PROGRAM
09.30-10.00 Registration
10.00-10.30 Welcome and chair
Dean, Dokuz Eylul University School of Medicine
Rector, Dokuz Eylul University
10.30-12.00 Session 1. Infrastructure of Early Phase Clinical Trials
Moderators:
Yeşim Tunçok
Cenk Ecevit
- How to meet TITCK requirements for Phase I clinical trials – Regulations on Phase I units
TİTCK , 20 min)
- Organizing Phase I units with Quality Management
Oğuz Akbaş, Monitor CRO, 20 min
- Dokuz Eylul University experience for establishing the Phase I Clinical Trial Unit
Fatih Demirkan, DEÜ, 20 min
- Safety considerations in early phase clinical trials
Kaan Kavaklı, Ege Ü, 20 min
12.00-13.00 Lunch break
13.00-14.30 Session 2. Trends in Early Drug Development
Moderators:
Fatih Demirkan
Necati Gökmen
- Adaptive Study Designs
Thomas Felix , Medical Development Director, Amgen Inc, USA, 20 min
- Early development of oncology and hematology treatments– novel targets and technology platforms
Thomas Felix , Medical Development Director, Amgen Inc, USA, 20 min
- Development of antibody drug conjugate (anetumab ravtansine) in advanced, metastatic and recurrent solid tumors
Cem Cüneyt Elbi, Global Clinical Leader, Global Clinical Development, Oncology, Bayer HealthCare, USA, 20 min
14.30-15.00 Coffee Break
15.00-16.30 Roundtable discussion: Opportunities and challenges of early phase clinical trials in Turkey: How to attract more early phase studies into Turkey
Moderators:
Fatih Demirkan
Yeşim Tunçok
TİTCK (Klinik Araştırmalar Dairesi Başkanlığı)
Hamdi Akan
Sibel Göksel
Emel Tetik
Aydın Erenmemişoğlu
İrfan Çiçin
Ayşe Pekkirişçi
Gökhan Duman
Serdar Altınel
Ersen Gökser
16.30-16.45 Closing remarks