BULGARIAN ASSOCIATION FOR DRUG INFORMATION

(BADI)

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SEMINAR

29.03.2019

Free for BADI members 2019

SPEAKERS & MODERATORS:

Daniela Cherneva, Regulatory Affairs Manager, Medochemie Ltd.,

Bulgaria

In 2008, Daniela graduated in Sofia University “St. Kliment

Ohridski” with a Bachelor’s degree in Russian philology. In 2011, she

graduated from New Bulgarian University in Sofia with Master’s

degree in International Business and in June 2015, she obtained a

Master’s degree in Public Health and Healthcare Management from

the Medical University in Sofia. Starting from March 2017 Daniela is

a PhD Student in the Faculty of Public Health, Medical University in

Sofia.

She has 11 years of experience in the regulatory affairs. She joined

the Pharmaceutical industry in 2008 as a Regulatory affairs specialist in Medochemie Ltd.

Representative Office in Bulgaria and then became Regulatory Affairs Manager in 2010.

During her professional life, she gained broad experience not only in Regulatory Affairs, but

also in pricing and reimbursement, market access, pharmacovigilance, life-cycle product

management, etc. Currently she is responsible of the entire Medochemie’s portfolio in

Bulgaria, consisting of 150+ marketing authorizations/ strength distributed in 50 INNs in

different therapeutic areas – cardio-vascular, NSAIDs, CNS, antibiotics, OTC – several

medical devices and food supplements.

Rozalina Kulaksazova graduated from the Faculty of Pharmacy,

Medical Academy in Sofia with a Master thesis. She obtained a

specialty in Clinical Pharmacy as a post-graduate study.

In 1987 after a competition, Rozalina Kulaksazova joint the

Pharmaceutical Dosage Forms Section at the Chemical

Pharmaceutical Research Institute in Sofia as a research associate

and worked in the field of parenteral dosage forms. In 1999

Rozalina Kulaksazova joint the Bulgarian Drug Agency where

currently she holds the position of Director of Drug Information

and Non-interventional Studies Department. Her main

responsibilities are focused on product information of centrally authorised medicinal

products and related issues, and evaluation of post-authorisation studies. Currently

Rozalina Kulaksazova is a member of the Committee for Advanced Therapies (CAT)

at the European Medicines Agency. As a member of CAT she has been involved in the

ATMPs classification procedure.

Rozalina Kulaksazova has been invited to deliver presentations in her field at different

international regulatory and professional forums – in London, Berlin, Shanghai, etc.

BULGARIAN ASSOCIATION FOR DRUG INFORMATION

(BADI)

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Mr. Kiril Runevski, M.Sc.

Graduated Sofia University in 2009 with subject Biophysical

Chemistry in Medicine and Pharmacology with a Master’s degree. In

2013, he passed a postgraduate education for non-pharmacists

working in pharmaceutical industry at the Medicinal University of

Sofia in the Faculty of Pharmacy. His professional experience started

as a Chemist-Analyst in the QC department of GE Pharmaceuticals

Ltd. In 2012, he became a Quality specialist “Qualification and

Validation“in the QA department of GE Pharmaceuticals Ltd. In

2013, he became a Qualified Person. Since 2014, he is a Head of

Quality Control and Qualified Person at Meditrial Internationals Ltd.

Julian Uzunov is a management consultant, founder and partner in

Top Management Advisors Ltd, established in 1990. He is a Certified

Management Consultant at the Institute of Management Consultancy

(London) since 1998 and a member of the Bulgarian Association of

Management Consultants. His qualifications include Lead Auditor

under ISO 19011 to several management standards (ISO 9001, ISO

14001 and ISO/IEC 27001). In the pharmaceutical field, he delivers

consultancy and training in GDP and quality management in GMP.

His expertise includes human resource management, consultancy to a

range of management standards, and training in a variety of

management and soft skills. Since 2004 he is guest lecturer at the

Master’s Programme of the New Bulgarian University in subjects such

as Compensation & Rewards Systems and Organizational Development.

Since 2004, Julian Usunov has been publishing (to a limited circle of subscribers) monthly

analysis and reviews related to the pharmaceutical sector in Bulgaria: regulatory affairs,

pharma market developments and trends. He has published a number of articles in the press

and has made numerous presentations in conferences on pharmaceuticals and management

standards.

