donoŠenje odluka zasnovano na dokazima u

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15 - 16. maj 2014. Hotel Zira, Beograd, SRBIJA 15 th and 16 th of May 2014 Belgrade, Hotel Zira, SERBIA Četvrta međunarodna konferencija DONOŠENJE ODLUKA ZASNOVANO NA DOKAZIMA U ZDRAVSTVU CENTRALNE I ISTOČNE EVROPE The Fourth International Conference EVIDENCE BASED DECISION MAKING IN CENTRAL EASTERN EUROPE HEALTH CARE

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Page 1: DONOŠENJE ODLUKA ZASNOVANO NA DOKAZIMA U

15 - 16. maj 2014.Hotel Zira, Beograd, SRBIJA

15th and 16th of May 2014Belgrade, Hotel Zira, SERBIA

Četvrta međunarodna konferencija

DONOŠENJE ODLUKA ZASNOVANONA DOKAZIMA U ZDRAVSTVU

CENTRALNE I ISTOČNE EVROPE

The Fourth International Conference

EVIDENCE BASED DECISIONMAKING IN CENTRAL EASTERN

EUROPE HEALTH CARE

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Pharmacoeconomics SectionPharmaceutical Association of Serbia

The Fourth International Conference

EVIDENCE BASED DECISION MAKINGIN CENTRAL EASTERN EUROPE HEALTH CARE15th and 16th of May 2014Belgrade, Hotel Zira

The Pharmacoeconomics Section of the Pharmaceutical Association of Serbia (SFE SFUS) is or-ganising the Fourth International Conference with the topic: “EVIDENCE BASED DECISION MAK-ING IN CENTRAL EASTERN EUROPE HEALTH CARE”, which will take place in Belgrade on the 15th and 16th of May 2014. (http://www.farmakoekonomija.org and http://www.farmacija.org).

The purpose of the Conference is to present the characteristics of decision making policies of health care in Europe with strong emphasis upon Central and Eastern Europe and Serbia. To help participants improve the quality of their healthcare systems by better utilization of phar-macoeconomic studies and Health Technology Assessment reports. The aim of this conference is also to present best practices in Pricing and Reimbursement decision making in Europe, to present new pharmacoeconomic methodologies and outcomes research techniques and learn about the latest standards in health economics modelling.

Participants of the Conference will have the opportunity to meet experts from Health Eco-nomics Units from York University and University of Liverpool Management School (United Kingdom), Hamburg University and Berlin University (Germany), as well as the experts from World Bank, Australia, Poland, Croatia, Bosnia and Herzegovina and Serbia and exchange their experience and opinions.

The conference program is targeted at decision and health policy makers, managers of health care institutions, employees of pharmaceutical companies (employees in the sectors of health economics, pricing and reimbursement, regulatory, sales and marketing, and market access). The Conference agenda is tailored to assist doctors and pharmacists who work in the public and private sectors to better understand the importance of health economics in every-day decision making.

English is official language of the Conference.

We look forward to welcoming you in person at the Fourth International Conference, organized by

PHARMACOECONOMICS SECTION OF PHARMACEUTICAL ASSOCIATION OF SERBIA

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Sekcija za farmakoekonomijuSavez farmaceutskih udruženja Srbije

Četvrta međunarodna konferencija

DONOŠENJE ODLUKA ZASNOVANO NA DOKAZIMAU ZDRAVSTVU CENTRALNE I ISTOČNE EVROPE15 - 16. maj 2014.Hotel Zira, Beograd, SRBIJA

Sekcija za farmakoekonomiju Saveza farmaceutskih udruženja Srbije (SFE SFUS) organizuje Četvrtu međunarodnu konferenciju sa temom: „Donošenje odluka zasnovano na dokazima u zdravstvu centralne i istočne Evrope“ koja će biti održana 15 - 16. maja 2014. godine, u Beogradu (http://www.farmakoekonomija.org i http://www.farmacija.org/).

Cilj konferencije je da se predstave osobenosti donošenja odluka u zdravstvu u Evropi sa posebnim naglaskom na zemlje centralne i istočne Evrope i Srbiju. Takođe cilj konferencije je da pomogne učesnicima konferencije da unaprede kvalitet zdravstvenog sistema boljim korišćenjem farmakoekonomskih analiza i izveštaja za procenu zdravstvenih tehnologija. Cilj konferencije je i da predstavi najbolje prakse prilikom donošenja odluka u procesu formiranja cena i refundacije u Evropi, da predstavi nove farmakoekonomske metode i tehnike istraživanja ishoda i novi standard u zdravstveno ekonomskom modelovanju.

Učesnici konferencije će imati priliku da upoznaju poznate eksperte sa katedre za zdravstve-nu ekonomiju Univerziteta u Yorku i Fakulteta za menadžment Univerziteta u Liverpulu (Velika Britanija) zatim Univerziteta u Hamburgu i Berlinu (Nemačka), kao i eksperte Svetske Banke, Australije, Poljske, Bosne i Hercegovine, Hrvatske i Srbije i razmene svoja iskustva i mišljenja.

Program konferencije je namenjen donosiocima odluka, kreatorima zdravstvene politike, menadžerima u zdravstvenim ustanovama, zaposlenima u farmaceutskim kompanijama (u se-ktorima zdravstvene ekonomije, formiranja cena i refundacije, regulative, marketinga, prodaje i pristupa tržišta). Program konferencije je prilagođen i lekarima i farmaceutima koji rade u javnom i privatnom sektoru u cilju boljeg razumevanja važnosti zdravstvene ekonomije.

Program konferencije je predat za akreditaciju Zdravstvenom savetu Srbije kao međunarodni kurs I kategorije (7 bodova za učesnike i 12 bodova za predavače).

Velika nam je čast da Vas pozovemo na Četvrtu međunarodnu konferencijuSEKCIJE ZA FARMAKOEKONOMIJU

SAVEZA FARMACEUTSKIH UDRUŽENJA SRBIJE!

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Honorary Board

Prof. dr Ivanka Miletic

Prof. dr Guenka Petrova

Prof. dr Darko Ivanovic

Prof. dr Nada Kovacevic

Scientific Board

Prof. York Zöllner

Mark Parker

Tanja Novakovic

Krzysztof Landa

Magdalena Wladysiuk

Organizing Board

Dragana Baltezarevic

Dubravka Urosev

Gordana Simic

4 BOARDS

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Počasni odbor

Prof. dr Ivanka Miletić

Prof. dr Guenka Petrova

Prof. dr Darko Ivanović

Prof. dr Nada Kovačević

Naučni odbor

Prof. York Zöllner

Mark Parker

Tanja Novaković

Krzysztof Landa

Magdalena Wladysiuk

Organizacioni odbor

Dragana Baltezarević

Dubravka Urošev

Gordana Simić

ODBORI 5

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THURSDAY, 15th May 2014

09:00-09:30 Registration

09:30-09:45 Introduction speech Prof. dr Ivanka Miletic, President of the Pharmaceutical Association of Serbia (SFUS) Prof. dr Momcilo Babic, Director of the Republic Fund for Health Insurance, Serbia MSc. Pharm Tanja Novakovic, President of the Pharmacoeconomics Section (SFE), Galenika a.d., Serbia

PANEL I Health Care Decision Making09:45-10:15 HTA for decision making in pricing – the Australian IHPA and the Agency for Tariffs planned in Poland Krzysztof Landa, M.D., CEO HTA Audit, Poland

10:15 -10.45 Decision criteria Mr Mark Parker, Health Economics Unit, University of Liverpool Management School, United Kingdom

10:45-10:55 Discussion

10:55-11:10 Coffee networking break

PANEL II Evidence and tools in Decision Making 11:10-11:40 Evidence and tools in decision making Magdalena Wladysiuk, M.D., HTA Consulting Vice president and CEESTACH president, Poland

11:40 -12:00 Patients registers as a tool to access new medicines Tarik Catic, MSc., ISPOR Bosnia and Herzegovina President

12:00 -12:20 Market access in CEE countries Vanesa Benkovic, MSc., Senior HTA and Health research consultant, Croatia

12:20 -12:40 Big data in health care Tanja Novakovic, MSc., President of the Pharmacoeconomics Section SFUS, Galenika a.d., Serbia

12:40 -12:55 Discussion

12:55 -13.55 Lunch break

PANEL III Clinical data in Decision making13:55-14:25 Clinical effectiveness in decision making Janko Samardzic, M.D. PhD., Medical Faculty, University of Belgrade, Republic Fund for Health Insurance, Serbia

14:25 - 14:45 Off-label agents as comparators in health technology assessments and decision making Eldon Spackman, PhD, Research Fellow, Centre for Health Economics at University of York, United Kingdom

14:45-14:55 Discussion

WORKSHOP14:55-16:40 Discrete event simulations and big data Mr Mark Parker, Health Economics Unit, University of Liverpool Management School, United Kingdom

6 FINAL PROGRAM

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FRIDAY, 16th May 2014

PANEL IV Best Practices in Decision making 09:20-09:45 Merging theory and practice: Germany’s approach to evidence-based decision-making Prof. dr York Zöllner, Professor of Health Economics, Hamburg University of Applied Sciences, Germany

