Health post COVID-19: Supranational regulatory reliance and coordination

The dominant position of the U.S. Food and Drug Administration (FDA) as the most influential regulator in the world has been particularly salient during the COVID-19 pandemic, in the context of COVID-19 vaccines' emergency use authorizations. In the context of adjustment toward a post-COVID-19 regulatory order of harmonization for medicines approval, this essay proposes a critical reflection about the justifications and political dynamics behind the FDA's power and its impact in latinamerican countries' regulatory systems, considering the already regulatory reliance on the FDA. In particular, this essay asks whether regulatory 'agility' and 'coordination' will benefit countries of the region in addressing the problems of scarcity and inequitable access to medicines that have become evident with the pandemic. © 2023 The Author(s). Oxford University Press and New York University School of Law. All rights reserved.

Medicinal Product Development and Regulatory Agilities Implemented During the Early Phases of the COVID-19 Pandemic: Experiences and Implications for the Future-An Industry View.

The COVID-19 pandemic caused considerable disruption to the development, regulatory evaluation, production, and distribution of medicinal products. Key healthcare stakeholders were under pressure to develop and review medicinal products to address the health emergency, while preserving the continuity of activities to ensure patient access to other medicinal products. In the light of this challenging situation, the National Regulatory Authorities (NRAs) and the biopharmaceutical industry applied and utilized product development and regulatory agilities to accelerate the development and authorization of safe, effective and quality COVID-19 vaccines and treatments as well as other non-COVID-19 medicinal products. On the basis of the literature review and primary research conducted, this review article gathered insights on experiences and challenges in the use of agilities related to regulatory assessment of initial marketing and post-approval change (PAC) applications, oversight of product manufacturing quality and supply chain continuity, and product development/clinical trial processes during the early phases of the COVID-19 pandemic. Agilities were thus implemented in an emergency context characterized by the lack of medicinal products to help tackle a disease that was devastating for the global public health. This review article concludes that useful lessons can be learned from these insights to improve product development practices and regulatory processes during both normal and health emergency times. Standard regulatory frameworks during normal times can be enhanced by leveraging digitalization, further simplifying and harmonizing requirements, and using reliance mechanisms which can help to increase efficiency in regulatory decision-making regarding medicinal products. During health emergencies, such as a pandemic, maximizing global coordination, collaboration, reliance, and harmonization of regulatory requirements and guidance are important to facilitate the rapid development and assessment of key medicinal products to address the health emergency.

Indian Sugar Industry: Towards Self-reliance for Sustainability.

The South-Asian region including India is a major hub of sugar producing countries with ample presence in the global sugar scenario. India has a rich history of sugarcane and sugar production since time immemorial, and the industry has gradually evolved to find a place among the top sugar producing countries of the world. The innovative technological interventions for sugarcane improvement, production and management have helped the industry to progress towards a diversified and bio-based productive, sustainable and profitable one, thereby gradually becoming self-reliant. This self-reliant industry with the right mix of linkages and collaborations, has been successful in tackling the various unforeseen challenges including those that cropped up during COVID-19 pandemic. The industry also fulfils its Corporate Social Responsibilities leading to the overall betterment of its stakeholders. This has enabled the Indian sugar industry to align itself with the 2030 Agenda for Sustainable Development Goals.

Salud postpandemia: influencia supranacional y coordinacion regulatoria Health post COVID-19: Supranational regulatory reliance and coordination

The dominant position of the U.S. Food and Drug Administration (FDA) as the most influential regulator in the world has been particularly salient during the COVID-19 pandemic, in the context of COVID-19 vaccines' emergency use authorizations. In the context of adjustment toward a post-COVID-19 regulatory order of harmonization for medicines approval, this essay proposes a critical reflection about the justifications and political dynamics behind the FDA's power and its impact in latinamerican countries' regulatory systems, considering the already regulatory reliance on the FDA. In particular, this essay asks whether regulatory 'agility' and 'coordination' will benefit countries of the region in addressing the problems of scarcity and inequitable access to medicines that have become evident with the pandemic.

