Drug and Medical Device Approval Process in the United Arab Emirates (UAE)
This course offers a detailed examination of the drug and medical device approval process in the United Arab Emirates (UAE), highlighting the robust regulatory framework overseen by the Ministry of Health and Prevention (MOHAP) and other key agencies. It provides a comprehensive overview of submission requirements, dossier content, and defined timelines for both drugs and medical devices, emphasizing rigorous standards for safety, efficacy, and quality. You will also explore advanced regulatory methodologies, including risk-based assessments and the adoption of digital submission systems, which streamline the approval process and enhance transparency. Additionally, it discusses the integral role of Health Economics and Outcomes Research (HEOR) in Health Technology Assessments (HTA) and market access decisions, while highlighting opportunities such as capacity building, digital transformation, and regional collaboration to further advance the UAE’s regulatory landscape and its position as a global leader in healthcare innovation.
Enrollment fee for full access is AED 775 ($210 USD)
Enrollment fee for full access is AED 775 ($210 USD)
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