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The current animal-based food systems are being challenged by environmental, social and economic sustainability issues. A systemic transformation from conventional agriculture to a more sustainable cellular agriculture utilising cell-cultivation technologies to produce animal products has been proposed. The aim of this study is to explore the political and policy stakeholders’ perceptions about cellular agriculture; how they perceive of the current food system and its potential transformation into a cellular agricultural system. The qualitative data comprises 13 interviews conducted with representatives of German stakeholders. The data were analysed with the Transformative Innovation Policy approach. Perceptions of the transformative potential of cultured products were classified into drivers and bottlenecks that either advance or hinder the progress of cellular agriculture in Germany. The results show that the political and policy stakeholders are aware of the changes that are needed, but anticipate that large-scale transformation to the cellular agriculture system may not be a plausible solution in the near future.

Cultured meat production requires the robust differentiation of satellite cells into mature muscle fibres without the use of animal-derived components. Current protocols induce myogenic differentiation in vitro through serum starvation, that is, an abrupt reduction in serum concentration. Here we used RNA sequencing to investigate the transcriptomic remodelling of bovine satellite cells during myogenic differentiation induced by serum starvation. We characterized canonical myogenic gene expression, and identified surface receptors upregulated during the early phase of differentiation, including IGF1R, TFRC and LPAR1. Supplementation of ligands to these receptors enabled the formulation of a chemically defined media that induced differentiation in the absence of serum starvation and/or transgene expression. Serum-free myogenic differentiation was of similar extent to that induced by serum starvation, as evaluated by transcriptome analysis, protein expression and the presence of a functional contractile apparatus. Moreover, the serum-free differentiation media supported the fabrication of three-dimensional bioartificial muscle constructs, demonstrating its suitability for cultured beef production.Bovine satellite cells undergoing myogenic differentiation in a chemically defined, serum-free medium are comparable to those undergoing serum starvation-demonstrating the suitability of this formulation for cultured meat production.

Background: Solubility properties of drugs intensify a crucial role during the formulation development process. Aqueous solubility is one of the most significant factors concerning drug bioavailability analysis. Cyclodextrins [CDs] are supportive, competent excipients, required an ever-rising way to disguise unwanted pharmaceutical characteristics, exclusively poor aqueous solubility. Main Text: CDs are actively useful in medicinal industries for copious purposes, including improving drug solubility, safety, physicochemical stability, and bioavailability. Different solubility enhancement methods can resolve several approaches to trouble insolubility. Conclusions: Among all, the reported one complexation technique has been incorporated as one of the imperative and the exigent concept, to enhance the solubility of poorly water-soluble drugs. The standard CDs and their explicit derivatives are quite essential in enabling pharmaceutical excipients, which improve the aqueous solubility of poorly soluble drugs, raise the permeability of drugs through the biological membranes, and advances the drug dissolution rate and bioavailability. This review discusses some of the findings and broad applications of CDs and their derivatives in various drug delivery areas. This review also addresses the aspects regarding the new CD-based therapeutics, possible future uses and issues, and regulatory perspective in the modern scenario.

Global energy mix is shifting from fossil fuels to renewable energy. Most developed nations are working towards decarbonizing their economy while ensuring sustainable energy. This energy transformation is also expected to gain momentum in the developing world as new ecosystems are forming and new technologies are emerging. These developments in technology that developed nations have keyed into are helping to grow renewable, develop new energy carriers, improve energy efficiency, reduce emissions and create new markets for carbon and other by-products as part of an increasingly circular economy. At COP26, it was made compulsory for developing countries to transition from fossil fuels to a decarbonized economy. Climate change financing is now viewed as part of adaptation, mitigation and economic development measures. These measures are expected to help reduce the harsh effects of global climate change. This is not the case in Nigeria where many of these commonly pursued steps to decarbonisation, such as increased electrification, wide-scale use of renewable energy and intensifying energy efficiency measures are mired by regulatory challenges. This article using doctrinal research methodology aims to explore how developing countries like Nigeria with heavy reliance on fossil fuel can accelerate decarbonisation over the next decade and achieve the timelines for the 2030 National Determined Contributions (NDCs), which has been advanced from 2025 to the end of 2022 at the COP26.

