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This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified,...
This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox.Over the past decade, pharmaceutical companies and regulatory agencies...
Benefit-risk assessment is at the centre of the approval process for every new medicine. The ability to assess the risks of a new medicine accurately and to balance these against the benefits the medicine could bring is critical for every regulatory authority and...
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