Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation)

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Browsing by Author "Egieyeh, Samuel"

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    Feasibility of an internationally recognized conformitè europëenne equivalent mark for medical devices in africa: a review of current literature
    (University of the Western cape, 2024) Nkuku, Khanyisile Zachia; Egieyeh, Samuel
    Medical devices are crucial to health systems and are critical to addressing the disease burden of African countries. In light of the importance of diagnosis and surgical intervention in healthcare, medical devices such as radiation emitting devices and devices incorporating a substance, are held to a high standard of quality and safety. Hence, the regulation of medical devices is required to optimize their use in healthcare within Africa. To successfully transition from the existing unregulated medical device sector to a thorough regulatory framework, many nations lack both the financial and technological resources. Consequently, organizations attempting to manufacture and market medical devices confront numerous obstacles, such as navigating the regulatory frameworks of various other nations and creating sustainable business models for imported medical devices. Many nations, including countries in Africa such as South Africa, Nigeria, and Ghana, require Conformitè Europëenne (CE) marked products which can only be obtained in Europe, making it extremely costly for local African manufacturers of medical devices to bring their products onto the market in these African countries
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    Feasibility of an internationally recognized conformitè europëenne equivalent mark for medical devices in Africa: a review of current literature
    (Universty of the Western Cape, 2024) Nkuku, Khanyisile Zachia; Egieyeh, Samuel
    Medical devices are crucial to health systems and are critical to addressing the disease burden of African countries. In light of the importance of diagnosis and surgical intervention in healthcare, medical devices such as radiation emitting devices and devices incorporating a substance, are held to a high standard of quality and safety. Hence, the regulation of medical devices is required to optimize their use in healthcare within Africa. To successfully transition from the existing unregulated medical device sector to a thorough regulatory framework, many nations lack both the financial and technological resources. Consequently, organizations attempting to manufacture and market medical devices confront numerous obstacles, such as navigating the regulatory frameworks of various other nations and creating sustainable business models for imported medical devices. Many nations, including countries in Africa such as South Africa, Nigeria, and Ghana, require Conformitè Europëenne (CE) marked products which can only be obtained in Europe, making it extremely costly for local African manufacturers of medical devices to bring their products onto the market in these African countries. This study examined the feasibility of establishing an African-based equivalent of Conformitè Europëenne mark (CE mark) with a similar standard to that in Europe for indigenous African medical device manufacturers. The study also explored how such African-based CE mark will encourage innovation and expand access to medical devices in Africa.
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    Knowledge, perceptions and practices of risk-based monitoring among clinical practitioners in the United States
    (University of the Western Cape, 2018) Hockin, Jennifer; Egieyeh, Samuel
    This study investigated the current knowledge, perceptions, and practices of Risk-Based Monitoring (RBM) using written and verbal responses to an ethics review board approved questionnaire. Responses were collected from individuals involved in the practice, oversight, and implementation of clinical trial monitoring in the USA. RBM was viewed as a positive force with a bright future. However the results suggested that a renewed focus on change management strategies is needed to ensure RBM practices penetrate all levels of clinical trial management. The site sponsor/site operational relationship was identified as a key RBM component. Shortcomings in this relationship were identified as significant operational barriers to effective RBM practice. Respondents indicated that current RBM training efforts were lacking. Because RBM is new and its practices deviate significantly from the past total monitoring efforts, both industry and the clinic need to work harder to ensure that everyone involved in clinical trial monitoring understands these differences. Fortunately, overcoming the identified barriers will not require massive changes to current RBM practice. By refocusing efforts on the sponsor/CRO and investigative sites to attain RBM governance, develop quality control plans, institute an optimal RBM platform, and improve training, the true promise of RBM is within reach. Each of these are critical pieces to an effective RBM implementation methodology and correcting initial stumbles in their implementation can assure the RBM future is as promised.