The Role of Stakeholder Engagement in Developing New Technologies and Innovation for Nitrogen Reduction in Waters: A Longitudinal Study

Better nitrogen management, technologies, and regulation are required to reduce nitrogen losses in the aquatic environment. New innovative technologies can support farmers in a more targeted planning of fertilizer application and crop management at the field level to increase the effect of measures when reducing nitrogen losses. However, if farmers do not perceive the need for such a concept, the demand (market pull) will be minimal, making the implementation of such a technology difficult. The lack of this market pull could, however, be counterbalanced by a market push from research or requirements from public sector stakeholders (regulators). Within this domain, the main objective of this paper was to study technological change over time and identify and understand the crucial stakeholder involvement using the Functions of Innovation Systems Approach. This article shows how stakeholders’ perceptions and participation evolved over a 10-year period. It examines the interplay between technology readiness and the perceived readiness and acceptance by affected stakeholders. We demonstrate how stakeholder engagement was crucial to ensure the development of the technologies by creating marketable options for their future implementation. A key dynamic that emerged in this process was the transition from a research push to a regulator pull. We demonstrate the fact that without the regulatory requirement linked to changes towards more targeting of measures, the technology would not, on its own, be a business case, although it would provide new knowledge, thus representing a gain for society. The specific findings can be used in countries where new technologies need to be developed, and where a link to the regulation can ensure the active use of the new technology and, therefore, make their implementation worthwhile.

Overview of Post-Closure Criticality Safety – RD&D Topics in Switzerland

The demonstration of post-closure criticality safety of spent nuclear fuel in a deep geological repository is a regulatory requirement in Switzerland and many other countries. One of the main challenges stems from the very long timescale (1 million years in Switzerland) that has to be considered. Nagra, the Swiss National Cooperative for the Disposal of Radioactive Waste, is presently elaborating the technical and scientific foundation of the criticality safety assessment in view of the upcoming general licence application for the Swiss Spent Fuel and HLW repository. In this context, Nagra supports and pursues a focussed RD&D programme in collaboration with several renowned research institutes. Nagra's safety concept relies on natural and technical barriers. For the initial thermal phase of the repository, a steel canister assures complete containment of the spent fuel. The canisters are foreseen to remain intact for approximately 10 000 years; however, the subcriticality of the system has to be ensured for a much longer period. In this context, an important part of the research activities pursued by Nagra address the nearfield evolution and the formulation of scenarios for the corresponding evolution of the canister and spent fuel system. The role that variations in the canister design and material composition have on the system's reactivity are also investigated. Other research topics focus on developing a reliable methodology for carrying out the criticality safety assessment. This symposium contribution gives an overview of the post-closure criticality RD&D activities pursued and envisioned by Nagra. The general context and Nagra's fundamental approach to elaborating the current phase of the criticality safety assessment are presented first. Following this, the current RD&D landscape and the most important technical considerations underpinning Nagra's technical basis for the post-closure criticality safety assessment in particular are discussed. Future planned research topics and points of interest are also presented as an outlook of this presentation.

Overview of the Tolerance Limit Calculations with Application to TSURFER

To establish confidence in the results of computerized physics models, a key regulatory requirement is to develop a scientifically defendable process. The methods employed for confidence, characterization, and consolidation, or C3, are statistically involved and are often accessible only to avid statisticians. This manuscript serves as a pedagogical presentation of the C3 process to all stakeholders—including researchers, industrial practitioners, and regulators—to impart an intuitive understanding of the key concepts and mathematical methods entailed by C3. The primary focus is on calculation of tolerance limits, which is the overall goal of the C3 process. Tolerance limits encode the confidence in the calculation results as communicated to the regulator. Understanding the C3 process is especially critical today, as the nuclear industry is considering more innovative ways to assess new technologies, including new reactor and fuel concepts, via an integrated approach that optimally combines modeling and simulation and minimal targeted validation experiments. This manuscript employs intuitive, analytical, numerical, and visual representations to explain how tolerance limits may be calculated for a wide range of configurations, and it also describes how their values may be interpreted. Various verification tests have been developed to test the calculated tolerance limits and to help delineate their values. The manuscript demonstrates the calculation of tolerance limits for TSURFER, a computer code developed by the Oak Ridge National Laboratory for criticality safety applications. The goal is to evaluate the tolerance limit for TSURFER-determined criticality biases to support the determination of upper, subcritical limits for regulatory purposes.