Refugees in the Digital Economy: The Future of Work among the Forcibly Displaced

The current scale and duration of displacement prompts renewed urgency about livelihoods prospects for displaced people and the role of humanitarian organisations in fostering them. This special issue focuses on how aid organisations, together with the private sector and other actors, have worked to include refugees in new forms of online work within the web-based digital economy. Building on comparative analysis and a comprehensive review of the field of digital livelihoods among the forcibly displaced, in this introductory article we argue that including refugees in this digital economy is currently neither a sustainable form of humanitarian relief nor is it a development solution that provides large-scale decent work. We show how digital livelihoods approaches have gained a special footing in the middle ground between short-term economic relief and long-term development. Indeed, digital economies seemingly offer a variety of ‘quick-fix' solutions at the transition from humanitarian emergency towards long-term development efforts. While digital economies harbour significant potential, this cannot be fully realised unless current efforts to include refugees in digital economies are complemented by efforts to address digital divides, uphold refugees' rights, and ensure more decent working conditions.

Financial Inclusion or Encampment? Rethinking Digital Finance for Refugees

Humanitarian actors touting financial inclusion posit that access to financial services builds refugees' resilience and self-reliance. They claim that new digital financial tools create more efficient and dignified pathways for humanitarian assistance and enable refugees to better manage their savings and invest in livelihoods, especially during protracted displacement. Our in-depth, repeat interviews with refugees in Kenya and Jordan refute this narrative. Instead, self-reliance was hindered primarily by refugees' lack of foundational rights to move and work. Financial services had limited ability to support livelihoods in the absence of those rights. The digital financial services offered to refugees under the banner of ‘financial inclusion' were not mainstream services designed to empower and connect. Instead, they were segregated, second-class offerings meant to further isolate and limit refugee transactions in line with broader political desires to encamp and exclude them. The article raises questions about the circumstances in which humanitarian funding ought to fund financial service interventions and what those interventions are capable of achieving.

Telemedicine Use by Age in Louisiana Medicaid During COVID-19: Claims-Based Longitudinal Analysis.

BACKGROUND: Limited availability of in-person health care services and fear of contracting COVID-19 during the pandemic promoted an increased reliance on telemedicine. However, long-standing inequities in telemedicine due to unequal levels of digital literacy and internet connectivity among different age groups raise concerns about whether the uptake of telemedicine has exacerbated or alleviated those inequities. OBJECTIVE: The aim of this study is to examine changes in telemedicine and in-person health service use during the COVID-19 pandemic across age groups for Medicaid beneficiaries in the state of Louisiana. METHODS: Interrupted time series models were used on Louisiana Medicaid claims data to estimate trends in total, in-person, and telemedicine monthly office visit claims per 1000 Medicaid beneficiaries between January 2018 and December 2020. Changes in care pattern trends and levels were estimated around the infection peaks (April 2020 and July 2020) and for an end-of-year infection leveling off period (December 2020). Four mutually exclusive age categories (0 to 17, 18 to 34, 35 to 49, and 50 to 64 years) were used to compare the differences. RESULTS: Prior to the COVID-19 pandemic, telemedicine services accounted for less than 1% of total office visit claim volume across the age groups. Each age group followed similar patterns of sharp increases in April 2020, downward trends until sharp increases again in July 2020, followed by flat trends thereafter until December 2020. These sharp increases were most pronounced for older patients, with those aged 50 to 64 years seeing increases of 184.09 telemedicine claims per 1000 Medicaid beneficiaries in April 2020 (95% CI 172.19 to 195.99) and 120.81 in July 2020 (95% CI 101.32 to 140.31) compared with those aged 18 to 34 years, seeing increases of 84.47 (95% CI 78.64 to 90.31) and 57.00 (95% CI 48.21 to 65.79), respectively. This resulted in overall changes from baseline to December 2020 levels of 123.65 (95% CI 112.79 to 134.51) for those aged 50 to 64 years compared with 59.07 (95% CI 53.89 to 64.24) for those aged 18 to 34 years. CONCLUSIONS: Older Medicaid beneficiaries in Louisiana had higher rates of telemedicine claim volume during the COVID-19 pandemic compared with younger beneficiaries.

