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Scientific advice constitutes an important part of the development strategy as it can increase the likelihood of regulatory success. For this reason, its timing has to be carefully planned. There are essentially two routes which c...
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Scientific advice constitutes an important part of the development strategy as it can increase the likelihood of regulatory success. For this reason, its timing has to be carefully planned. There are essentially two routes which can be followed to get scientific advice in the EU: a "national advice", which is a decentralised procedure and involves meeting with one national authority; a "scientific advice" at the CHMP level, which is centralised, called protocol assistance for designated orphan drugs. This is a pan-European advice, which is adopted by the CHMP based on the recommedations of the SAWP.
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Scientific uncertainty affects all parts of the fisheries management process. This study reviews methods for quantifying scientific uncertainty for presentation as part of the scientific advice to fisheries managers. We surveyed s...
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Scientific uncertainty affects all parts of the fisheries management process. This study reviews methods for quantifying scientific uncertainty for presentation as part of the scientific advice to fisheries managers. We surveyed stock assessment scientists to a) identify the methods commonly used to quantify uncertainty, b) describe how method use has changed over time, c) investigate the factors that influence which methods are used, and d) characterize how scientific uncertainty is presented to fisheries managers. We found that scientific uncertainty is being quantified and included in scientific advice across multiple fishery management systems. Frequentist approaches for quantifying uncertainty are used more broadly than Bayesian approaches, and the survey did not detect this changing over time. Time restrictions and methodology requests during the scientific review process were commonly reported as factors influencing the use of uncertainty methods. Uncertainty in estimates of management targets (e.g., fishing mortality or biomass), projections, and catch limits were the quantities most frequently included in the scientific advice presented to fisheries managers. Methods for quantifying uncertainty and their incorporation into management advice are quickly advancing, and our approaches for reviewing progress towards clearly and explicitly communicating the sources, treatment, and impacts of uncertainty in management processes must keep pace.
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In the nine years since its establishment in 1988, the Intergovernmental Panel on Climate Change (IPCC) has attempted to walk the tightrope of being scientifically sound and politically acceptable. This paper investigates how the ...
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In the nine years since its establishment in 1988, the Intergovernmental Panel on Climate Change (IPCC) has attempted to walk the tightrope of being scientifically sound and politically acceptable. This paper investigates how the IPCC has evolved over two assessment cycles. It provides an in-depth examination of important characteristics of the IPCC process including the peer review mechanism, participation of developing countries, and its interactions with the intergovernmental negotiation process on climate change.
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Traditional advice for fisheries management, especially in the ICES world, focuses on short-term stock projections relative to reference points. Primarily, two numbers, spawning-stock biomass and fishing mortality rate, are consid...
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Traditional advice for fisheries management, especially in the ICES world, focuses on short-term stock projections relative to reference points. Primarily, two numbers, spawning-stock biomass and fishing mortality rate, are considered in the advice, although a range of biological processes are included in the stock assessment models. We propose an alternative form of final advice that would not rely on stock predictions and only two numbers, but on a suite of indicators that are combined to provide stock assessment and management advice. For a single stock, the approach consists of monitoring a set of indicators of population state and fishing pressure. Stock reference status at some time in the past is assessed, based on these indicators and/or other available information. Changes in indicator values after this reference time are then estimated, interpreted, and finally combined into a diagnostic that highlights possible causes of the changes observed. After considering management objectives, appropriate management actions can then be proposed. The proposed approach is illustrated for anglerfish stocks in the Celtic Sea and the Bay of Biscay.
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This article deals with scientific advice to the public where the relevant science is subject to public attention and uncertainty of knowledge. It focuses on a tension in the management and presentation of scientific uncertainty b...