09:45-10:05 Evidence requirements in pharmaceutical policies across Europe: implications for the future Brian Godman, PhD, Division of Clinical Pharmacology, Karolinska Institute, Stockholm, Sweden, Professor at the Strathclyde Institute of Pharmacy and Biomedical Sciences, Strathclyde University, Glasgow, Scotland

10:05-10:25 Health Technology Assessment in Serbia Ruth Lopert, M.D., Department of Health, Principal Adviser, Therapeutic Goods Administration, Australia

10:25-10:45 Health Technology Assessment System in Romania – From Past to Future Alin Liviu PREDA, MD, ISPOR Romania Chapter Ciprian-Paul RADU, MD, PhD, ISPOR Romania Chapter, Romania

10:45-11:00 Discussion

11:00-11:15 Coffee networking break

PANEL V DECISION MAKING IN SERBIA11:15-11:35 Use of DRG data in decision making Predrag Djukic, M.D., DILS, Ministry of Health, Serbia

11:35-11:55 Pricing and Reimbursement of medicines in Serbia Dragana Baltezarević, M.D., Pharmacoeconomics Section SFUS, Republic Fund for Health Insurance, Serbia

11:55-12:15 Outcomes of the central public procurement of medicines in Serbia Biljana Kozlović, M.D., Assistant Director for medicines, Republic Fund for Health Insurance

12:15-12:35 Deciding to innovate Bojan Trkulja, M.D., Managing Director of INOVIA, Serbia

12:35-12:55 Discussion

12:55-14:10 Lunch break

WORKSHOP14:10 -16:10 Decision making in action (Therapy of rheumatoid arthritis) Mr Mark Parker, BA Economics and Computer Science, MSc Health Economics, Health Economics Unit, University of Liverpool Management School, United Kingdom and World Bank experts

16:10-16:30 Final test, Evaluation and Closing of the Conference

FINAL PROGRAM 7

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Četvrtak 15. maj 2014. godine

09:00-09:30 Registracija učesnika

09:30-09:45 Otvaranje konferencije Prof. dr Ivanka Miletić, predsednica Saveza farmaceutskih udruženja Srbije Prof. dr Momčilo Babić, Direktor Republičkog fonda za zdravstveno osiguranje, Srbija Mr sc. farm. Tanja Novaković, predsednica Sekcije za farmakoekonomiju SFUS, Galenika a.d., Srbija

PANEL I Donošenje odluka u zdravstvu09:45-10:15 Procena zdravstvenih tehnologija prilikom formiranja cena – Australijski IHPA (Independent Hospital Pricing Authority-IHPA) i Agencija za tarife planirane za Poljsku Dr Krzysztof Landa, HTA Audit, Poljska

10:15 -10.45 Kriterijumi za odlučivanje Mr sc. Mark Parker, Fakultet za menadžment, Katedra za zdravstvenu ekonomiju, Univerzitet u Liverpulu, Velika Britanija

10:45-10:55 Diskusija

10:55-11:10 Pauza za kafu

PANEL II Dokazi i alati za donošenje odluka11:10-11:40 Dokazi i alati za donošenje odluka Dr Magdalena Wladysiuk, HTA Consulting i predsednica CEESTACH, Poljska

11:40 -12:00 Baze i registri pacijenata kao sredstvo za pristup tržištu lekova, Mr sc. Tarik Ćatić, predsednik ISPOR Bosna i Hercegovina, BIH

12:00 -12:20 Pristup tržištu u zemljama centralne i istočne Evrope, Mr sc. Vanesa Benković, konsultant za procenu zdravstvenih tehnologija i istraživanja u zdravstvu, Hrvatska

12:20-12:40 Veliki podaci u zdravstvu, Mr sc. farm. Tanja Novaković, predsednica Sekcije za farmakoekonomiju SFUS, Galenika a.d., Srbija

12:40-12:55 Diskusija

12:55-13.55 Pauza za ručak

PANEL III Klinički podaci i donošenje odluka13:55-14:25 Klinička efikasnost u donošenju odluka, Doc. dr Janko Samardžić, Institut za farmakologiju, kliničku farmakologiju i toksikologiju, Medicinski fakultet, Univerzitet u Beogradu, Republički fond za zdravstveno osiguranje, Srbija

14:25-14:45 „Off label“ komparatori pri proceni zdravstvenih tehnologija i donošenju odluka, Dr sci. Eldon Spackman, Istraživač, Centar za zdravstvenu ekonomiju, Univerzitet u Jorku, Velika Britanija

14:45-14:55 Diskusija

RADIONICA14:55-16:40 Simulacija disketnih događaja i veliki podaci Mr sc. Mark Parker, Fakultet za menadžment, Katedra za zdravstvenu ekonomiju, Univerzitet u Liverpulu, Velika Britanija

8 FINALNI PROGRAM

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PETAK 16. maj 2014. godine

PANEL IV NAJBOLJE PRAKSE U DONOŠENJU ODLUKA09:20-09:45 Spajanje teorije i prakse: Nemački pristup u donošenju odluka zasnovanom na dokazima Prof. dr York Zöllner, Katedra za zdravstvenu ekonomiju, Univerzitet u Hamburgu, Nemačka

09:45-10:05 Zahtevi za dokazima u farmaceutskim politikama širom Evrope: posledice za budućnost Dr sci. Brian Godman, Odeljenje za kliničku farmakologiju, Institut Karolinska, Stokholm, Švedska, profesor na Institutu za farmaciju Strathclide i biomedicinskih nauka, Univerzitet Strathclide, Glazgov, Škotska

10:05-10:25 Procena zdravstvenih tehnologija u Srbiji Dr Ruth Lopert, Svetska Banka, Ministarstvo zdravlja - Uprava za lekove, Australija

10:25-10:45 Sistem procene zdravstvenih tehnologija u Rumuniji - od prošlosti do budućnosti Dr Alin Liviu PREDA, ISPOR Rumunija Dr sci Ciprian-Paul RADU, ISPOR Rumunija

10:45-11:00 Diskusija

11:00-11:15 Pauza za kafu

PANEL V DONOŠENJE ODLUKA U SRBIJI11:15-11:35 Upotreba podataka dijagnostički srodnih grupa prilikom donošenja odluka Predrag Djukić, M.D., DILS, Ministarstvo zdravlja, Srbija

11:35-11:55 Formiranje cena i refundacija lekova Dr Dragana Baltezarević, Sekcija za farmakoekonomiju SFUS, Republički Fond za zdravstveno osiguranje (RFZO), Srbija

11:55-12:15 Rezultati postupka javnih nabavki lekova u Srbiji Dr Biljana Kozlović, Svetska Banka, Republički Fond za zdravstveno osiguranje (RFZO), Srbija

12:15-12:35 Odluka za inovaciju Dr Bojan Trkulja, Direktor Udruženja proizvođača inovativnih lekova - INOVIA, Srbija

12:35-12:55 Diskusija

12:55-14:10 Pauza za ručak

RADIONICA14:10-16:10 Donošenje odluka u praksi (Terapija reumatoidnog artritisa) Mr Mark Parker, Katedra za zdravstvenu ekonomiju, Fakultet za menadžment, Univerzitet u Liverpulu, Velika Britanija i eksperti Svetske Banke

16:10-16:30 Završni test, evaluacija i zatvaranje konferencije

FINALNI PROGRAM 9

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HTA for decision making in pricing – the Australian IHPA and the Agency for Tariffs planned in PolandKrzysztof Łanda, M.D., HTA Audit

Considering cost accounting of health services and the Pricing Agency cannot be done with-out the understanding of several primary issues which have significant implications in this re-gard: One should be aware of what valuation is and what purpose it serves and one must clearly differentiate between cost of services and valuation of services. Valuation is always arbitrary. Prices make transactions either possible or impossible. In exchange for payment, somebody waives their right to certain goods or provides services. If the main aim of setting forth prices is ensuring the adequate supply of certain services, then valuation does not have to be performed on the basis of a cost analysis (although in some cases - ca. 10-15% of services - such an analy-sis will be used; for the majority of services however, it is neither necessary nor possible to be performed - see information below). One must be aware of the subject matter we are dealing with, that is: The number of services in the guaranteed benefits package, the variability of the package’s content and the variability of service costs over time, and consequently the variabil-ity in interrelations of health care service costs. Only that can depict the possibilities for cost accounting of health care services.

Before preparing a draft act on the Pricing Agency, a feasibility study for several possible scenarios of its functioning should be performed. Among others, one should pose a question of whether performing functions of the Pricing Agency by different institutions would not impair the basic functions of those institution which they were primary established to perform, and most certainly the function of valuation should not be performed jointly with appraisal for the purpose of reimbursement decisions (i.e. decisions on including a technology in the guaranteed benefits package). Establishing the Pricing Agency within AHTAPol does not seem to be the best permanent solution, it can however be considered a temporary one.

Decision CriteriaMark Parker, MSc. Health Economics Unit, University of Liverpool Management School, United Kingdom

Decision Making within a healthcare system is a simple matter of life and death, at the population level. Within a constrained budget healthcare decision makers face the very real problem that choosing to allocate resources to one area necessarily means those resources are not available to another.

To address these problems Health Economists have equipped decision makers with an ar-ray of tools to enable them to make informed and transparent choices, providing a podium for discussion whereby each interested stakeholder can ensure their interests are considered, and place them within the context of the healthcare system.

