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National Regulatory Authorities (NRAs) globally are facing the challenge of evaluating pharmaceutical products in a speedy manner, whilst simultaneously ensuring adequate efficacy, safety and quality of approved products. Additionally, common expectations include that the evaluation process is competent, flexible, commensurate with risk, efficient and rapid. In 2014, the Australian regulatory system was out of step with global regulatory developments which led to a comprehensive regulatory review and reform process. As part of the reforms, two Facilitated Regulatory Pathways (FRP) were developed for prescription medicines: Priority Review (PR) and Provisional Approval (PA). Furthermore, regulatory reliance and recognition arrangements have been expanded with the Therapeutic Goods Administration (TGA) making increased use of evaluation reports by trusted NRAs. The new pathways have been utilised by the pharmaceutical industry in Australia since 2017, with the number of medicines going through these pathways gradually increasing. Additional facilitated pathways have been developed following the review, providing alternatives to the standard pathway for registration of prescription medicines in Australia. The reform is timely, helping to position Australia well in the current global regulatory climate. [ABSTRACT FROM AUTHOR]

The primary aim of this study was to evaluate the perceptions of Australian anaesthetists in relation to smartphone use within anaesthetic practice. In particular, we aimed to assess the frequency of smartphone use, the types and number of smartphone applications used, how reliant anaesthetists perceive themselves to be on smartphones and whether they perceive them to be a factor that aids or distracts from their practice. Secondly, we assessed whether there is an association between the type, frequency, reliance and perceptions of smartphone use and the years of experience as an anaesthetist. A 24-item questionnaire addressing these questions was created and distributed to an email list of credentialled anaesthetists in Melbourne, Australia. A total of 113 consultant anaesthetists who practise at 55 hospitals in Melbourne completed the questionnaire. Our results suggest that the majority of anaesthetists are using smartphones regularly in their practice. About 74% of respondents agreed that they rely on their smartphone for their work. We found that respondents were more likely to rely on smartphones and consider them to aid patient safety than to consider them a distraction. This phenomenon was particularly apparent in those who had been a consultant anaesthetist for less than three years. Furthermore, those who had been a consultant anaesthetist for less than three years were more likely to have more smartphone apps relating to anaesthetics, use them more often and rely on them to a greater degree. Our results highlight the ubiquitous and perceived useful nature of smartphones in anaesthetic practice. [ABSTRACT FROM AUTHOR]

Few natural resource management (NRM) studies discriminate between trust and trustworthiness. However, this approach, which combines the attitude of one actor with the characteristics of another actor, is common in the organisational management literature. Our case study, set in a wildfire management context in Australia, sought to explore: (1) how community members and NRM staff defined trust and described trustworthiness; (2) how these trust definitions did, or did not, reflect conceptualisations in the literature; and, (3) whether explicitly differentiating between trust and trustworthiness is useful in an NRM context. Our findings suggest that participants defined trust in three main ways: as ‘having a good relationship’; as ‘being able to rely on others’ in a one-way manner; and, as ‘a relationship where parties rely on one another’ in a reciprocal manner. Our findings also suggest that participants differentiated these trust definitions from trustworthiness, that is, from the characteristics and actions which made an individual or agency worthy of trust. These findings suggest that it is useful to differentiate trust from trustworthiness, because it allows NRM managers and researchers to better understand both the trusting intentions of community members and the characteristics of the agency which contribute to that trust. [ABSTRACT FROM AUTHOR]