Comparative analysis of rule elements for transportation of cell therapy products among regulations and standards.

Aim: This study aimed to identify the elements involved in the transportation of cell therapy products by conducting a comparative analysis of four related international standards for temperature-controlled delivery and good distribution practice (GDP). Methods: An analytical framework was constructed to cover the entire transportation process. The descriptions of each element in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) GDP, International Organization for Standardization (ISO) 21973, Foundation for the Accreditation of Cellular Therapy Common Standards for Cellular Therapies and ISO 23412 were compared. Results: The study identified some elements that were present in the PIC/S GDP and other standards but were absent in ISO 21973, and vice versa. These elements are crucial in view of the increasing opportunities to transport allogeneic cells in the future. Conclusion: The study identified the necessary elements that should be included in the development of transport regulations for cell therapy products.

The quality of cell therapy products needs to be ensured during transportation to the hospital, just like during their manufacture. However, cell therapy products are living cells, and ensuring their quality during transportation is challenging. The International Organization for Standardization (ISO) has published ISO 21973 to address this issue, but transport regulations for cell therapy products have not been modified yet. To create draft guidance for the transportation of cell therapy products, it is necessary to analyze the relationship between ISO 21973, good distribution practice, Foundation for the Accreditation of Cellular Therapy Common Standards and ISO 23412. We compared these regulations and standards and identified some elements that are necessary for transporting cell therapy products. These elements are crucial in view of the increasing opportunities to transport allogeneic cells in the future. This study proposed elements to be included in the development of transport regulations for cell therapy products.

Corporate political activity in the context of unhealthy food advertising restrictions across Transport for London: A qualitative case study.

BACKGROUND: Diets with high proportions of foods high in fat, sugar, and/or salt (HFSS) contribute to malnutrition and rising rates of childhood obesity, with effects throughout the life course. Given compelling evidence on the detrimental impact HFSS advertising has on children's diets, the World Health Organization unequivocally supports the adoption of restrictions on HFSS marketing and advertising. In February 2019, the Greater London Authority introduced novel restrictions on HFSS advertising across Transport for London (TfL), one of the most valuable out-of-home advertising estates. In this study, we examined whether and how commercial actors attempted to influence the development of these advertising restrictions. METHODS AND FINDINGS: Using requests under the Freedom of Information Act, we obtained industry responses to the London Food Strategy consultation, correspondence between officials and key industry actors, and information on meetings. We used an existing model of corporate political activity, the Policy Dystopia Model, to systematically analyse arguments and activities used to counter the policy. The majority of food and advertising industry consultation respondents opposed the proposed advertising restrictions, many promoting voluntary approaches instead. Industry actors who supported the policy were predominantly smaller businesses. To oppose the policy, industry respondents deployed a range of strategies. They exaggerated potential costs and underplayed potential benefits of the policy, for instance, warning of negative economic consequences and questioning the evidence underlying the proposal. Despite challenging the evidence for the policy, they offered little evidence in support of their own claims. Commercial actors had significant access to the policy process and officials through the consultation and numerous meetings, yet attempted to increase access, for example, in applying to join the London Child Obesity Taskforce and inviting its members to events. They also employed coalition management, engaging directly and through business associations to amplify their arguments. Some advertising industry actors also raised the potential of legal challenges. The key limitation of this study is that our data focused on industry-policymaker interactions; thus, our findings are unable to present a comprehensive picture of political activity. CONCLUSIONS: In this study, we identified substantial opposition from food and advertising industry actors to the TfL advertising restrictions. We mapped arguments and activities used to oppose the policy, which might help other public authorities anticipate industry efforts to prevent similar restrictions in HFSS advertising. Given the potential consequences of commercial influence in these kinds of policy spaces, public bodies should consider how they engage with industry actors.

Quantifying responses to changes in the jurisdiction of a congestion charge: A study of the London western extension.