Budget Impact, Cost Effectiveness/Utility Analysis and now Value Based Pricing and Multi Criteria Decision Analysis have emerged as the tools of choice to summarise concisely complex decision problems, emerging from various legal battles between patients, the pharmaceutical

10 ABSTRACTS

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industry and health insurance organisations, Health Technology Assessment Agencies are quickly emerging as a means to keep these problems out of the courts, submissions to the various differ-ent agencies across the world effectively now form legal briefs, which lay out in intricate detail what is meant by “Best Practice”, and by inference the harm caused to a countries population should healthcare deviate from this practice.

Market access in CEE countriesVanesa Benkovic, HTA, Health research consultant, Croatia

There is an increased demand for healthcare, owing to the ageing of the population. The rate of unemployment is quite high in CEE countries, which reduces the numbers of people mak-ing contributions for the healthcare system. However, as in many countries, slower GDP [gross domestic product] growth has affected the availability of money for spending in the healthcare sector. As a result, there is a lot of pressure on healthcare services, and on prices. Each of the CEE countries has different profile of health financing percentage from the GDP as well as the share of public financing, which all comes back to the amount of money reserved for drug and devices budget. Issues of referencing, pricing and models of reimbursement make similar hurdles with more-less same level of complexity. On the other hand, state regulation of market access for drugs and devices is present in CEE countries with many variations. Restrictions are increasingly being placed on reimbursement; drugs are being approved for smaller target popu-lations, or only following the failure of other agents. Risk sharing and other forms of managed entry agreements are also becoming more frequent, in relation to the uncertain outcomes of the use of some products. Under such agreements companies are required to monitor the per-formance of their products and reimbursement will only be granted for responsive patients. The development of an electronic health system may come as a transparent solution for managing prescribing, enabling better overview and control, and may serve as real-time info on consump-tion, unmet needs and proper follow up of clinical guidelines.

Patients registers as a tool to access new medicinesTarik Catic, MSc., ISPOR Bosnia and Herzegovina President

Access to innovative medicines is currently limited in CEE countries and different policies have been set to combat this. The main obstacle is budget limitations but also a lack of HTA implementation in decision making. Recently some improvements have been made except most payers base their decision criteria on budget impact.

New approaches in reimbursement of new/innovative and expensive therapeutic options should be high priority in order to improve therapeutic outcomes and patient satisfaction. De-velopment of risk-sharing schemes, conditional reimbursement and follow up on therapeutic outcomes could be the chance to increase access to novel therapeutics.

Patient data and registries are collections of secondary data related to patients with a spe-cific diagnosis, condition, or procedure, and they play an important role in post marketing surveillance of pharmaceuticals. Most frequently registries vary in sophistication from simple

ABSTRACTS 11

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spreadsheets that only can be accessed by a small group of physicians to very complex data-bases that are accessed online across multiple institutions. Even when some epidemiology data exists in CEE countries, the data collected does not meet the requirements to follow up product performance and outcomes. Mostly, these data are general indexes, but through introduction of disease/product registries more detailed analysis could be performed. Registries can be as-sociated with pay-for-performance agreements. In order to implement such registries, authori-ties could develop partnerships with industry, taking care of data confidentiality, ethical and technical issues.

Big data in Health CareTanja Novakovic, MSsc. Pharm President of the Pharmacoeconomics Section (SFE), Galenika a.d., Serbia

Clinical data from randomised controlled trials represents the gold standard in evidence for medical decision making, however, these trials represent just a small subset of the data avail-able, and are not necessarily applicable to real life practice.

Furthermore cost data often represents the most uncertain aspects of any health technol-ogy assessment, either because such data was not collected during these trials, or the trials were conducted in countries with a different healthcare structure, and therefore not applicable in other countries.

Data collected from ongoing clinical practice however is often cumbersome in size, difficult to interpret due to the lack of control groups and subject to deep privacy concerns. Realising the value of this data and overcoming these problems will soon help all healthcare providers better manage their budgets and greatly improve the quality and quantity of services they provide, by providing a sounder and more current information base for their decisions, and real time monitoring of the outcomes of their decisions.

Achieving this will require potentially difficult collaborations between the healthcare and pharmaceutical industries, but turning the emerging and massive streams of incomprehensible data into valuable information will revolutionise the way healthcare is delivered.

Clinical effectiveness in decision makingJanko Samardžić, M.D.,PhD, Institure of Pharmacology, Clinical Pharmacology and Toxicology, Medical Faculty, University of Belgrade, Republic Health Insurance Fund, Serbia

In most countries of Europe, physicians have the exclusive right to prescribe medicines. There-fore, they play a crucial role in determining whether medicines are consumed rationally or not. However, in reality, physicians face different pressures, such as staying objective in the choice of treatment, being up-to-date with innovations in therapy, keeping the budgets, earning an income, etc. Thus, there are a number of measures to improve physicians’ prescription behavior, such as prescription monitoring, prescription guidelines, requirements for prescribing by the international non-proprietary name (INN), financial, educational and information tools.

12 ABSTRACTS

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At least 24 EU Member States already have prescription guidelines. Guidelines consist of clinical prescription protocols based on evidence and may include financial considerations. In Austria, Belgium, Germany and Hungary these guidelines are compulsory, which are expected to be implemented in Serbia soon. Of course, combining different measures, such as electronic prescription monitoring and guidelines linked with electronic systems appears to be one the most effective way. The guidelines are mostly based on evidence gathered from randomized controlled clinical trials from phases I to III. These trials are very good at assessing efficacy, but it should be taken into account that these trials are not without substantial biases, such as selective and information bias. Furthermore, efficacy is not the same as effectiveness. Efficacy means if the drug works in ideal circumstances, and it could be assessed by clinical trials of phases II and III. Effectiveness means if the drug works in real life and cannot be evaluated in controlled trials, but through observational studies into phase IV. On the other hand, according to the procedures of Health Insurance Fund, pharmacological report represents a part of appli-cation file for reimbursement lists. The report has to illustrate the completed pharmacological, therapeutic and social value of drug and it should be based on clinical data and guidelines, in order to improve the clinical effectiveness of the new medicine vs. comparator.

Should off-label agents be used as comparators in Health Technology Assessments?Eldon Spackman, PhD, Research Fellow, Centre for Health Economics at University of York, United Kingdom

HTA bodies provide guidance and advice to improve health of the population. Their remit is to compare clinical and economic evidence to provide recommendations on reimbursement of new technologies. The value of a new technology is dependent on the costs and outcomes of current practice. To improve overall health a new technology must improve health more than all the treatments it will displace due to its costs.

In practice, treatment alternatives to the new technology may be off-label. As an example, twenty-four NICE technology appraisals from 2008-2012 included an off-label comparator and in 8 (33%) of these appraisals the new technology was rejected. Some question whether new technologies should be compared to off-label agents since if the new technology is found to compare unfavourably, then it will be rejected in favour of the off-label agent. NICE does not have remit to recommend off-label agents however rejection of a new treatment may be considered an indirect recommendation for use of the off-label agent.

Cost-effectiveness principles suggest that all possible comparators, even off-label agents, should be included in an evaluation. Pragmatically there may be some issues: some HTA bodies may be restricted by remit, off-label agents may have less developed evidence and there may be some risk or liability involved in an indirect recommendation. Cost-effectiveness methods are ideal for understanding these issues.

ABSTRACTS 13

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Merging theory and practice: Germany’s approach to evidence-based decision-makingYork Zöllner, Hamburg University of Applied Sciences, Germany

Since the advent of the new drug pricing & reimbursement law from AMNOG in 2011, the German pharmaceutical market has ceased to be a “free pricing” market for patented drugs. While there were earlier attempts to regulate drug pricing, these were highly debated and relatively short-lived.

In order to portray and interpret the current paradigm in pricing and reimbursement deci-sion-making for newly launched drugs, and discuss whether and how the former can claim to be a reasonable compromise between scientific judgement and business practicalities:

Market figures (size, trends) will be presented and interpreted (price/volume decomposition, international comparison).

Regulations will be classified into structural and process-based elements, incentive (dysin-centive) based measures to foster innovation (discourage me-too’s) as well as straightforward interventionist measures to contain or cut expenditures.

The record of payor decisions taken so far including the underlying reasoning will be exam-ined; similarly, as manufacturer reactions thereto will be interpreted.

The role of health economic evaluation as well as other elements of economics – e.g. nego-tiations, embedded into a game theory framework – will be addressed.

An outlook regarding potential future domestic developments as well the scope for Euro-pean harmonization will be given.

