Home UAE Emirates Drug Establishment launches national programme for inspecting pharmacovigilance practices

Emirates Drug Establishment launches national programme for inspecting pharmacovigilance practices

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  • By Staff Reporter

DUBAI:  The Emirates Drug Establishment (EDE) has launched a specialised workshop dedicated to inspecting pharmacovigilance practices, to be implemented in collaboration between the Establishment and the pharmaceutical sector in the country.

The programme aims to equip national cadres with advanced skills to assess pharmacovigilance systems within pharmaceutical companies and to establish a proactive regulatory framework based on risk detection and analysis. It also aims to ensure the continued safety of medication and the quality of healthcare provided to patients in the UAE.

The workshop is the first of its kind to be held jointly by the Emirates Drug Establishment and the pharmaceutical sector in the field of pharmacovigilance inspection, in collaboration with the global company Sanofi. It is set to support the Establishment’s efforts in enhancing inspection readiness and introducing modern regulatory frameworks.

The workshop also falls under an integrated institutional approach adopted by the Establishment to implement its strategy of developing an advanced regulatory framework, strengthening medication safety and protecting patients through building specialised national capabilities and enhancing regulatory inspection preparedness in line with international best practices.

The two-day workshop explored ways to transfer practical expertise in inspecting pharmacovigilance practices. It trained participants on the full inspection cycle, including pre-inspection planning, identifying required documentation and regulatory requirements, implementing field procedures, and preparing detailed reports and follow-up plans.

The event reflects the partnership between the Establishment and the pharmaceutical sector aimed at accelerating medication-safety initiatives and enhancing transparency in pharmaceutical regulation and pharmacovigilance based on data and scientific evidence.

Dr. Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, said, “The launch of the national programme for inspecting pharmacovigilance practices will play a key role in supporting the Establishment’s strategy to build an integrated regulatory system that prioritises patient safety and is built on effective partnerships with the pharmaceutical sector. The Establishment is committed to developing a leading pharmaceutical oversight system based on proactive readiness and scientific evidence and driven by national competencies capable of leading this qualitative transformation.”

She added, “This initiative aligns perfectly with the Establishment’s strategy to develop an advanced health and pharmaceutical sector within a set of flexible and reliable regulatory frameworks that support innovation and strengthen trust in the healthcare system.”

The Establishment, Al Kaabi added, is currently exploring the expansion of this initiative to include advanced regulatory inspection programmes, the development of updated national guidelines for pharmacovigilance practices, and the integration of inspection outcomes into digital and analytical systems that support evidence-based decision-making, ultimately establishing a sustainable model for medication safety and quality of life in the UAE.

For her part, Preeti Futnani, MCO Lead & General Manager for Sanofi Specialty Care, GCC, said, “We are proud to support the Emirates Drug Establishment in this workshop implemented through official collaboration between regulatory authorities and the pharmaceutical sector. The UAE has established a clear vision for regulatory development, and we are committed to providing our global expertise to contribute to this endeavour. Pharmacovigilance is a shared responsibility, and by building strong systems together, we enhance trust and elevate the quality of care.”

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