ENDÜSTRİ BİLGİLENDİRME DOSYASI Dear Par'cipants, Turkish Clinical Research Associa?on aims to to foster health innova?ons in Turkey according to 2023 vision by crea?ng a plaLorm among all par?es to emphasize the importance of and increase the awareness in clinical research thus contribute to new product development na?onally. With the success of the 1st Clinical Research Congress in 2013, Turkish Clinical Research Associa?on organizes the 2nd Clinical Research Congress on March 27th & 28th, 2015 in Wydham Grand Hotel, Levent Istanbul. Our objec?ve is to bring together the pharmaceu?cal and medical devices sectors, academia and governmental bodies to share the know-­‐how in clinical research through an experienced plaLorm. The success of the congress lies in combining forces of all stakeholders and your sustained support will be the key to accomplish that objec?ve for this up-­‐coming and future congresses. We welcome you not as any par?cipant but as a complementary component of the congress. It is very important for us that you are present ac?vely in the congress media. In addi?on to the sponsorship op?ons to pharmaceu?cal and medical devices companies, your poster submissions are highly appreciated. We would like to thank you in advance for your contribu?on to our efforts in organizing the congress that we believe will enhance the coopera?on and communica?on among stakeholders in clinical research con?nuously. Turkish Clinical Research Associa'on 2 ORGANIZATION COMMITTEE President Prof. Hamdi Akan, MD Scien'fic Secretary Hilal İlbars, PhD Pharm Administra've Secretary Nurşah Çe'nkaya 3 AGENDA March 27, 2015 Friday 09:00-­‐09:30
09:30-­‐10:30
10:30-­‐11:00
11:00-­‐12:45
12:45-­‐14:00
14:00-­‐14:45
OPENING REMARKS Prof. Hamdi AKAN ,MD, President-­‐ Turkish Clinical Research Associa?on Prof. Seçil ÖZKAN, MD, Former President-­‐ Turkish Public Health Agency, Ministry of Health Prof.Özkan ÜNAL, MD, President-­‐ Turkish Medicines and Medical Devices Agency, Ministry of Health Prof. İrfan ŞENCAN,MD, Deputy Secretary, Ministry of Health Prof. Necdet ÜNÜVAR, MD, Head of Health, Family, Labour and Social Affairs Commission Parliament of Turkey (to be confirmed) PERSONALIZED MEDICINE AND CLINICAL RESEARCH Prof. Emin KANSU, MD, President-­‐ Interna?onal Society of Hematology Coffee Break MEDICAL DEVICES and CLINICAL RESEARCH Moderator: Ali Sait SEPTİOĞLU, MD, Vice President-­‐ Turkish Medicines and Medical Devices Agency, Ministry of Health Research and Development of Medical Devices in Turkey and the World Prof. Cengizhan ÖZTÜRK, MD, Boğaziçi University Department of Biomedical Engineering The Importance of Clinical Research in Medical Device Produc?on Asım HOCAOĞLU, Unit Manager-­‐ Turkish Medicines and Medical Devices Agency, Medical Device and Clinical Research Department Inves?gator’s View in Clinical Research of Medical Devices Prof. Ayşe Adile KÜÇÜKDEVECİ, MD, Ankara University Medical Faculty Department of Physical Therapy and Rehabilita?on Current Status and Boklenecks in Medical Device Development in Turkey Prof. Murat SEZER, MD, Koç University Medical Faculty Department of Cardiology Lunch Break CLINICAL RESEARCH in HERBAL PRODUCTS and COSMETICS Moderator: Prof. Işık TUĞLULAR, MD, Ege University Center of Pharmaceu?cal Development and Pharmacokine?cs Research (ARGEFAR) Clinical Research in Herbal Products Prof. Ulvi ZEYBEK, MD, Ege University Dean of Pharmacy Faculty Cosme?cs and Clinical Research Prof. Tuğrul DERELİ, MD, Ege University Faculty of Medicine Department of Dermatology 4 AGENDA March 27, 2015 Friday 14:45-­‐15:30
15:30-­‐15:45
15:45-­‐16:15
16:15-­‐17:15
17:15-­‐17:45