This paper quantifies behavioural responses to changes in the jurisdiction of a congestion charge, with a successive focus on (i) an extension and (ii) a reduction in the size of the charging zone. We exploit the unanticipated nature of both the implementation and removal of London's Western Expansion Zone (WEZ) as quasi-natural experiments to test whether individual responses to policies are asymmetric. We use the UK Department of Transport Annual Average Daily Flow (AADF) data, which records traffic flows for seven transport modes (including cars, buses, bicycles, heavy and light goods vehicles). Using a difference-in-differences approach, we find that the introduction of the WEZ led to a 4.9% decline in road traffic flows in the new congestion charge area. These results are robust to different model specifications. HGVs traffic did not significantly change post-WEZ, which indicates that their road demand is price inelastic. The removal of the WEZ led to no significant variations in traffic. This result indicates asymmetry in behaviour with persistent changes in post-intervention traffic demand levels.

Spreading the sharing economy: Institutional conditions for the international diffusion of Uber, 2010-2017.

This study examines the factors that facilitated the international diffusion of Uber, one of the fastest growing global companies in the sharing economy. We particularly focus on the legal and institutional conditions under which this ride-sharing platform could spread to customers online. Using a unique cross-national, longitudinal dataset, we employ event history models to investigate the effect of institutional environment on the diffusion of Uber. The results suggest that the establishment of the rule of law has a positive impact on the spread of Uber, even after controlling for economic and political characteristics. In addition, the overall quality of governmental regulations on markets is positively related to the diffusion of this ride-sharing platform. Our study contributes to the emerging literature on the sharing economy by identifying critical institutional factors that enable the transformation of business models worldwide.

Coronavírus: transporte público

Saiba mais em www.saopaulo.sp.gov.br/coronavirus

Coronavírus: como será a regulamentação do Decreto que obriga o uso de máscaras?

Saiba mais em www.saopaulo.sp.gov.br/coronavirus

Coletiva de imprensa: medidas de combate ao coronavírus (COVID-19) - 29/04/2020

Saiba mais em www.saopaulo.sp.gov.br/coronavirus

A framework for testing independence between lane change and cooperative intelligent transportation system.

Cooperative Intelligent Transportation Systems (C-ITS) are being deployed in several cities around the world. We are preparing for the largest Field Operational Test (FOT) in Australia to evaluate C-ITS safety benefits. Two of the safety benefit hypotheses we formulated assume a dependency between lane changes and C-ITS warnings displayed on the Human Machine Interface (HMI) during safety events. Lane change detection is done by processing many predictors from several sensors at the time of the safety event. However, in our planned FOT, the participating vehicles are only equipped with the vehicle C-ITS and the IMU. Therefore, in this paper, we propose a framework to test lane change and C-ITS dependency. In this framework, we train a random forest classifier using data collected from the IMU to detect lane changes. Consequently, the random forest output probabilities of the testing data in case of C-ITS and control are used to construct a 2x2 contingency table. Then we develop a permutation test to calculate the null hypothesis needed to test the independence of the lane change during safety events and the C-ITS.

Analysis of Non-conformities in Road Transport of Animals in Poland.

The paper presents the results of analysis of inspections of animal transport vehicles in Poland in 2007-2016. Due to animal welfare and the increased epidemiological risk the animal control system included the points of carriage provided for in the animal carriage law, i.e., during transport, at the sites of shipment, sites of rest, at destination points as well as at fairs and purchase points. The largest number of non-conformities were revealed at destination points (slaughterhouses), where the highest number of inspections were carried out. Inspections were conducted by veterinary inspectors and non-conformities were mainly related to animal health, documentation, transport practices and vehicles. The calculation of non-conformity rates enabled the evaluation of the condition of the inspected means of transport in the aspect of animal welfare. In addition, number of inspections, number of detected non-conformities and the non-conformity rates calculated for Poland were compared with the values for selected countries neighboring Poland (the Czech Republic, Lithuania and Germany).

Road vehicle transportation of children with physical and behavioral disabilities: A literature review.