HTA System in Romania – From Past to FutureAlin Liviu Preda, MD, Health Outcomes Specialist, GSK RomaniaCiprian-Paul RADU, MD, PhD, Market Access Manager, Roche Romania

The transition from a Semashkoto Bismarck model health care system began for Romania after 1989, but, in practice, “the big reform” started in 1998 with the development of the social health insurance scheme and the organization of National Health Insurance House. Although in 1992, following a study financed through World Bank, it was identified the need for devel-oping a Health Technology Assessment (HTA) system in Romania, no practical decision was taken because of lack of involvement at political level. During the period 1992-2002 some form of mentorship offered by Alberta Heritage Foundation Canada was performed in this area and HTA was brought in the attention of the authorities (without any initiation of a Governmental program), but HTA remained a subject only for the academic and research purposes.Very little words are to be said about HTA in the silent period of 2002-2011, then,in 2011, NICE Inter-national (contracted by the Romanian MoH) made a report evaluating the basic health care package, where among many other recommendations included a strong point on building HTA capacity and guidelines specific for Romania environment. Consequently in June 2012, MoH published a new HTA methodology to be used for approval of new drugs or new indications, considering the fact that no new drugs /indication were approved in Romania from 2008. The

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Romanian HTA system is based on a scoring card system, taking into consideration 6 aspects: (1) HTA reports from France and (2) UK; (3) number of EU countries where the submitted drug is reimbursed; (4) relative effectiveness; (5) relative safety and (6) relative Patient Reported Outcomes. Beside this, a simple Budget Impact Model is required as an orientation instrument used for imposing restriction for reimbursement. The dossiers evaluation is done by the new HTA Unit created within the Ministry of Health, the Specialty Commissions within the MoH and the National Commission for the coordination of the Specialty Commissions, which in summarizing the provided evidence for the decision making used some of the EVIDEM Collabo-ration tools. The first wave of HTA dossiers was submitted in June and July 2013, arriving at over 200 dossiers by the end of 2013. By February 2014, most of the dossiers submitted have been evaluated by the HTA Unit (167 HTA dossiers) and the MoH has made public results for these submitted dossiers, which include both new molecules and new indications. There has been an acceptance rate (score above 6 points) of about 80% and the draft of the new reimbursement list was published for public debate.The final publishing of the List in the Official Gazette is still pending because of the changes in the political environment and because the authorities and Pharma industry are still discussion on the alignment of the new List with the clawback taxation and price legislation update in Romania. Finally, we can appreciate that even the HTA process is working in Romania from the technical perspective, there are still a lot of things to be done in terms of health policy and decision making based on HTA, because the public re-imbursement remains a highly political dependent process which leads to large delays in the access of patients for new therapies. Without a strong commitment from the political officials to integrate the reimbursement process with the entire health care reform, there is a risk for the patients to continuously lack access to better technologies.

Evidence requirements in pharmaceutical policies across Europe: implication for the futureBrian Godman, Institute for Pharmacological Research ‘Mario Negri’, Milan, Italy Prescribing Research Group, University of Liverpool Management School, Liverpool, UK Di-vision of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital, Huddinge, Stockholm, Sweden

Pharmaceutical expenditure has been rising steadily across Europe during the past decade. It has recently fallen following the economic crisis, but due to rise again due to ageing popula-tions and the continued launch of new premium priced products. This has necessitated ongoing reforms and initiatives across Europe to help ensure the ideals of equitable and comprehensive healthcare. Measures include new models to optimise the utilisation of new drugs incorpo-rating horizon scanning pre-launch as well as critical evaluation of the health gain alongside requested prices given that only a minority of new drugs are truly innovative. In addition, evalu-ation of potential managed entry agreements to enhance reimbursement as well as post launch follow-up activities. These include monitoring the prescribing of new drugs against agreed clini-cal guidance, as well as assessing their effectiveness and safety in routine clinical practice. Ini-tiatives for established drugs include measures to improve their rational use with the help of formularies such as the ‘Wise List’ launched by the regional Drug and Therapeutics Committee

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in Stockholm, Sweden, combined with extensive communication and education programmes. In addition, encouraging INN prescribing to reduce patient confusion, especially if patients are dispensed different branded generics on each occasion, as well as enhance their use versus originators once multiple sources become available. This alongside transparency in the pricing of generics to obtain lower prices. These measures, together with numerous examples from across Europe, will be discussed in the presentation. The objective is to try and ensure sustain-able universal access for healthcare across Europe including Serbia

Pharmaceutical expenditure in Serbia - current and future scope for HTARuth Lopert, PhD, Department of Health, Principal Adviser, Therapeutic Goods Administration, Australia

In Serbia, although per capita spending is low, pharmaceuticals consume a high propor-tion of health expenditure. A review of current reimbursement lists and expenditure patterns sought to identify opportunities to improve value for money.

While in the short term major gains are possible through improving procurement mecha-nisms for off-patent, ‘essential’ medicines, better value for money from patented ‘specialty’ medicines may also be achieved through adapting the results of health technology assess-ments (HTAs) conducted in other, selected jurisdictions. Rather than setting wholesale prices by external reference pricing, the application of ‘de facto’ HTA - referencing prices and listing conditions in another jurisdiction with established HTA processes, and determining a cost-effective price by adjusting for relative per capita GDP - could guide both listing decisions and price negotiations. For drugs yet to be listed, the de facto HTA method could be applied to set conditions of listing and as a basis for declining listing of drugs for indications not considered cost-effective or clinically appropriate there.

Although specialty medicines currently represent a small proportion of overall expenditure, utilization is growing rapidly. Over the medium term building Serbian HTA capacity will be increasingly important as high cost drugs become a growing proportion of the total drug bud-get, particularly as off-patent prices are reduced. The development of robust, evidence-based HTA processes will be important to improve Serbia’s capacity to: Assess value for money in the selection, listing and pricing of medicines and provide a means of prioritizing expenditure in a resource limited environment.

Use of DRG data in decision makingPredrag Djukic, M.D.

As part of the overall health reform efforts in Serbia, introduction of different provider pay-ment mechanisms is being planned. There is a national consensus confirmed by National As-sembly that diagnostic related groups (DRG) as patient classification system and as funding mechanism should be introduced for inpatient acute care services. Implementation of a DRG system in Serbia is under way. It is planned that DRG system should be used at first as reporting and analytical tool and later as a payment mechanism.

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DRG is a system based on activities. It provides a variety of data related to the activities and performance of the hospitals. It provides insight into operations of the hospital and enables comparison of different hospitals. It can point out differences related to performance and put forward questions related to reasons for those differences. As a payment mechanism it pro-vides a tool for payment based on performance and not capacities.

Moreover, role of HTA should be very important in defining cost-effective therapies and paths of care to be included in DRG weights setting procedure, in order to finance provision of the best possible care with optimal use of scarce resources and avoid paying for inefficiencies in the system as much as possible.

All of it provides a whole new set of information available for managers and decision-mak-ers that should help managing institutions and health system in general.

Reimbursement of medicines in SerbiaDragana Baltezarević, M.D., Health Insurance Fund, Serbia

The Serbian healthcare system is based on the principles of equality and solidarity. Citizens pay health insurance contributions as a percentage of their income while healthcare services are used according to their needs. Serbia as the poorest country in Europe, disposing of only 300€ per capita for funding the total healthcare system, spends only 50€ per capita for medi-cines. The Serbian Reimbursement List is still an integral part of the Rulebook on Reimburse-ment list which is published in the Official Gazette.

The general criteria for listing are: The RFZO financial plan, public health importance, pharmacotherapeutic and pharmacoeconomics aspects. For the first time the “Rulebook on criteria” recognizes special agreements and shorter application procedure for generic medi-cines. The newly established Central Committee for medicines determines which medicines will be listed, based on the opinion of the Republic Expert Committees and the Committee for evaluation of pharmacoeconomics reports. In addition, the current structure of the Ser-bian Reimbursement List, as well as the new “Rulebook on criteria” enable price reduction, cost control and adoption of the pharmacoeconomic priniples during the decision-making regarding the reimbursement of medicines. The main goal is still budget reallocation and sav-ings, for listing more new medicines.

Outcomes of the Central Public Procurement of Medicines in SerbiaBiljana Kozlović, M.D., Assistant Director for medicines, Health Insurance Fund, Serbia

As a part of the World Bank Second Serbia Health Project preparation, the Republic Health Insurance Fund (HIF), as central purchasing body, has successfully completed centralized pro-curement of the most expensive medicines for hospitals and primary health care centers with generated savings of close to 3 billion dinars (25 million EUR). This system, introduced as a pilot project in 2013, has helped to reduce prices on drugs by an average of 27%, compared to the previous system. In the first and the largest centralized public procurement of medicines from the Drug List B, 22 bidders competed for 183 lots of medicines. Framework agreements were

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concluded with the total of 15 suppliers and manufacturers that offered the lowest prices of medicines and which, based on defined prices of medicines, are concluding individual supply contracts with health care facilities till the end of 2014. The framework agreements were con-cluded after open tender procedure, with one supplier for each separate lot. Their enforcement is mandatory for all health care facilities, and the framework agreements have a validity period of 12 months. This is only the beginning of the public procurement reform in the health sector that will be the backbone of the new World Bank Second Serbia Health Project.

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Krzysztof Landa, M.D.

Krzysztof Landa is the CEO of HTA Audit, a company dealing with the quality of HTA (Heal-th Technology Assessment) reports directed to authorities and public institutions in Poland and the President of the Watch Health Care Foundation. From 2010 till 2011 he was President of Central & Eastern European Society of Technology Assessment in Health Care. In 2006-2007 Dr Landa was the Director of Drug Policy Department in the Central Office of National Health Fund. In 2004 Krzysztof Landa was elected to the Board of Directors of Health Technology Assessment International (HTAi) and performed his duties till mid 2007. He was the Chairman of the LOC of the first HTAi Annual Meeting 2004, held in Krakow, Poland.

