International Pesticide Operator Safety Meeting 2021: hand-held application scenarios in low- and middle-income countries

An international web meeting on the topic of operator safety for pesticide operators was held on 20–21 September 2021. The meeting provided an opportunity for experts from regulatory agencies, pesticide industry, the Food and Agriculture Organization (FAO), and other organizations to discuss operator safety in low- and middle-income countries (LMIC). The meeting focused on risk assessment and risk mitigation, the first steps to address operator safety. The key message at the meeting was the need for an operator exposure model that includes common hand-held scenarios used in LMIC and consistent personal protective equipment communication. The experts supported a transparent collaborative process that will enable us to build on the past efforts.

In Silico Trial Approach For Biomedical Products: A Regulatory Perspective

The modern pharmaceutical industry is creating a transition from traditional methods to advanced technologies like artificial intelligence. In the current scenario, continuous efforts are being made to incorporate computational modelling and simulation in drug discovery, development, design, and optimization. With the advancement in technology and modernization, many pharmaceutical companies are approaching in silico trials to develop safe and efficacious medicinal products. To obtain marketing authorization for a medicinal product from the concerned National regulatory Authority, manufacturers must provide evidence for the safety, efficacy, and quality of medical products in the form of in vitro or in vivo methods. However, more recently this evidence was provided to regulatory agencies in the form of modelling and simulation, i.e., in silico evidence. Such evidence (computational or experimental) will only be accepted by the regulatory authorities if it considered as qualified by them and this will require the assessment of the overall credibility of the method. One must consider the scrutiny provided by the regulatory authority to develop or use the new in silico evidence. The United States Food and Drug Administration and European Medicines Agency are the two regulatory agencies in the world that accept and encourage the use of modelling and simulation within the regulatory process. More efforts must be made by other regulatory agencies worldwide to incorporate such new evidence, i.e., modelling and simulation (in silico) within the regulatory process. This review article focuses on the approaches of in silico trials, its verification, validation, and uncertainty quantification involved in the regulatory evaluation of biomedical products that utilize predictive models.

The Role of the University in Entrepreneurial Ecosystems

Entrepreneurial ecosystems (EEs) exist to allow new ideas to flourish. EEs are made of many component parts: investors, established businesses, government and other regulatory agencies, entrepreneurs, and universities. Universities serve many purposes in the EE. They are sources of innovation and research, as well as training grounds for new talent. As they exist currently, universities have the potential to make profound impacts on the EEs they participate in, but they also have room for improvement. This chapter will discuss universities' current contributions to entrepreneurial ecosystems, the ways that they fail to reach their potential, and potential changes and improvements that could better enable them to support and encourage innovation.

Application of Plasma for the Removal of Pharmaceuticals in Synthetic Urine

Removal of pharmaceuticals in source-separated urine is an important step toward gaining acceptance of urine-derived fertilizers among important stakeholders such as consumers, farmers, and regulatory agencies. Advanced oxidation processes (AOPs)...

Food Adulteration

Food adulteration is a prevalent issue in the food industry. It affects safety and quality of food and causes harm to the health of the consumer. To reduce incidence of adulteration in food, it is necessary to study adulterants being added to food. Food safety concerns arise when adulteration occurs for a variety of reasons. The act includes use of expired ingredients, deceptive adulterated food labels, addition of harmful compounds to food, and more. Tests and techniques for suspected food items that are commonly adulterated with certain food or non-food products are studied and described here. The detection of adulteration in food sectors can be done qualitatively and quantitatively. Various methods like chemical analysis, spectroscopic, and chromatographic techniques used to detect adulteration are reviewed. Various laws and regulations are in effect around the world in order to prevent adulteration and ensure food safety to protect the consumers. Regulatory agencies play an important role in putting a check to food adulteration by monitoring the quality of food and penalizing defaulters.

Can Digital Therapeutics Open a New Era of Sleep Medicine?

Digital therapeutics (DTx) are products that provide evidence-based interventions driven by high-quality software programs to prevent, manage, or treat a medical disease. DTx are receiving increasing attention as a new therapeutic approach. Several DTx for insomnia are on the market, some of which have received approval by national regulatory agencies. DTx for insomnia are usually based on cognitive behavioral therapy for insomnia. No DTx for other sleep disorders, such as narcolepsy or sleep-related breathing disorders, have received regulatory authority approval as a medical device. DTx have the substantial benefits of being accessible and relatively low-cost. However, several issues related to DTx have not yet been fully resolved, and discussions regarding DTx are still in the early stages. To use DTx for sleep disorders as an effective treatment option in the future, considering the current status of DTx is necessary. This review discusses definitions and background of DTx; specific DTx for insomnia that have been developed; use of DTx for sleep and related psychiatric comorbid symptoms; global regulatory processes for DTx, including prescribing and medical billing issues; and remaining challenges regarding the use of DTx.

