French Regulations Research Articles

Assessment of Molybdenum and Antimony speciation in excavated rocks and soils from the Parisian basin using mineralogical and chemical analyses coupled to geochemical modelling

In the Parisian basin area, soils excavated from public works sites often reveal naturally occurring trace elements contaminations, especially in Molybdenum (Mo) and Antimony (Sb). More specifically, the relatively strong solubility of Mo and Sb in these excavated soils prevents them from being re-used or disposed of in inert waste type landfills according to the French regulation, which is based on leaching rather than total content. Furthermore, the observed total contents are in general relatively low making it difficult to determine correctly the speciation of the trace elements. Yet, this is a key information to estimate the potential environmental risks associated to Mo and/or Sb leaching.Various direct and indirect methods of mineralogical and chemical characterizations were used in this study and coupled to geochemical modelling in the objective to determine the speciation and potential mobility of Mo and Sb in 4 samples of excavated rocks and soils from the Parisian basin. Three of them were raw materials, each one excavated in a single (but different) geological formation during classic earthworks. The fourth was a tunnel muck (a slurry) dug at the border between two geological formations and having undergone various treatments (e.g. liming) during the process of excavation. Studied samples all showed low total content of Mo and Sb. Mobility was particularly concerning for Mo in the carbonated sample (CS) and the tunnel muck (TM). Mo was found systematically carried by strontium sulfates (celestite, SrSO4) in marly limestones samples. pH dependence leaching tests coupled to geochemical modelling confirmed celestite as a major sink of Mo, while also pointing out its influence on Sb speciation. In the calcareous sample, Mo and Sb mobility was mainly controlled by complexation onto iron oxides surfaces with high pH dependency. Furthermore, in this sample, correlations between Trace Elements (TE) and Sr concentrations were assumed to occur through incorporation in carbonates rather than through associations with celestite. Associations with iron sulfides were suggested to be responsible for a small fraction of total leachable Mo and only under basic conditions. Finally, geochemical modelling was used to describe accurately Mo and Sb speciations in the tunnel muck pointing out a more complex partitioning influenced by the treatment undergone during the excavation process. Results presented here suggested that Mo and Sb speciations show great similarities and vary significantly depending on the excavated material. It is also inferred that pH changes of materials especially expected for the alkaline tunnel muck could further increase TE mobility.

Formal modelling of the electricity markets: the example of the load reduction of electricity mechanism “NEBEF”

The liberalisation of the electricity market initiated at the beginning of the 21st century has opened it to new parties. To ensure the growth of participants’ number will support the system’s balance, the EU regulation 2019/943 confirms that “all market participants should be financially responsible of the imbalances they cause”. In their respective area, the transmission system operators develops the regulation in compliance with this condition. However, as the regulation takes into account the new realities of the market such as renewables, the interactions between the participants become more complex. One of the risks is that the imbalance of an actor may not be due to its own actions, not complying with the EU regulation then. To analyse this kind of implicit condition, we propose a formal approach to model the exchanges of energy. Using the French regulation as a base, we model the participants and their interactions in the form of symbolic equations using the energy-related terms as variables. In this paper, to illustrate the model we will use to analyse the entire electricity market, we apply it to the NEBEF mechanism only. This mechanism is dedicated to the selling of demand response in France and introduces a third party between the final producer and the final consumer: the demand response operator. We model the mechanism and analyse how the mechanism complies with the balancing responsibility. Our results demonstrate that the mechanism complies with the regulation but there are some limits due to the calculation method of the reference consumption.

An analysis of how lobbying by the alcohol industry has eroded the French marketing regulation law

Abstract Background In response to the positive association between alcohol marketing and young people's alcohol consumption, several countries have adopted marketing regulation laws. This is the case in France with the 1991 Evin Law, which prohibits advertising in media targeting young people and regulates content in authorized media. However, this law has faced intense opposition from its inception. The aim of this research is to identify the arguments and lobbying strategies deployed by the alcohol industry to undermine it. Methods We conducted semi-structured interviews with 18 French key informants involved in implementing and/or updating the Evin Law, including initiators of the law, former ministers, non-governmental organizations, national public health institutes and academic associations and institutions. A thematic analysis was conducted to highlight strategies and arguments employed by the alcohol industry to undermine the Evin Law using Savell et al. framework (2016). Results Several of the identified strategies and arguments to combat marketing regulations were similar to those identified in other countries, while some strategies and arguments were specific to the French context. These include highlighting winegrowing and its integration into decision-making bodies, and forming alliances with parliamentarians. These specific features may in part be explained by the economic significance of alcohol and wine at the heart of French culture. Conclusions For the first time, the long-term lobbying strategies and arguments used by the alcohol industry to weaken the Evin Law are analyzed from the perspectives of those closely involved in its implementation. This study may be useful for other countries that have - or are in the process of - implementing alcohol marketing regulation laws. Key messages The pioneering French alcohol marketing regulation law has faced intense opposition from the alcohol industry, in particular viticulture. Analyzing the strategies and arguments used by the alcohol industry to erode this pioneering law is important to better counter them.