Dr Landa is a graduate of the University School of Medicine and received his management education at the Postgraduate School of Public Health of Jagiellonian University in Krakow. Promotion of HTA in the region of CEE resulted in international cooperation in education and HTA. Dr Landa organized many national and international HTA workshops and conferences.

In years 2006 – 2008 Dr Landa provided consultancy for the Serbian Ministry of Health. He was team leader of the World Bank project aimed at introduction of HTA in Serbia, imple-mentation of EBHC principles to the management of basic benefit package and designing a governmental HTA Agency.

Mark Parker, MSc

Mark Parker is Senior Economic modeller for the University of Liverpool Health Economic Unit, Liverpool Cancer Trials Unit and Technical director of Evaluate Econ Ltd, UK. Early bac-kground was in software and electronic engineering (University of Manchester) and real time Digital Signal Processing, along with RF design. Completed the MSc in Health Economics at the University of York, UK (2009). Currently PhD submission pending in Health Economic Mode-lling at the University of Liverpool. These roles have mostly involved developing models and evidence based messages for a wide range of disease areas for global value dossiers and HTA submissions to NICE, SMC and CVZ, along with internal decision-making. Working with GSK (vaccines), Sanofi Aventis (Diabetes), Wirral Primary Care Trust (Real world data validation), CHAMPS (weight management interventions) and Shire (biological in a chronic condition).

Experience in a vast range of disease areas and population modelling, with a strong educati-onal background in economics, software development, distributed systems and computation, Artificial Intelligence (1st, BSc Economics and Computer Science, UoL). Applying these skills to develop evidence based value arguments for Health Technology Assessment. This training, education and experience provide the means to apply the world’s most advanced techniques to solve complex problems in a methodical, transparent and comprehensible way, with a core focus on knowledge transfer. Enjoys a wide range of water, snow and motor sports.

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Magdalena Wladysiuk, M.D.

Magdalena Wladysiuk is a president and owner of HTA Consulting. She is the president of the Central & Eastern European Society of Technology Assessment in Health Care (CEESTACH).

She is a medical doctor with MBA in Technology Management. She is one of the authors of 100 HTA reports for industry and public health insurance and financialanalyses developed since 2001 (some are in Polish and some are available in English). From 2006 till 2008 she provided consultancy services for the Serbian Ministry of Health (MoH) in respect to evidence based basic benefit package, design and feasibility study on different models of HTA Agency in Serbia and quality of best practice guidelines. In addition she was also involved in the Evidence Based Heath care (EBHC) development, HTA systemic implementation, in-depth training of Serbian HTA analysts and development of 3 country specific HTA reports.

Currently she closely works with MoH Poland counterparts and private sector, develops strategic planning, economic analysis, health promotion, standards, cost reduction and clini-cal/health information systems.

Magdalena Wladysiuk is involved in promotion of HTA in the region of CEE which resulted in international cooperation in education and HTA. She organized many national and internati-onal HTA workshops and conferences and she was a speaker at most of them.

Tarik Catic, MSc

Tarik Catic is founder and president of ISPOR Bosnia and Herzegovina Regional Chapter and president of Section for pharmacoinformatics and pharmacoeconomics at Pharmaceutical Society of Federation of Bosnia and Herzegovina. He graduated at Faculty for Pharmacy in Sa-rajevo, and since 2010 he holds master degree in health economics and pharmacoeconomics, PompeuFabra University, Barcelona, Spain.

He is employed in pharmaceutical industry working on position of product manager in area of CNS, rheumatology, osteoporosis, anti-infectives and oncology portfolio, experienced in pharmaceutical marketing, drug regulatory, market access, clinical trials, and was team leader in Adriatic region. He was included in different projects in area of business development, mar-ket potential analysis and evaluation and portfolio development. Tarik is permanent member of ISPOR HTA Round table for Europe.

As ISPOR BH president Tarik initiated and actively participated in several projects like translati-on and adoption of ISPOR Book of Terms, ISPOR Good research practices, ISPOR distance learning modules, he was firs chief editor of ISPOR BH Newsletter. Tarik participated as organizing com-mittee member for pharmacoeconomic conferences, congresses and scientific meetings. He was team leader for development of ISPOR BH learning modules for basic pharmacoeconomic course and is lecturer in this course program as part of continuing medical education. Tarik published a several scientific papers published in indexed scientific journals, he participated in numerous local and international congresses and conferences as invited lecturer and poster presenter. He actively works on promotion of pharmacoeconomics and education in this field and HTA implementation in decision making in health care in Bosnia and Herzegovina.

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Vanesa Benkovic, MSc Pharm

Vanesa Benkovic, graduated her masters study as manager in health and health services at Medical Faculty, University of Zagreb. She is currently finishing her PhD thesis on health inequ-alities at Faculty of Philosophy, Sociology Dpt. University of Zagreb.

Vanesa graduated several educations in field of pharmacoeconomics, health economics and advanced modeling in HTA in France and Austria. She received Open Society scholarship at Global Health Economics project by European University of StPetersburg, Russia. She teaches pharmacoeconomics and health economics at Faculty of Medicine, Faculty of Pharmacy Uni-versity of Zagreb, and health statistics at European University of StPetersburg GHE courses. Her field of work includes extensive list of health economic analysis for drugs, devices, tech-nologies and cost of illness studies in Croatia, Slovenia and Bosnia and Herzegovina, as well as research methodology for various EU JA projects such as Urban health centers Europe and Cross border patient registries initiative (PARENT). She also designs and performs market and scientific research in health. Her latest engagements include health business intelligence for a World Bank project for Croatian Ministry of Health and strategic consultancy both for pharma-industry and budget holders.

She publishes papers in area of research methodology, public health, pharmacoeconomics and health economics. Currently Vanesa is setting up business including IT applications for polypharmacy.

Tanja Novakovic, MSc Pharm

Tanja Novakovic M.Sc. Pharm is the president of the Pharmacoeconomics Section within the Pharmaceutical Association of Serbia. She is founder of the ISPOR Serbian chapter and between 2007 and 2009 its vice president. Since 2001 she has been working in Galenika a.d., a pharmaceutical company, as a product manager for drugs of the central nervous system.

Tanja Novakovic is a graduate of the University of Belgrade, Faculty of Pharmacy finishing her postgraduate studies at the Faculty of Pharmacy at Ghent University in Belgium. She is the author of the “Handbook for pharmacoeconomic evaluations”, the first such publication in the field of pharmacoeconomics in the Serbian language. Through the Pharmacoeconomics Section she is constantly increasing awareness of health economics, pharmacoeconomics and the importance of Health Technology Assessment (HTA). She is active in shaping healthcare policy, writing the first Guidelines for pharmacoeconomic evaluations for Serbia. She was also co author in one of the three HTA analyses first completed in Serbia, and was engaged to lead a group of experts to define all existing elements of basic benefit package in Serbia (World Bank/Ministry of Health of Serbia projects).

Tanja has organized and presented in many national meetings and international conferences which have resulted in international cooperation in education and the developing of pharma-coeconomics and HTA in Serbia.

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Janko Samardzic, M.D., PhD, spec.

Janko Samardzic is a specialist in Clinical Pharmacology at the Institute of Pharmacolo-gy, Clinical Pharmacology and Toxicology in Belgrade. He is teaching at the Medical Faculty, University of Belgrade, Serbia. Dr Samardžić has a master degree in Experimental Pharmaco-logy and PhD in the field of Medical Pharmacology. He completed postgraduate courses in the pharmaco-epidemiology and clinical trials at Erasmus University Medical Center Rotterdam, The Netherlands. Currently he holds the position of Chief for Pharmacoeconomics in Republic Health Insurance Fund.

As a researcher, Dr Samardžic is a member of the Science Project by the Ministry of Educa-tion, Science and Technological Development, Republic of Serbia. He is a member of Serbian Pharmacological Society, Austrian Pharmacological Society and European Colleague of Neu-ropsycho- pharmacology (ECNP). Also, he is an expert for preclinical and clinical drug evaluati-ons at the regional Agencies for Medicines and Medical Devices.

Dr Samardzic has extensive experience and expertise in Pharmacology, he is the author of a large number of peer reviewed papers, and also a regular speaker at international medical and pharmaceutical workshops and conferences.

Eldon Spackman, PhD

Eldon Spackman is a Research Fellow in the Team for Economic Evaluation and Health Te-chnology Assessment at the Centre for Health Economics, University of York. He joined the Centre for Health Economics in 2010. He holds a BA (2002) and MA (2006) in Economics from the University of Calgary and a PhD (2009) from the Pharmaceutical Outcomes and Policy Program at the University of Washington.

His research interests include methods for incorporating uncertainty in the decision making framework, the effects of investment and irrecoverable costs in HTA and assessments of scree-ning and diagnostics. Eldon has recently worked on empirical estimates of the UK cost-effecti-veness threshold and methods to support the UK Department of Health on the implementation of value based pricing. He has also been involved in model development or clinical trials in a number of disease areas including Alzheimer’s disease, asthma, psoriatic arthritis, depression and prostate cancer.

He is an associate editor for BMC Public Health and a member of the PSSRU unit cost ad-visory group. Eldon is also a member of the Technology Appraisal Committee for the National Institute for Health and Clinical Excellence (NICE) and supports method development as a member of NICE’s Decision Support Unit.

