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A subject and maintenance of dissertations for the degree of Doctor and the Candidate of historical sciences which were defended in the specialized scientific advice D 08.051.14 in the Oles Honchar Dnipropetrovsk National University in 2013 is considered. Only for a year 6 dissertations for the degree of Doctor (specialty 07.00.01 – «Нistory of Ukraine» – 5 works; 07.00.02 – «World history» – 1 work) and 16 dissertations for the degree of the Candidate (specialty 07.00.01 – «Нistory of Ukraine» – 10 works, 07.00.02 – «world history» – 4 works, 07.00.06 – «Нistoriography, a source study and special historical disciplines» – 2 works) were defended. All dissertations were ratified by the Department of education and science of Ukraine. It is given the following information on every research work: theme, specialty, place (department) of work implementation, date of defense of dissertation, scientific consultant (for doctoral thesis) or leader (for candidate’s thesis), his scientific degree and rank, place of work, data about official opponents. Considerable attention is spared to the compressed review of the personal achievements of authors especially to scientific novelty of their researches.

The use of health technology assessment (HTA) to inform policy-making is established in most developed countries. Compared to licensing agencies, HTA agencies have different interests and, therefore, different evidence requirements. Criteria for coverage or reimbursement decisions on pharmaceutical compounds vary; however, it is common to include, as part of the HTA, a comparative effectiveness evaluation. This type of clinical data might go beyond that required for market authorization, thus creating an additional evidence gap between the regulatory and the reimbursement submission. The relevance of submissions to HTA agencies is consistently increasing in a pharmaceutical company's perspective, as market prospects are strongly influenced by third-party payers' coverage. In this study, we aim to describe current HTA activities with a potential impact throughout the drug development process of pharmaceuticals, with a comparative emphasis on the systems in place in Italy and in the UK. Based on an extensive literature and website review, we identified three major classes of HTA activities, beyond mainstream HTA, with the potential to influence the drug development program: 1) horizon scanning and early HTA; 2) bipartite and tripartite early dialogue between manufacturers, regulators, and HTA assessors; and 3) managed market entry agreements. From early stages of clinical research up to postauthorization studies, there is a trend toward increased collaboration between parties, anticipation of market access evidence collection, and postmarketing risk-sharing. Heterogeneity of HTA practices increases the complexity of the market access environment. Overall, there are signals that market access departments are gaining importance in the pharmaceutical companies, but there is still a lack of evidence and reporting on how the increasing relevance of HTA has reshaped the way clinical development is designed and managed.

International audience; Since the very first European research project initiated in 1993, much progress has been made in Europe on the development ofCO2 geological storage as a key tool for combating climate change. A review of the main achievements and remaining obstaclesin Europe is proposed, with a glance at what is going on at global level. Scientific, technical, economic, regulatory and policyaspects are considered. The increasing role of the growing CO2GeoNet Association, a reference pan-European scientific body onCO2 geological storage, is emphasized, with actions both on the EU and global scene for enabling efficient and safe storage.

The World Health Organization (WHO) has been a leading intergovernmental organization in the effort to prevent diseases related to food and improve global food safety and security. These efforts have been focused on the provision of independent scientific advice on foodborne risks, the development of international food standards, through the work of the Food and Agricultural Organization of the United Nations/WHO Codex Alimentarius Commission, and the support of Member States through direct policy advice as well as through the creation of laboratory and authority networks sharing experience and building capacity. WHO has also promoted the development and spread of new policy thinking in the food safety area, including especially the introduction of the new risk analysis paradigm, the holistic, farm-to-fork thinking in relation to food production, now often referred to as ‘One Health,’ and finally the focus on simple and efficient messaging toward preventing food risks through a better understanding of good food preparation practices in all sectors.