Development of a thermo-mechanical behaviour model adapted to the ITER vacuum vessel material

The ITER machine has been classified as a Basic Nuclear Installation French nuclear regulator (INB n°174), which implies that it will be the first fusion reactor to go through complete French nuclear licencing. The combination of mechanic and electromagnetic phenomena with the heat loads caused by neutron streaming requires a multi-physics approach to the damage assessment, which has not yet been implemented in the common nuclear codes and standards.The general damage prevention methodology consists in guaranteeing the structural integrity of a component. The development of design rules has mainly two origins: prevention of damage from monotonic mechanical loads and prevention of damage from repeated application of loads. In most cases, structural integrity is justified within a linear elastic behaviour but when this route is not enough to respect the design criteria, several non-linear approaches to the material's mechanical behaviour can be considered, requiring more elaborated demonstration of the design compliance. Nevertheless, the models proposed in the nuclear model database are sometimes not sufficient to properly describe the experimentally observed cyclic plasticity behaviour and, in particular, the ratcheting and shakedown phenomena.According to ITER community experts in materials and analyses, a thermo-mechanical behaviour model fitting the ITER Tokamak materials data will guarantee the best prediction of the damage considering a nuclear and a multi-physic loading condition.This paper describes the assessment of the non-linear behaviour of Vacuum Vessel (VV) material with a strong thermo-mechanical coupling and a damage parameter to prevent crack initiation. More precisely, Chaboche's models available in the literature (elasto-(visco)-plasticity models, with various types of hardening) have been enriched in order to explicitly take into account the influence of the temperature on the mechanical behaviour and, reciprocally, the influence of the mechanical behaviour on the temperature. Mechanical cycling tests have been performed on the VV constitutive material, emphasizing on the progressive deformation state up to failure mode, i.e., ratcheting. The proposed models have been tested on a homogeneous problem and the results compared with uniaxial test results; this type of simulation is commonly called “0D”analysis. The last part of this document describes the finite element implementation of the constitutive material model and its application to the ITER VV welded support.

The Characteristics of the Romanian Infantry Tactics during the Interwar Period

Abstract This article examines the main tactical characteristics of the Romanian infantry during the interwar period under the influence of the French principles, in the context in which the First World War proved the need to consider providing the units with a variety of technical equipment for a greater firepower on the battlefield. This article presents the basic forms of warfare according to the regulations of the time, defining the tactical rules of the battalion, presenting the new concepts that have emerged in the infantry tactics after the great world conflagration. It also presents aspects of subunit training, as well as the main technical characteristics of the infantry weaponry compared to that of the French army. On the other hand, it identifies the difficulties encountered in adapting the tactical principles of the French Regulations to the specificities of the Romanian infantry which had to take into account the physiognomy of a possible war, the troops available, but also the differences in army industry development.

Notion of Market Manipulation in the Areas of Administrative Law and Criminal Law in the Legal Systems of Selected Member States of the European Union

The aim of the author of this paper is to show boundaries between penalised market manipulation and market manipulation which can be sanctioned only by administrative countermeasures. This task was achieved in result of analysing German, French, Italian and Spanish legal regulations concerning market manipulation. Above- –mentioned analysis is based on theoretical issues which are discussed in the part of this work concerning definition of market manipulation. European regulations related to market manipulation are also elaborated in this article. Differences between penalised market manipulation and administrative market manipulation are creatively and synthetically discussed in the separate part of this work. Theoretical sources of differences between discussed regulations concerning administrative market manipulation and criminal market manipulation are elaborated in the summary.