Social work for vulnerable and marginalized people during COVID-19 in Japan

During the Coronavirus disease pandemic (COVID-19), working conditions became increasingly difficult for social workers, as they had to deal with new challenges and added workloads. This study describes the difficulties faced by social workers of the Self-Reliance Support System in Japan and clarifies the solution for each difficulty while conducting their duties to support vulnerable people during COVID-19. To this end, we conducted an open-ended questionnaire survey and an interview survey. The data were analyzed using qualitative coding. The results showed that the difficulties faced in consultation support work included supporting hitherto socially invisible groups such as sole traders and foreigners. Social workers also faced an ethical dilemma, as they could not provide support to clients who "did not try to solve their problems” or for whom "interventional attempts did not lead to counseling support” and who only sought benefits at the risk of becoming isolated and impoverished. Following this, consultants collaborated to resolve such difficulties while maximizing the use of various local resources. The study's findings clarify that it would be effective to understand the difficulties faced by social workers to obtain hints toward their resolution. © 2023 John Wiley & Sons Australia, Ltd.

Quantitative Study on the Anxiety Level of High School Students in Pandemic Life

COVID-19 has impacted life of high school students worldwide. As distant learning became prevalent in the pandemic, the form of social anxiety has been taken from contingent and noncontingent interaction to a new degree of internet interaction, which will be divided into traits of loneliness, self-doubt, and internet reliance. This paper presented a survey resulting from a range of 235 students either distant or in-person learning examining their anxiety level in the three degrees. In addition, results were separated in grade and gender to test a deeper understanding of various factors that affect the level of social anxiety. Two factorial MANOVA analyses were executed with the result indicating no interaction significance between gender∗class grade∗class but significance difference among the gender level under the three anxiety variables. This contradicts the concept of what we define pandemic and online learning as greatly depressing. As distant learning became prevalent, one cannot conclude this mode had influenced students to become more anxious compared to the in-person learning ones, but the result of the study supported the idea that a higher anxiety level was reached in the general high-school students. © 2022 IEEE.

Lessons for resilience building in tourism and hospitality: the case of New Zealand. (Special Issue: What innovations would enable the tourism and hospitality industry to re-build?)

Purpose: This opinion piece outlines the actions taken by the New Zealand government and tourism sectors in response to Covid-19 and to explore the potential lessons for resilience building in tourism for other destinations. Design/methodology/approach: The analysis integrates descriptions of the Covid-19 outbreak and tourism related policy responses in New Zealand, taken from prominent medical, governmental and journalistic accounts. Findings: The resilience of the economy and domestic tourism was a major New Zealand policy priority, but this was seen by the Ardern administration as best achieved by first ensuring the health and well-being of the populace, as quickly and comprehensively as possible. This, in turn, required proactive, nationally coordinated measures designed to minimize the spread of Covid-19 including: lockdowns, preventive social-distancing and mask mandates, a four-level graduated strategy for ensuring national Covid-19 recovery (which later morphed into the "traffic light" system) and closely following the medical and epidemiological advice of experts in the related academic sciences. As a result of these, the negative impact on health, the overall economy and the tourism sector was substantially minimized, when compared with many other similar nations during the 2020-2022 period. Originality/value: The New Zealand experience holds important lessons for preserving and rebuilding the hospitality and tourism industry in the aftermath of Covid-19, and during future similar pandemics.

Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines.