The global trend towards increased demand for organic food, greener environments, and the integration of biological control agents into pest management strategies has greatly enhanced the need for biopesticides. Biopesticides are made from micro-organisms or other natural substances and are, hence, generally environmentally friendly. However, despite their great potential—and in part due to regulatory challenges—relatively few biopesticides have been registered and commercialised in Nigeria compared to other African countries, such as South Africa and Kenya. Biological active agents are so diverse that applying the same safety standards to all of them is almost impossible. A comparative review of risk assessment processes of Nigeria’s biopesticide regulations with other developing African countries (South Africa and Kenya) and developed regions (the European Union and the United States of America) was conducted. Prolonged field testing, lack of bridged risk assessments, and technical checklists were identified as key factors hampering the research and development of biopesticides in Nigeria. Suitable amendments to the existing regulations guiding biopesticide formulation and utilisation in Nigeria are recommended. Risk assessment matrices for microbial and biochemical pesticides and a scientific/technical checklist have also been developed. It is apparent that harmonisation and data exchange among countries in the region could enhance the advancement of scientific and technical knowledge for sustainable regulation of, and cross-border trade in, biopesticides.

Cultured meat has been presented as an environmentally friendlier option to conventional meat, but due to the limited data, the studies related to its performance are scarce and based on hypothetical production processes. This work provides a short literature review of the published environmental assessments of cultured meat. The main findings of this critical analysis showed that the lack of real data related to cultured meat decreased the level of accuracy of each study. The missing environmental profile of the process itself, including the proliferation and differentiation phases in bioreactors, along with key ingredients such as growth factors and other recombinant proteins, increase the difficulty of achieving reliable conclusions. In order to bridge the highlighted gaps, a complete production system is modelled and analysed from an engineering and life-cycle perspective. Furthermore, an overview of the supply chains of different products used in the process is provided, together with recommendations on how they should be considered in future life-cycle assessments. In essence, this work provides a structured pathway for upcoming consistent environmental assessments in this field, with the objective of setting the basis to understand the potential of cultured meat.

The aim of cellular agriculture is to use cell-culturing technologies to produce alternatives to agricultural products. Cultured meat is an example of a cellular agriculture product, made by using tissue engineering methods. This study aims to improve the understanding of the potential environmental impacts of cultured meat production by comparing between different bioprocess design scenarios. This was done by carrying out a life cycle assessment (LCA) for a bioprocess system using hollow fiber bioreactors, and utilizing bench-scale experimental data for C2C12 cell proliferation, differentiation and media metabolism. Scenario and sensitivity analyses were used to test the impact of changes in the system design, data sources, and LCA methods on the results to support process design decision making. We compared alternative scenarios to a baseline of C2C12 cells cultured in hollow fiber bioreactors using media consisting of DMEM with serum, for a 16-day proliferation stage and 7-day differentiation stage. The baseline LCA used the average UK electricity mix as the energy source, and heat treatment for wastewater sterilization. The greatest reduction in environmental impacts were achieved with the scenarios using CHO cell metabolism instead of C2C12 cell metabolisim (64–67 % reduction); achieving 128 % cell biomass increase during differentiation instead of no increase (42–56 % reduction); using wind electricity instead of average UK electricity (6–39 % reduction); and adjusting the amino acid use based on experimental data (16–27 % reduction). The use of chemical wastewater treatment instead of heat treatment increased all environmental impacts, except energy demand, by 1–16 %. This study provides valuable insights for the cultured meat field to understand the effects of different process design scenarios on environmental impacts, and therefore provides a framework for deciding where to focus development efforts for improving the environmental performance of the production system.