The Shifting role role of unions in the social dialogue

The article deals with the declining union density and shrinking coverage of collective agreements in most EU/EES countries, in particular in Eastern Europe and Greece. In many countries, international organizations pushed through “structural reforms” weakening trade unions. The result is declining union density and decreased capacity to conclude sectoral collective agreements and avoid downwards derogations at company level. Even in some core eurozone countries have governments without much of social dialogue carried through “internal devaluation” to restore competitiveness. High union density (Finland) or high union mobilization capacity (France) could not prevent this development. The economic performance of a country and degree of globalization, including the absence of a national currency, appear to be more important. The Swedish (and Nordic) model of self-regulation, resting on negotiations between the labour market parties, contrasts sharply to French state regulation with its high frequency of state extension of collective agreements and minimum wages set by the state. Union density in Sweden is still among the highest in the world but has declined considerably the last twenty years, in particular among the rapidly growing share of foreign-born blue-collar workers. As a small, strongly export-dependent country dominated by large transnational groups, Swedish economy is very influenced by globalization. This has shifted the balance of power to the advantage of employers, and by that circumscribed the unions’ efforts to achieve developing jobs and improved working environment.

Characterisation and chemometric evaluation of 17 elements in ten seaweed species from Greenland.

Several Greenland seaweed species have potential as foods or food ingredients, both for local consumption and export. However, knowledge regarding their content of beneficial and deleterious elements on a species specific and geographical basis is lacking. This study investigated the content of 17 elements (As, Ca, Cd, Cr, Cu, Fe, Hg, I, K, Mg, Mn, Na, Ni, P, Pb, Se and Zn) in 77 samples of ten species (Agarum clathratum, Alaria esculenta, Ascophyllum nodosum, Fucus distichus, Fucus vesiculosus, Hedophyllum nigripes, Laminaria solidungula, Palmaria palmata, Saccharina latissima and Saccharina longicruris). Element profiles differed between species but showed similar patterns within the same family. For five species, different thallus parts were investigated separately, and showed different element profiles. A geographic origin comparison of Fucus species indicated regional differences. The seaweeds investigated were especially good sources of macrominerals (K > Na > Ca > Mg) and trace minerals, such as Fe. Iodine contents were high, especially in macroalgae of the family Laminariaceae. None of the samples exceeded the EU maximum levels for Cd, Hg or Pb, but some exceeded the stricter French regulations, especially for Cd and I. In conclusion, these ten species are promising food items.

Market strategies for large-scale energy storage: Vertical integration versus stand-alone player

New projects using existing storage technologies such as Pumped Hydro Storage (PHS) face uncertainty due to the lack of clear business models. Market regimes have generally tended to embed storage and generators within the central management of operators with multiple assets such as the French EdF (Electricité de France). By means of back-casting, this study depicts the role of storage in the power market, within the vertical integration in the governance portfolio of EdF. A dynamic algorithm simulates hourly operation under two different storage strategies, daily and weekly, and the results are compared with actual patterns over the period 2015–2019. This reveals missing money for a stand-alone player due to price arbitrage caused by low spread, and missing market opportunities. This suggests that the economics of storage are not driven by spot prices alone, but by other services, such as the energy block provision in support of nuclear power. Differential calculus is used to estimate the value of flows integrating the duration of storage and its seasonality. These findings further support the French regulator to install new PHS despite the lack of profitability, by means of capacity-energy hybrid contracts for new competitors in place of the existing government-industry structure.

Does corporate tax aggressiveness explain future stock price crash? Empirical evidence from France

PurposeThis study aims to examine the impact of corporate tax aggressiveness on future stock price crash. It also tests the impact of corporate tax aggressivness in predicting stock price crash for a two-year forecast window.Design/methodology/approachThe study sample consisted of 1,169 firm-years observations. The multivariate analysis uses three measures of stock price crash risk, as a dependent variable. The key variable is tax aggressiveness lagged by one period (one year) as all independent variables. As a robustness check, this paper uses alternate measures of earning management and a longer forecast window (two years) to predict stock price crash risk.FindingsTax aggressiveness activity is positively related to a firm-specific future stock price crash. Moreover, corporate tax aggressiveness predicts stock price crash risk for a long forecast window (two years). The findings are robust to a number of checks and have several policy implications.Practical implicationsThe cost of continuing to accumulate bad news will be greater than the cost of revealing them. Thus, board of directors should encourage disclosure in order to reveal private news and then, to increase the amount of firm-specific information in returns. Another point is that tax aggressiveness behavior implies a risk to be perceived by the market as socially irresponsible, and may harm the firm reputation. This fact leads, in terms of portfolio management, to deter investment in firm-equity. Therefore, Investors should be cautious about the different risks of corporate tax aggressiveness.Social implicationsThe accounting system in France, as in most European countries, relies upon codified rules and government requirement. Thus, our results provide some evidence of the effectiveness of the French laws and regulations in preventing indirectly earnings management from affecting stock price crash risk.Originality/valueFrench companies are among the heavily taxed in Europe which makes France a particularly suitable context for studying tax aggressiveness issues. To the best of our knowledge, this study is the first in the french context, that document a signifcant and positive relation between tax aggressiveness and future crash risk. It focuses on the important role of corporate tax planning as a means of withholding bad news and its consequences in inflating stock prices.