Background: A literature review in 2001 found that children with disabilities were frequently transported in unsafe conditions and further research was required to investigate the gap between regulations, standards and actual transportation practices.Objectives: To synthesize available evidence on the transportation of children with disabilities in road vehicles.Methods: Four databases were systematically searched: CINAHL; Medline; National Transport Library Catalogue (Sweden); and Transport Research International Documentation.Results: Nineteen studies ranging in methodological quality from poor to excellent were included in the review. The findings are presented under the following six major themes: child safety restraints, wheelchairs, vehicles, travel habits, parental and professional knowledge. The results are mapped onto two groups of children, those with behavioral problems and those with physical disabilities.Conclusion: The literature reflected little change across the six major themes since the previous review. Children with disabilities continue to be inappropriately restrained in vehicles, constituting an ongoing road safety problem. There is a strong need to increase parent knowledge, upskill health professionals and provide families with financial assistance to enable them to ensure the safe transportation of children with disabilities to minimize the risk of injury and fatalities on the road, and enhance their participation in the community.

A Transport Policy Whose Injury Impacts May Go Unnoticed: More Walking, Cycling and Use of Public Transport.

It is an objective of transport policy in many countries and cities to promote walking, cycling and the use of public transport. This policy seeks to improve public health and reduce emissions contributing to global warming. It is, however, very likely that more walking, cycling and use of public transport will be associated with an increase in traffic injury. Moreover, it is likely that most of this increase will go unnoticed and not be recorded in official road accident statistics. Official statistics on traffic injury are known to be very incomplete as far as injuries to pedestrians, cyclists and public transport passengers are concerned. This incompleteness is a problem when assessing health impacts of more walking, cycling and travel by public transport. In this paper, studies made in the city of Oslo, Norway (population 700,000) are used to develop numerical examples showing how the estimated real and recorded number of injuries may change when 10% of person km of travel performed by car are transferred to walking, cycling or public transport. It is shown that not more than about 2% of the estimated change in the actual number of injured road users will be recorded by official statistics on traffic injury.

The Carle-Illinois (Urbana, Illinois USA) Transport Protocol for LEK9s: Guidelines for Emergency Medical Service Providers.

Three states and one county now allow Emergency Medical Services (EMS) providers to transport injured law enforcement K9s (LEK9s) as long as no human needs the ambulance at the time. Several other states either have pending legislation or are in discussions about this topic. As additional states ponder these laws, it is likely that the EMS transport of LEK9s will become legal in many states. In the wake of this legislation, a significant void was created. Currently, there are no published protocols for the safe transport of LEK9s by EMS providers. Additionally, the transport destination for these LEK9s is unlikely to be programmed into vehicle Global Positioning Systems. The authors of this report convened a Joint Task Force on Working Dog Care, consisting of veterinarians, EMS directors, EMS physicians, and LEK9 handlers, who met to develop a protocol for LEK9s being transported to a veterinary facility. The protocol covers the logistics of getting the LEK9 into the ambulance (eg, when the handler is or is not available), appropriate restraint, and the importance of prior arrangements with a veterinary emergency facility. A LEK9 hand-off form and a Transport Policy Form are provided, downloadable, and customizable for each EMS provider. This protocol provides essential information on safety and transport logistics for injured LEK9s. The hope is that this protocol will assist EMS providers to streamline the transport of an injured LEK9 to an appropriate veterinary facility.

The Carle-Illinois (Urbana, Illinois USA) Treatment Protocol for Law Enforcement K9s: Guidelines for Emergency Medical Services.

This document is a resource for Emergency Medical Services (EMS) treating an injured law enforcement K9 (LEK9) in the field and/or during transport by ambulance to a veterinary hospital. A Joint Task Force on Working Dog Care was created, which included veterinarians, EMS directors, EMS physicians, and canine handlers, who met to develop a treatment protocol for injured LEK9s. The protocol covers many major life-threatening injuries that LEK9s may sustain in the line of duty, and also discusses personnel safety and necessary equipment. This protocol may help train EMS providers to save the life of an injured LEK9.