18:00 CLINICAL RESEARCH in STEM CELLS and VACCINES Moderator: Prof. Osman İLHAN, MD, Ankara University Medical Faculty Department of Hematology Stem Cell Studies in Turkey Murat ÖZTÜRK, MD, Department Head-­‐ Organ, Tissue Transplanta?on and Dialysis Services, General Directorate of Health Services Vaccine Studies in Turkey Prof. Aykut ÖZDARENDELİ, Erciyes University Medical Faculty Department of Medical Microbiology Coffee Break POSSIBLE MANIPULATIONS and MISTAKES in BIOAVAILABILITY/BIOEQUIVALENCE STUDIES Prof. Aydın ERENMEMiŞOĞLU, MD, Head-­‐ Erciyes University Hakan Çe?nsaya Good Clinical Prac?ce and Research Center TRANSPARENCY in CLINICAL RESEARCH Moderator: Prof. İsmail Hakkı AYHAN, MD, Board Member Turkish Clinical Research Associa?on Legal View for Transparency Inia?ves and Clinical Study Registry Systems Sevi FIRAT, Board Member Transparency Interna?onal Turkey Registry Requirements for Clinical Research and Observa?onal Drug Studies in Turkey Süheyla TOPRAK, Pharm, Unit Manager Clinical Research Department-­‐ Turkish Medicines and Medical Devices Agency, Ministry of Health TURKISH CLINICAL RESEARCH ASSOCIATION POSTER AWARDS Moderator: Hilal İLBARS, PhD, Head of Clinical Research Department-­‐ Turkish Medicines and Medical Devices Agency, Ministry of Health Steering Commikee Members; Prof. Meral TUNCER, MD, Başkent University Medical Faculty Department of Pharmacology Prof. Semra ŞARDAŞ, Marmara University Pharmacy Faculty Department of Toxicology Prof. Şule OKTAY, MD, KAPPA Training, Consultancy, Research Mee'ng Adjourn-­‐ Networking Coctail 5 AGENDA March 28, 2015 Saturday 09:30 -­‐10:30 10:30 -­‐11:00
11:00 -­‐12:30
PANEL DISCUSSION: WHAT SHOULD BE DONE in CLINICAL RESEARCH TO REACH THE OBJECTIVES in 2023 VISION of TURKEY? Moderator: Prof. Ahmet ARAMAN, Istanbul University Dean of Pharmacy Faculty Clinical Research of Pharmaceu?cals in Turkey Hüseyin YILMAZ, MD, Vice President-­‐ Turkish Medicines and Medical Devices Agency, Ministry of Health Current Status and Boklenecks in Pharmaceu?cal Development in Turkey Prof. Ahmet GÜL,MD, Istanbul University Istanbul Medical Faculty Department of Rheumatology Coffee Break INVESTIGATOR SPONSORED RESEARCH Moderator: Prof. Yağız ÜRESİN, MD, Istanbul University Istanbul Medical Faculty Department of Pharmacology NIH Support Programs Luis SALICRUP, Na?onal Ins?tute of Health, USA Turkish Ministry of Health Support Programs Assoc. Prof. Sema ZERGEROĞLU, MD, Department Head-­‐ General Directorate of Health Research, Ministry of Health Inves?gator Experience in Conduc?ng Research with EU Funds In Turkey Prof. İlhan SATMAN, MD, İstanbul University İstanbul Medical Faculty Department of Endocrinology ve Metabolism Inves?gator Experience in Conduc?ng Research with NIH funds In Turkey Prof. İlgi ERTEM, MD, Ankara University Medical Faculty Department of Pediatrics
12:30-­‐14:00
14:00-­‐14:30
14:30-­‐15:30
Lunch Break EXPANDED ACCESS to DRUGS Banu BAYAR, MD, Unit Head-­‐ Department of Ra?onal Drug Administra?on and Drug Supply Chain Management Turkish Medicines and Medical Devices Agency, MoH PANEL DISCUSSION: PATIENTS AS PARTNERS in CLINICAL RESEARCH Moderator: Prof. Kaan KAVAKLI, MD, Ege University Medical Faculty Department of Pediatric Prof. Yeşim KİRAZLI, MD, Ege University Medical Faculty Department of Physical Therapy and Rehabilita?on
Volunteer Representa?ves 6 AGENDA March 28, 2015 Saturday 15:30 -­‐15:45 Coffee Break 15:45-­‐16:15 RECENT STATUS of EUROPEAN DIRECTIVES in CLINICAL RESEARCH Şebnem YILDIRIMOĞLU, Associa?on of Contract Research Organisa?ons in Turkey 16:15-­‐17:00 DIGITAL WORLD and CLINICAL RESEARCH Moderator: Prof. Reşat ÖZARAS, MD, İstanbul University Cerrahpaşa Medical Faculty Department of Infec?ous Diseases Electronical Systems and Their Contribu?ons to Clinical Research Ayşe Ceren CÖRÜT, Yekta AYHAN, Murat EROĞLU Associa?on of Research Based Pharmaceu?cal Companies 17:00 CLOSING REMARKS Prof. İsmail Hakkı AYHAN, MD, Turkish Clinical Research Associa?on 7 
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March 28, 2015 Saturday AGENDA