Do Board Gender Quotas Benefit Minority Shareholders? An Illustration through Related‐Party Transactions

AbstractWe use a sample of French firms over the period 2001–2017 to investigate the relationship between board gender diversity and related‐party transactions (RPTs). Although some of these transactions are efficient, RPTs are usually perceived negatively by outsiders because of the existence of conflict‐of‐interest transactions deemed to be value‐destroying. Based on agency theory and managerial power theory, we argue that female directors have the ability and motivation to challenge managers’ use of RPTs. Consistently with this argument, we find that board gender diversity negatively correlates with the number of reported RPTs. This negative correlation is driven by female directors involved in the board's monitoring duties (female independent directors and members of the audit committee). However, because they are less likely to be able to challenge managers, female inside directors do not affect the occurrence of RPTs. In January 2011, the French regulator enacted a gender quota law resulting in a significant increase in female board representativeness. We find that the marginal effect after enacting the gender quota law on the number of reported RPTs is negative for the proportion of female independent directors and female audit committee members, and positive for female inside directors.

ILC3-derived acetylcholine promotes protease-driven allergic lung pathology

ILC3-derived acetylcholine promotes protease-driven allergic lung pathology

Organized denial at work: The difficult search for consistencies in French pesticide regulation

AbstractWhy does it always take a long time to acknowledge environmental hazards such as climate change or air pollution, even when knowledge on their dangers has been available for years? Drawing on the case of French pesticide regulation, this article shows that this gap between knowledge and consequent action results not only from secretive corporate leverage on public decisions and expertise but also from the expertise and bureaucratic machinery behind pesticide regulation. This machinery fosters an organized denial where regulators systematically exclude uncomfortable knowledge that could challenge official risk assessment. Organized denial that legally maintains ignorance fulfills an implicit function. It preserves the legitimacy of the risk management system and, through it, the administrative and commercial organization of agricultural production in France.

“Si la France le savait...”: a utilização do estado de sítio na França (1791-1918)

O estado de sítio como instituição é uma criação jurídica francesa do final do século XVIII e está no campo da exceção. Com a normatização francesa, a medida reafirmou o sentido transitório do instituto, pois o estado de sítio flerta com o autoritarismo ao hipertrofiar o poder no Executivo e permitir medidas de repressão mais severas. O artigo trabalha com fontes francesas (documentos militares, legislativos e jurídicos) para, após apresentar as noções de formulação constitucional do instituto, analisar a sua utilização na França da Revolução Francesa à Primeira Guerra Mundial. A medida, que não foi letra fria da lei, esteve presente nos regimes políticos seguintes depois da fase revolucionária e conquistou grande repercussão em outras legislações. Metodologicamente, recorre-se à perspectiva normativa para definição do instituto do estado de sítio, avaliando-se o seu desenvolvimento, bem como promovendo uma análise quantitativa e qualitativa do uso do instituto. Os dados levantados são colocados em diálogo com o que há de mais recente na historiografia internacional, sobretudo francesa, sobre o assunto. Conclui-se, então, que sua transposição de uma noção militar de campo de batalha para uma noção fictícia aplicada em contexto político foi repleta de aplicações viabilizando o uso expressivo do arbítrio por meio legal.

