Development of a checklist for the assessment of pharmacovigilance guidelines in Southern Africa: a document review.
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SUBMITTER: Makhene NL
PROVIDER: S-EPMC9880583 | biostudies-literature | 2023
REPOSITORIES: biostudies-literature
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Development of a checklist for the assessment of pharmacovigilance guidelines in Southern Africa: a document review.
Makhene Nokuthula L NL Steyn Hanlie H Vorster Martine M Lubbe Martie S MS Burger Johanita R JR
Therapeutic advances in drug safety 20230124
<h4>Introduction</h4>National regulatory systems in Southern Africa reflect various stages of maturity, and pharmacovigilance (PV) practices are not aligned. In the absence of guidance for formulating PV guidelines in Southern African Development Community (SADC) countries, this study aimed to create a checklist that may be used to assess the rigour of PV guidelines in this region and provide guidance for the National Medicines Regulatory Agency (NMRA) authors.<h4>Methods</h4>A document analysis ...[more]
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