Regulatory Procedure of Post Approval Changes and Comparative Requirements of EU and USA Regulatory Regions

Aim: The current research paper describes the “Regulatory procedure of post approval changes and comparative regulatory requirement of EU and USA regulatory regions”. Study Design: The present study is a type of Retrospective analysis of Regulatory requirements and the reviewed data was subjected to systemic review. Understanding of the same led to several observations regarding regulatory requirements of EU and USA regulatory regions. Place and Duration of Study: The present study was carried out at Amneal Pharmaceutical Ltd., Ahmedabad, Gujarat, India from January, 2021 to April, 2021. Methodology: Several guidelines were profoundly reviewed to compare the requirements of post approval changes in EU and USA regulatory regions. Various regulatory review aspects were focused i.e. requirements for manufacturing sites addition/or Transfer, process parameters, container and closures, packaging and labelling of medicinal products. Results: The post approval changes in manufacturing sites of solid or semisolid dosage form considered as a major change for USA while considered as Moderate change for EU. The transfer of manufacturing section is major variation for USA while it is a minor but immediate inform type for EU. Change in manufacturing processes, containers, labelling section of sterile products considered as major variation for both. Semisolid and solid categories are falling under the same type of variation for EU and USA regulatory regions. Conclusion: This work demonstrated that the drug approvals in US, EU are the most demanding globally and the available guidance and procedures for the triggered changes are clear in both countries. Applicant should have scientific rationale to any change pertaining to Approved product ; Since the all change control are falling under the scope of Audit, so Applicant should maintain the all the records online.

Development and Stability of Forced Degradation Studies Indicating Different Brands of Metformin Drugs

In present study, Accouring to specification of Indian pharmacopeia the content official limit of not less than (98.5%) and not more than (101.0%) of the lable amount our hypothesis was that when all different brands of metformin were expose to the different degradation parameters. The Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package. A forced degradation study is an essential step in the design of a regulatory compliant stability program for both drug substances and products, and formalized as a regulatory requirement in ICH Guideline Q1A in 1993. Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions.

Long-Term Changes in the Abundance of Benthic Foraging Birds in a Restored Wetland

Estuaries have historically been subject to considerable habitat loss, and continue to be subjected to such in areas where the natural landward migration of intertidal habitats is constrained by hard coastal defences. Thus, in estuaries where direct (e.g., port development) or indirect (e.g., sea level rise) processes are predicted to threaten intertidal habitats and associated waterbird species, there is a regulatory requirement to produce compensatory intertidal habitats. Managed realignment (MR) is a shoreline management practise that is undertaken to build sustainable coastal defences and create intertidal habitats in estuaries. This nature-based solution brings multiple benefits in the form of carbon storage, increased resilience to flooding, and, potentially, the formation of new habitats, which is the topic of this study. A 75-ha site at the Paull Holme Strays (Humber Estuary, United Kingdom) was monitored over a 10-year period following MR to examine the change in the abundance of waterbirds in the chosen site in response to the physical processes occurring there. Using digital terrain models (DTMs) collected via light detection and ranging (LiDAR), we examined how four compensatory target species responded to changes in elevation after the creation of the site. It was shown that the very rapid accretion of estuarine sediment occurred in the first decade of the new re-created intertidal, which, over time, led to changes in the numbers of benthic foraging birds supported. Furthermore, elevation change was also driven by this sediment accretion, the rate of which depended on the initial bed elevation of the sectors within the site. Ten years after the recreation of the habitat, the spatial heterogeneity in the bed elevation remained high; however, the sectors with the lowest elevations accreted the most over the 10-year period. The foraging number of the four waterbird species that colonised the MR site significantly declined above a certain elevation, with this effect being most pronounced for the Eurasian curlew (Numenius arquata). The number of common shelducks (Tadorna tadorna), dunlins (Calidris alpina), and common redshanks (Tringa totanus) declined significantly after initial peaks 5–7 years after the creation of the site, reflecting the ongoing elevation changes. Thus, this study highlighted the need for long-term studies to understand how species respond to large-scale habitat construction. It can also aid in predicting the suitability of an MR site for waterbirds in the medium and long term.