Cultured meat is an emergent technology with the potential for significant environmental and animal welfare benefits. Accurate mimicry of traditional meat requires fat tissue; a key contributor to both the flavour and texture of meat. Here, we show that fibro-adipogenic progenitor cells (FAPs) are present in bovine muscle, and are transcriptionally and immunophenotypically distinct from satellite cells. These two cell types can be purified from a single muscle sample using a simple fluorescence-activated cell sorting (FACS) strategy. FAPs demonstrate high levels of adipogenic potential, as measured by gene expression changes and lipid accumulation, and can be proliferated for a large number of population doublings, demonstrating their suitability for a scalable cultured meat production process. Crucially, FAPs reach a mature level of adipogenic differentiation in three-dimensional, edible hydrogels. The resultant tissue accurately mimics traditional beef fat in terms of lipid profile and taste, and FAPs thus represent a promising candidate cell type for the production of cultured fat.

MBA, North-West University, Mafikeng Campus, 2018 "Abstract not copied" Masters

The development of nanotechnology-enabled health products offers innovative therapeutic and diagnostic opportunities to address medical needs. At the moment, no specific regulatory framework exists for such products since they can be covered by the existing frameworks for medicinal products and medical devices. However, these frameworks do require additional guidance to fully cover the particularities of nanotechnology-enabled products. After a detailed analysis of regulatory guidance documents, standards, and scientific publications originating mainly from Europe and the US, the European project “REFINE” has released a White Paper summarising the main needs in the field. The selection of the regulatory pathway, the identification of regulatory information needs, as well as the availability of standardised testing methods are among the identified regulatory challenges. Furthermore, additional guidance is needed on how the similarity of follow-on medicinal products can be demonstrated. Also, challenges related to the classification and assessment of nanotechnology-enabled medical devices are presented. The project consortium is now collecting feedback on the identified challenges through a dedicated survey and published comments on this manuscript. The resulting discussions within the scientific community should help to understand how essential knowledge, methods, tools, and approaches can be obtained with to advance the regulatory science in the area of nanotechnology-enabled health products.

With cultured meat now available for purchase in Singapore and more countries expected to follow soon, more and more research has explored the impact of particular individual factors and information provision. To this point, no research has looked explicitly at a counter-messaging approach, whereby problems of conventional meat production are leveraged to make the case for cultured meat. This study employs a 3x1 randomized experimental design with a sample of 302 British adults where participants are provided one of two differently focused counter-messages (animal welfare or environmental impact) or a control text. The study utilizes two repeated measures (before and after information provision) to examine the change in acceptance and investigate related informational effects. Though we find the focus of counter-messaging makes no difference, such an approach does generally promote consumer acceptance. Whereas acceptance of cultured meat is higher among men, younger consumers, and those who eat meat more often, change in acceptance is predicted by perceived consumer effectiveness and, marginally, lack of prior knowledge. By demonstrating the potential of a counter-messaging approach and offering a first examination of determinants of change in acceptance, this research should prove useful for researchers, policymakers, and proponents planning for the ongoing development and marketing of cultured meat.

The article provides a description of the Autonomous ship, studies existing relevant projects, and examines the related Operational, Regulatory, and Quality assurance challenges raised due to the development and actual deployment of such vessels in the near future. After reviewing the main operational procedures, existing regulations, and quality assurance standards, a number of possible solutions and approaches to overcome the identified challenges are indicated. Some of the conclusions may be used not only in the Autonomous ships but also in traditionally manned vessels.