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Professor York F. Zöllner

York F. Zöllner is professor of health economics at Hamburg University of Applied Sciences since March 2010. As such, he will do his share in ‘producing’ the next generation of skilled yo-ung health economics experts. Likewise, he will strive to make his own contribution to research and public health by conducting meaningful analysis in the fields of cost-of-illness, cost-ef-fectiveness of healthcare interventions, and equity issues. Prior to rejoining academia, he was Research Director with a contract research organization in the HEOR and P&R space. Previo-usly, he was Director of Global Health Economics with a mid-sized European pharmaceutical company, where he was accountable for the P&R status of the worldwide product portfolio, ranging from conception of late-phase clinical trials to hands-on payer submissions at national level. York is member of the editorial board of the Journal of Medical Economics and regular peer reviewer for a number of other journals.

Brian Godman, PhD

Brian Godman is researcher at Division of Clinical Pharmacology, Karolinska Institute, Stock-holm, Sweden and also positions with Mario Negri Institute for Pharmacological Research, Milan, Italy and Prescribing Research Group, Liverpool University, United Kingdom. Brian Godman is acti-vely working with health authorities and health insurance companies across Europe, South Ame-rica, UAE (Abu Dhabi) and USA, evaluating the impact of measures to enhance both the quality and efficiency of prescribing of both new and existing products. This includes Serbia. Prior to active research, Brian spent thirteen years in European and Global healthcare consultancy undertaking numerous projects including appraising current and planned reforms to enhance the quality and ef-ficiency of prescribing, their transferability, and implications for all key stakeholders groups. It also included evaluating developments in the pricing and reimbursement of drugs and their influence on product development and market access strategies. He is author of 37 scientific journals.

Predrag Djukic, M.D., MSc

Since 2006 Predrag is working on the implementation of the health sector reform projects of the Ministry of Health of Serbia that are financed from the World Bank loans. He held both managerial and expert positions in the implementation of those projects. Furthermore, Predrag also provided consultancy services in Serbia and abroad. His expertise is in Health Financing, with focus on provider payment mechanisms, including diagnosis related groups in particular. Other main interests include Health Technology Assessment both in methodological sense and in the sense of institutionalization of HTA in Serbia.

Predrag is a medical doctor with a Masters degrees in Clinical Anatomy from the University of Belgrade School of Medicine and in International Health Care Management, Economics and Policy from the Bocconi University in Milan, Italy. He is a founding member of ISPOR Serbia and has a close association with CEESTAHC.

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Ruth Lopert, M.D., PhD

Ruth Lopert, a public health physician and pharmacoeconomist, is Principal Adviser at the Au-stralian Therapeutic Goods Administration (TGA). In 2011-12 she was Visiting Professor in Health Policy at George Washington University (GW), and from 2008-2011 was the chief medical officer at the TGA. In 2006-07 she held a Harkness Fellowship in Health Policy and in 2005-06 was direc-tor of Pharmaceutical Policy in the Australian Department of Health, responsible for developing policy to support sustainability of Australia’s drug coverage program. She had previously served as both director of the program, and clinical and technical adviser to the national formulary com-mittee. Ruth is currently also Adjunct Professor of Health Policy at GW.

Dragana Baltezarevic, M.D., spec.

Dragana Baltezarevic is currently employed at the Pricing and Reimbursement Department at the Health Insurance Fund, Serbia (RFZO). She is a medical doctor. Previously she has been working at the pharmaceutical company “Hemofarm- STADA” for more than five years, as a Medical representative, Product (SBU) manager and Medical adviser at the central Portfolio Service and as a consultant for the DRG system implementation with the World Bank project “Serbia Health Project – AF”. Meanwhile, she completed postgraduate master degree at the Faculty of Pharmacy :”Pharmacoeconomics and pharmaceutical legislation”. As a pricing and reimbursement specialist at the RFZO, she is responsible for analysis of the reimbursement list, pharmaceutical reimbursement strategy and drug application processing, as well as monitoring of drug utilisation. She is a member of the Subcommittees for: A, H, M, V groups and central tender Committees for: blood and blood derivates, oxygen therapy and biological therapy. She is also a member of the Committees for approving the therapy (adalimumab/infliksimab, gefitinib/erlotinib and trastuzumab) as well as the Committee for Pharmacoeconomics and “off-label” use. She also carries out communication between Serbian and other HIFs through the PPRI network. Dragana enjoys practising Yoga.

Biljana Kozlovic, M.D.

Biljana Kozlovic is a medical doctor with 20 years of experience in management and consul-ting in pharmaceutical industry and clinical trials. She is engaged as a World Bank consultant for pharmaceuticals and procurement. As of September 2013, she holds the position of deputy director in charge of pharmaceutical affairs at Republic Health Insurance Fund in Belgrade.

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Bojan Trkulja, M.D.

Bojan Trkulja, director of the Association of Manufacturers of innovative medicines INOVIA in Belgrade, Serbia from 1st December 2010. He was born in 1971 in Belgrade, where he com-pleted his elementary, high school and medical university. After a successful intern-ship and passing the state exam, he worked in the office of F. Hoffmann - La Roche in Belgrade, from December 1999. Over the last 11 years he held a variety of positions, from associate through the Medical Product Manager, Compliance Officer and Market Access Manager.

Bojan is happily married.

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Dr Krzysztof Landa

Krzysztof Landa je generalni direktor kompanije HTA Audit, koja se bavi procenom kvaliteta izveštaja procena zdravstvenih tehnologija (HTA - Health Technology Assessment) namenje-nih državnim institucijama u Poljskoj. Takođe je predsednik Watch Health Care Foundation. Od 2010. do 2011. bio je predsednik Udruženja CEESTAHC - vodećeg udruženja za medicinu zasnovanu na dokazima i procenu zdravstvenih tehnologija za centralnu i istočnu Evropu, a 2004. godine je izabran za člana borda direktora međunarodne organizacije za HTA – HTAi i na dužnosti je bio do 2007. godine.

Dr Landa je bio predsednik naučnog odbora Prvog godišnjeg HTAi sastanka u Krakovu, Polj-ska. Diplomirao je na Medicinskom fakultetu, a postdiplomske studije iz menadžmenta završio je na Institutu za javno zdravlje Jagiellonian Univerziteta u Krakovu. Promocija HTA u regionu centralne i istočne Evrope rezultirala je međunarodnom saradnjom u edukaciji i proceni zdrav-stvenih tehnologija. Dr Landa je organizovao brojne nacionalne i međunarodne HTA kurseve i konferencije. Od 2006-2007. godine, dr Landa je bio direktor Odeljenja za lekove u Nacio-nalnom zdravstvenom fondu Poljske. Od 2006 do 2008. godine, bio je konsultant Ministar-stva zdravlja Republike Srbije i vođa tima na projektu Svetske banke za uvođenje HTA u Srbiju, implementaciju paketa osnovnih zdravstvenih usluga zasnovanih na dokazima i projektovanje HTA agencije.

Mr sci. Mark Parker

Mark Parker je viši saradnik za ekonomsko modelovanje odseka za zdrаvstvenu ekonomiju Univerziteta u Liverpulu, Velika Britаnija i Jedinice za kliničke studije iz oblasti kancera, Liverpul. Tehnički je direktor kompanije Evaluate Econ Ltd. Osnovno obrazovanje završio je iz oblasti softvera i elektronskog inženjerstva i realnog vremena “digitalna obrada signala”, zajedno sa RF dizajnom, na Univerzitetu u Mančesteru. Mаgistаrske studije iz zdrаvstvene ekonomije nа Univerzitetu u Yorku, završio je 2009. godine. Trenutno radi na doktorskoj tezi iz oblasti zdrav-stveno ekonomskog modelovanja na Univerizitetu u Liverpulu. Mark Parker je autor modela i poruka zasnovanih na dokаzima za globalne dosijee za širok spektаr bolesti i za HTA izveštaje koji se podnose NICE, SMC i CVZ, kao i analiza za interno donošenje odlukа. U svojoj profesi-onalnoj karijeri radio je sa sledećim kompanijama: GSK (vаkcine), Sаnofi Aventis (dijаbetes), Wirral Primary Care Trust (validacija podataka iz realnog života), CHAMPS (intervencije za re-gulisanje telesne težine) i Shire (biološka terapija u hroničnim stanjima).

Mark Parker ima veliko iskustvo i stručnost u više terapijskih oblasti, populacionom mode-lovanju, ekonomiji, razvoju softvera, distributivnim sistemima i računarstvu, veštačkoj intelin-genciji (1st, BSc Economics and Computer Science, UoL). Primenjujući stečene veštine i znanja razvio je argumente zasnovane na dokazima za procene zdravstvenih tehnologija.

Navedene obuke, obrаzovаnje i iskustvo omogućili su primenu nаjsаvremenijih svetskih teh-nika zа rešаvаnje složenih problemа na metodički, trаnspаrentаn i rаzumljiv nаčin, sа osnovnim fokusom nа trаnsfer znаnjа.

Uživa u sportovima na vodi, snegu i vožnji motorom.

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Dr Magdalena Wladysiuk

Magdalena Wladysiuk je vlasnica kompanije HTA Consulting u kojoj je od osnivanja 2001. godine.

