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2022 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Ana Claudia Mazzonetto ◽  
Ana Carolina Fernandes ◽  
Aretusa Dias de Souza ◽  
Vanessa Mello Rodrigues ◽  
Tailane Scapin ◽  
...  

PurposeThis study aimed to examine the perceptions and preferences of Brazilian adult consumers about four different front-of-pack (FOP) food labeling systems proposed by the Brazilian National Health Regulatory Agency.Design/methodology/approachThis is a qualitative study conducted with 33 participants allocated in six focus groups. Four different types of FOP labels were displayed on processed and packaged bread: three interpretive warning labels (black triangle, black octagon and red ellipse) and a hybrid model (nutritional traffic light). Thematic analysis was used to identify the key topics addressed by participants.FindingsThree topics were identified: label design, clarity and precision of information. The results demonstrated an influence of labels on product development and consumers' food choices. Most participants expressed a preference for black warning labels and reported the importance of statements endorsed by the Ministry of Health, which provide credibility and could influence food choices. Furthermore, participants agreed that the traffic light system provides more information but is difficult to interpret when comparing products. Warning labels were reported to have the greatest influence on purchase decisions. However, participants were concerned about how to understand the lack of warning labels on some products.Practical implicationsThe results may help and support the Brazilian Health Regulatory Agency to identify and recommend the most effective FOP labeling system to be adopted in Brazil.Originality/valueFew studies investigating adult consumers' perceptions of different FOP label formats have been conducted in the Brazilian context. Our study contributes to the small pool of evidence on the topic by demonstrating that FOP labels can be helpful for consumers when they are presented in an intuitive, interpretative and trustworthy format.


BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e052686
Author(s):  
Ekaterine Ruadze ◽  
Ekaterine Cherkezishvili ◽  
Elisa Roma ◽  
Kieran Walsh ◽  
Tamar Gabunia ◽  
...  

ObjectiveContinuing medical education (CME) is a vital component of health systems. Setting up a CME system is a complex task, requiring involvement of stakeholders including educators, learners, institutions and policy makers. The aim of the study was to conduct qualitative research involving multiple stakeholders to explore the perceived effectiveness and shortcomings of the CME system in Georgia, its place in the health system and potential means of improving it.DesignThis is a qualitative study. All data were collected using semistructured individual interviews. The questions were derived from the relevant literature. Data analysis was conducted using comparative strategy.ParticipantsWe interviewed individuals from CME providers, medical establishments, the professional development board (PDB), and the Regulatory Agency for Medical and Pharmaceutical Activities. We thus interviewed 23 people (11 people from CME providers, 8 people from medical establishments, 3 PDB members and 1 person from Legal Entity under Public Law Regulatory Agency for Medical and Pharmaceutical Activities).ResultsGeorgia has had experience of mandatory CME in the past, which had been criticised for its poor quality and bureaucratic processes. CME is viewed as an essential developmental process for medical professionals, the outcome of which is to deliver high-quality medical care. Our interviewees identified a clear need for high-quality CME courses. However, significant challenges that need to be overcome include financial barriers, doctors’ attitudes to CME, a lack of CME courses in all medical specialties and relatively weak professional associations.ConclusionCME is widely recognised as an essential pillar in providing quality medical care. Establishing high-quality CME requires a strategic and holistic approach. In order to ensure the sustainable and effective implementation of the CME process, we need to take into account stakeholders’ interests and expectations, the socioeconomic status and development of the country, and past experiences of all relevant individuals and organisations.


2021 ◽  
Vol 59 (12) ◽  
pp. 184-184

AbstractOverview of: Medicines and Healthcare products Regulatory Agency. Topical corticosteroids: information on the risk of topical steroid withdrawal reactions. Drug Safety Update 2021;15(2):1.


