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Azza Saleh Radwan

Ministry of Health, Egypt

Title: Overview of the clinical trials control in Egypt

Biography

Biography: Azza Saleh Radwan

Abstract

In response to an increase in conduction of clinical trials, Egypt has established many research ethics committees (RECs) during the last few years. Egyptian Ministry of health established REC since 2007 and it has been acting since this time to review all clinical trials undertaken in Egypt in addition to all Master and Doctorate theses conducted in the governmental hospitals. This REC has created its own Standard Operating Procedures (SOPs) as well all the guidelines needed to be followed by the Egyptian researchers in their submission to the REC. In addition the ministry initiated a project to create "clinicaltrial.mohp.gov.eg" to register all the clinical trials conducted in Egypt. In order to control and supervise the Contract research organizations (CRO’s), we register all the CRO’s acting in Egypt. The total number of CRO’s registered in MOH till date are 16, the first CRO was registered in 2013. Although we are doing a lot of effort still many steps has to be taken to reach the standard we are aiming to: we undergo many training courses in the fields of research ethics, good clinical practice, research methodology and biostatistics to build the capacities of our health researchers to be able to conduct more clinical trials and to have Egypt as an attracting sites for them. We aim to have several clinical research centers with the needed qualified staff to conduct such trials.