Usefulness of 18F-Fluorodeoxyglucose Positron Emission Tomography in Diagnosing Polymyalgia Rheumatica and Large-Vessel Vasculitis: A Case-Control Study

Background: Polymyalgia rheumatica (PMR) is a relatively common disease among the elderly. None of the most common imaging techniques provides diagnostic certainty of PMR. 18F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) may be a useful candidate as it can be used to visualize articular and periarticular FDG uptake at different locations, as well as associated large-vessel vasculitis (LVV). However, in the absence of large-scale case-control studies, its usefulness needs to be evaluated. The purpose of this study was to determine the usefulness of FDG-PET/CT in diagnosing PMR and LVV. Methods: We analyzed FDG-PET/CT scans performed between January 2015 and December 2019 on patients diagnosed with PMR. For comparisons, patients with PMR were matched 1:1 to controls according to age and sex. FDG-PET/CT scans had been performed on controls over the same period for diagnosis of cancer-associated stroke. FDG uptake was scored visually for 17 articular or periarticular sites and 13 vascular sites using a semi-quantitative scoring system (score 0-3). The case and control groups were compared using generalized linear mixed models (binomial distribution, logit function) for binary outcomes, and linear mixed models for continuous outcomes, with matched sets as a random effect. Receiver operating characteristics (ROC) curve analysis, based on the area under the ROC curve (AUC), was used to assess the ability of the number of sites with significant hyperfixation (score ≥ 2) and the FDG uptake score to differentiate the two groups. From the ROC curves, we determined optimal threshold values by maximizing the Youden index. Sensitivity and specificity for the optimal threshold were calculated. Results: 81 patients with a diagnosis of PMR and 81 controls were included (mean (SD) age 70.7 (9.8) years; 44.4% women). Significant differences between the PMR and control groups were found at all articular and periarticular sites for: 1) FDG uptake score (p<0.001 for all locations); 2) number of patients per site with significant FDG uptake (score ≥ 2); 3) global FDG articular uptake scores (score 0-51) (31 [IQR, 21 to 37] versus 6 [IQR, 3 to 10], p<0.001); and 4) number of sites with significant FDG uptake (score ≥ 2) (score 0-17) (11 [IQR, 7 to 13] versus 1 [IQR, 0 to 2], p<0.001). ROC curve analysis revealed that the presence of 6 or more sites with significant FDG uptake (≥ 2) was associated with the diagnosis of PMR, with a sensitivity of 84% and a specificity of 96% (AUC 0.90 [95% CI 0.8593-0.95]). No significant differences in global FDG vascular uptake scores (score 0-39) or in number of patients with at least 1 significant vascular uptake site (score ≥ 2) were found between the PMR and control groups (1 [IQR, 0 to 4] versus 4 [IQR, 0 to 6], p=0.06, and 8 (11.3%) versus 10 (14.1%), p=0.62 respectively). Conclusion: Our results demonstrate that the FDG uptake score and the number of sites with significant FDG uptake could be relevant criteria for the diagnosis of PMR. However, unlike other authors, we found no evidence suggesting that FDG-PET/CT may be useful in diagnosing silent underlying LVV in patients with isolated PMR. Funding: None to declare. Declaration of Interest: None to declare. Ethical Approval: Since this is a retrospective study, it did not require ethical committee approval in accordance with the French laws and regulations. Informed consent was obtained from all patients for the FDG-PET/CT scans.

Digital and Blockchain-based Legal Regimes: An Eea Case Study Based on Innovative Legislations – Comparison of French and Liechtenstein Domestic Regulations

The financial crisis of 2007/08 had shattered the global financial system and led – besides a flood of regulations – to a wide range of new concepts and business models. One of these new concepts was “Bitcoin”, a private digital monetary system, which is characterized by decentralization, transparency and immutability. To date the underlying Blockchain or Distributed Ledger Technology (DLT) has evolved and offers an extensive range of possibilities, particularly in the financial industry. So far, an EU-wide legal basis for Blockchain or DLT applications and services is missing. France and the Principality of Liechtenstein took a step forward and adopted national laws trying to offer legal certainty in this field. This article aims to provide a comparison of the two acts and underline the similarities and differences.

