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

E-mailmilen.vrabevski@comac-medical.com

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