This publication provides some industry reflections on experiences from the Chemistry, Manufacturing, and Controls (CMC) development and manufacture and supply of vaccines and therapies in response to the COVID-19 pandemic. It integrates these experiences with the outcomes from the collaborative work between industry and regulators in recent years on innovative science- and risk-based CMC strategies to the development of new, high-quality products for unmet medical needs. The challenges for rapid development are discussed and various approaches to facilitate accelerated development and global supply are collated for consideration. Relevant regulatory aspects are reviewed, including the role of Emergency Use/Conditional Marketing Authorizations, the dialogue between sponsors and agencies to facilitate early decision-making and alignment, and the value of improving reliance/collaborative assessment and increased collaboration between regulatory authorities to reduce differences in global regulatory requirements. Five areas are highlighted for particular consideration in the implementation of strategies for the quality-related aspects of accelerated development and supply: (1) the substantial need to advance reliance or collaborative assessment; (2) the need for early decision making and streamlined engagement between industry and regulatory authorities on CMC matters; (3) the need to further facilitate 'post-approval' changes; (4) fully exploiting prior and platform knowledge; and (5) review and potential revision of legal frameworks. The recommendations in this publication are intended to contribute to the discussion on approaches that can result in earlier and greater access to high-quality pandemic vaccines and therapies for patients worldwide but could also be useful in general for innovative medicines addressing unmet medical needs.

Reliability but not bias: Developing a scale to measure preferred channels for risk information during the COVID pandemic.

To develop a new measure of preferred sources for risk information, two studies asked respondents to indicate what channels they were reliant on for information about COVID-19, from 25 news channels ranging across the political spectrum. Unexpectedly, dependencies clustered around level of reliability rather than the political orientation of the news channel. In other words, each cluster included media channels from both the left and right side of the political spectrum, while dependencies clustered into sources that varied by the degree to which their content is reliable. Participants who turned to lower reliability channels indicated lower risk perceptions, less accurate probability estimations, reduced vaccination intentions, and lower protective behavioral intentions. Those inclined to use higher reliability channels indicated higher risk perceptions, more accurate probability estimations, increased vaccination intentions, and higher protective behavioral intentions. These relationships are discussed in terms of implications for our understanding of source reliance and risk perception, information sufficiency, and implications for both future research and public health interventions.

Politics of prevention in the periphery: the initial response to COVID-19 on Barbuda and Puerto Rico. (Special Section: Islands of refuge, islands of contagion.)

The islands of Barbuda and Puerto Rico share a history of dispossession and exploitation, occupying a peripheric position in a core-periphery world system. Yet, each island's response to COVID-19, and the subsequent effects of the pandemic, could not be more different. This paper examines how colonialism and neocolonialism affected the islands' ability to respond to COVID-19. Barbuda relied on community traditions of support and self-reliance and was able to restrict all travel to and from the island, including travelers from the diaspora and those participating in its informal economic sector. In doing so, Barbuda effectively isolated itself from infection. On the other hand, Puerto Rico, in a protracted economic crisis, was particularly vulnerable to touristic flows, diasporic movements, and a large informal sector. The Puerto Rican response was shaped by deep politicization in the mainland U.S., which complicated an evidence-based strategy to combat the emergency. These cases show that islands, particularly those located in peripheric or subaltern spaces, cannot isolate themselves from the worst effects of COVID-19 through mere geography. Pandemics are not only driven by biological events but also by the narratives of colonialism, encompassing political, economic, and cultural factors, which determine their trajectories - sometimes with devastating outcomes.

Reliance is key to effective access and oversight of medical products in case of public health emergencies.

INTRODUCTION: Responding to new threats and public health emergencies (PHE) creates serious challenges to regulators. The pandemic due to SARS-CoV-2 has been the catalyzer for change in global and local regulatory practices. Intensified collaboration, rapid and coordinated actions, and reliance mechanisms were key elements of the regulators' response to COVID-19 for all regulatory functions. AREAS COVERED: This article presents how collaboration and reliance among regulators were crucial tools for the regulatory responses to COVID-19, describes the reliance approaches for authorization of COVID-19 vaccines and other commodities, and the importance of reliance for other regulatory functions to avoid duplication and save resources where possible. This article also presents the results of a follow-up survey of reliance approaches in case of public health emergencies conducted between the International Pharmaceutical Regulators Programme (IPRP) members and discusses the forward-looking potential of reliance, analyzing the journey from theoretical concepts to real-life implementation. EXPERT OPINION: Regulatory reliance is an essential tool for regulators to act quickly and collectively in times of public health emergencies. Reliance approaches facilitate regulatory approvals and allow a more efficient use of resources, ultimately serving patients by facilitating earlier access to quality assured, safe and effective medicines.