Patient and Citizen Participation in the Identification of Ethical Considerations Aiming to Address Uncertainty in the Evaluation of Promising Interventions in a Pandemic Context

Since the beginning of the COVID-19 pandemic, numerous studies have been conducted to identify interventions that could contribute to alleviating the burden it has caused. The Institut national d'excellence en santé et en services sociaux (INESSS) has played a key role in informing the government of Québec regarding the evaluation of specific pandemic-related interventions. This process took place in a context characterized by a sense of urgency to assess and recommend potential interventions that could save lives and reduce the effects of the disease on populations and healthcare systems, which increased the pressure on the regulatory agencies leading these evaluations. While some of the interventions examined were considered promising, results from COVID-19 studies often led to uncertainty regarding their efficacy or safety. Regulatory agencies evaluating the value of promising interventions thus face challenges in deciding whether these should be made available to the population, particularly when assessing their benefit-risk balance. To shed light on these challenges, we identified underlying ethical considerations that can influence such an assessment. A rapid literature review was conducted in February 2021, to identify the main challenges associated with the benefit-risk balance assessment of promising interventions. To reinforce our understanding of the underlying ethical considerations, we initiated a discussion among various social actors involved in critical thinking surrounding the evaluation of promising interventions, including ethicists, clinicians and researchers involved in clinical or public health practice, as well as patients and citizens. This discussion allowed us to create a space for exchange and mutual understanding among these various actors who contributed equally to the identification of ethical considerations. The knowledge and perspectives stemming from the scientific literature and those consulted were integrated in a common reflection on these ethical considerations. This allowed patients and citizens, directly affected by the evaluation of pandemic-related interventions and the resulting social choices, to contribute to the identification of the relevant ethical considerations. It also allowed for reflection on the responsibilities of the various actors involved in the development, evaluation, and distribution of promising interventions in a setting of urgency and uncertainty, such as that brought about by the COVID-19 pandemic.

RESISTANCE CONFERRING MUTATIONS IN SARS-CoV-2 DELTA FOLLOWING SOTROVIMAB INFUSION

Several Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) neutralising monoclonal antibodies (mAbs) have received emergency use authorisation by regulatory agencies for treatment and prevention of Coronavirus Disease 2019 (COVID-19), including in patients at risk for progression to severe disease. Here we report the persistence of viable SARS-CoV-2 in patients treated with sotrovimab and the rapid development of spike gene mutations that have been shown to confer high level resistance to sotrovimab in vitro. We highlight the need for SARS-CoV-2 genomic surveillance in at risk individuals to inform stewardship of mAbs use and prevent potential treatment failures.

Conflict of Interest Between Regulatory Agencies on Telecommunication Sector And Consequences of Improper Telecommunication Mast Installation in Nigeria

This paper examines various laws governing telecommunication installations in Nigeria with a view to addressing the perceived shortcomings in the laws. While the National Environmental Standards Regulatory and Enforcement Agency Act (NESREA Act) and the National Communications Commission (NCC Act) have been enacted to solve the problems associated with the effects of telecommunication mast installation in public places, the outcome of these laws seem inadequate for failure to provide effective means of enforcing same. The study considered the provisions of NESREA Act which is the principal Law enacted for ensuring that environ- mental standards are maintained and protected in Nigeria and the provisions of NCC Act which is the law that establishes the principal body which regulates telecommunication installations in Nigeria as well as other legislations. While NESREA in its Regulation provided for a setback of 10 metres, the NCC Act provided for a setback of 5 metres, which often conflicts and put victims at disadvantage and also conflict between the two regulatory bodies. It was observed that serious environmental hazards are linked to installation of tele- communication masts within/close to residential premises. Among these are leukemia, cancer, cracks on the buildings, pollution, such as water, land and air. The problems also include telecommunication masts falling on buildings and sometimes death due to sub- standard materials used in the installation as against the stated standard by the controlling regulatory bodies.

Assessment of Hazard and Risk Related Activities at Npdc-Ogini Oil Field Flow Station, Okpaile in Isoko North, Delta State, Nigeria

The activities of oil, Gas and energy contains numerous hazards which could lead to multiple disasters such as loss of capital, damage to reputation, and also degrading the environment. The Essence of job hazards analysis and risk assessment is to design a safe working environment and to control and reduced potential hazards. Both primary and secondary data sources were employed in this study. Topographic statistics were also obtained from goggle earth and STRM (30M x 30M resolution) download from the United State Geological Survey. Questionnaires were administered to 100 people from 3 different department at NPDC-Ogini flow station in a confidential manner. A descriptive statistics such as mean, mode, median and standard deviation were used through the Statistical Package for Social Sciences (SPSS) Version 20.2 and Microsoft Excel 2007 software to analyze the data generated. Inferential statistics were used to test the hypothesis. The hypothesis were tested using analysis of variance (ANOVA). The study has identified associated hazards and the risk level attached to the confirmed activities of Ogini field flow station. The analysis show that the F. calculated value was 0.759 and the F-table value was 0.471. Since the F- table value is less than the F-calculated value .The result of the hypothesis has also shown that there is no significant relationship between job hazards analysis and risk assessment of the flow station activities. Companies in this sector should have a proactive thinking and attitude towards all activities and also have a reasonable level of preparedness and preparedness plans in place in case of any incidence. If these hazards are properly managed and controlled with all measures in place and also adhering to all regulatory agencies both locally and internationally, the companies will achieve a zero goal in incidence and accidents.