Search Results - "Keyter, Andrea"

Can Standardisation of the Public Assessment Report Improve Benefit-Risk Communication? by Keyter, Andrea, Salek, Sam, Banoo, Shabir, Walker, Stuart

“…National regulatory authorities (NRAs) make the decision to register a medicine based on an assessment of its benefits and risks and publicly available…”
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South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access by Keyter, Andrea, Salek, Sam, Danks, Lorraine, Nkambule, Portia, Semete-Makokotlela, Boitumelo, Walker, Stuart

“…Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority…”
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The South African Medicines Control Council: Comparison of Its Registration Process With Australia, Canada, Singapore, and Switzerland by Keyter, Andrea, Salek, Sam, Banoo, Shabir, Walker, Stuart

“…Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into…”
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The South African Regulatory System: Past, Present, and Future by Keyter, Andrea, Banoo, Shabir, Salek, Sam, Walker, Stuart

“…The drive for improved regulatory systems and the establishment of a more effective regulatory framework in South Africa has been evident for the past two…”
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A Proposed Regulatory Review Model to Support the South African Health Products Regulatory Authority to Become a More Efficient and Effective Agency by Keyter, Andrea, Salek, Sam, Banoo, Shabir, Walker, Stuart

“…National regulatory agencies of various sizes and maturity levels, including the South African Health Products Regulatory Authority (SAHPRA), have had to…”
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The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System by Keyter, Andrea, Gouws, Joey, Salek, Sam, Walker, Stuart

“…The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the…”
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Evaluation of the Performance of the South Africa Regulatory Agency: Recommendations for Improved Patients' Access to Medicines by Keyter, Andrea, Salek, Sam, Gouws, Joey, Banoo, Shabir, Walker, Stuart

“…Timely access to new medicines may be addressed through strengthening of registration efficiencies and timelines by establishing and refining value-added…”
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