27 September, 2009 Sunday

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1 27-29 September, September, 2009 Sunday Registration/Venue: IH Event Center / IH Rendezvényközpont (address: Felső Tisza-part 2. H-6721 ) Opening ceremony Introduction of the Presidium. Short allocutions. Narrator: Tamara Mikó Professor György Benedek, Dean, Faculty of Medicine, University of László Solymos MD, Deputy Mayor of Szabolcs Szigeti, National Health Policy Officer, WHO Country Office for Hungary, Budapest Gábor Szepesi MD, President of the Hungarian Clinical Trial Management Society, Hungary Professor György Bártfai, Chairman of the Organizing and Scientific Committee, Department of Obstetrics and Gynaecology, University of Opportunities in health care in DKMT Euroregion (10 ) Eszter Csókási The Danube-Kris-Mures-Tisa Regional Cooperation, Scientific Program I. Chair: Professor Egon Diczfalusy and Professor János Julesz 16:00 16:30 Changing World - Changing Health Insurance Policy - Unchanged Good Clinical Practice Ferenc Oberfrank MD Institute of Experimental Medicine of the HAS, Budapest, 16:30 17:00 Quality of life key to healthy ageing Professor Ilpo T. Huhtaniemi FMedSci Department of Reproductive Biology, Imperial College London, Hammersmith Campus, Du Cane Road, London, UK Scientific Program II. Chair: Professor György Bártfai and Gábor Szepesi 17:00 17:30 Use, abuse and misuse of medicine/impact on prevention Professor Milan Stanulovic University of Novi Sad, Novi Sad, Serbia Assisted Reproductive Technologies and GCP Péter Kovács MD Kaali Institute, IVF Center, Budapest, Hungary 18: Current changes in the clinical trial approval process in Hungary Zsuzsanna Szepezdi PharmDr General Director, National Institute of Pharmacy, Budapest, Hungary Get together party (IH Event Center) 1

Narrator: Tamara Mikó Professor György Benedek, Dean, Faculty of Medicine, University of László Solymos MD, Deputy Mayor of Szabolcs Szigeti, National Health Policy Officer, WHO Country Office for

2 27-29 September, September, 2009 Monday Basic GCP Trainig Scientific Program III. Chair: Professor Dan Gaita and Professor Britt-Marie Landgren 08:30-08:50 Declaration of Helsinki and Ethics Committee Dorottya Mogyorósi MD Deputy Head of Department of the Office of the Parliamentary Comissioner for Future Generation, Member of the Steering Committe of Bioethics of the Council of Europe, Bureau Member 08:50 09:10 Ethical Aspects of GCP Professor János Julesz MD Endocrine Unit, 1 st Dept. of Internal Medicine, University of Szeged, 09:10 09:30 ICH guidelines László Veres MD Quintiles Ltd., Budapest, Hungary 09:30 10:00 Coffee break Scientific Program IV. Chair: Sinisa Radulovic and Gábor Renczes 10:20 10:40 Operational issues of Clinical Trials I. (pre-trial activities, feasibilities, site evaluation, site initiation) Judit Tarnai MD Pharm-Olam Hungary Medical Research Ltd., Budapest, Hungary 10:40 11:00 Operational issues of Clinical Trials II. (interim monitoring, close-down procedure) Petar Turcinovic DDS MSc CCRA Pharm-Olam Group Ltd. Belgrade, Serbia 11:00 11:20 Requirements of Clinical Research Site Csilla Pozsgay MD MSD Hungary Ltd. Budapest, Hungary 11:20 11:40 The Investigator: Role and Responsibilities Edgar J. Fenzl MD FGK Clinical Research GmbH, Munich, Germany 12:00-13:30 Lunch 2

Parliamentary Comissioner for Future Generation, Member of the Steering Committe of Bioethics of the Council of Europe, Bureau Member 08:50 09:10 Ethical Aspects of GCP Professor János Julesz MD

3 27-29 September, 2009 Scientific Program V. Chair: Paja Momcilov and Otto Skorán 13:30 13:50 Informed Consent Process I. Réka Borka-Balás MD Pharmaquest, Marosvásárhely/Tirgu Mures, Romania 13:50 14:10 Informed Consent Process II: Special Issues, Pediatric and Vulnerable Patients Linda Marschalkó JD Mediperfect Ltd., Budapest, Hungary. 14:10 14:30 Pharmacovigilance and Reporting procedures Zsuzsanna Lengyel MD Novartis Hungary Healthcare, Budapest, Hungary Scientific Program VI. Chair: Judit Tarnai and Tihomir Vejnovic 14:30 14:50 The Sponsor Role and Responsibilities Judit Korányi MD Wyeth Hungary Ltd. 14:50 15:10 The Role of study nurse and study coordinator János Antal MD Parexel Hungary Ltd., Budapest, Hungary 15:10 15:40 Human Drug Development: Phases and Methods Eduardo Fabian Bergel MD Department of Reproductive Health and Research, WHO, Geneva, Switzerland 15:40-16:00 Coffee break Scientific Program VII. Chair: Eduardo Bergel and Professor Ferenc Hajnal 16:00 16:20 Project Management of Clinical Trials Gábor Keszthelyi MD MBA i3research Ltd. 16:20 16:40 Quality issues; How to prepare for a successful audit? Kálmán Juszku MD AstraZeneca Ltd., Törökbálint, Hungary 16:40 17:00 Current organizational and outsourcing forms for conducting Clinical Trials Norbert Szakolczai-Sándor MD MBA Omnicare Clinical Research Ltd. Budapest 20:00 - Dinner at the Fehértói Fishermann s Inn (bus transfer from the Hotel Novotel at 19:30) 3

