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Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic

INTRODUCTION: Training opportunities for health product regulators are among the critical aspects in the strengthening of regulatory systems across the world. The need for training is reasonably higher among the National Regulatory Agencies (NRAs) in the Low- and Middle-Income countries (LMICs) whic...

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Autores principales: Dehaghi, Razieh Ostad Ali, Khadem Broojerdi, Alireza, Paganini, Lodovico, Sillo, Hiiti B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10233123/
https://www.ncbi.nlm.nih.gov/pubmed/37275356
http://dx.doi.org/10.3389/fmed.2023.1173291
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author Dehaghi, Razieh Ostad Ali
Khadem Broojerdi, Alireza
Paganini, Lodovico
Sillo, Hiiti B.
author_facet Dehaghi, Razieh Ostad Ali
Khadem Broojerdi, Alireza
Paganini, Lodovico
Sillo, Hiiti B.
author_sort Dehaghi, Razieh Ostad Ali
collection PubMed
description INTRODUCTION: Training opportunities for health product regulators are among the critical aspects in the strengthening of regulatory systems across the world. The need for training is reasonably higher among the National Regulatory Agencies (NRAs) in the Low- and Middle-Income countries (LMICs) which are faced with many regulatory challenges mostly rooted in the low availability of resources. The current study aimed at evaluating the suitability, impacts, and challenges related to the training of regulators from LMICs offered by the Swissmedic in collaboration with the World Health Organization (WHO). METHODOLOGY: An exploratory case study design using a qualitative approach was adopted to collect data from a total of 17 NRAs in different WHO regions using in-depth interviews and qualitative questionnaires. RESULTS: The participation of the trainees in the training was revealed to be motivated by the need to apply the obtained knowledge in addressing various challenges within their NRAs. Many lessons covering all key areas of health products regulation were reported by the trainees, whereby most of the lessons were already being implemented within their respective NRAs. However, challenges related to human, financial, and infrastructural resources were highlighted to hinder the ongoing efforts in putting the learned aspects into practice. Additionally, areas in which further regulatory assistance and suggestions for improving the training activities were pointed out. CONCLUSION: The highlighted gains from the WHO-Swissmedic collaborative training program call for other agencies and organizations to join hands in offering much-needed support towards addressing critical challenges facing the regulatory sector in the LMICs.
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spelling pubmed-102331232023-06-02 Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic Dehaghi, Razieh Ostad Ali Khadem Broojerdi, Alireza Paganini, Lodovico Sillo, Hiiti B. Front Med (Lausanne) Medicine INTRODUCTION: Training opportunities for health product regulators are among the critical aspects in the strengthening of regulatory systems across the world. The need for training is reasonably higher among the National Regulatory Agencies (NRAs) in the Low- and Middle-Income countries (LMICs) which are faced with many regulatory challenges mostly rooted in the low availability of resources. The current study aimed at evaluating the suitability, impacts, and challenges related to the training of regulators from LMICs offered by the Swissmedic in collaboration with the World Health Organization (WHO). METHODOLOGY: An exploratory case study design using a qualitative approach was adopted to collect data from a total of 17 NRAs in different WHO regions using in-depth interviews and qualitative questionnaires. RESULTS: The participation of the trainees in the training was revealed to be motivated by the need to apply the obtained knowledge in addressing various challenges within their NRAs. Many lessons covering all key areas of health products regulation were reported by the trainees, whereby most of the lessons were already being implemented within their respective NRAs. However, challenges related to human, financial, and infrastructural resources were highlighted to hinder the ongoing efforts in putting the learned aspects into practice. Additionally, areas in which further regulatory assistance and suggestions for improving the training activities were pointed out. CONCLUSION: The highlighted gains from the WHO-Swissmedic collaborative training program call for other agencies and organizations to join hands in offering much-needed support towards addressing critical challenges facing the regulatory sector in the LMICs. Frontiers Media S.A. 2023-05-18 /pmc/articles/PMC10233123/ /pubmed/37275356 http://dx.doi.org/10.3389/fmed.2023.1173291 Text en Copyright © 2023 Dehaghi, Khadem Broojerdi, Paganini and Sillo. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medicine
Dehaghi, Razieh Ostad Ali
Khadem Broojerdi, Alireza
Paganini, Lodovico
Sillo, Hiiti B.
Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic
title Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic
title_full Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic
title_fullStr Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic
title_full_unstemmed Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic
title_short Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic
title_sort collaborative training of regulators as an approach for strengthening regulatory systems in lmics: experiences of the who and swissmedic
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10233123/
https://www.ncbi.nlm.nih.gov/pubmed/37275356
http://dx.doi.org/10.3389/fmed.2023.1173291
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