Science advice based on physiology is supporting harvest decisions for sockeye salmon by providing a mechanistic understanding for in river mortality. This success is a function of political will, clarity in management objectives, and science management integration. Uncertainty in results and institutional caution are major challenges for using science advice., The inability of physiologists to effect change in fisheries management has been the source of frustration for many decades. Close collaboration between fisheries managers and researchers has afforded our interdisciplinary team an unusual opportunity to evaluate the emerging impact that physiology can have in providing relevant and credible scientific advice to assist in management decisions. We categorize the quality of scientific advice given to management into five levels based on the type of scientific activity and resulting advice (notions, observations, descriptions, predictions and prescriptions). We argue that, ideally, both managers and researchers have concomitant but separate responsibilities for increasing the level of scientific advice provided. The responsibility of managers involves clear communication of management objectives to researchers, including exact descriptions of knowledge needs and researchable problems. The role of the researcher is to provide scientific advice based on the current state of scientific information and the level of integration with management. The examples of scientific advice discussed herein relate to physiological research on the impact of high discharge and water temperature, pathogens, sex and fisheries interactions on in-river migration success of adult Fraser River sockeye salmon (Oncorhynchus nerka) and the increased understanding and quality of scientific advice that emerges. We submit that success in increasing the quality of scientific advice is a function of political motivation linked to funding, legal clarity in management objectives, collaborative structures in government and academia, personal relationships, access to interdisciplinary experts and scientific peer acceptance. The major challenges with advancing scientific advice include uncertainty in results, lack of integration with management needs and institutional caution in adopting new research. We hope that conservation physiologists can learn from our experiences of providing scientific advice to management to increase the potential for this growing field of research to have a positive influence on resource management.

Although transparency is a key concept in the social sciences, it remains an understudied phenomenon in global environmental governance. This paper analyzes effectiveness of ‘governance by transparency’ or governance by information disclosure as a key innovation in global environmental and risk governance. Information disclosure is central to current efforts to govern biosafety or safe trade in genetically modified organisms (GMOs). Through analyzing the dynamics of GMO-related information disclosure to the global Biosafety Clearing House (BCH), I argue that the originally intended normative and procedural aims of disclosure in this case—to facilitate a GMO-importing country's right to know and right to choose prior to trade in GMOs—are not yet being realized, partly because the burden of BCH disclosure currently rests, ironically, on importing countries. As a result, BCH disclosure may even have market-facilitating rather than originally intended market-regulating effects with regard to GMO trade, turning on its head the intended aims of governance by disclosure.

Trenkel, V. M., Rochet, M-J., and Mesnil, B. 2007. From model-based prescriptive advice to indicator-based interactive advice. – ICES Journal of Marine Science, 64: 768–774. 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.

This thesis concerns the role of scientific expertise in the decision-making process at the Swiss federal level of government. It aims to understand how institutional and issue-specific factors influence three things: the distribution of access to scientific expertise, its valuation by participants in policy for- mulation, and the consequence(s) its mobilization has on policy politics and design. The theoretical framework developed builds on the assumption that scientific expertise is a strategic resource. In order to effectively mobilize this resource, actors require financial and organizational resources, as well as the conviction that it can advance their instrumental interests within a particular action situation. Institutions of the political system allocate these financial and organizational resources, influence the supply of scientific expertise, and help shape the venue of its deployment. Issue structures, in turn, condition both interaction configurations and the way in which these are anticipated by actors. This affects the perceived utility of expertise mobilization, mediating its consequences. The findings of this study show that the ability to access and control scientific expertise is strongly concentrated in the hands of the federal administration. Civil society actors have weak capacities to mobilize it, and the autonomy of institutionalized advisory bodies is limited. Moreover, the production of scientific expertise is undergoing a process of professionalization which strengthens the position of the federal administration as the (main) mandating agent. Despite increased political polarization and less inclu- sive decision-making, scientific expertise remains anchored in the policy subsystem, rather than being used to legitimate policy through appeals to the wider population. Finally, the structure of a policy problem matters both for expertise mobilization and for the latter's impact on the policy process, be- cause it conditions conflict structures and their anticipation. Structured problems result in a greater overlap between the principal of expertise mobilization and its intended audience, thereby increasing the chance that expertise shapes policy design. Conversely, less structured problems, especially those that involve conflicts about values and goals, reduce the impact of expertise.

