1. Executive Summary
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1. Executive Summary
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Abu Dhabi is one of seven autonomous Emirates in the Federation of the United Arab Emirates (UAE). The highest legislative body in the UAE is the Federal Supreme Council which is comprised of seven members, one for each Emirate. The biotechnology and pharmaceutical industries in the UAE are regulated at both a federal and Emirate level. The UAE government has extensive powers of discretion and may impose fines or criminal sanctions for the breach of healthcare regulations. It is the intention of the UAE to position itself as a global player in the manufacture and provision of medication and healthcare services. This includes the implementation of leading technology and a focus on research and development to attract qualified medical professionals and researchers.
The regulations which have been developed by two of the Emirates, Abu Dhabi and Dubai, are the most advanced in the UAE and set the standard which is followed by the remaining five Emirates. In the Emirate of Abu Dhabi, the Department of Health (DOH) is the regulative body of the healthcare sector.
This guidebook focuses on the procedure to be followed for new clinical trial applications with medicinal investigational products in Abu Dhabi and will explore the acceptability of decentralized elements in clinical trials.
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