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The ISPOR-SMDM Joint Modeling Good Research Practices Task Force is developing seven good research practices papers, including a summary of preferred practices, on the following modeling topics: 1) conceptualization and data sources; 2) state-transition modeling; 3) discrete event simulation; 4) dynamic transmission modeling; 5) parameter estimation and uncertainty; and 6) transparency and validation. During this forum, key issues being addressed in the development of these seven modeling good research practice papers will be presented. 
Presented by J. Jaime Caro (Chair) and the ISPOR-SMDM Joint Modeling Good Research Practices Task Force

Moderator: J. Jaime Caro MD, Senior Vice President of Health Economics, United BioSource Corporation, Lexington, MA, USA

CONCEPTUALIZATION AND DATA SOURCES
Speaker: Mark Roberts MD, Professor and Chair, Department of Health Policy & Management, University of Pittsburgh, Pittsburgh, PA, USA (tentative)

STATE-TRANSITION MODELING
Speaker: Uwe Siebert MD, MPH, MSc, ScD, Professor of Public Health, University of Health Sciences, Medical Informatics & Technology, Hall, i.t, Austria (tentative)

DISCRETE EVENT SIMULATION
Speaker: Jörgen Möller MSc, Vice President, Modeling, United BioSource Corporation, Eslov, Sweden (tentative)

DYNAMIC TRANSMISSION MODELING & PARAMETER ESTIMATION AND UNCERTAINTY
Speaker: Andrew Briggs DPhil, Lindsay Chair in Health Policy & Economic Evaluation, Public Health & Health Policy, University of Glasgow, Glasgow, UK (tentative)

TRANSPARENCY AND VALIDATION
Speaker:  J. Jaime Caro MD, Senior Vice President of Health Economics, United BioSource Corporation, Lexington, MA, USA (tentative)

Well-designed observational research has an important role in generating data about comparative effectiveness in real-world clinical practice. A recent ISPOR task-force identified good research practices for the retrospective analyses of existing databases. A new task-force is addressing good research practices for prospective observational studies that are “fit-for-purpose” to inform health policy decisions involving comparative effectiveness. These new good practice recommendations will build on the prior report as well as recommendations from other sources such as the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) project.
Presented by the ISPOR Prospective Observational Clinical Studies Task-Force

Moderator: Marc Berger MD, Vice President, Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA
Speakers:  Sharon-Lise Normand PhD, Professor of Health Care Policy (Biostatistics), Harvard Medical School and Professor, Harvard School of Public Health Boston, MA, USA; Adrian Towse MA, Director, Office of Health Economics, London, UK; Nancy Dryer PhD, MPH, Chief of Scientific Affairs & Senior Vice President, Outcome Cambridge, MA, USA

The goal of the ISPOR Health Economic Publication Guidelines Task Force is to develop clear and easy to use guidelines explicitly for the publication of health economic (HE) research.  This group, consisting of representatives of various journals and health economic organizations, will present the results of a comprehensive review and synthesis of HE guidelines and HE quality assessment publications.
Presented by the ISPOR Health Economic Publication Guidelines Task Force

Moderator: Donna Rindress PhD, Chair, ISPOR Health Economic Publication Guidelines Task Force; President & Managing Director, BioMedCom Consultants, Inc., Montreal, Quebec, Canada
Speakers: Donna Rindress PhD, Chair, ISPOR Health Economic Publication Guidelines Task Force; President & Managing Director, BioMedCom Consultants, Inc., Montreal, Quebec, Canada; Federico Augustovski MD, MSc, Professor of Public Health, Universidad de Buenos Aires, Argentina; Dan Greenberg PhD, Senior Lecturer, Department of Health Systems Management, Faculty of Health Sciences, University of the Negev, Beer-Sheva, Israel

The FDA's Risk Evaluation and Mitigation Strategies (REMS) and the EMA's Risk Management Plans (RMP) have similar goals but differ in requirements for risk benefit assessment.  This forum will compare and contrast REMs and RMPs for 29 recently approved New Chemical Entities (NCEs) and biological products.
Presented by the ISPOR Risk Benefit Management Special Interest Group

Moderator: Anthony Lockett PhD, MD, MBA, Medical Director, Information Change Organization Ltd., Leeds, UK
Speakers: Yvonne Lis PhD, Independent Consultant, Director, Health Outcomes, PAREXEL International, Uxbridge, UK; Dennis W. Raisch PhD, MS, RPh, Professor, Pharmacoeconomics, Epidemiology, Public Policy and Outcomes Research, College of Pharmacy, University of New Mexico, Albuquerque, NM, USA