2021 ◽  
Author(s):  
Solomon Shiihi ◽  
U G Okafor ◽  
Zita Ekeocha ◽  
Stephen Robert Byrn ◽  
Kari L Clase

Approximately 90% of the pharmaceutical inspectors in a pharmacy practice regulatory agency in West Africa have not updated their training on Good Manufacturing Practice (GMP) inspection in at least eight years. However, in the last two years the inspectors relied on learning-on-the job skills. During this time, the agency introduced about 17% of its inspectors to hands-on GMP trainings. GMP is the part of quality assurance that ensures the production or manufacture of medicinal products is consistent in order to control the quality standards appropriate for their intended use as required by the specification of the product. Inspection reports on the Agency’s GMP inspection format in-between 2013 to 2019 across the six geopolitical zones in the country were reviewed retrospectively for gap analysis. Sampling was done in two phases. During the first phase sampling of reports was done by random selection, using a stratified sampling method. In the second phase, inspectors from the Regulatory Agency from different regions were contacted on phone to send in four reports each by email. For those that forwarded four reports, two, were selected. However for those who forwarded one or two, all were considered. Also, the Agency’s inspection format/checklist was compared with the World Health Organization (WHO) GMP checklist and the GMP practice observed. The purpose of this study was to evaluate the reporting skills and the ability of inspectors to interpret findings vis-à-vis their proficiency in inspection activities hence the efficiency of the system. Secondly, the study seeks to establish shortfalls or adequacies of the Agency’s checklist with the aim of reviewing and improving in-line with best global practices. It was observed that different inspectors have different styles and methods of writing reports from the same check-list/inspection format, leading to non-conformances. Interpretations of findings were found to be subjective. However, it was also observed that inspection reports from the few inspectors with the hands-on training in the last two year were more coherent. This indicates that pharmaceutical inspectors need to be trained regularly to increase their knowledge and skills in order to be kept on the same pace. It was also observed that there is a slight deviation in placing sub indicators under the GMP components in the Agency’s GMP inspection format, as compared to the WHO checklist.


2021 ◽  
pp. 009539972110570
Author(s):  
Jolien van de Sande ◽  
Bert de Graaff ◽  
Diana Delnoij ◽  
Antoinette de Bont

In this paper, we explore how multiple accountability (MA) can enable an independent regulatory agency to deal with multiple conflicting public values in a complex and politically salient decision-making process. We examined the decision-making process of the Dutch National Health Care Institute on quality regulation of emergency care in the Netherlands. Using insights derived from ethnography, document analysis, and interviews, we show that MA resulted from strategic interactions between the Institute’s vertical and horizontal accountability forums. We argue that MA impeded efficiency but also enabled the Institute to deal with multiple conflicting public values.


Author(s):  
Daniel Cunha ◽  
◽  
Michelle Andrade ◽  

Expert perceptions have been increasingly used to perform risk assessments in airport predictive risk assessments in recent years. Although it is known that biases are less influential in groups of experts when compared to laypeople, they still can be residually present in such tasks with this specific group. Therefore, this article aims to propose (1) the pragmatic organization of knowledge about the biases that may affect airport risk assessments by groups of experts and (2) which of them most often arise in this type of analysis and at what intensity. For the development of the work, we carried out a dense bibliographic review of the theme. Later, we performed a predictive risk assessment and a survey, with the support of an experienced group of 30 experts from Brazilian regulatory agency and airport operators. After 1224 risk judgments, experts were able to clearly indicate regulations and their sections that are disproportionately more and less important in terms of risk, leading States to a better regulatory quality only by changing their logic of actions to a risk-based approach. Later the group answered a survey on a list of 12 heuristic biases created from the bibliographic review. Results showed that, in fact experts have a resistance to biases influence, mainly based in their academic and professional background, but also showed this influence is not exactly negligible. It was also possible to rank the heuristic biases in terms of importance and indicate that experts tend to concern with three hierarchical information characteristics when judging risk: at first, would be the form in which risk problems are presented; second, how they interpret information presented; and third, the amount of information presented.