Time-Lapse Integration at FWU: Fluids, Rock Physics, Numerical Model Integration, and Field Data Comparison

We present the current status of time-lapse seismic integration at the Farnsworth (FWU) CO2 WAG (water-alternating-gas) EOR (Enhanced Oil Recovery) project at Ochiltree County, northwest Texas. As a potential carbon sequestration mechanism, CO2 WAG projects will be subject to some degree of monitoring and verification, either as a regulatory requirement or to qualify for economic incentives. In order to evaluate the viability of time-lapse seismic as a monitoring method the Southwest Partnership (SWP) has conducted time-lapse seismic monitoring at FWU using the 3D Vertical Seismic Profiling (VSP) method. The efficacy of seismic time-lapse depends on a number of key factors, which vary widely from one application to another. Most important among these are the thermophysical properties of the original fluid in place and the displacing fluid, followed by the petrophysical properties of the rock matrix, which together determine the effective elastic properties of the rock fluid system. We present systematic analysis of fluid thermodynamics and resulting thermophysical properties, petrophysics and rock frame elastic properties, and elastic property modeling through fluid substitution using data collected at FWU. These analyses will be framed in realistic scenarios presented by the FWU CO2 WAG development. The resulting fluid/rock physics models will be applied to output from the calibrated FWU compositional reservoir simulation model to forward model the time-lapse seismic response. Modeled results are compared with field time-lapse seismic measurements and strategies for numerical model feedback/update are discussed. While mechanical effects are neglected in the work presented here, complementary parallel studies are underway in which laboratory measurements are introduced to introduce stress dependence of matrix elastic moduli.

Anti-money laundering in the United Kingdom: new directions for a more effective regime

Purpose This paper aims to provide a more nuanced understanding of the effectiveness of the anti-money laundering (AML) regime in the UK and explore opportunities to improve policy and performance. Design/methodology/approach Qualitative research design using semi-structured interviews and a focus group with practitioners from both public and private sectors. Findings This paper identifies preventive measures are underfunded by the public sector; there is a disconnect between the regulatory requirement and the regulators’ supervisory approach leading to the ineffective application of the risk-based approach; and authorities have limited ability to stop low-utility reports. Increased collaboration across institutions and sectors, better utilisation of innovative technologies and a sustainable funding plan are needed to drive a collective response to money laundering. Research limitations/implications Few practitioners in the industry have the knowledge and expertise to discuss the topic at a strategic level and participants were limited (n = 8). Practical implications This paper adds to the growing corpus of research showing that the AML regime in the UK is ineffective and needs reform. Social implications This paper encourages practitioners to improve the AML regime, this research contributes to the reform of the existing measures against financial crime. Originality/value This paper presents new data from AML practitioners to provide a better understanding of the limitations of the AML regime in the UK.

Professor Endrenyi’s Legacy: An Evaluation of the Regulatory Requirement “Fixed Effects, Rather Than Random Effects, Should Be Used for All Terms”

Purpose: In the latest revision of the guideline for evaluation of bioequivalence (BE), European regulators introduced the requirement for using subjects as fixed factors in the underlying statistical models, even in replicate and semi-replicate studies. The implication was that estimates of within-subject variability were derived with a linear model rather than with a mixed model based on restricted maximum likelihood (REML). While REML-based methods are generally thought to give rise to less biased estimates of variance components, there have been no studies that compared the quality of REML-based estimates and estimates derived via linear models. Methods: A publication by Endrenyi and Tothfalusi from 1999 described simulations in a fashion that is useful for testing the European Medicines Agency’s (EMA) requirement. This study defines 7 scenarios within which 10,000 individual 2-sequence, 2-treatment, 4-period trials are simulated and makes a comparison of the quality of estimates. Results: It is concluded that estimates based on REML are closer to the true values than estimates based on linear models, but significant differences are only shown in two of the seven scenarios tested. REML-based estimators have less variability. Both types of estimates appear negatively biased and will therefore decrease the width of the acceptance range.