Predsednica je Udruženja CEESTAHC - Central & Eastern European Society of Technology Assessment in Health Care. Ona je doktor medicine sa završenim MBA programom u upravlja-nju tehnologijama. Jedan je od autora 100 različitih HTA izveštaja za farmaceutsku industriju i fondove zdravstvenih osiguranja. Učestvovala je u razvoju metodologije, strukture i inicijalne namene osnovnog paketa zdravstvenih usluga za Poljsku. Od 2006 do 2008. godine, radila je kao konsultant za Ministarstvo zdravlja Republike Srbije na implementaciji zdravstvene zaštite zasnovane na dokazima i osnovnog paketa zdravstvenih usluga, studiji izvodljivosti za različite modele HTA Agencija, razvoju medicine zasnovane na dokazima, sistemskoj implementaciji HTA, sveobuhvatnom treningu iz oblasti HTA analize i izradi 3 HTA vodiča čije su teme izabrane od strane Ministarstva zdravlja.

Trenutno blisko sarađuje sa kolegama iz Ministarstva zdravlja Poljske i privatnog sektora na ra-zvoju strateškog planiranja, ekonomskih analiza, promociju zdravlja, standarda, redukcije troškova i kliničko - zdravstvenog informacionog sistema. Dr Wladysiuk učestvuje aktivno u promociji HTA u CEE regionu što je rezultiralo međunarodnom saradnjom u oblasti obrazovanja i HTA. Organizo-vala je brojne nacionalne i međunarodne HTA kurseve i konferencije na kojima je i predavač.

Mr sci. Tarik Čatić

Tarik Čatić je osnivač i predsednik ISPOR Bosna i Hercegovina regionalnog ogranka i ruko-vodilac Sekcije za farmakoinformatiku i farmakoekonomiku Farmaceutskog društva Federacije Bosne i Hercegovine.

Diplomirao je na Farmaceutskom fakultetu u Sarajevu, a 2010. godine stekao je zvanje ma-gistra nauke iz farmakoekonomije i zdravstvane ekonomije na Univerzitetu Pompeu Fabra, Barcelona, Španija. Zaposlen je u farmaceutskoj industriji gdje je radio na poslovima produkt menadžera za centralni nervni sistem, reumatologiju, osteoporozu, antiinfektive i onkološki portfolio, poseduje iskustvo vezano za marketing, registraciju lekova, pristup tržištu, klinička istraživanja, i kao rukovodilac tima u regionu Adriatik. Bio je uključen u projekte razvoja poslo-vanja, analize tržišnih potencijala i razvoja portfolija.

Stalni je član ISPOR HTA Okruglog stola za Europu. Kao predsednik ISPOR BH inicirao je i učestvovao u nekoliko značajnih projekata kao što je prevod i adaptacija ISPOR knjige termina na jezike naroda BiH, prevod ISPOR dobrih istraživačkih praksi, vodio je projekt prevoda i adap-tacije ISPOR modula za učenje na daljinu, urednik je ISPOR BH Newsletter-a, učestvovao je u organizaciji ISPOR BH konferencija, kongresa i stručnih skupova. Kao rukovodilac tima ISPOR BH učestvovao je u razvoju edukativnih modula u okviru kontinuirane medicinske edukacije, i kao predavač. Objavio je nekoliko naučnih članaka u indeksiranim časopisima, učestvovao u brojnim međunarodnim skupovima kao predavač po pozivu, prezentovao je nekoliko poster prezentacija. Aktivno radi na promociji farmakoekonomije i edukacije iz ove oblasti, kao i na implementaciji HTA u sistem odlučivanja u zdravstvu u BiH.

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Mr sci. Vanesa Benković

Vanesa Benković je magistrirala menadžment u zdravstvu na Medicinskom fakultetu u Za-grebu. Trenutno završava doktorsku disertaciju iz zdravstvenih nejednakosti na Odsjeku za so-ciologiju Filozofskog fakulteta u Zagrebu.

Završila je niz edukacija iz oblasti farmakoekonomije, zdravstvene ekonomije i naprednog modelovanja procene zdravstvenih tehnologija u Francuskoj i Austriji. Dobitnica je stipendije Otvorenog društva za trogodišnji program Global Health Economics koji sprovodi European University of St.Petersburg, u saradnji sa LSE i MIT fakultetima. Predaje farmakoekonomiju, finansiranje i zdravstvenu ekonomiju na Medicinskom fakultetu i Fakultetu za farmaciju i bio-kemiju u Zagrebu, kao i zdravstvenu statistiku na kursu European University of St.Petersburg - GHE. Njeno područje rada uključuje iscrpnu listu zdravstveno ekonomskih analiza lekova, pomagala, tehnologija i studija tereta bolesti za Hrvatsku, Sloveniju i BiH, kao i niz istraživačkih metodologija za razne EU JA projekte kao što su Urban health centers Europe i Cross border patient registries initiative (PARENT). Vanesa se takođe bavi dizajnom i sprovođenjem tržišnih i naučnih istraživanja u zdravstvu. Njeni nedavni angažmani uključuju poslove analitike zdrav-stvene poslovne inteligencije za projekat Ministarstva zdravlja HR finansiran od Svetske banke, strateška savetovanja za farma industriju i zdravstvene upravne autoritete u regionu.

Objavljuje radove iz područja metodologije, zdravstvenih registara, farmakoekonomije i zdrav-stvene ekonomije. Trenutno radi na primeni IT rešenja na području polifarmacije i adherencije.

Mr sci. farm. Tanja Novaković

Tanja Novaković je od osnivanja 2006. godine predsednica Sekcije za farmakoekonomiju Saveza farmaceutskih udruženja Srbije. Osnivač je udruženja ISPOR Srbija i od 2007 do 2009. godine bila je potpredsednica ISPOR Srbija.

Od 2001. godine radi u farmaceutskoj kompaniji, Galenika a.d., kao produkt menadžer za neuropsihijatrijske lekove. Tanja Novaković je diplomirala na Farmaceutskom fakultetu Univer-ziteta u Beogradu i završila poslediplomske studije na Farmaceutskom fakultetu Univerziteta u Gentu, u Belgiji. Ona je autor “Priručnika za farmakoekonomske evaluacije”, prve takve publi-kacije iz oblasti farmakoekonomije u Srbiji. Kao predsednica Sekcije za farmakoekonomiju kroz aktivnosti Sekcije učestvuje u razvoju zdravstvene ekonomije, farmakoekonomije i procene zdravstvenih tehnologija.

Kao autor prvog Vodiča za farmakoekonomske evaluacije, Tanja Novaković učestvuje u kre-iranju zdravstvene politike u Srbiji. Koautor je u jednom od prva tri HTA izveštaja za Srbiju. Takođe je bila angažovana da vodi grupu eksperata za definisanje postojećih elemenata paketa osnovnih zdravstvenih usluga u Srbiji (projekat Svetske banke i Ministarstva zdravlja Srbije). Tanja Novaković je organizovala i bila govornik na mnogim nacionalnim skupovima i među-narodnim konferencijama koje su rezultirale u međunarodnoj saradnji u oblasti obrazovanja i razvijanju farmakoekonomije i HTA u Srbiji.

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Dr sci. med. Janko Samardžić, spec.

Janko Samardžić je lekar - specijalista kliničke farmakologije na Institutu za farmakolo-giju, kliničku farmakologiju i toksikologiju u Beogradu i predavač na Medicinskom fakultetu, Univerziteta u Beogradu. Dr Samardžić ima zvanje Akademskog specijaliste eksperimentalne farmakologije i Doktora medicinskih nauka iz oblasti Medicinske farmakologije. Poslediplom-ska usavršavanja iz oblasti farmakoepidemiologije i kliničkih ispitivanja završio je na Erasmus Univerzitetu, Medicinskog Centra Roterdam, u Holandiji. Trenutno je na poziciji načelnika za farmaekonomiju u RFZO.

Kao istraživač, Dr Samardžić je uključen u realizaciju projekta Ministarstva prosvete, nauke i tehnološkog razvoja, Republike Srbije. Član je Srpskog farmakološkog društva, Austrijskog far-makološkog društva i Evropskog udruženja za neuropsihofarmakologiju (ECNP). Ekspert je za procenu pretkliničke i kliničke dokumentacije za lekove pri regionalnim Agencijama za lekove i medicinska sredstva.

Dr Samardžić ima sveobuhvatno iskustvo i stručnost u oblasti farmakologije, autor je broj-nih reprezentativnih publikacija i predavač po pozivu na međunarodnim medicinskim i farmace-utskim seminarima i konferencijama.

Dr sci. Eldon Spackman

Eldon Spackman je od 2010. godine istraživač u timu za ekonomske evaluacije i procenu zdravstvenih tehnologija u Centru za zdravstvenu ekonomiju Univerziteta u Yorku, Velika Bri-tanija. Završio je diplomske studije iz ekonomije 2002. godine, master studije 2006. godine na Ekonomskom Univerzitetu Kalgari, a 2009. godine i doktorat iz oblasti istraživanja ishoda i farmaceutske politike na Univerzitetu u Vašingtonu. Njegov naučno-istraživački rad uključuje metode inkorporiranja neizvesnosti u okvir donošenja odluka, efekata investiranja i nenaplati-vosti troškova u proceni zdravstvenih tehnologija, kao i proceni skrininga i dijagnostike.