Did tourism dependence exacerbate economic contractions over and above COVID? Preliminary evidence and clues for identifying optimal tourism levels

The COVID pandemic brought an unwelcome but rare natural quasi-experimental condition to empirically observe the effect of varying levels of tourism dependence on the intensity of economic contraction, vulnerability, and exposure to risks faced by countries when extreme circumstances and global shock events such as COVID cause travel and tourism activity to contract to zero or near-zero levels. Previous studies examining how to optimize tourism specialization, activity, or carrying capacity have thus far ignored scenarios in which global and local travel could be severely curtailed in such short, unexpected, manner and on a massive scale involving nearly all countries. This study aims to fill this knowledge void. Findings suggest that while almost all economies faced extraordinary contraction in 2020 due to the COVID pandemic, countries more heavily reliant on tourism for economic growth fared more poorly. Analysis also suggests that tourism dependence likely inflicted greater impact on economic contraction than the pandemic itself. Implications for long-term sustainable tourism levels incorporating worst case scenarios and based on the rare circumstance ushered by the pandemic are discussed.

Career beliefs, self-efficacy and VUCA skills: a study among generation Z female students of tourism and hospitality. (Special Issue: Hospitality, leisure, sport and tourism education and COVID-19 disruptions.)

The purpose of the paper is to understand the relationship among career beliefs, career self-efficacy, and social support in developing the VUCA skillset among female tourism and hospitality students from generation Z in India. The COVID-19 pandemic is an apt example of the VUCA. Data was collected from 655 female tourism and hospitality students from the northeastern region of India, and analyzed with structural equation modeling. Results reveal that career belief and career self-efficacy values were positively related to social support and explain the variance in social support. However, career belief does not have a significant effect on VUCA.

CORPORATE GOVERNANCE MECHANISM AND FINANCIAL STATEMENT FRAUD: THE COMPLIANCE TO MCCG 2017 DURING COVID-19 PANDEMIC

Business governance is definitely a worrying issue within the worldwide level, since the incidences associated with business problems plus insolvencies are usually upsurging quickly, particularly in the building nations such as Malaysia. Even though rules in addition to rules are usually created in order to motivate clear monetary confirming amongst businesses, the particular effectiveness from the execution is nevertheless something, given that the particular opportunistic behavior regarding professionals plus administration continue to be within the increase. With regards to the particular scams triangular design, the problem in the Covid-19 outbreak offers an additional chance for companies to do deceptive confirming in order to hide their own company deficits, therefore showing up a lot more lucrative with regard to traders. Consequently, the purpose of this particular research would be to evaluate the result associated with inner company governance system around the event of economic declaration scam throughout Covid-19 outbreak. The particular factors involving corporate and business governance are usually from the particular Malaysian Program code upon Business Governance 2017. Typically the supplementary information were extracted from the particular 2020 Yearly Reviews associated with 265 businesses which are on the Primary Marketplace regarding Bursa Malaysia. The program associated with SPSS has been utilized to carry out information evaluation with this examine. The outcomes uncover that this factors involving table self-reliance, panel sex plus review panel self-reliance possess an unfavorable organization along with economic declaration fraudulence. On the other hand, the particular factors associated with table age group, plank racial and even examine panel experience had been discovered to indicate an optimistic partnership together with deceitful confirming. Apart from, the outcomes furthermore highlighted that will panel period failed to possess any kind of partnership along with economical declaration scams, that was contrary to a lot of literatures previously. In addition, underneath the evaluation associated with mediating parameters, review panel dimension has been discovered to possess a mediating impact on typically the organization among taxation panel self-reliance together with monetary assertion scams. Nevertheless, the particular adjustable associated with aboard sizing had not been capable to mediate the connection in between mother board period plus fiscal declaration scam. Lastly, within the facet of assessment among possible in addition to non-potential bogus companies, it had been identified of which each forms of businesses experienced various conformity towards the business governance factors. Therefore, in line with the results, this specific analyze has furnished a few suggestions plus recommendations for long term research to improve typically the books this place.

Developing a sense of self-reliance: caregivers of infants with single-ventricle heart disease during the interstage period.