Background Since the first methodological publications on adaptive study design approaches in the 1990s, the application of these approaches in drug development has raised increasing interest among academia, industry and regulators. The European Medicines Agency (EMA) as well as the Food and Drug Administration (FDA) have published guidance documents addressing the potentials and limitations of adaptive designs in the regulatory context. Since there is limited experience in the implementation and interpretation of adaptive clinical trials, early interaction with regulators is recommended. The EMA offers such interactions through scientific advice and protocol assistance procedures. Methods We performed a text search of scientific advice letters issued between 1 January 2007 and 8 May 2012 that contained relevant key terms. Letters containing questions related to adaptive clinical trials in phases II or III were selected for further analysis. From the selected letters, important characteristics of the proposed design and its context in the drug development program, as well as the responses of the Committee for Human Medicinal Products (CHMP)/Scientific Advice Working Party (SAWP), were extracted and categorized. For 41 more recent procedures (1 January 2009 to 8 May 2012), additional details of the trial design and the CHMP/SAWP responses were assessed. In addition, case studies are presented as examples. Results Over a range of 5½ years, 59 scientific advices were identified that address adaptive study designs in phase II and phase III clinical trials. Almost all were proposed as confirmatory phase III or phase II/III studies. The most frequently proposed adaptation was sample size reassessment, followed by dropping of treatment arms and population enrichment. While 12 (20%) of the 59 proposals for an adaptive clinical trial were not accepted, the great majority of proposals were accepted (15, 25%) or conditionally accepted (32, 54%). In the more recent 41 procedures, the most frequent concerns raised by CHMP/SAWP were insufficient justifications of the adaptation strategy, type I error rate control and bias. Conclusions For the majority of proposed adaptive clinical trials, an overall positive opinion was given albeit with critical comments. Type I error rate control, bias and the justification of the design are common issues raised by the CHMP/SAWP.

The role and design of global expert organizations such as the Intergovernmental Panel on Climate Change (IPCC) or the Intergovernmental Platform on Biodiversity and Ecosystem Services (IPBES) needs rethinking. Acknowledging that a one-size-fits-all model does not exist, we suggest a reflexive turn that implies treating the governance of expertise as a matter of political contestation., Science role in international environmental governance. Climate change, biodiversity and air pollution

Over its first three mandates the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) has provided scientific advice on a range of issues related to human nutrition. The scientific outputs adopted over this time are summarised within the six main areas within the remit of the Panel: (i) tolerable upper intake levels for nutrients; (ii) safety of novel foods; (iii) food allergens; (iv) dietetic products; (v) population reference intakes for nutrients; and (vi) nutrition and health claims on foods. The scientific advice of the Panel was provided mainly in response to requests from the European Commission and applications for authorisation of novel foods, health claims and for exemption from allergen labelling. The outputs of the Panel have been extensively used by the European Commission and Member States in the implementation of European Union (EU) policy and legislation. In addition, some of the scientific opinions assess key elements of the evidence on nutrition in obesity and other diet related diseases and are an important source of scientific advice for policy makers who wish to address these important issues in public health. Throughout the different areas of its work, the Panel has placed considerable focus on consultation with stakeholders. In the area of health claims in particular, EFSA has had continuing consultation with stakeholders in developing extensive guidance for applicants. This article summarises the nature of the advice provided by the Panel, its regulatory context and how it is applied in the implementation of EU policy and legislation.

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. Methodology A cross-sectional analysis was performed of SA provided by the Dutch Medicines Evaluation Board (MEB) in 2006–2008. Definition of company size was based on ranking by total revenues (Scrip’s Pharmaceutical Company League Tables 2008). The content of each SA question was scored according to predefined domains (quality, nonclinical, clinical, regulatory, and product information), their subdomains (e.g., efficacy), and a selection of additional content variables (e.g., endpoints, choice of active comparator). Results In total, 201 SA documents including 1,087 questions could be identified. Small, medium-sized, and large companies asked for SA 110 (54.7%), 40 (19.9%), and 51 (25.4%) times, respectively. Clinical questions were asked most often (65.9%), mainly including efficacy (33.2%) and safety questions (24.0%). The most frequent topics were overall efficacy and safety strategy. Small companies asked quality and nonclinical questions more often (P

CO2GeoNet is a Network of Excellence on the geological storage of CO2, initiated by the EC's 6th research framework programme in 2004 and integrating Europe's key research institutes to create a scientific reference body dedicated to the development of CO2 geological storage as a viable option for mitigating climate change. It has gained international recognition through bodies such as CSLF and IEA-GHG. It emerges as the world's largest integrated scientific community on this theme. In 2008, the network has been transformed into a legally registered Association, thus reinforcing its identity as a durable entity engaged for the safe and reliable deployment of CO2 geological storage. CO2GeoNet's activities encompass joint research, training, scientific advice, and information and communication on CO2 geological storage. © 2009 Elsevier Ltd. All rights reserved.

