Trials within the
Scope of Current EU Regulations
Certificate of Attendance - The Implementation of EU Directive on Good Clinical
practice in Bulgaria, Sofia
Clinical research & Monitoring skills – training by Jo Burmester, UK
Sep 2001
Oct 2001
Jan 2002
Feb 2002
Feb 2002
Feb 2002
Mar 2002
Apr 2002
Jun 2002
Jun 2002
Sep 2002
Oct 2002
Nov 2002
Dec 2002
Mar 2003
Apr 2003
May 2003
May 2003
Jun 2003
Jun 2003
Sep 2003
Sep 2003
Sep 2003
Sep 2003
Dec 2003
Apr 2004
May 2004
May 2004
May 2004
Jun 2005
EDUCATION AND TRAINING
Bulgarian Regulation in Clinical Research and Drug Safety. GCP in Bulgaria – training
by Dr. Emil Hristov, Executive director of BDA (Bulgarian Drug Agency)
Training Certificate “Preparing for FDA’s inspection. Notice on pediatric research.
New trends in clinical research – phase 0 studies. BA/BE studies. Advertising and
promotion in clinical research” Sofia
Clinical Trials Design. Clinical Trial for Bioequivalence Assessment - training by Assoc.
Prof. Ivanka Atanassova, Bulgarian Drug Agency
PAREXEL WSOP Training
Certificate of Attendance EFGCP Conference on “Clinical Trials in Serbia - Looking
upon GCP, Regulatory Issues and Bio-ethics”, Belgrade, Serbia
Serving as DIA, ACRP, EFGCP Education events Speaker, Program Committee
Member, Program Chairperson, Program Advisor
Certificate of Attendance - Training on Principles of Good Clinical Practice
Training Certificates
Jun 2005
May 2005
Aug 2005
Aug 2005
Sep 2006
2002 - 2009
Jan 2009
1996-2005
EDUCATION AND TRAINING
SOCIAL ACTIVITIES
Member of the Academic Council at Medical University, Varna
Founder and Chairman of Association for GCP and Clinical Research Development
Certificate of Appreciation for donation for contribution to the recovery of the
Boyana Church, a World Heritage Site
Certificate of Donation by Association “Pliska” for reconstruction of the soldier
monuments in Novo Selo, Macedonia
Citizens for European Development of Bulgaria (GERB) nominee for Member of
European Parliament
Citizens for European Development of Bulgaria (GERB) nominee for Member of Sofia
Municipal Council
Founder, Chairman & Sponsor of Bulgarian Memory Foundation (www.bgmf.eu)
Certificate of Donation by the Foundation “I Want a Baby”
Diploma from First Language School Varna for sponsorship of the writing contest
Speaker at the National Round Table – “The Future of Bulgaria’s Cultural Heritage”-
Veliko Tarnovo, Bulgaria
Certificate of Appreciation – Municipality of Pernik, for providing generous
sponsorship in the organization and conduct of Krakra archaeological expedition
Honorary high school student for his efforts and striving to maintain the Bulgarian
spirit and identity and for donations and joint initiatives in relation to the high school
anniversary celebration
Diploma from the Kardzhali Regional History Museum for contribution to the
preservation of the cultural memory of the Bulgarian country
Association „Enterpreneurs - GERB” - member of National Executive Council
Lecturer at START UP 2008 – Bulgarian Forum for Starting Entrepreneurs at the
University of National and World Economy – Sofia, Bulgaria
‘Person of the Year’ - Special Award of the Association of Bulgarians in Ukraine for an
exceptional contribution to strengthening the economic and cultural relations
between Ukraine and Bulgaria
Certificate of Appreciation - Americans of Bulgarian Descent Federation for
contribution to the further development of the relations between Bulgaria and the
United States of America
1989 – 1995
Apr 2002
2006
Nov 2006
Mar 2007
Oct 2007
Dec 2007
Dec 2007
2007
Jul 2008
2008
2008
Oct 2008
Oct 2008
Nov 2008
2009
2009
Speaker at US Business Forum 2010: Turkey & the Balkans “Connecting Business
Leaders” - New York, USA
Presented with the Special Prize of the Bulgarian Donor’s Forum – Person of the Year
for outstanding contribution to philanthropy in Bulgaria
Lecturer at Bulgarian School of Politics panel discussion “Democracy and Values” –
Pravets, Bulgaria
Co-organizer and moderator of the Bulgarian days in European Parliament under the
patronage of the Bulgarian President – Bulgaria: State of Spirit and Alphabet
Member of Clinton Global Initiative
Member of the of the Republic of Bulgaria President’s Council on Spirituality, Culture
and National Identity
Medal of Honor of the Autonomous Republic of Gagauzia
Co-organizer and moderator of the Bulgarian days in European Parliament –
Bulgaria: Sanctuary of the Word
European Citizen’s Prize Laureate for 2013
Presented with the of Medal of Honor with Ribbon by the Mayor of Varna
Award “Individual Donor with Cause” of Workshop for Civic Initiatives Foundation
for the best charity initiative in education
“Modern Enlightener” 2014
Award “Pythagoras 2016” of the Ministry of Education and Science (MES) - category
“Company with the largest investments in science.” - “Comac Medical”
Award "Apostle of the Bulgarian National Traits 2016"
Member of the Public Council of the Bulgarian National Radio
Bulgarian Memory Foundation in 2016
Charity Certificates
Award “Dad of the Year 2016”
Other
language(s)
SOCIAL ACTIVITIES
Sep 2010
Nov 2011
Dec 2011
Feb-Mar 2012
May 2012
Jun 2012
2012
Feb-Mar 2012
Jul 2013
Aug 2013
Jul 2014
Oct 2014
May 2016
Aug 2016
Nov 2016
2016
2003-2015
Feb 2017
English
Russian
French
Mother tongue(s): Bulgarian