Agenda. Speaker: Zdravko Mauko, Director, Farmavita Regulanet, Croatia. Cocktail & networking party - restaurant Hortenzija, hotel Ambasador

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Agenda Wednesday, 5 th June 2013 - Hall Magnolija 15.00 17-00 17.00 17.30 17.30-18.15 Registration of delegates Opening and Introduction Comparison of Market Access Data Across SEE Background country information for Albania, Bosnia & Herzegovina, Bulgaria, Croatia, Greece, Kosovo, Macedonia, Montenegro, Romania, Serbia, Turkey Common pricing policies Innovative and generic drugs pricing and reimbursement differences Speaker: Zdravko Mauko, Director, Farmavita Regulanet, Croatia 19.00 20.00 20.00 22.00 Dinner - restaurant Hortenzija, hotel Ambasador Cocktail & networking party - restaurant Hortenzija, hotel Ambasador Thursday, 6 th June 2013 - Hall Magnolija 9.00 9.45 Impact of the Economic Recession on the Pharmaceutical Sector and Public Health Budgets Policies and measures implemented in EU Implementation of a reference price system Analyses of : generics/brands, acute/chronic and top-10 active substances according to the prescribed volume Speaker: Christine Leopold, Austrian Health Institute, Austria 9.45 10.30 Additional Patient Related Benefits are Key to Price Negotiations Practical experience with benefit dossiers and the assessment process in Germany Guiding through the German assessment process for drugs with new chemical entities (NCE) Arbitration body where negotiations fails

Speaker: Olaf Pirk, Olaf Pirk Consult; Germany 10.30-11.00 Coffee Break 11.00 11.45 Market Access Models and Requirements Rising cost of Health Care in the 21 st century Research-based drug industry vs. payers need R&D process and highly valued new products Cost-effectiveness recognition Speaker: Paul de Nijs, Global Head of Market Access, ThromboGenics 11.45-12.30 Pharmaceutical Industry Perspective Benefits and disadvantages of increased competition in pharmaceutical industry Way for improvement of patients access to medicines in SEE Current trends and perspectives of pharmaceutical industry in SEE Speaker: TBD 12.30 14.00 14.00 14.45 Lunch P&R Country Report Turkey, recent country reforms Market Access Strategy Reimbursement List System Payer Pricing Strategy National Drug Tenders Speaker: Umut Gumusbas, ANKofis Consultancy Ltd., Ankara, Turkey 14.45 15.30 P&R Country Report Romania; 7 years without changing the reimbursement list! Is there a lesson to learn?, recent country reforms Market Access Strategy Reimbursement List System Payer Pricing Strategy National Drug Tenders Speaker: Prof. Sorin Paveliu, Professor, Department of Pharmacology, Titu

Maiorescu University Bucharest and Publich health and drug policy expert for Romanian Academic Society (NGO) 15.30 16.00 16.00 16.45 Coffee Break P&R Country Report Bulgaria; Recent changes and challenges Market access regulatory framework in Bulgaria Recent changes in pricing and reimbursement Cost containment measures and the impact of the regulatory changes on the prices of medicinal products and NHIF budget Pharmacoeconomics in the reimbursement decision-making Introduction of HTA Speaker: Assoc. prof. Assena Stoimenova, Ph.D., M.Sc.Pharm. Department of Social Pharmacy, Faculty of Pharmacy 16.45 17.30 Pharmaceutical Pricing and Reimbursement in Serbia Overview of the Serbian healthcare system Public health insurance System Pricing policy in Serbia Pharmaceutical reimbursement process National drug tenders Speakers: Tanja Novaković, Pharmaceutical Association of Serbia SFUS for pharmacoeconomics and Danka Tešić, Serbian Drug and Medical Devices Agency - ALIMS Department 17.30 18.15 P&R Country Report Croatia, recent country reforms Market Access Strategy Reimbursement List System Payer Pricing Strategy National Drug Tenders Speaker: Vanesa Benković, Senior Consultant Health Economics, Croatian Society for Pharmacoeconomics and Health Economics 20.00 till late Dinner at Kukuriku restaurant http://kukuriku.hr/en/ Friday, 7 th June 2013 - Hall Magnolija

9.00 9.45 Patient influence - Key for success: WORKING TOGETHER Debra Croatia starting 1996 Starting the collaboration with hospitals to engage the team of specialists Connect and organize patient families Networking and sharing experiences to improve quality of life Organizing special social services today Speaker: Mrs. Vlasta Zmazek, President of Debra Croatia, Board of Directors Rare disease patient organisations in Europe - EURORDIS 9.45 10.30 Case Study - Managment of Complex International Market Access Projects This session will provide tools to help manage compex international market access projects: - development of project plan and workload breakdown - consultant resources used - estimated budget vs. final financial outcome - timeliness, - issues encountered and solved during the project delivery - final project outcome and impact on client's business performance Speaker: Thomas Gurney BSc, Business Development and Market Access, Dr. Regenold GmbH, Germany 10.30-11.00 Coffee Break 11.00 12.15 Why are orphan drugs different? Achieving sustainable access for orphan drugs in CEE Orphan drug regulation and market access incentives in Europe and CEE Specific R&D and market access challenges for orphan drugs The challenge of demonstrating the value of orphan medicines Stakeholder engagement to address rare disease and orphan drug challenges; examples National plans for rare diseases in CEE EU member countries Speaker: Dr Günter Harms, Shire Deutschland GmbH, Market Access & Public Affairs Director, EMEA, 12.15 13.00 Payer perspective Health Insurance Fund Reimbursement list strategies Drug list update frequency Speaker: TBD

13.00 14.00 Lunch Departure Venue: Hotel Ambasador, Opatija, Croatia (http://www.liburnia.hr/en/hotel-ambasador) Official conference language: English

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