BACKGROUND: Caring for infants after the first-stage palliative surgery for single-ventricle heart disease bring challenges beyond the usual parenting responsibilities. Current studies fail to capture the nuances of caregivers' experiences during the most critical "interstage" period between the first and second surgery. OBJECTIVES: To explore the perceptions of caregivers about their experiences while transitioning to caregiver roles, including the successes and challenges associated with caregiving during the interstage period. METHODS: Constructivist Grounded Theory methodology guided the collection and analysis of data from in person or telephonic interviews with caregivers after their infants underwent the first-stage palliative surgery for single-ventricle heart disease, and were sent to home for 2-4 months before returning for their second surgery. Symbolic interactionism informed data analyses and interpretation. RESULTS: Our sample included 14 parents, who were interviewed 1-2 times between November, 2019 and July, 2020. Most patients were mothers (71%), Latinx (64%), with household incomes <$30K (42%). Data analysis led to the development of a Grounded Theory called Developing a Sense of Self-Reliance with three categories: (1) Owning caregiving responsibilities despite grave fears, (2) Figuring out how "to make it work" in the interstage period, and (3) Gaining a sense of self-reliance. CONCLUSIONS: Parents transitioned to caregiver roles by developing a sense of self-reliance and, in the process, gained self-confidence and decision-making skills. Our study responded to the key research priority from the AHA Scientific Statement to address the knowledge gap in home monitoring for interstage infants through qualitative research design.

The need for revision of selected aspects of online Master's and doctoral student supervision

Since the onset of the COVID-19 pandemic, higher education institutions have been concerned about their Master and doctoral students, in particular how and when they would be able to continue and complete their research activities and dissertations. Scholars have noted the potential deterioration in the quality of research projects for a variety of reasons (transformation and/ or abandoning of approved research methods, anxiety-related lowered performance rates, altered modes of supervision and delays in completion times). In this article, I discuss the findings of a small-scale study, undertaken in July 2020, on whether there has been a significant change in the supervision of Master's and doctoral students in Africa due to the outbreak and impact of the COVID-19 pandemic. I used a Google Form online survey to obtain participants' opinion on the frequency of interactions between supervisors and supervisees, the medium of interaction as well as the Master's and doctoral candidates' general progress. The study participants were all instructors in higher education who supervise Master and PhD students. There has been a change in frequency and means of supervision, that there is more reliance on videoconferencing tools and interaction "at a distance". However, the data cannot conclusively confirm that there has been a significant transformation in the way students are supervised because many study participants indicated their wish to return to the way things were done pre-pandemic. Nevertheless, there will probably be more reliance on social media, email and other online tools such as Zoom and Skype post-pandemic. In the words of the study participants, "online supervision is developing" and "the pandemic has also given us more tools of engagement, which is good".

Actually Existing Commons: Using the Commons to Reclaim the City

In Paraisópolis, a slum in São Paulo (Brazil) housing over 100.000 inhabitants, the Covid crisis seemed to have less of a death toll (0,0217%) than in other areas of the city (an average of 0,0652% as of May 2020);or at least it did at first. The sense of community in the area is strong, leading to many community initiatives and organisations to rise to the challenge of combating the pandemic with little help from the authorities. The community’s initial efficient response to the Covid crisis relied heavily on self‐reliance and self‐organization to mobilise common resources. Despite their later failure in containing the virus, the community’s response to the pandemic is exemplary of a well‐known phenomenon: how communities are able to mobilise the commons to create general welfare. The commons concept is used in this contribution to help us better understand slum governance and the power and limitations of community reliance. At the same time, we aim to refine our understanding of the commons as a contentious category rooted in agonistic relationships instead of the romanticised leftist social imaginary that views the commons as purely anti‐capitalist. Thus, we explicitly argue for a view of the commons and commoning that transcends the narrow “Leftist imaginary” of the commons as egalitarian, inclusive, anti‐capitalist, horizontal, and as expressions of sharing (and caring), and instead views the commons as embedded in everyday realities, where commoning practices emerge as practises that support the reproduction of (social) life. © 2022 by the author(s);.