Dimitar Dimitrov graduated Medical Academy (Faculty of

Pharmacy) in 1986. In 2003, he defended post-graduation degree

in „GMP and production of sterile medicinal forms“. From 1986

to 1989 he worked in „Pharmacia“ AD Dupnitza as technologist

in solid forms. From 1989 up to 2006, he worked in Bulgarian

Drug Agency. From 1993 up to 2004, he was an expert to 4th

panel of International Pharmacopoeia in WHO. From 1999 to

2006, he was a member of ad-hoc meeting group in EMEA. From

2006 to 2012, he was head of quality in Actavis Troyan. From

2012 up to now – head of quality and qualified person in Kendy

Bulgaria.

BULGARIAN ASSOCIATION FOR DRUG INFORMATION

(BADI)

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Prof. Assena Stoimenova, Faculty of Public Health, MU-Sofia,

received the M.S. degree in Pharmacy from Medical University-

Sofia, in 1996, the PhD degree in Social Medicines and

Organization of Healthcare and Pharmacy in 2007, and the M.S.

degree in Health Management and Public Health in 2012, both from

Medical University-Sofia. She was Associate Professor at the

Department of Social Pharmacy and Pharmacoeconomics, Faculty

of Pharmacy, Medical University in Sofia for 6 years and as of July

2018, she is a full-time professor at the Health Policy and

Management Department in the Faculty of Public Health, Medical

University-Sofia. Her research interests include quality

management, pharmacoeconomics, pharmaceutical legislation, social pharmacy, postgraduate

education of pharmacists and medicinal products and food supplements usage. Prof.

Stoimenova is author and co-author of more than 100 articles in scientific journals in her areas

of research interests. She is lead auditor for ISO 9001, specialized in health care

(pharmaceutical manufacturers and wholesalers, CROs, hospitals etc.) As quality consultant,

she developed more than 30 quality management systems in the area of pharmaceutical

manufacturing and distribution of medicines. She served as Chairman of Quality Committee

of Bulgarian Pharmaceutical Union (2007-2010) and as Vice President of Bulgarian

Pharmaceutical Union (2010-2013). Besides her academic carrier, prof. Stoimenova gained

more than 14 years’ experience in the pharmaceutical industry in the areas of quality

management, regulatory affairs, marketing and drug safety. Former member of National

Council of Pricing and Reimbursement – 2013-2014. Since Jul.2014 until Aug.2018 prof.

Stoimenova served as an Executive Director of Bulgarian Drug Agency.

Prof. Tatyana Benisheva - Dimitrova, DSc, President of

BADI is a professor in the Faculty of Public Health at Medical

University, Sofia. After receiving an ЕС-CADREAC

scholarship she completed master’s degree in Drug Regulatory

Affairs (2004/2005) at the University of Bonn and later in 2010

a Master degree in “Public Health” at the Medical University of

Sofia, Bulgaria.

She was a Director of the “Drug Policy” Department at the

Ministry of Health (2000-2005) and has over 10 years of

experience at the Bulgarian Drug Agency (BDA). As the first

president of the National Council on Prices and Reimbursement of Medicinal Products 2013-

2014 she started an EU-project-OPAC for establishing of electronic database of medicinal

product. As a managing director of consulting in Bulgaria Betaconsult Pharma Ltd. (2007-

2013), she developed activities at the global regulatory database IDRAC of the Thompson

Reuters (2006-2012). She was involved like an expert in the project of the European

Commission - PLAC assignment medicinal product pricing in Serbia, in 2016. Prof.

Benisheva is member of DIA and DGRA and Board member of the EAMEA, Advisory

council at the DIA in Europe, since 2017. Her 25 years of experience in drug regulatory

affairs (life cycle management and market access of medicinal product) is complemented by

more than 100 publications in the regulatory science field of medicines.

BULGARIAN ASSOCIATION FOR DRUG INFORMATION

(BADI)

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Prof. Dobriana Sigjimova, PhD graduated Sofia University in 1998

with subject Russian Philology with a Master`s degree. In 2001 she

defended Master`s degree in Public Relations at the Sofia University.

In 2003, she obtained Master`s degree in Health Management at the

Medical University of Sofia in the Faculty of Public Health. In 2005,

she defended a PhD thesis. Her professional experience started as a

State Expert in the PR Department of the National Health Insurance

Fund. In 2006, she became an Assistant Professor at the Faculty of

Public Health in the Medical University of Sofia. Since 2008, she is

an Associate Professor in the Faculty of Public Health, Medical

University-Sofia. In 2014, she obtained "Health Economics" specialty. Until 14th

of May

2015, she was Chairman of Board of Directors of BADI.