Ograniczenia zdolności prawnej osób duchownych w pracach kodyfikacyjnych doby Królestwa Kongresowego

Artykuł dotyczy ograniczenia uprawnień duchownych katolickich w pracach kodyfikacyjnych w Królestwie Kongresowym. Zgodnie z prawem kanonicznym, które w znacznym zakresie było respektowane przez sądy Rzeczypospolitej Obojga Narodów, zakonnicy i zakonnice mieli poważnie ograniczone uprawnienia w zakresie prawa spadkowego (co do możliwości spadkobrania czy sporządzenia testamentu). Wobec w pełni wyznaniowego charakteru prawa małżeńskiego osoby zobowiązane do celibatu nie mogły też rzecz jasna zawrzeć małżeństwa.&#x0D; Reguły te pozostały w znacznym stopniu w mocy po zaprowadzeniu na dawne ziemie koronne praw pruskich i austro-galicyjskich. Z kolei Kodeks Napoleona, któremu nadano moc obowiązującą w Księstwie Warszawskim, nie znał ograniczeń duchownych ani w zakresie prawa spadkowego, ani co do możliwości zawierania małżeństw. Po przejęciu kontroli nad centralnymi ziemiami polskimi przez Aleksandra I oczywistą była potrzeba reformy prawa cywilnego. Jej zakres i zasady jednak budziły kontrowersje. Poza dyskusją pozostawało wyłączenie możliwości zawierania małżeństw przez duchownych katolickich, lecz zakres ewentualnego ograniczenia zdolności prawnej oraz zdolności do czynności prawnych zakonników i zakonnic był przedmiotem sporów. Tarcia w powołanej po obradach Sejmu w 1820 r. deputacji prawodawczej były tak wielkie, że konieczne okazało się rozstrzygnięcie tej kwestii przez samego cara. Opinia monarchy wychyliła się wówczas w stronę klerykalną, czego skutkiem było ograniczenie praw cywilnych zakonników i zakonnic przez art. 10 Kodeksu Cywilnego Królestwa Polskiego. Pełniejszy niż dotychczas opis tych kontrowersji był możliwy dzięki uwzględnieniu niewykorzystywanych dotychczas przez polskich badaczy materiałów przechowywanych w jednym z moskiewskich archiwów.

Management of acromioclavicular joint disease by manual therapy versus corticosteroid injections: the protocol of a non-inferiority study

IntroductionDegenerative acromioclavicular joint pain accounts for about 4% of shoulder pain. Various medical and non-medical treatment strategies are available for acromioclavicular joint disease but it is difficult to conduct a...

Pluricentric Languages Policy Features through the Example of French

Introduction.The paper reviews features of the French language policy inFrance,Belguim,Canada, andSwitzerland. The novelty of the study is implied by the fact that features of the language policy are analyzed with previously unknown circumstances taken into account: the circumstances that allow French to be seen as a pluricentric language. The relevance of the study is conditioned by the necessity of observing the sociopolitical space of language functioning, as well as the importance of both analyzing the dynamics of pluricentric languages spreading and identifying mechanisms of using a single language for either uniting disparate nations or countries manipulating.Methodology and sources.The method of the study is a comprehensive approach with a number of linguistic and social variables correlations. The study was conducted using official websites of Organisation international dela Francophonie describing official bodies and institutions responsible for language policy implementation, as well as articles of various publications (Le soir, The Guardian, Ethnologies), devoted to the discussion of French norm regulation problems as the material of the study.Resultsanddiscussion.The main result of the study is a review of the status of French as a pluricentric language worldwide, particularly in countries considered to be centres of French variants development and having French as an official language. Main features of a pluricentric language, as well as the factors that turn a monocentric language into a pluricentric one (through the example of French) are looked at. The actions taken by the Organisation internationale dela Francophonie and aimed at the strengthening of relations between French-speaking countries and the promoting of the French language worldwide are described. The study also illustrates the dependence of peripheral language centres fromFrance. An emphasis is put on the politics of the Académie Française aimed at the French language unification in all the countries having it as an official language. An assumption on the reasons of different deviation extent of French variants inCanada,Belgium, andSwitzerland from Standard French is made.Conclusion.It is impossible to consider language to be an independent and isolated phenomenon as it exists and evolves within society serving its needs. Institutions pursuing a language policy are in position to affect its development directly, yet in the context of pluricentric languages it is insufficient to have a single centre of linguistic regulation. Local institutions may have a policy that runs contrary to the language policy of the centre. Gender reforms can also become a new wave of linguistic changes leading to further distancing of different language variants.