O presente texto foi submetido e aceite para publicação no E.Tec Yearbook AI & Robotics, JusGov (Research Centre for Justice and Governance School of Law), University of Minho, sob coordenação de MARIA MIGUEL CARVALHO., O uso habitual e intensivo dos modernos meios informáticos e de telecomunicações, da inteligência artificial e dos algoritmos têm vindo a permitir a realização de trabalho subordinado fora do tradicional centro de trabalho, invocando-se, a este propósito, o fenómeno do teletrabalho. Trata-se de uma forma de prestação de trabalho elogiada por uns e criticada por outros, sendo, em parte, ambivalente. Em todo o caso, as suas eventuais vantagens e possíveis inconvenientes não são ontológicos ou congénitos, podendo, em parte, ser potenciados ou reduzidos em função das opções tomadas pelo legislador na regulamentação do fenómeno. A partir de março de 2020 verificou-se uma revolução quase copernicana quando cerca de 1 milhão de portugueses passou a laborar à distância, particularmente em teletrabalho, como forma de reduzir o contacto social e, assim, evitar uma maior propagação do vírus COVID-19. Esta experiência efetiva e em número significativo evidenciam a necessidade de repensar as respostas jurídicas atuais, ou a falta de algumas delas, a propósito de múltiplos aspetos do regime do teletrabalho, tais como a duração e organização do tempo de trabalho, a mobilidade funcional e geográfica, a formação profissional, os direitos coletivos, as condições de saúde e segurança no trabalho, a proteção em caso de acidente de trabalho e doenças profissionais., The usual and intensive use of modern computer and telecommunications means, artificial intelligence and algorithms has allowed the performance of subordinate work outside the traditional work center, invoking, in this regard, the phenomenon of telework. It is a form of work that is praised by some and criticized by others and is partly ambivalent. In any event, its possible advantages and possible drawbacks are not ontological or congenital and may, in part, be enhanced or reduced depending on the choices taken by the legislature in the regulation of the phenomenon. From March 2020 there was an almost Copernican revolution when about 1 million Portuguese began to work remotely, particularly in telework, to reduce social contact and thus prevent further spread of the COVID-19 virus. This effective experience and significant number evidence the need to rethink current legal responses, or the lack of some of them, regarding multiple aspects of the telework regime, such as the duration and organization of working time, functional and geographical mobility, professional training, collective rights, health and safety conditions at work, protection in the event of work accidents and occupational diseases.

Un requisito fundamental para la experimentación en el ámbito biomédico es que sea licita, es decir, que el objeto perseguido, el fin de la acción y las circunstancias, sean acordes a los Derechos Humanos y la norma. Así, la función del congreso es destacar estas reflexiones axiológicas dominantes y elaborar normas sancionables para salvaguardar la vida, la integridad personal, honra y dignidad, y regular aquellos extremos que puedan quedar a libre interpretación. De manera que es de vital importancia el dialogo entre la labor legislativa con la ciencia para lograr la protección del ser humano y su entorno, así como fomentar el desarrollo de la investigación científica, siempre y cuando esta sea beneficiosa para la humanidad. Entre tanto, algunas innovaciones han incursionado el que hacer médico, sin contar con regulación jurídica, lo cual representa desafíos normativos en cuanto a las posibilidades de emprender nuevas alternativas sobre el cuerpo, situación que conlleva a que las relaciones entre ciencia – sociedad no estén en su totalidad reguladas. Esta propuesta de investigación se enmarca en un tipo de corte cualitativo; pues se pretende el análisis de información documental; esto es, constitucional, legal, jurisprudencial y doctrinal que proporcione información para desarrollar la pregunta problema que se plantea de la siguiente manera; ¿En qué forma los avances biomédicos representan un desafío constitucional contemporáneo en Colombia? A fundamental requirement for experimentation in the biomedical field is that it be lawful, that is, that the object sought, the purpose of the action and the circumstances be consistent with human rights and the norm. Thus, the competence of the congress is to point out these preponderant axiological reflections and elaborate sanctionable norms to safeguard life, personal integrity, honor and dignity, and limit those extremes that may remain for free interpretation. So it is of vital importance the dialogue between legislative work with science to achieve the protection of human beings and their environment, as well as to encourage the development of scientific research, as long as it is beneficial for humanity. In the meantime, some innovations have dabbled in the medical task, without legal regulation, which represents normative challenges in terms of the possibilities of undertaking new alternatives on the body, a situation that leads to the relationship between science and society not are fully regulated. This research proposal is framed in a type of qualitative court, since the analysis of documentary information is intended, that is, constitutional, legal, jurisprudential and doctrinal, that provides information to develop the problem question that is posed as follows: How do biomedical advances represent a contemporary constitutional challenge in Colombia? Abogado http://www.ustamed.edu.co/index.php/dependencias/unidades/investigacion Pregrado