This paper deals with the comparative analysis of different policy options for water resources management in three south-eastern Mediterranean countries. The applied methodology follows a participatory approach throughout its implementation and is supported by the use of three different software packages dealing with water allocation budget, water quality simulation, and Multi Criteria Analysis, respectively. The paper briefly describes the general objectives of the SMART project and then presents the three local case studies, the valuation objectives and the applied methodology - developed as a general replicable framework suitable for implementation in other decision-making processes. All the steps needed for a correct implementation are therefore described. Following the conceptualisation of the problem, the choice of the appropriate indicators as well as the calculation of their weighting and value functions are detailed. The paper concludes with the results of the Multi Criteria and the related Sensitivity Analyses performed, showing how the different policy responses under consideration can be assessed and furthermore compared through case studies thanks to their relative performances. The adopted methodology was found to be an effective operational approach for bridging scientific modelling and policy making by integrating the model outputs in a conceptual framework that can be understood and utilised by non experts, thus showing concrete potential for participatory decision making.

A feature of policy-making today is its dependence on scientific advice to deliver public policies that are robust, credible, and effective. This paper discusses how policy-making profits from scientific advice in areas where science and technology are significant. Particular attention is given to issues holding a high level of uncertainty, either because of inherent variability, because science is incomplete or controversial, or because data are inadequate to support a definitive answer. First, we analyse the social context that characterises the relationship between science and policy-making, with a focus on the decrease of public confidence in politicians and scientists. Second, we compare three different sets of guidelines on the collection and use of expertise in policy-making (issued by the UK, Canada and the European Commission, respectively) and identify two different approaches to scientific advice in policy-making. Third, based on a set of cross-national and multi-disciplinary case studies, we look at how the relationship between science and policy-making works in practice and propose a set of recommendations towards the establishment of a more robust and effective policy-making process.

During the spring session of the ICES Advisory Committee for Fisheries Management (ACFM) 48 stocks assessed by 7 Working Groups have been analyzed and reviewed, among these all herring stocks in the ICES area, blue whiting and most demersal stocks in the Baltic, Arctic and North-Western area. As in previous years, ICES recommends a reduction in fishing mortality for a number of stocks or even the establishment of recovery and management plans, to safeguard a continuous development of the stocks towards safe biological limits. ICES recommended a 90% reduction of the cod fishery in the Baltic Sea, while most of the herring stocks are in good condition. Johann Heinrich von Thünen-Institute, Federal Research Institute for Rural Areas, Forestry and Fisheries began publishing the Informationen aus der Fischereiforschung = Information on Fishery Research in 2010.

The implementation of the precautionary approach in the mid-1990s required commercial fish stocks to be classified into different categories. These are based on the degree to which stocks have been exploited or are threatened by fishing activities. According to current ICES terminology, stocks are classified as being either “within” or “outside safe biological limits”, or as being “harvested outside safe biological limits”. Between 1996 and 2002, the relative share of stocks in these three categories remained relatively stable (at about 20 %, 30 % and 15 %, respectively). Over the same time span, the number of stocks were insufficient data is available to quantify and thus to appropriately classify the state of the spawning stock biomass (“status unknown”) has increased. Neglecting potential impacts of fishing pressure, the combined average proportion of all stocks with sufficiently high spawning stock biomass is at about one third, while only one fifth of the stocks assessed have been managed sustainably. For some important fish stocks in the ICES environment – specifically demersal ones –, science recently had to call for rebuilding plans or even a closure of the fishery to allow recovery, in spite of the management’s agreement to manage the resources according to the precautionary approach. This obvious difference between approach and implementation has a number of potential causes: erroneous or imprecise input data (landings, discard and sampling information), insufficient assessment models, problems in the understanding of the scientific advice, and implementation errors. The latter could be either a difference between advised and implemented total allowable catches (TACs), or an excess of legal TACs. During the fifteen years covered by this analysis (1987 to 2002), the average deviation between the implemented TACs for a specific stock and that recommended by ICES for the same stock was more than 30 %. The overall average deviation (summed over all stocks) for the entire period was 34 %, excluding, however, four extreme outliers in the data, representing cases in which scientific recommendations were exceeded by as much as 1000 to 2500 %. If these were included, the overall average would be as high as 45 %. The annual deviation has substantially increased in recent years (from roughly 20 % in earlier years of the surveyed period). This recently observed high deviation also matches ICES’s estimate that the fishing mortality in the ICES convention area in the 1990s was well above recommended sustainable levels in the pelagic and demersal fishery. A direct comparison of scientifically proposed and politically implemented TACs is problematic in many case