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This article deals with scientific advice to the public where the relevant science is subject to public attention and uncertainty of knowledge. It focuses on a tension in the management and presentation of scientific uncertainty between the uncertain nature of science and the expectation that scientific advisers will provide clear public guidance. In the first part of the paper the tension is illustrated by the presentation of results from a recent interview study with nutrition scientists in Denmark. According to the study, nutrition scientists feel their roles as ‘‘public advisers’’ and ‘‘scientists’’ differ in that the former involves an expectation that they will provide unambiguous advice of the kind that might relegate scientific uncertainty to the background. In the second, more general, part of the paper we provide a normative analysis of different strategies of dealing with the tension. The analysis is structured around the extremes of either total concealment or full openness regarding scientific uncertainty. The result of analysis is that scientific advisers should not simply ‘‘feed’’ scientific conclusions to the public. They should rather attempt to promote the ability and willingness of the public to assess and scrutinize scientific knowledge by displaying uncertainties in the scientific basis of advice. On the other hand, scientific advisers must accommodate the public’s need for guidance. Such guidance should be restricted by careful consideration of what it is relevant for the public to know in order to evaluate scientific advice in practical terms.
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The 2000 BSE Inquiry report points out that the most serious failure of the UK Government was one of risk communication. This paper argues that the government's failure to communicate the risks BSE posed to humans to a large degre...
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The 2000 BSE Inquiry report points out that the most serious failure of the UK Government was one of risk communication. This paper argues that the government's failure to communicate the risks BSE posed to humans to a large degree can be traced back to a lack of transparency in the first risk assessment by the Southwood Working Party. This lack of transparency ensured that the working party's risk characterization and recommendations were ambiguous and thus hard to interpret. It also meant that uncertainties were not addressed in a satisfactory way. In the recommendations, the attitude to uncertainty was implicit rather than explicit.
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Purpose To assess whether the content of Scientific Advice (SA) questions addressed to a national drug regulatory agency is associated with company size. This may help to increase understanding about the knowledge, strategic, and ...
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Purpose To assess whether the content of Scientific Advice (SA) questions addressed to a national drug regulatory agency is associated with company size. This may help to increase understanding about the knowledge, strategic, and regulatory gaps companies face during drug development.
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This article seeks to identify the key principles that should guide the definition of the mandate and institutional structure for acquiring scientific advice in support of the European Maritime Policy. The EU has stated that, as c...
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This article seeks to identify the key principles that should guide the definition of the mandate and institutional structure for acquiring scientific advice in support of the European Maritime Policy. The EU has stated that, as concerns the Maritime Policy, the relations between science and policy ought to reflect a 'new form of governance'. Far from being an easy task, however, the EU has observed that there are problems of credibility and legitimacy in the relations between science and society (including policymakers), which first need to be overcome. Against this background, the article draws on some of the newest conceptual and empirical research on science-policy relations, which has sought to analyse and ultimately provide frameworks for overcoming such challenges. On this basis, the article investigates the principles that need to be applied to constitute a 'new form of governance' as a means of paving the way toward a more credible and legitimate use of scientific data, information and knowledge within policymaking and implementation processes.
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The Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA) have provided a wide range of regulatory and scientific consultation menus to cover any development stage of drugs and regenerative medi...
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The Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA) have provided a wide range of regulatory and scientific consultation menus to cover any development stage of drugs and regenerative medicine products, respectively. The current study compares Consultations by PMDA and Scientific Advice by EMA in terms of consultation types, consultation performances, and specific consultation procedures with timelines. Each agency sets intensive but highly professional procedures and timelines in order to provide sufficient advice in a timely manner. Both agencies complete the consultation process for approximately 3 months while an application is reviewed by experts and close communication with the applicant is provided. Although PMDA and EMA have some differences of approaches to provide well-considered scientific opinions as quickly as possible, both agencies have made efforts to support the development of better products for patients. Sharing technical insights through consultation experiences will contribute to earlier access of patents to new products in both Japan and the EU.
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Abstract In a modern democracy, a public health system includes mechanisms for the provision of expert scientific advice to elected officials. The decisions of elected officials generally will be degraded by expert failure, that i...
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Abstract In a modern democracy, a public health system includes mechanisms for the provision of expert scientific advice to elected officials. The decisions of elected officials generally will be degraded by expert failure, that is, the provision of bad advice. The theory of expert failure suggests that competition among experts generally is the best safeguard against expert failure. Monopoly power of experts increases the chance of expert failure. The risk of expert failure also is greater when scientific advice is provided by only one or a few disciplines. A national government can simulate a competitive market for expert advice by structuring the scientific advice it receives to ensure the production of multiple perspectives from multiple disciplines. I apply these general principles to the United Kingdom’s Scientific Advisory Group for Emergencies (SAGE).
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