Prof. Tatyana Benisheva-Dimitrova, MD, DSci

Biography:

Professor Dr. Tatyana Benisheva-Dimitrova, MD, is a physician and professor at the Faculty of Public Health of the Medical University - Sofia, Bulgaria. 

She was awarded an EU-CADREAC scholarship, which enabled her to complete a master's degree in Drug Regulatory Affairs (2004/2005) at the University of Bonn (Germany). Later, in 2010, she obtained a master’s degree in Public Health at the Medical University of Sofia, Bulgaria.

Professor Tatyana Benisheva, DSCi, is part of the Department of Health Management and Health Economics at the Faculty of Public Health, Medical University. She began her academic career in 2006 and was elected Vice Dean in 2012. She teaches medical students and master's and bachelor's programs related to health management, pharmaceuticals, medical devices, and cosmetic products at the Faculty of Public Health at MU-Sofia. 

Her teaching covers the entire life cycle of medicines, including drug regulation, market authorization, clinical trials, drug safety, pricing, and reimbursement policies in public health, along with various financial indicators for public reporting of pharmaceutical expenditures. She supervises nine doctoral students, six of whom have already obtained their PhDs.

She is the first chairwoman of the "Council on Prices and Reimbursement of Medicines" at the Council of Ministers and was director of the Ministry of Health of the "Drug Policy" Directorate and a full-time advisor to the Health Committee of the 38th National Assembly and has over 10 years of experience at the National Institute of Medicines (today BDA). 

He has participated in a number of projects, including in recent years: 

Project "Development of Proposals for Improving Public Participation in the Pricing and Reimbursement of Medicines, Formation, and Accounting of Public/Budgetary Healthcare Expenditures in the Field of Medicines," funded by the "Good Governance" Operational Program, co-financed by the EU through the European Social Fund (2019-2021).

"Operational Program Administrative Capacity" (OPAC): The National Council on Drug Pricing and Reimbursement was a beneficiary under this project, implemented with financial support from the Operational Program "Administrative Capacity" 2007-2013, co-financed by the EU through the European Social Fund, Priority Axis III: "Quality Administrative Service and Development of E-Governance," and executed under Contract 13-31-13/11.04.2014.

Membership in committees:

• Member of the Standing Committee on Health and Sports at the National Agency for Assessment and Accreditation (NAAA) (2019-2024);
• –Member of the Ethics Committee for Clinical Trials at the Ministry of Health and MedEthicsEU.

Member of Bulgarian organizations:

Chairperson of Bulgarian Association for Drug Information (BADI) - www.badibg.org www.badibg.org

• Member of the Board of the Union of Bulgarian Medical Specialists
• Member of the Bulgarian Public Health Association 
• Member of the Bulgarian Association for Personalized Medicine
• Member of the Bulgarian Association for Patient Protection 

Member of international organizations: 

• Advisory Council Europe of DIA (ACE – DIA) 2010 -2018,
• DGRA, Drug Regulatory Affairs – www.dgra.de (since 2005)
• IFAPP - International Federation of Associations of Pharmaceutical Physicians & Pharmaceutical Medicine - Board Member - www.ifapp.org

Awards  

• "Golden Panacea" Award – 2010 from the Academic Council at MU-Sofia 
• Award with the honorary sign SIGMUS LAUDIS – 2024 from the Academic Council at MU-Sofia
• Award for the class of 2006, University of Bonn – Germany

With over 25 years of experience in drug regulatory affairs (lifecycle management and market access of medicinal products), she has authored more than 150 publications and three monographs, with over 100 citations in the field of pharmaceutical regulatory science.