During the autumn session of the ICES Advisory Committee for Fisheries Management (ACFM) 58 stocks assessed in 7 Working Groups have been analyzed and reviewed, among these the demersal stocks in the North Sea and the Mackerel stock. As in previous years, ICES recommends a reduction in fishing mortality for a number of stocks or even the establishment of recovery and management plans, to safeguard a continuous development of the stocks towards safe biological limits. ICES reiterated last year’s recommendation to close the directed cod fishery and any fishery taking cod as by-catch in the North Sea, west of Scotland and in the Irish Sea. This year, the stocks of plaice in the North Sea, southern hake and southern anglers are (among others) in a critical state and in urgent need of protecting or rebuilding measures. This will again have an enormous impact on almost all mixed fisheries in the European Union. Johann Heinrich von Thünen-Institute, Federal Research Institute for Rural Areas, Forestry and Fisheries began publishing the Informationen aus der Fischereiforschung = Information on Fishery Research in 2010.

During the spring session of the ICES Advisory Committee for Fisheries Management (ACFM) the stocks of the Northern Pelagic and Blue Whiting, North Western, Baltic, Arctic and Deep Sea Working Groups have been analysed and assessed, as well as the Nephrops stocks. As in previous years ICES recommends a reduction in fishing mortality for a number of stocks. Moreover, ICES recommends for many stocks to establish recovery and management plans, to safeguard a continuous development of the stocks towards safe biological limits. Detailed recovery plans were proposed for cod and hake in the North Sea. Johann Heinrich von Thünen-Institute, Federal Research Institute for Rural Areas, Forestry and Fisheries began publishing the Informationen aus der Fischereiforschung = Information on Fishery Research in 2010.

During the autumn session of the ICES Advisory Committee for Fisheries Management (ACFM) the stock of the Arctic, Northern and Southern Shelf, North Sea and Skagerrak have been analysed and assessed, as well as the mackerel and horse mackerel, sardine, anchovy and Pandalus, eel and harp and hooded seals. For a number of stocks ICES recommends a reduction in fishing mortality. Moreover, ICES recommends for many stocks to establish recovery and management plans, to safe guarda continuous development of the stocks towards safe biological limits. Johann Heinrich von Thünen-Institute, Federal Research Institute for Rural Areas, Forestry and Fisheries began publishing the Informationen aus der Fischereiforschung = Information on Fishery Research in 2010.

The spring session of ACFM gave advice for a number of stocks in the North Atlantic, North Sea and Baltic. The present assessment of the situation is given here for stocks of importance for the German fishery. These are: Blue Whiting: the stock size is rapidly decreasing due to high catches; ICES recommends a closure of the fishery. Herring (Atlanto-Scandian, Norwegian spring spawner): Stock is within save biological limits, weak recruitment of the recent years will lead to a further reduction of biomass. Herring (North Sea): revision of the assessment led to a different perception of the stock: SSB was in 2000 below Blim. Excellent recruitment will lead to an increase of SSB over Blim within this year, but ICES recommends to reduce fishing mortality on adults significantly. Herring (Baltic spring spawner in 22–24, IIIa): Still no increasing tendency is detectable. Herring (VIaNorth): stable. Redfish: generally further decreasing tendency observed, a reduction of the fishery is recommended. Signs of recovery visible only for two units. Greenland Halibut: State of the stock not quite clear, but slightly positive tendencies. The present fishing intensity should be reduced. Cod (Kattegat): Weak recruitment, outside safe biological limits. ICES recommends a closure of the fishery. Cod (22–24, Western Baltic): Stock situation unclear due to extensive migrations. F should be reduced by at least 10%. Johann Heinrich von Thünen-Institute, Federal Research Institute for Rural Areas, Forestry and Fisheries began publishing the Informationen aus der Fischereiforschung = Information on Fishery Research in 2010.

During the autumn session of the ICES Advisory Committee for Fisheries Management (ACFM) the stock of the Northern and Southern Shelfs, North Sea and Skagerrak have been analysed and assessed, as well as the mackerel and horse mackerel, sardine, anchovy, Pandalus and Eel. As in previous years ICES recommends a reduction in fishing mortality for a number of stocks. Moreover, ICES recommends for many stocks to establish recovery and management plans, to safeguard a continuous development of the stocks towards safe biological limits. Johann Heinrich von Thünen-Institute, Federal Research Institute for Rural Areas, Forestry and Fisheries began publishing the Informationen aus der Fischereiforschung = Information on Fishery Research in 2010.