Dietary supplements, including those containing botanical ingredients and botanical-derived compounds, have been marketed to consumers globally for many decades. However, the legislative framework for such products remains inconsistent across jurisdictions internationally. This study aims to compare the regulatory framework of botanical food supplements in the EU, USA, Canada, Australia, New Zealand, India, Japan, and China. The study also aims to investigate and describe safety assessment criteria for botanical food supplements where they are present in the above said jurisdictions, and attempts to analyze whether these criteria are suitable for addressing the toxicological risks associated with the use of botanical food supplement products, based on the evaluation of reported adverse effects related to botanical food supplement use as examples. Finally, this study discusses some future issues that need further attention, such as the consideration of less than lifetime exposures, potential for misidentification, and adulteration of botanical supplements by pharmacologically active substances. It is concluded that the regulatory approaches towards botanical food supplements differ significantly across jurisdictions. In addition, national authorities are increasingly considering having more regulatory oversight for such products. Further consideration of the actual impact of adverse events arising from botanical food supplement usage will be helpful in guiding such decisions.

The recent proliferation of mobile financial services in developing countries has increased access to financial services among underserved rural and low-income populations. Mobile credit is one emerging mobile financial service that allows consumers to quickly apply for and receive loans over mobile devices. Mobile credit services have achieved early success in Kenya and Tanzania, two mature markets for mobile financial services. While these new services have the potential to further promote financial inclusion, they also raise novel regulatory issues and do not fit neatly into pre-existing regulatory categories. This is due to the nature of mobile credit and the variety of entities and regulatory frameworks implicated in the business models found in these two markets. Policymakers and regulators will need to make choices about how to regulate mobile credit with respect to consumer protection, credit reporting and the use of mobile and mobile money services transactional data, a key input for credit evaluation decisions. These choices will need to take into account promotion of financial inclusion and protection of consumers while limiting disincentives for innovation and investment.

Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes examples of some of the regulatory challenges faced and some resources for those who wish to learn more about them.

In many ways debate about how best to legislate and regulate crowd-sourced equity funding grapples with concerns similar to those that existed at the time of the introduction of limited liability in the United Kingdom. How best can we balance the interests of investors and businesses seeking to raise funds? In Australia these policy deliberations are taking place within a broader debate as to how to formulate a regulatory framework supportive of innovation and entrepreneurship. This paper considers how these objectives might be achieved to the best advantage of small business and the economy. The immense potential of innovative businesses may turn on the effectiveness of such policy development and its place within the legal framework. This paper argues that the legal challenge is to recognise that the regulation of crowd-sourced equity funding is not a simple matter of accommodating new fundraising activities within an existing legal framework designed for big business. Rather, the law must re-conceptualise its approach to fundraising consistent with the broader policy ambition of supporting the businesses most likely to require access to non-traditional, innovative funding models such as crowd-sourced equity funding; namely innovative firms, entrepreneurial business, start-ups and other micro, small and medium enterprises which have emerged in recent times. Part 1 considers the regulatory challenges and policy underlying the introduction of crowd-sourced equity funding regulation. I propose that the challenges in supporting innovation and entrepreneurship include the shape and range of corporate forms available to enterprise. In Part 2 crowdfunding and fintech are explained. Part 3 outlines amendments to the Corporations Act 2001 (Cth) introducing crowd-sourced equity funding. Part 4 examines the extent to which the law has met its policy objectives. In part 5 the paper suggests that it is time to rethink the corporate form in Australia with a firm eye on the reality of the corporate landscape, and that any rethink of the nature and shape of corporate vehicles should include an understanding and acknowledgement of the long term economic benefits of the innovation agenda. The paper concludes in part 6.