Real-World Experience with a New Human Fibrinogen Concentrate (Fibryga®) in France for the Treatment of Bleeding Episodes and Surgical Prophylaxis

Introduction: Fibrinogen deficiency can be either congenital, or acquired due to situations such as trauma, excessive surgical bleeding, or post-partum hemorrhage (PPH). Transfusion of human fibrinogen concentrate (HFC) can correct this deficiency, preventing hemorrhage and excessive blood loss. This study aimed to describe the use of a new, highly purified HFC (Fibryga®; Octapharma) recently granted temporary import authorization for use in congenital and acquired fibrinogen deficiencies in France. Methods: This observational, non-interventional, retrospective database study was conducted in five French hospitals, according to French regulations and data protection laws. Data was retrieved from the medical files of patients with fibrinogen deficiency who received the new HFC from December 2017 to July 2019. Indication, modality, efficacy and safety outcomes were recorded. Success for treatment of bleeding episodes was defined as control of bleeding or hemoglobin loss &amp;lt;20%. In surgical prophylaxis, treatment success was defined as the absence of major perioperative hemorrhage, according to hospital records. Results: The interim analysis included 110 patients with a mean (±SD) age of 56.9 (±17.7) years. All patients presented with acquired fibrinogen deficiency requiring administration of HFC, with indications and doses shown in Table 1. Treatment success rates were 88.4% (95% Confidence Interval [CI]: 78.8-98.0%) for non-surgical bleeding, 96.8% (95% CI 90.6-100%) for surgical bleeding (SB) and 91.2% (95% CI 81.6-100%) for surgical prophylaxis. Overall tolerance was good. Subgroup analyses were performed for patients undergoing cardiac surgery and those with PPH. Cardiac Surgery In total, 52 patients underwent cardiac surgery (aortic dissection repair, aortic surgery, cardiac valvuloplasty, coronary bypass, complex aortic surgery or heart transplantation). Patients were aged 64.9 ± 12.3 years and 69% were male. Indications were SB (n=26, 50%) and prevention of SB (n=26, 50%). Mean total doses of HFC were 1.85 ± 0.97 g for SB and 2.27 ± 1.37 g for prevention of SB. Success rates were 100% (95% CI 100-100%] and 92.3% [95% CI 82.1-100%] respectively. In a subset of pediatric patients (n=17), aged between 4 days and 6 years (with the exception of two who were 17) patients received on-demand HFC for bleeding prevention prior to cardiac surgery. Mean total dose of HFC was lower than in the full population (0.74 ± 0.58 g) with a mean of 1.06 ± 0.43 doses per patient. Two patients received more than one dose, with a mean of 0.65 ± 0.82 hours between doses. The success rate for bleeding prevention was 94.12% (95% CI: 82.93-100.00%]. No patients reported a hemoglobin variation of &amp;lt;20%. One patient received a red blood cell transfusion prior to HFC treatment, and no patients required transfusions following HFC. PPH A total of 44 (40.0%) patients in the interim analysis were female. Of these, 29 (65.9%) were not pregnant and 15 (34.1%) were post-partum and presented with PPH. Mean age for the PPH patients was 32.8 (±4.9) years, and mean weight 84.67 (±19.58) kg. For women with PPH (N=15), the mean total dose of HFC was 2.53 ± 0.74 g (29.64 ± 9.68 mg/kg) with mean number of doses of 1.33 ± 0.72. Time between first and second dose was 2.88 ± 3.63 hours. The treatment success rate for PPH patients was and 86.7% (95% CI: 69.5-100%) for PPH with bleeding control achieved for 9 (60.0%) with a mean blood loss of 1.87 (±0.88) L. A total of 11 (73.3%) PPH patients required transfusions, 8 (72.7%) before HFC and 3 following HFC. Overall, tolerance was good for all patients with no adverse drug reactions reported. Conclusions: In real-world practice, the new HFC was used mostly for bleeding control. In around one third of patients, HFC was administered as prophylaxis to avoid surgical bleeding. HFC was found to be effective in specific subpopulations including patients undergoing cardiac surgery and women with PPH. Use of HFC was associated with favorable efficacy outcomes and no safety concerns were identified. Disclosures Stephan: Octapharma: Research Funding. Gutermann:Octapharma: Research Funding. Pennetier:Octapharma: Research Funding. Bourget:Octapharma: Research Funding. Djabarouti:Octapharma: Research Funding. Berdugo:Octapharma: Research Funding. Fardini:Octapharma: Research Funding. Clerson:Octapharma: Research Funding. Schwartz:Octapharma: Current Employment.