Eldon je nedavno radio na empirijskim procenama granične vrednosti isplativosti u Velikoj Britaniji i metodama za podršku Ministrastva zdravlja Velike Britanije na implementaciji tzv. “value based pricing”-a. Radio je na razvoju modela u kliničkim istraživanjima brojnih bolesti: Alchajmerova bolest, astma, psorijazni artritis, depresija i karcinom prostate.

Zamenik je urednika za BMC Public Health i član PSSRU (The Personal Social Services Rese-arch Unit) odeljenja za savete u oblasti troškova. Eldon je član Komisije za procenu zdravstvenih tehnologija i Jedinice za podršku donošenja odluka u NICE-u.

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Prof. dr York F. Zöllner

York F. Zöllner je od marta 2010. godine profesor zdravstvene ekonomije na Univerzitetu primenjenih nauka u Hamburgu. Njegov cilj je da edukuje i “produkuje” naredne generacije mladih kvalifikovanih zdravstveno ekonomskih eksperata i da doprinese istraživanju i javnom zdravlju sprovođenjem analiza troškova bolesti, analiza isplativosti intervencija i istraživanja pitanja jednakosti. Pre akademskog angažmana, bio je direktor Sektora za istraživanje u kom-paniji za sprovođenje kliničkih istraživanja za oblasti zdravstvene ekonomije, politike cena i refundacije (P&R).

Na početku svoje karijere je radio kao globalni direktor za zdravstvenu ekonomoju u far-maceutskoj kompaniji gde je bio odgovoran za P&R status produkt portfolia na globalnom nivou, od početka kasne kliničke faze do podnošenja zahteva za stavljanje leka na listu na na-cionalnom nivou. York je član uredništva časopisa Medicinska ekonomija i redovni recenzent brojnih časopisa.

Dr sci. Brian Godman

Brian Godman je istraživač pri Odseku za kliničku farmakologiju, Univerzitet Karolinska, Švedska i takođe sa pozicijom na Institutu za farmakološko istraživanje ‘Mario Negri’, Italija i na Univerzitetu u Liverpulu, Velika Britanija. Osnovne studije je završio na King’s College, Lon-don, Velika Britanija iz oblasti farmakologije, a zvanje doktora nauka je ostvario 2011. godine na Open University, u Velikoj Britaniji. Brian aktivno sarađuje sa zdravstvenim autoritetima i zdrav-stvenim osiguravajućim društvima u Evropi, Južnoj Americi, UAE (Abu Dabi) i SAD, procenjujući uticaj mera da bi se poboljšao kvalitet i efikasnost propisivanja novih i postojećih proizvoda, uključuju i Srbiju. Pre aktivnog istraživačkog rada, Brian je proveo trinaest godina u evropskim i svetskim konsultantskim agencijama preduzimajući brojne projekte, uključujući ocjenjivanje trenutnih i planiranih reformi kako bi se poboljšao kvalitet i efikasnost propisivanja, njihovu prenosivost i implikacije za sve ključne interesne grupe. Takođe je radio na proceni kretanja cena i refundacije lekova i njihovog uticaja na razvoj proizvoda i strategije pristupa tržištima. Autor je oko 37 radova objavljenih u celosti u međunarodnim naučnim časopisima.

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Dr Predrag Djukić

Od 2006. godine Predrag radi na implementaciji reformskih projekata Ministarstva zdravlja Republike Srbije koji su finansirani iz zajmova Svetske banke.

Bio je i na ekspertskim i na upravljačkim pozicijama u implementaciji pomenutih projekata. Predrag je, takođe, pružao konsultantske usluge u Srbiji i inostranstvu. Primarno se bavi finansi-ranjem u zdravstvu, sa fokusom na mehanizme plaćanja pružalaca usluga, uključujući naročito dijagnostički srodne grupe. Druga interesovanja uključuju procenu zdravstvenih tehnologija (PZT) kako u metodološkom smislu, tako i u smislu institucionalizacije PZT u Srbiji.

Predrag je lekar. Magistar je medicinskih nauka sa magisterijumom iz oblasti kliničke i pri-menjene anatomije sa Medicinskog fakluteta Univerziteta u Beogradu. Završio je i master stu-dije iz oblasti međunarodnog zdravstvenog menadžmenta, ekonomije i politike na Univerzite-tu Bokoni u Milanu, Italija (Universita Commerciale Luigi Bocconi). Predrag je osnivač srpskog ogranka Međunarodnog društva za farmakoekonomiju i istraživanje ishoda (ISPOR Serbia), i blisko sarađuje sa Društvom za procenu tehnologija u zdravstvenoj zaštiti centralne i istočne Evrope (CEESTAHC).

Dr Dragana Baltezarević, spec.

Dragana Baltezarević radi u Odeljenju za lekove, u Republičkom Fondu za zdravstveno osigu-ranje (RFZO) Republike Srbije. Nakon završenog Medicinskog fakulteta i obavljenog lekarskog staža, radila je u farmaceutskoj kompaniji „Hemofarm AD - član STADA grupe“ kao medicinski predstavnik, produkt (SPJ) menadžer i medical adviser, a zatim i na projektu Svetske Banke „Ra-zvoj zdravstva Srbije“, kao konsultant na uvođenju novog načina izveštavanja i finansiranja po sistemu „dijagnostički srodnih grupa“ (DSG). U međuvremenu, dr Baltezarević je stekla zvanje akademskog specijaliste iz oblasti Farmakoekonomije i farmaceutske legislative na Farmaceut-skom fakultetu Univerziteta u Beogradu.

Organizovala je i bila predavač na brojnim nacionalnim i međunarodnim konferencijama. Danas radi na poslovima obrade zahteva za stavljanje lekova na Listu lekova i praćenju njene

primene. Zadužena je za analizu potrošnje lekova van liste lekova. Član je stručnih podkomisija za lekove za ATC grupe: А, V, H i M, Komsije za farmakoekonomiju, Komisija RFZO za odobra-vanje upotrebe neregistrovanih lekova i biološke terapije: adalimumab i infliksimab u lečenju obolelih od Crohn-ove bolesti i ulceroznog kolitisa, gefitinib i erlotinib u lečenju karcinoma plu-ća kao i novoformirane Komisije za uvođenje leka trastuzumab u terapiju karcinoma dojke. Od 2013. godine, član je PPRI mreže i projekta EURIPID, čime je omogućila da i Srbija pristupi bazi cena zemalja EU. Od 2007. godine, član je Sekcije za farmakoekonomiju Saveza farmaceutskih udruženja Srbije.

Uživa u časovima joge i čitanju.

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Dr Biljana Kozlović

Biljana Kozlović je doktor medicine sa 20 godina iskustva u menadžmentu i konsaltingu u farmaceutskoj industriji i kliničkim ispitivanjima lekova. Angažovana je kao konsultant Svetske banke za lekove i nabavke. Od septembra 2013. godine je na poziciji zamenika direktora za po-slove u oblasti lekova u Republičkom fondu za zdravstveno osiguranje u Beogradu.

Dr sci. Ruth Lopert

Ruth Lopert, specijalista javnog zdravlja i farmakoekonomista, glavni je savetnik u Upravi za lekove Therapeutic Goods Administration – TGA, u Ministarstvu zdravlja Australije. Od 2011 do 2012. radila je kao gostujući profesor na katedri za zdravstenu politiku na George Washington Univerzitetu, SAD. Od 2008 do 2011. godine kao šef medicinskog odeljenja u Upravi za lekove. Od 2006 do 2007. godine, bila je stipendista Harkness Fellowship-a, a od 2005 do 2006. radila je kao direktor Sektora za farmaceutsku politiku u Ministarstvu zdravlja Australije, gde je bila odgovorna za podršku održivosti Australijskog programa za lekove.

Prethodno je radila i kao direktor, klinički i tehnički savetnik u Komisiji za izradu Nacional-nog Registra lekova. Ruth je trenutno profesor zdravstvene politike na George Washington Univerzitetu.

Dr Bojan Trkulja

Bojan Trkulja je direktor Udruženja proizvođača inovativnih lekova – INOVIA, od 2010. godi-ne. Rođen je 1971. u Beogradu, gde je završio osnovnu i srednju školu i Medicinski fakultet Uni-verziteta u Beogradu. Po obavljenom stažu i položenom državnom ispitu, od decembra 1999. godine radio je u predstavništvu kompanije „F. Hoffmann La Roche“ u Beogradu. Tokom nared-nih 11 godina radio je na različitim pozicijama, od stručnog saradnika, preko Medical i Product Manager-a, Compliance Officer-a i Market Access Manager-a.

Bojan je srećno oženjen.

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NOTES / BELEŠKE 33

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34 NOTES / BELEŠKE

NOTE Program of the Conference is accredited by the decision of the Health Council of ••Serbia as a First category International course, for pharmacists and physicians with 7 points for participants and 13 points for lectures. English is official language of the Conference.••

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NOTES / BELEŠKE 35

OBAVEŠTENJE Program Konferencije akreditovan je Odlukom Zdravstvenog saveta Srbije kao ••Međunarodni kurs I kategorije, za ciljnu grupu farmaceute i lekare sa 7 bodova za slušaoce i 13 bodova za predavače. Zvaničan jezik konferencije je engleski. ••

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General Sponsor / Generalni sponzor

Golden Sponsor / Zlatni sponzor

Lunch break Sponsor / Sponzor pauze za ručak

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