Introduction The increasing complexities of conducting multiregional trials and an evolving regulatory environment contribute to unprecedented new challenges for use of patient-reported outcome measures (PROMs) 1 within clinical trials. This paper presents these challenges and potential solutions. Methods Real-world examples and situations are reviewed from an industry and patient-reported outcome (PRO) 2 expert position. Conclusions An increase in the pursuit of new therapeutic targets, changes to the regulatory environment, and business pressures to expand clinical trials to more countries have significantly increased the complexity of confirmatory clinical studies that incorporate PROMs. Decisions to participate in collaborative efforts for endpoint development or proceed independently are made in the context of competing priorities of drug development timelines, drug differentiation strategies, the need for patient-related value messages, and the depth of a sponsor pipeline within specific disease areas. Study logistics are critically important; factors such as concept cultural relevancy, respondent literacy level, and quality of cross-cultural adaptation of PROMs must be evaluated when integrating into confirmatory clinical trials. Awareness of the issues relating to PROs in multiregional studies will enable companies to better plan studies and interpret results.

Dietary supplements, including those containing botanical ingredients and botanical-derived compounds, have been marketed to consumers globally for many decades. However, the legislative framework for such products remains inconsistent across jurisdictions internationally. This study aims to compare the regulatory framework of botanical food supplements in the EU, USA, Canada, Australia, New Zealand, India, Japan, and China. The study also aims to investigate and describe safety assessment criteria for botanical food supplements where they are present in the above said jurisdictions, and attempts to analyze whether these criteria are suitable for addressing the toxicological risks associated with the use of botanical food supplement products, based on the evaluation of reported adverse effects related to botanical food supplement use as examples. Finally, this study discusses some future issues that need further attention, such as the consideration of less than lifetime exposures, potential for misidentification, and adulteration of botanical supplements by pharmacologically active substances. It is concluded that the regulatory approaches towards botanical food supplements differ significantly across jurisdictions. In addition, national authorities are increasingly considering having more regulatory oversight for such products. Further consideration of the actual impact of adverse events arising from botanical food supplement usage will be helpful in guiding such decisions.

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This paper offers a critical survey of the microfinance literature of the past 10 years. It reviews studies on the effectiveness of different microfinance techniques and offers a critical assessment of the impact literature of microfinance. The literature so far suggests moderate but not transformative effects of microcredit, with effects being conditional on individuals’ characteristics. The effects of micro-savings interventions seem more promising, while micro-insurance interventions suffer mostly from limited take-up. The biggest impact seems to come from expanding payment services. The paper discusses these findings in the broader context of the financial development literature and touches on methodological issues and regulatory challenges.

Sa pojavom Interneta dolazi do slabljenja državne kontrole informacija koje se objavljuju u okviru njenih granica ili u vezi njenih državljana. Informacija postaje globalna, dostupna svima. Svako ima pravo da se slobodno izrazi na Internetu. Ali koje su posledice toga? Da li ograničenja slobode izražavanja iz fizičkog, realnog, sveta uopšte mogu biti primenjena na Internet? Ako da, kako? Ako ne, na koji način se druga ljudska prava mogu zaštititi? Kako se određuje nadležnost jedne države nad Internet aktivnostima? Šta se dešava kada dođe do međudržavnog spora? Da li je moguće primeniti sankciju na kršenje prava na slobodu izražavanja na Internetu? Da li je Internet zasebna jurisdikcija ili se ipak njegovi elementi nalaze i u fizičkom svetu? With the expansion of the Internet, state control over information published within its borders or about its citizens becomes weaker. Information becomes global, accessible to everyone. Everyone has the right to freely express themselves on the Internet. But what are the consequences of this? Can the limitations of freedom of expression from the physical, real world, apply to the Internet? If yes, how? If not, how can human rights be protected? How can a state's jurisdiction over the Internet be specified? What happens when the legal dispute between the countries occur? Is it possible to apply a sanction for violation of the right to freedom of expression on the Internet? Is the Internet a separate jurisdiction or can its elements also be found in the physical world?