Browsing Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation) by Author "Dube, Admire"
Now showing items 1-4 of 4
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A Comprehensive Study on the Global Regulatory Requirements for the submission of a Post-Approval Change, specifically a Change in Manufacturing Site
Hoey, Barbara (University of the Western Cape, 2017)Regulatory requirements for post-approval changes vary for different countries around the world. It is a challenging and costly process for pharmaceutical companies to manage changes to the approved regulatory dossier over ... -
Ongoing development of guidelines for biosimilar medicines assessment in Uganda: Critical evaluation and recommendations for inclusion
Nantongo, Eva (University of Western Cape, 2020)A Biosimilar is defined as a biologic product that is similar but not identical to the reference/originator biologic product. Biologic products have raised hopes of improving the quality of life especially in the treatment ... -
Perceptions of the pharmaceutical industry and regulators in South Africa towards registration harmonisation in the Southern African Development Community (SADC)
Dhanraj, Keshnee (University of the Western Cape, 2021)Medicines have to be regulated in an effort to monitor their quality, safety, and efficacy. The process of medicines registration is lengthy, costly, and document-heavy. Many countries have limited expertise and resources ... -
Situation analysis study on nanomedicines regulation and assessment practices in Zazibona active countries
Mudyiwenyama, Linda Gracious (University of Western Cape, 2021)Nanomedicines are loosely defined as medicines that seek to apply nanotechnology. Currently, nanomedicines are available for clinical use, including treatments for cancer, high cholesterol, hepatitis, COVID-19 vaccination, ...