2021 ◽  
Vol 6 (10) ◽  
pp. 413-428
Author(s):  
Norazlina Abdul Aziz ◽  
Siti Sarah Sulaiman ◽  
Muhammad Azril Roslan ◽  
Ku Mohd Amir Aizat Ku Yusof

The urge to be vaccinated has increased rapidly during the outbreak of the COVID-19 pandemic. Resorting vaccine products is seen as the only way to break the chain of COVID-19 spread and eventually stop the pandemic. To this dire need, many consumers face the dilemma to be vaccinated or to opt-out of the vaccination program when the safety issues of vaccine products are widely circulated. The Muslim consumers, particularly, experiences double worry on the issue of safety and halal status of the vaccine product. Due to the emergency call to have the vaccine in the market as soon as possible, the innovation and production were carried out in an expedited manner, and the necessity to have the vaccine be certified as halal was bypass. When the news on the vaccine product uses non-halal ingredients reaches the Muslim community in Malaysia, they were taken aback and demanded immediate answers from the authorities. Thus, in addressing this issue, this study intends to critically analyse the role of NPRA and JAKIM in ensuring the safety and halal status of a product with the aim of suggesting a review of the existing role. This article adopts a qualitative research methodology where interviews will be the supporting method to a library-based and doctrinal study.


Diversity ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 477
Author(s):  
Sergio Albertazzi ◽  
Elisa Monterastelli ◽  
Manuela Giovanetti ◽  
Emanuele Luigi Zenga ◽  
Simone Flaminio ◽  
...  

There is increasing interest in evaluating biodiversity to preserve ecosystem services. Researchers can sustain policymakers by providing tools, such as indexes and indicators, that need constant implementation to become accepted standards. Implementation may vary from re-evaluation of existing indicators to introduction of new ones based on emerging threats to biodiversity. With the aim of contributing to the compelling need to estimate and counterbalance pollinator loss, we screened existing bioindicators. We first selected indexes/indicators applied to agricultural contexts and concurrently endorsed by a regulatory agency. We then extended our analysis to indexes/indicators based on arthropod taxa and formally recognized at least by national bodies. Our procedure identified a combination of surveys of various animal taxa and remote landscape analyses (e.g., using a GIS and other cartographic tools). When the animals are arthropods, most indexes/indicators can only address confined environments (e.g., grasslands, riversides). Indicator strength was improved by the simultaneous inclusion of biotic and abiotic components. Pollinator sensitivity to changes at micro-habitat level is widely appreciated and may help distinguish agricultural practices. A biodiversity index based on pollinators, including a wide monitoring scheme supplemented by citizen science, is currently fostered at the European level. The results obtained using such an index may finally enable focusing of strategic funding. Our analysis will help to reach this goal.


Animals ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. 2797
Author(s):  
Sarah Depenbrock ◽  
Tara Urbano ◽  
Jessie Ziegler ◽  
Scott Wetzlich ◽  
Maaike O. Clapham ◽  
...  

Meloxicam is an anti-inflammatory drug used to treat pain and inflammation in ruminants including sheep, and pharmacokinetic studies are needed to protect the food supply from drug residues after use in food-producing animals. This study estimated plasma pharmacokinetic parameters and meat withdrawal intervals (WDI) for market sheep after multiple daily oral doses of meloxicam. Single and multiple dose plasma pharmacokinetic studies, a multi-dose tissue depletion study, and a follow-up study to investigate if events prior to slaughter were associated with differences in plasma meloxicam concentrations, all using sample data collected after completion of dosing, were completed. Using regulatory agency methods for calculating withdrawal times, an estimated WDI of at least 10 d following the last dose is recommended for market lambs treated with 10 daily oral 1 mg/kg doses of meloxicam tablets suspended in water. The effect of events surrounding slaughter on plasma meloxicam concentrations in lambs is unknown but should be considered if plasma samples are obtained immediately prior to or during the slaughter process and used for pharmacokinetic investigations.


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