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Training Needs Assessment and Capacity Building of Clinical Trial Assessors and Ethical Reviewers to Strengthen Regulatory Review in Tanzania.

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Title: Training Needs Assessment and Capacity Building of Clinical Trial Assessors and Ethical Reviewers to Strengthen Regulatory Review in Tanzania.
Authors: Mwamwitwa KW; Tanzania Medicines and Medical Devices Authority (TMDA), P. O. Box 77150, Dar es Salaam, Tanzania. ki313ssa@yahoo.com.; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania. ki313ssa@yahoo.com.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania. ki313ssa@yahoo.com., Munishi CG; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania., Makoye PM; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania., Maganga AM; Tanzania Medicines and Medical Devices Authority (TMDA), P. O. Box 77150, Dar es Salaam, Tanzania., Chambiri SM; Tanzania Medicines and Medical Devices Authority (TMDA), P. O. Box 77150, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania., Nyondo GG; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania., Mlugu EM; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania., Mwalwisi YH; Tanzania Medicines and Medical Devices Authority (TMDA), P. O. Box 77150, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania., Oriyo N; National Institute for Medical Research (NIMR), P. O. Box 9653, Dar es Salaam, Tanzania., Ally MS; Zanzibar Health Research Institute, P. O. Box 236, Zanzibar, Tanzania., Simai BO; Zanzibar Food and Drugs Agency, P. O. Box 3595, Zanzibar, Tanzania., Sabiiti W; Division of Infection and Global Health, School of Medicine, University of St. Andrews, St. Andrews, UK., Mmbaga BT; Kilimanjaro Clinical Research Institute (KCRI), P. O. Box 2236, Moshi, Kilimanjaro, Tanzania.; Kilimanjaro Christian Medical University College (KCMUCo), P. O. Box 2044, Moshi, Kilimanjaro, Tanzania., Mloka D; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania., Ntinginya NE; National Institute for Medical Research - Mbeya Medical Research Centre, Mbeya, Tanzania., Fimbo AM; Tanzania Medicines and Medical Devices Authority (TMDA), P. O. Box 77150, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania., Kaale EA; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.
Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2026 Jul; Vol. 60 (4), pp. 1135-1143. Date of Electronic Publication: 2026 Apr 27.
Publication Type: Journal Article
Journal Info: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE
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  Data: Training Needs Assessment and Capacity Building of Clinical Trial Assessors and Ethical Reviewers to Strengthen Regulatory Review in Tanzania.
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  Data: <searchLink fieldCode="AU" term="%22Mwamwitwa+KW%22">Mwamwitwa KW</searchLink>; Tanzania Medicines and Medical Devices Authority (TMDA), P. O. Box 77150, Dar es Salaam, Tanzania. ki313ssa@yahoo.com.; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania. ki313ssa@yahoo.com.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania. ki313ssa@yahoo.com.<br /><searchLink fieldCode="AU" term="%22Munishi+CG%22">Munishi CG</searchLink>; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.<br /><searchLink fieldCode="AU" term="%22Makoye+PM%22">Makoye PM</searchLink>; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.<br /><searchLink fieldCode="AU" term="%22Maganga+AM%22">Maganga AM</searchLink>; Tanzania Medicines and Medical Devices Authority (TMDA), P. O. Box 77150, Dar es Salaam, Tanzania.<br /><searchLink fieldCode="AU" term="%22Chambiri+SM%22">Chambiri SM</searchLink>; Tanzania Medicines and Medical Devices Authority (TMDA), P. O. Box 77150, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.<br /><searchLink fieldCode="AU" term="%22Nyondo+GG%22">Nyondo GG</searchLink>; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.<br /><searchLink fieldCode="AU" term="%22Mlugu+EM%22">Mlugu EM</searchLink>; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.<br /><searchLink fieldCode="AU" term="%22Mwalwisi+YH%22">Mwalwisi YH</searchLink>; Tanzania Medicines and Medical Devices Authority (TMDA), P. O. Box 77150, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.<br /><searchLink fieldCode="AU" term="%22Oriyo+N%22">Oriyo N</searchLink>; National Institute for Medical Research (NIMR), P. O. Box 9653, Dar es Salaam, Tanzania.<br /><searchLink fieldCode="AU" term="%22Ally+MS%22">Ally MS</searchLink>; Zanzibar Health Research Institute, P. O. Box 236, Zanzibar, Tanzania.<br /><searchLink fieldCode="AU" term="%22Simai+BO%22">Simai BO</searchLink>; Zanzibar Food and Drugs Agency, P. O. Box 3595, Zanzibar, Tanzania.<br /><searchLink fieldCode="AU" term="%22Sabiiti+W%22">Sabiiti W</searchLink>; Division of Infection and Global Health, School of Medicine, University of St. Andrews, St. Andrews, UK.<br /><searchLink fieldCode="AU" term="%22Mmbaga+BT%22">Mmbaga BT</searchLink>; Kilimanjaro Clinical Research Institute (KCRI), P. O. Box 2236, Moshi, Kilimanjaro, Tanzania.; Kilimanjaro Christian Medical University College (KCMUCo), P. O. Box 2044, Moshi, Kilimanjaro, Tanzania.<br /><searchLink fieldCode="AU" term="%22Mloka+D%22">Mloka D</searchLink>; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.<br /><searchLink fieldCode="AU" term="%22Ntinginya+NE%22">Ntinginya NE</searchLink>; National Institute for Medical Research - Mbeya Medical Research Centre, Mbeya, Tanzania.<br /><searchLink fieldCode="AU" term="%22Fimbo+AM%22">Fimbo AM</searchLink>; Tanzania Medicines and Medical Devices Authority (TMDA), P. O. Box 77150, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.<br /><searchLink fieldCode="AU" term="%22Kaale+EA%22">Kaale EA</searchLink>; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.; Regional Centre of Regulatory Excellence, (MUHAS-TMDA), School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.
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  Data: <searchLink fieldCode="JN" term="%22101597411%22">Therapeutic innovation & regulatory science</searchLink> [Ther Innov Regul Sci] 2026 Jul; Vol. 60 (4), pp. 1135-1143. <i>Date of Electronic Publication: </i>2026 Apr 27.
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