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Optimal governance of and stakeholder involvement in a medicines regulatory authority to enable pharmaceutical innovation
Mini Dissertation (MBA)--University of Pretoria, 2017.
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| Format: | Thesis |
| Language: | English |
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University of Pretoria
2017
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| _version_ | 1867613549675675648 |
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| access_status_str | Open Access |
| author2 | Sutherland, Margie |
| author_browse | Sutherland, Margie |
| author_facet | Sutherland, Margie |
| collection | Thesis |
| dc_rights_str_mv | © 2017 University of Pretoria. All rights reserved. The copyright in this work vests in the University of Pretoria. |
| description | Mini Dissertation (MBA)--University of Pretoria, 2017. |
| format | Thesis |
| id | oai:repository.up.ac.za:2263/59740 |
| institution | University of Pretoria (South Africa) |
| language | English |
| last_indexed | 2026-06-10T12:37:55.093Z |
| license_str | Other — see source repository |
| provenance_str_mv | Harvested via OAI-PMH from UPSpace — University of Pretoria Institutional Repository |
| publishDate | 2017 |
| publishDateRange | 2017 |
| publishDateSort | 2017 |
| publisher | University of Pretoria |
| publisherStr | University of Pretoria |
| record_format | dspace |
| source_str | UPSpace — University of Pretoria Institutional Repository |
| spelling | oai:repository.up.ac.za:2263/59740 Optimal governance of and stakeholder involvement in a medicines regulatory authority to enable pharmaceutical innovation Sutherland, Margie ichelp@gibs.co.za Calder, Amanda UCTD Mini Dissertation (MBA)--University of Pretoria, 2017. The South African medicines regulatory authority will shortly be moving from under the control of the National Department of Health to become a Section 3A public entity with its own governance structure. This presents the ideal opportunity to address the urgent need for evaluation of stakeholder engagement and mechanisms to improve the efficiency of the regulatory authority. This research was designed in order to join and contribute to the on-going conversation regarding the optimum functioning of the medicines regulatory authority by evaluating stakeholder engagement and governance, through the perceptions of stakeholders involved in the regulation and approval of medicines in South Africa. Governance, stakeholder and industry dynamics theory provided the foundation on which the research was based, allowing the researcher to create a lens through which the results of the research were viewed. Qualitative, deductive exploratory research was performed using perceptions of twelve respondents. These included key stakeholders involved in the provision of pharmaceuticals, as well as medicine regulatory decision-makers. Perceptions of previous experiences with, and proposed future optimal frameworks for, stakeholder interaction and governance of the medicines regulator to enable innovation in the pharmaceutical industry were derived from in-depth interviews. The research found many areas of improvement urgently needed in the current model of governance of the medicines regulatory authority. New academic insight was developed into the efficiencies needed within a medicines regulatory authority, as well as the stakeholder interactions to improve efficiencies and operating conditions within the pharmaceutical industry. It was found that internal efficiencies within the medicines regulatory authority as well as more effective stakeholder interaction framework would better enable innovation of products and processes within the pharmaceutical industry. Analysis of themes derived from in-depth stakeholder interviews, along with the literature review, was used to construct a framework of optimal governance and stakeholder interaction of the new medicines regulatory authority. This provides a contribution to theoretical management literature and provides guidance for regulators and stakeholders to create an efficient regulatory system to allow for innovation and result in better quality healthcare for the public. ms2017 Gordon Institute of Business Science (GIBS) MBA Unrestricted 2017-04-07T13:05:25Z 2017-04-07T13:05:25Z 2017-03-30 2017 Mini Dissertation Calder, A 2017, Optimal governance of and stakeholder involvement in a medicines regulatory authority to enable pharmaceutical innovation, MBA Mini Dissertation, University of Pretoria, Pretoria, viewed yymmdd <http://hdl.handle.net/2263/59740> http://hdl.handle.net/2263/59740 en © 2017 University of Pretoria. All rights reserved. The copyright in this work vests in the University of Pretoria. application/pdf University of Pretoria |
| spellingShingle | UCTD Optimal governance of and stakeholder involvement in a medicines regulatory authority to enable pharmaceutical innovation |
| title | Optimal governance of and stakeholder involvement in a medicines regulatory authority to enable pharmaceutical innovation |
| title_full | Optimal governance of and stakeholder involvement in a medicines regulatory authority to enable pharmaceutical innovation |
| title_fullStr | Optimal governance of and stakeholder involvement in a medicines regulatory authority to enable pharmaceutical innovation |
| title_full_unstemmed | Optimal governance of and stakeholder involvement in a medicines regulatory authority to enable pharmaceutical innovation |
| title_short | Optimal governance of and stakeholder involvement in a medicines regulatory authority to enable pharmaceutical innovation |
| title_sort | optimal governance of and stakeholder involvement in a medicines regulatory authority to enable pharmaceutical innovation |
| topic | UCTD |
| url | http://hdl.handle.net/2263/59740 |