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Oct 26, 2017

Scientific program of the 3. National Clinical Research Congress..

Download the program in pdf..

Program – Friday November 24th, 2017

08:00-09:00

REGISTRATION

 

09:00-09:15

OPENING REMARKS

Prof. Ismail Hakki AYHAN, Clinical Research Association of Turkey

Hakki GURSOZ, President, Ministry of Health Turkish (MoH) Medicines and Medical Devices Agency

Prof. Fahrettin KELESTEMUR, President, Health Institutes of Turkey

09:15-10:30

POSITION OF CLINICAL RESEARCH AMONG THE PRIMARY TRANSFORMATION PROGRAMS

Chairperson: Prof. Emin KANSU, Turkish Academy of Sciences

Clinical Research in the Program of Health Industries Structural Transformation

Nihan Burul BOZKURT, Head of Clinical Research Department MoH Turkish Medicines and Medical Devices Agency

Support Programs of the Scientific and Technological Research Council of Turkey (TUBİTAK)

Prof. Sevim AYDIN, TUBİTAK Academic Research Funding Directorate

Health Institutes of Turkey’s view about Clinical Research

Prof. Dr. Ilhan SATMAN, Health Institutes of Turkey

10:30-11:00

Coffee Break

 

 

 

 

 

 

11:00-12:15

SUCCESSFUL CLINICAL RESEARCH ENVIRONMENT DEVELOPMENTAL MODELS FROM THE WORLD

Chairperson: Mete HUSEMOGLU, Association of Research Based Pharmaceutical Companies

Korean National Enterprise for Clinical Trials (KoNect)

Deborah CHEE, President KoNect, South Korea

South Korean Model in Clinical Research

Betul Erdogan SARILICAN, MSD Turkey, Clinical Research Director for Turkey, Middle East, Egypt

The UK as a Clinical Research Destination

Divya Chadra MANEK, NIHR Clinical Research Network, UK

12:15-13:45

Lunch

 


 

Program – Friday November 24th, 2017

 

13:45-15:00

RECENT DEVELOPMENTS ABOUT CLINICAL RESEARCH IN TURKEY

Chairperson: Ali ALKAN, Vice President MoH Turkish Medicines and Medical Devices Agency

Current Situation of Clinical Research in Pharmaceuticals

Inci SOMUNCUOGLU, Head of Unit for Approval of Clinical Studies MoH Turkish Medicines and Medical Devices Agency Clinical Research Department

Recent Updates in Clinical Research of Medical Device

Asim HOCAOGLU, Head of Department for Notified Bodies and Medical Device Clinical Research- MoH Turkish Medicines and Medical Devices Agency

Regulation of Clinical Research in Cosmetic Products and Situation in Practice

Prof. Ozgen OZER, Ege University Faculty of Pharmacy Department of Pharmaceutical Technology

15:00-15:30

Council of Higher Education view about Clinical Research

Assoc. Prof. Zeliha Kocak TUFAN, Council of Higher Education

15:30-16:00

Coffee Break

16:00-16:30

OVERVIEW OF TURKISH MEDICINES AND MEDICAL DEVICES AGENCY (TMMDA) ABOUT INSPECTION IN CLINICAL RESEARCH

Chairperson: Fatih TAN, Vice President MoH TMMDA

Adem ABAY, Inspector, MoH TMMDA

Serkan OZTURK, Head of GCP/GLP Inspection Unit MoH TMMDA

16:30-17:00

NON-COMMERCIAL CLINICAL STUDIES

Prof. Dr. Yagiz URESIN, Istanbul University Istanbul Faculty of Medicine Department of Pharmacology  

17:00-17:30

ASSOCIATION OF CLINICAL RESEARCH BEST POSTER AWARDS

Chairperson: Prof. Dr. Meral TUNCER, Baskent University Faculty of Medicine Department of Pharmacology

Selection Committee Members;

Prof. Semra SARDAS, Marmara University Faculty of Pharmacy Department of Toxicology

Prof. Sule OKTAY, KAPPA Education Consulting Research

Emel TETIK, Sanofi Clinical Research Director for Turkey and Middle East

17:30

RECEPTION

 


 

Program – Saturday, November 25th, 2017

09:00-10:15

CLINICAL RESEARCH IN BIOLOGICAL MOLECULES

Chairperson: Prof. Aydin ERENMEMISOGLU, Erciyes University Hakan Cetinsaya Good Clinical Practice and Research Center

Preclinical and Clinical Research in Biological Molecules

Irem YENICE, ARVEN Pharmaceuticals

High Quality Biosimilar Product Development: Preclinical and Clinical Study Principles

Prof. Serdar ALPAN, Head of TURGUT Biotechnology Group

What should be our Strategy in Biological Molecules?

Tuygan GOKER, TR-PHARM

10:15-10:45

Coffee Break

 

 

 

 

 

 

10:45-11:30

CLINICAL RESEARCH IN RARE DISEASES

Chairperson: Prof.Dr. Ahmet GUL, Istanbul University Istanbul Faculty of Medicine Department of Rheumatology

Orphanet and Rare Diseases in Turkey

Prof. Ugur OZBEK, Acibadem University Faculty of Medicine Department of Medical Genetics

Problems of Investigators in Rare Diseases

Prof.Dr. Meral KAYIKCIOGLU, Ege University Faculty of Medicine Department of Cardiology

11:30-12:00

CLINICIAN versus STATISTICIAN

Prof Mutlu HAYRAN, Hacettepe University Institute of Oncology

Prof.Hamdi AKAN, Ankara University Faculty of Medicine, Hematology Clinical Research Unit

12:00- 13:00

Lunch

 

 

 

 

 

 

13:00-13:45

PHASE 1 CLINICAL RESEARCH SITES IN TURKEY

Chairperson: Prof. Kaan KAVAKLI, Ege University Faculty of Medicine Department of Pediatric Hematology

Being a Phase 1 Site in Turkey

Ass. Prof. Zafer SEZER, Erciyes University Hakan Cetinsaya Good Clinical Practice and Research Center

Site Selection Criteria for Early/Late Phase I Studies

Semra YORUK, Sanofi R&D Global Medical Operation, Oncology and Rare Diseases

 

Program – Saturday, November 25th, 2017

 

 

13:45-14:30

SUBJECTS IN CLINICAL RESEARCH

Chairperson: Prof. Meral BEKSAC, Ankara University Faculty of Medicine Department of Hematology

Healthy Volunteers

Dr. Ozgur SOYDAN, Hakan Cetinsaya Good Clinical Practise Center Quality Assurance Department

BEING A VOLUNTEER IN CLINICAL RESEARCH

Volunteer Representative

14:30-15:00

Coffee Break

15:00-16:45

FUTURE ASPECTS IN CLINICAL RESEARCH

Chairperson: Prof. Murat AKOVA, Hacettepe University Faculty of Medicine Department of Infection Diseases and Clinical Microbiology

New Designs in Clinical Studies

Prof. Irfan CICIN, Trakya University Faculty of Medicine Department of Oncology

Informatics in Clinical Research

Prof. Alper CİHAN, MoH Council of Health Politics

Latest Developments of Clinical Research in the EU Directive

Tome DENORME, MSD Regulatory Project Lead, Global Clinical Trials Operations, Belgium

Predictable Budget in Clinical Research in Turkey and Problems about Contract Process

Ebru Kubra TASKENT, ICON

16:45-17:00

CLOSING REMARKS

Nursah CETINKAYA, NER Medical Research Consulting

 

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