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

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1 First Announcement

2 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 the experience of WHO Prof. Giuseppe Benagiano Scientific Session II. 10:00 10:20 Chair: Prof. János Julesz Contemporary problems of drug developments Prof. Sándor Kerpel-Fronius Scientific Session III. 10:30 12:00 Chair: Csilla Pozsgay, Prof. Ana Mitrovic Jovanovic 10:30 10:45 Current trends in global clinical research László Veres 10:45-11:00 Human drug development: phases and methods Gábor Renczes 11:00-11:15 Declaration of Helsinki and Ethics Committee Dóra Mogyorósi 11:15-11:30 Ethical aspects of GCP and ICH-GCP Guidelines Prof. Mario Festin 11:30-11:45 Non interventional clinical trials Gábor Szepesi 11:45-12:00 Discussion 12:00 13:00 Lunch Scientific Session IV. 13:00 14:30 Chair: Ottó Skorán, Prof. György Ábrahám 13:00-13:15 Main operational issues of clinical trials I./Site selection and site initiation process Judit Tarnai 13:15-13:45 Operational Issues of Clinical trial II/III: Interim Monitoring and Site Close Out Petar Turcinovic 13:45-14:00 Main operational issues of clinical trials IV./Filling systems László Vastag 14:00-14:15 Investigator s roles and responsibilities/site aspects in clinical trials Vendel Kemény 14:15-14:30 Discussion updated: 6 October

3 Scientific Session V. 14:30 16:05 Chair: Gábor Szepesi, Prof. Tihomir Vejnovic 14:30-14:45 Informed consent process Special and vulnerable patient group Balázs Halgas 14:45-15:00 Risk management in clinical trials Prof. Mario Festin 15:00-15:15 Quality managemant in clinical trials Zsuzsanna Lengyel 15:15-15:30 Pediatric clinical trials Ottó Skorán 15:30-16:10 Discussion 16:10 16:45 Coffee break Scientific Session VI. 16:45 18:00 Chair: Judit Tarnai, Prof. Gheorghe Furau 16:45-17:00 The sponsor s role and responsibilities Csilla Pozsgay 17:00-17:15 Pharmacovigilance in Clinical Trials (TBC) Gábor Koncsik 17:15-17:30 The role of study nurse and study coordinator Péter Sipos 17:30-17:45 Data management Wouter Wijker 17:45-18:00 Discussion 18:00-18:15 Written test 19:00-21:00 Get together party updated: 6 October

4 11 OCTOBER, 2014 SATURDAY 08:30-10:30 Scientific Session VII. Risk based monitoring Round table discussion with invited speakers Moderators: Norbert Szakolczai-Sándor, Pavle Vukojevic 08:30-08:45 General introduction of RBM including regulatory aspects Norbert Szakolczaí-Sándor 08:45-09:00 Risk assessment Dániel Szabó 09:00-09:15 Practical experiences with RBM including limitations and opportunities from CRO point of view Pavle Vukojevic 09:15-09:30 Challenges of RBM from the investigator/ site staff point of view Adrian Dorko 9:30-10:30 Round table discussion 10:30-10:45 Coffee Break 10:45-12:45 Scientific Session VIII. Oncology clinical trial Round table discussion with invited speakers Moderators: Prof. János Borvendég, Kata Mazalin Speakers: Prof. János Borvendég, Prof. Zsuzsanna Kahán, Balázs Mihály, Kata Mazalin 12:45 13:00 Closing Remarks Mario Festin, Prof. György Bártfai,Judit Tarnai Important information for lecturers An abstract book with ISBN number will be edited and distributed for participants. Please send: - the abstract of your presentation (for the course publication),. your coloured photo - two questions concerning your lecture, mark the right answer for the test exam. not later than 27 September, 2014 to the following e address: Required form of the abstract: 2-4 pages (A4 size) MS Word document file in English (title, presenter, institute, text) Times New Roman character (size 12), 1.5 line spacing updated: 6 October

5 General information Conference venue: Hotel Novotel address: H-6721 Szeged, Maros utca 1. Conference date: Official language: 10 October, 2014 (Friday) 11 October, 2014 (Saturday) The official language of the conference is English Website of the Conference: Conference Committee: Technical Secretariat: Prof. György Bártfai Chairman of the Organizing and Scientific Committee Dr. Judit Tarnai Dr. Tamás Bitó Dr. László Veres Dr. Ottó Skorán Dept. of Obstetrics and Gynaecology University of Szeged address: H-6725 Szeged, Semmelweis u Top Congress Kft. address: H-6725 Szeged, Pálfy utca 14. phone: fax: Registration check-in time: 7 September, 2014 Registration fees: reduced rates after 7 September on site registration Participants/for October (2 days) 205 HUF HUF HUF Daily ticket/ for 10 October (1 day) 120 HUF HUF HUF Daily ticket/ for 11 October (1 day) 95 HUF HUF HUF Registration fee for accompanying person(s): 50 HUF The fees do not contain any kind of insurance. The organizers do not accept liability for personal accidents, losses or damage. Accommodation offer: Lunch offer: Hotel Novotel Szeged single room: 55/night = HUF double room: 66/night = HUF October, 2014 Restaurant Novotel lunch 16/pers. = HUF Payment: You can pay your registration, hotel and lunch fees by bank transfer to: MKB Bank Zrt.(H-1056 Budapest, Váci utca 38. Hungary) SWIFT(BIC)code: MKKB HUHB Beneficiary: Top Congress Kft. Szeged Account No: updated: 6 October

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