Clinical Research at MENA

Challenges and Solutions

Inbunden, Engelska, 2022

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The meaning of Clinical Trials for humans has recently changed significantly,“evolved”, so to speak. In today’s environment, where ethical validity is much morestrictly controlled, this meaning is far beyond “human drug testing” and much closerto the “therapeutic goal”. The number of clinical trials in western countries that haveperceived this change has increased rapidly and continues to increase. Althoughthe number of clinical studies in the MENA region is increasing day by day, it is stillfar from its potential. Among the reasons for this are legal, technological, ethical,epidemiological, educational and economic factors. This book presents both thedifficulties encountered in conducting clinical trials in MENA and suggestions forsolving these difficulties.

Produktinformation

Utgivningsdatum2022-01-19
Mått148 x 210 x 0 mm
Vikt262 g
FormatInbunden
SpråkEngelska
Antal sidor142
FörlagPeter Lang AG
ISBN9783631811139

Tillhör följande kategorier

Medicinsk utrustning och medicinska tekniker inom Medicin
Nationalekonomi inom Ekonomi och ledarskap
Klinisk medicin och internmedicin inom Medicin
Farmakologi inom Medicin

Fatih Özdener graduated as a medical doctor from Hacettepe University Faculty ofMedicine in 1990 and practiced clinical medicine in Turkey for 5 years. He obtainedPhD in Pharmacology from Temple University in USA in 2000 and worked as apostdoctoral researcher at the same university prior to joining academia.Fatih Özdener has broad pharmaceutical industry experience at different local andregional medical functions including clinical operations, clinical quality and medicalmanagement in Turkey, Middle East and Africa. He has more than twenty publicationsin the fields of molecular and clinical pharmacology.Currently, he is a faculty member and a member of management board at BahcesehirUniversity School of Medicine and the program coordinator of PharmaceuticalMedicine master’s degree program at the same university.

Fatih Özdener : General Picture of Clinical Research at MENA — Hamdi Akan : Clinical Trial Designs of the Future – Getting Ready at MENA — Nihan Burul Bozkurt, Gökhan Özkan : The Role of Regulatory Authorities and TITCK — İrfan Çiçin, Ali Gökyer : Role of Investigator — Peri Aytaç, Aydın Erenmemişoğlu : Early Phase Clinical Trials – Importance of Entry to MENA — Özgür Kasapçopur, Mehmet Yıldız, Fatih Özdener : Ethical Considerations (Clinical Research in Pediatric and Sensitive Populations) — Bilge Aydın Temiz : The Requirement and Importance of Legal Regulations in Drug Clinical Trials — Mutlu Hayran, Deniz Yüce : Importance of Epidemiological Data — Barış Erdoğan, Le Vin Chin : Clinical Research and Healthcare Digitalization in the Middle East and Turkey — Fatih Ozdener : Sponsoring Clinical Trials at MENA – Need for New Pharmacoeconomic Models — Fatih Özdener, Alihan Sürsal, Zülfiye Gül : Good Clinical Practice Training from the Perspective of Raising Clinical Trial Awareness .