This forum will present examples of health care decisions and their past and future impact.  Implications and lessons to be learned will be explored.  Audience participation will be encouraged. 
Presented by the ISPOR Regional Chapters of Poland, Hungary, Serbia & Greece

Moderator: Dragana Atanasijevic MD, MSc, Consultant, EBM and HTA Coordinator, Quality Improvement, DILS/SHPAF Projects, Ministry of Health, Belgrade, Serbia
Speakers: Karina Jahnz-Rozyk MD, PhD, Professor, Head of Department of Immunology & Clinical Allergology, Military Institute of Medicine, Warsaw, Poland; Imre Boncz MD, MSc, PhD, Department of Health Economics, Policy & Management (HEPOM), University of Pécs, Pécs, Hungary; Mary Geitona, PhD, Assistant Professor of Health Economics, Department of Economics, University of Thessaly, Volos, Greece

This forum will review the development, implementation and policy implications of Health Technology Assesment guidelines development  in Central and Eastern Europe.  Countries, which have not adopted these guidelines, will provide an overview of the current decision making process and its impact on health care systems.  Forum participants will share experiences in the adoption of the guidelines, their content and implementation, and will make recommendations on how ISPOR Local chapters can best contribute to improving the HTA guidelines. 
Presented by the ISPOR Regional Chapters of Bosnia-Herzegovina, Croatia, Serbia & Greece

Moderator: Vladimir Zah PhD, Health Economics Consultant, Belgrade, Serbia
Speakers: Mirjana Huić MD, MSc, Assistant Director, Department for Development, Research and HTA, Agency for Quality and Accreditation in Health, Zagreb, Croatia; John Yfantopoulos PhD, Professor, Health Economics and Social Policy, University of Athens, Athens, Greece; Tarik Čatić MSc, Pharm, Pharmacoeconomics and Health Economics Consultant, Sarajevo, Bosnia and Herzegovina

During the last 5 years the importance and acceptability of Health Technology Assesment /Health Economics in Central and Eastern Europe has increased, however real influence on the decision-making process is still variable and unpredictable. The major barriers to deeper utilization of HTA/HE in each country will be discussed and experiences shared.
Presented by the ISPOR Regional Chapters of the Czech Republic, Slovakia, Croatia & Turkey

Moderator: Tomáš Doležal MD, PhD, Director, Institute for Health Economics and Technology Assessment (IHETA), Prague, Czech Republic
Speakers: Jana Skoupá MD, MBA, Pharma Projects s.r.o., Prague, Czech Republic; Martin Višňanský PharmD, MBA, PhD, Member of the Board and Director, Department of Strategy and Health Policies, General Health Insurance Inc., Bratislava, Slovakia; Viola Macolić-Šarinić MD, M.Sc, Head of Department of Pharmacovigilance, Drug Consumption and Rational Pharmacotherapy, Zagreb, Croatia; Yalcin Kaya MD, MPH, Health Policies Manager, Association of Research Based Pharmaceutical Companies, Istanbul, Turkey

In some countries in Eastern and Central Europe, there is limited capacity to assess a new technology. This limitation may be due to the lack of trained personnel to assess a new technology or limited resources to hire trained personnel. Building capacity by focusing on HTA education, as well as knowing what information with which to collaborate and with whom to collaborate [i.e. monitoring the recommendation of other HTA agencies] will be presented.

Health Technology Assessment with Limited Resources – Now and Future Trends in Central and Eastern Europe

Moderator/Speaker: Tomáš Doležal, MD, PhD, Director, Institute for Health Economics and Technology Assessment (IHETA), Prague, Czech Republic

Evaluating Health Care Technologies with Limited Resources: Lessons Learned from Austria

Speaker: Eva Baumer MPH, Director, Federal Institute for Quality in Health Care (BIQG), Health Austria GmbH, Vienna, Austria

Evaluating Health Care Technologies with Limited Resources: Lessons Learned from Scotland

Speaker: Ken Paterson MBChB, FRCP, FFPM, Chair, Scottish Medicines Consortium and Consultant Physician, Glasgow Royal Infirmary, Glasgow, UK

Evaluating Health Care Technologies with Limited Resources: Lessons Learned from Poland

Speaker: Iga Lipska MD, Director of Health Technology Assessment, Agency for Health Technology Assessment in Poland (AHTAPol), Warsaw, Poland

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