, Budapest, Hungary. 14:10 14:30 Pharmacovigilance and Reporting procedures Zsuzsanna Lengyel MD Novartis Hungary Healthcare, Budapest, Hungary Scientific Program VI.

4 27-29 September, September, 2009 Tuesday Scientific Program VIII. Clinical Trials in Oncology / Round-table discussion Coordinator: Éva Végh 08:00-08:20 Clinical trials in oncology drug development Éva Végh MD Ominis Research Ltd. Budapest, Hungary 08:20 08:40 A single institution experience with clinical trials László Torday MD Department of Oncotherapy, University of Szeged, 08:40 09:00 Clinical Trials in Oncology Professor Nevena Secen MD Head of Department for Chemotherapy, Institute for Pulmonary Diseases, Sremska Kamenica, Novi Sad, Serbia 09:00 09:20 Site and country performance in Central and Eastern Europe Zsolt Somodi MD, János Antal MD PAREXEL Hungary Ltd., Budapest, Hungary 09:20 09:30 Cooperation of European Clinical Drug Development Course/Planned Network of Pharmaceutical Medicine Education / EU Project Professor Sándor Kerpel-Fronius Department of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest, Hungary 09:30 09:50 Coffe break Scientific Program IX. Biological Medicinal Products / Round-table Discussion Coordinator: Professor Sándor Kerpel-Fronius 09:50 10:10 Biological Medicinal Products Professor Sándor Kerpel-Fronius Department of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest, Hungary 10:10 10:30 The biological therapy of rheumatoid arthritis Bernadette Rojkovich MD Department of Rheumatology, Brothers of St. John of God Hospital, Budapest, Hungary 4

Budapest, Hungary 08:20 08:40 A single institution experience with clinical trials László Torday MD Department of Oncotherapy, University of Szeged, 08:40 09:00 Clinical Trials in Oncology Professor

5 27-29 September, :30 10:50 Biological therapy in dermatology Professor Lajos Kemény MD Department of Dermatology and Allergology, University of Szeged, 10:50-11:10 Biological medicinal agents used in cancer treatment Mátyás Szentiványi MD Roche (Hungary) Ltd., Budapest, Hungary Scientific Program X. Problems of Phase I. clinical Trials / Round-table Discussion Coordinator: Professor János Borvendég 11:10 11:30 Problems of Phase I. Clinical Trials Trends and Possibilities Professor János Borvendég MD National Institute of Pharmacy, Budapest, Hungary 11:30 11:50 Current challenges of Phase I clinical research in CEE Gábor Renczes MD GXP Ltd., Szentendre, Hungary 11:50 12:10 Problems of Phase I. Clinical Trials/Site Aspects Eva Lundqvist, Director Academic Alliances TFS Trial Form Support International, Sweden 12:10 12:25 Experience in clinical pharmacological studies in the 1 st Department of Internal Medicine, University of Szeged Andrea Tiszai MD 1 st Internal Medical Department, University of 12:25-12:40 Closing remarks Eduardo Fabian Bergel MD Coordinator, Statistics and Informatics Services UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) WHO, Geneva, Switzerland Professor Attila Pál MD, President of the Albert Szent-Györgyi Clinical Center, University of Gábor Szepesi MD President of the Hungarian Clinical Trial Management Society, Hungary Professor György Bártfai MD. Chairman of the Organizing and Scientific Committee, Department of Obstetrics and Gynaecology, University of 12:40 13:00 Written Test 13:00 Lunch 5

clinical Trials / Round-table Discussion Coordinator: Professor János Borvendég 11:10 11:30 Problems of Phase I.

Preliminary program 10 OCTOBER, 2014 FRIDAY. 9:10 9:30 Opening ceremony

Preliminary program 10 OCTOBER, 2014 FRIDAY. 9:10 9:30 Opening ceremony First Announcement 10 OCTOBER, 2014 FRIDAY 8:00 9:10 Registration 9:10 9:30 Opening ceremony Scientific Session I. 9:30 10:00 Chair: Prof. György Bártfai Key-Note Lecture: Multinational trials providing