4th Good Clinical Practice (GCP) Course September 28-30, 2008 – Szeged, Hungary Program 28 September 2008 (Sunday) 13:00-15:30 Registration Hotel Novotel Szeged**** - Address: Maros utca 1. H-6721 Szeged, Hungary 15:30-16:00 Opening ceremony Introduction of the Presidium. Short allocutions. Narrator: Márta Szűcs Prof. Dr. Gábor Szabó, Rector, University of Szeged, Hungary Prof. Dr. György Benedek, Dean, Faculty of Medicine, University of Szeged, Hungary Dr. László Botka, Mayor of Szeged, Hungary Dr. Helena von Hertzen, Medical Officer, Department of Reproductive Health and Research (RHR), World Health Organization, Geneva, Switzerland Dr. Gábor Szepesi, President of the Hungarian Clinical Trial Management Society, Hungary Prof. Dr. Attila Pál, President of the Albert Szent-Györgyi Clinical Center, University of Szeged, Hungary Prof. Dr. György Bártfai, Chairman of the Organizing and Scientific Committee, Department of Obstetrics and Gynaecology, University of Szeged, Hungary Handing over the Diploma of Honorary Membership of the Hungarian Society of Obstetrics and Gynaecology Prof. Dr. Attila Pál, President of the Hungarian Society of Obstetrics and Gynaecology Scientific Program I. Chairs: Helena von Hertzen MD, Professor Attila Pál 16:00-16:30 Homo sapiens; an undefiniable entity – 30’ Professor Egon Diczfalusy (Karolinska Institutet, Stockholm, Sweden) 16:30-17:00 Reproductive attitudes: warning natality trends in the DKMT euroregion – 30’ Professor Aleksandra Novakov Mikic (Department of Obstetrics and Gynaecology, Clinical Center Novi Sad, Serbia) 17:00-17:15 Coffee break Scientific Program II. Chairs: Professor Tihomir Vejnovic, Gábor Szepesi MD 17:15-17:45 Responsibilities of regulatory authorities in Clinical Trials – 30’ Krisztina Szabóné Nemesy PharmDr (National Institute of Pharmacy, Budapest, Hungary) 17:45-18:15 The impact of the randomized trials of gynaecological surgery on Good Clinical Practice – 30’ Professor Serban-Dan Costa (Department of Obstetrics and Gynaecology, Otto-von-Guericke University, Magdeburg, Germany) 19:00-20:30 Concert of the Chamber Orchestra Weiner at the New Synagogue (bus transfer from the Hotel Novotel Szeged at 18:30) 20:45- Welcome reception at the Hotel Novotel Szeged 1 4th Good Clinical Practice (GCP) Course September 28-30, 2008 – Szeged, Hungary Program 29 September 2008 (Monday) Scientific Program III. Chairs: Professor Ferenc Hajnal, Paja Momcilov MD 8:00-8:20 Practical Issues of Central Ethics Committies – 20’ Professor János Julesz (Endocrine Unit, 1st Department of Internal Medicine, University of Szeged, Szeged, Hungary) 8:20-8:40 Human Drug Development: Phases and Methods – 20’ Gábor Renczes MD (GR Goodwill Research Ltd., Budapest, Hungary) 8:40-9:00 Declaration of Helsinki and Ethics Committee - 20’ Dorottya Mogyorósi MD (Medical Research Council, Ministry of Health, Budapest, Hungary) 9:00-9:20 Understanding thrombophilia in women and consequences for clinical practice– 20’ Professor Thomas Rabe (Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Germany) 9:20-9:40 Discussion 9:40-10:00 Coffee break Scientific Program IV. Chairs: Ottó Skorán MD, Pavle Vukojevic MD 10:00-10:30 Clinical trial regulations – the Romanian experience - 30’ Cristina Dragomirescu MD (IFE Romania Srl., Timisoara, Romania) 10:30-10:50 Operational issues of Clinical Trials (part I): pre-trial activities, site evaluation, site initiation procedures - 20’ Judit Tarnai MD (Pharm-Olam Hungary Medical Research Ltd., Budapest, Hungary) 10:50-11:10 Operational issues of Clinical Trials (part II) interim monitoring, close-down procedures - 20’ Zsuzsanna Scheily MD (Baxter Nutrition, Medication Delivery, Maurepas, France) 11:10-11:30 Clinical Trial Site: Requirements - 20’ Zsuzsanna Lengyel MD (Ominis Ltd., Budapest, Hungary) 11:30-12:00 The Investigator: Role and Responsibilities - 30’ Edgar Fenzl MD (FGK Clinical Research GmbH, Munich, Germany) 12:00-12:20 The Sponsor: Role and Responsibilities - 20’ Csilla Pozsgay MD (MSD Hungary Ltd., Budapest, Hungary) 12:20-12:30 Discussion 12:30-14:00 Lunch 2 4th Good Clinical Practice (GCP) Course September 28-30, 2008 – Szeged, Hungary Program Scientific Program V. Chairs: Professor Tibor Wittmann 14:00-14:30 GCP - clinical research procedure - the Russian experience - 30’ Alexey Butylin MD (Crocusmedical, Moscow, Russia) 14:30-14:50 Human drug development: Biotechnology, Biosimilars / The Sponsor’s aspects - 20’ Ildikó Aradi MD (Richter Gedeon Plc., Budapest, Hungary) 14:50-15:20 Informed Consent Process: WHO Guidelines - 30’ Helena von Hertzen MD (WHO, Geneva, Switzerland) 15:20-15:40 Informed Consent Process: Special Issues, Pediatric and Vulnerable Patients - 20’ Professor Lajos Kósa (National Clinic for Allergy, Immunology and Pulmonology, Svábhegy, Budapest, Hungary) 15:40-16:00 Discussion 16:00-16:30 Coffee break Scientific Program VI. Chairs: Judit Tarnai MD, Professor Sándor Kerpel-Fronius 16:30-18:10 Vaccination and gen therapy - Round Table Discussion Advanced therapy and biological medicinal products, vaccination Introductory remarks Professor Sándor Kerpel-Fronius (Institute of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest, Hungary) Participants: Special conditions in clinical development of targeted biological therapies Zsolt Szabó MD (Amgen Ltd. Budapest, Hungary) Specific aspects of vaccine clinical trials József Kovács MD (GlaxoSmithKline Ltd., Budapest, Hungary) Combined artificial chromosome-stem cell therapy Professor Gyula Hadlaczky (Institute of Genetics, Biological Research Center of the Hungarian Academy of Sciences, Szeged, Hungary) Vaccines, answer to pandemic diseases Csaba Kovács MD (Novartis Vaccines, Budapest, Hungary) 18:10-18:30 Discussion 20:00- Tisza-Party, Dinner at the Kiskőrössy Fishermann’s Inn (bus transfer from the Hotel Novotel Szeged at 19:45) 3 4th Good Clinical Practice (GCP) Course September 28-30, 2008 – Szeged, Hungary Program 30 September 2008 (Tuesday) Scientific program VII. Chairs: Cristina Dragomirescu MD, Csilla Pozsgay MD 8:00-8:30 Adverse Events: Definitions and Reporting - 30’ Helena von Hertzen MD (WHO, Geneva, Switzerland) 8:30-8:50 ICH guidelines – 20’ László Veres MD, Quintiles Ltd., Budapest, Hungary) 8:50-9:10 How to prepare for a successful audit? – 20’ Kálmán Juszku MD (AstraZeneca Ltd., Törökbálint, Hungary) 9:10-9:30 Discussion 9:30-10:00 Coffee break Scientific program VIII. Chair: Professor János Borvendég 10:00-11:20 Patient Reported Outcome - Round Table Discussion Patient Reported Outcomes Measures Opening remarks Professor János Borvendég, Coordinator (Hungarian Medical Research Council, Ministry of Health, Budapest, Hungary) Participants: Health related quality of life: assessment and significance in the clinical practice István Mucsi MD (1st Department of Internal Medicine and Institute of Behavioral Sciences, Semmelweis University, Budapest, Hungary) Use of QoL measurement in clinical trials and its application for priority setting Zoltán Kaló MD (Health Economics Research Centre, Eötvös Lóránd University, Budapest, Hungary) The assessment of quality of life in diabetes Professor Gyula Soltész (Department of Paediatrics, University of Pécs, Pécs, Hungary) 11:20-11:40 Discussion Scientific program IX. Chair: Professor György Bártfai 11:40-12:10 Valedictory lecture: The Ethics of Medicine and of Society - GCP – 30’ Professor Miguel Oliveira da Silva (Institute of Preventive Medicine, University of Lisboa, Portugal) 12:10-12:50 Written test 12:50-13:00 Closing remarks 13:00- Lunch 4 .