Agency Committee Research Articles

The National Electrical Safety Code, powerline clearances, and wildfires

AbstractThe provisions of the National Electrical Safety Code (NESC) have a long, but undocumented history. They are the primary means by which Public Utilities Commission agencies in various States in the United States enforce requirements for electrical clearances pertinent to high‐voltage powerlines. Examination of the NESC provisions for clearances between grounded guy wires and distribution phase conductors in the context of the Woolsey Fire indicates a comprehensive lack of realism in the Code provisions. While they may be entirely sufficient to prevent sparkover under normal operating conditions, they are wholly insufficient to cope with even modest adverse events. The profession should consider explicitly assessing factors beyond sparkover that affect the adequacy of clearance requirements. The provisions of the NESC (and California's parallel General Order No. 95) should be systematically reexamined in order to ensure that safety regulations can cope with adverse events that are serious, but not extreme. Since the vast majority of the electrical power network is aging and not new construction, a scheme should be developed to establish priorities for upgrading existing facilities at the highest risk of failure.

Real-World Evidence to Support EU Regulatory Decision Making-Results From a Pilot of Regulatory Use Cases.

Studies using real-world data (RWD) can complement evidence from clinical trials and fill evidence gaps during different stages of a medicine's lifecycle. This review presents the experience resulting from the European Medicines Agency (EMA) pilot to generate RWE to support evaluations by EU regulators and down-stream decision makers from September 2021 to February 2023. A total of 61 research topics were identified for RWE generation during this period, covering a wide range of research questions, primarily generating evidence on medicines safety (22, 36%), followed by questions on the design and feasibility of clinical trials (11, 18%), drug utilization (10, 16%), clinical management (10, 16%), and disease epidemiology. A significant number of questions were related to the pediatric population and/or rare diseases. A total of 27 regulatory-led RWD studies have been conducted. Most studies were descriptive and aimed at estimating incidence and prevalence rates of clinical outcomes including adverse events or to evaluate medicines utilization. The review highlights key learnings to guide further efforts to enable the use and establish the value of real-world evidence (RWE) for regulatory decisions. For instance, there is a need to access additional fit-for-purpose and representative data, and to explore further means to provide timely evidence that meets regulatory timelines. The need for early interactions and close collaboration with study requesters, e.g., from the Agency's scientific Committees, to better understand the research question is equally important. Finally, the review provides our perspective on the way forward to maximize the potential of regulatory-led RWE generation.

합의제 행정기관의 의사결정에 대한 기관구성원 개인의 법적 책임

Where needs arise to perform part of duties independently, an administratve agency may establish a representative administrative agency, such as administrative committee, etc., as prescribed by statutes. Such a a representative administrative agency or administrative committee makes decisions in the name of committee.
 Therefore a member of committee doesn’t accept personal liability for decision making of representative administrative agencies. Nevertheless, there are a lot of cases where a member of committee is at risk of disciplinary punishment, criminal liability, civil liability for decision making of representative administrative agencies. A strict requirement for personal liability of a member should be established, even though decision making of representative administrative agencies is decided that it is illegal. It is such an example that certain member of committee manipulates, omits, overestimates, underestimates essential data for decision making by intention or gross negligence for one’s advantage or disadvantage or illegal decision making. Conclusionally, the personal liability of a member of committee can’t be accepted because that violates, independence, neutrality, fariness, autonomy of committee.

Personalised human albumin in patients with cirrhosis and ascites: design and rationale for the ALB-TRIAL - a randomised clinical biomarker validation trial

IntroductionHuman albumin is used in the treatment of complications of cirrhosis. However, the use of long-term human albumin administration is costly and resource demanding for both patients and healthcare systems....

Physician Awareness of the Safe Use of Cyproterone Acetate in Europe: A Survey on the Effectiveness of Additional Risk Minimization Measures.

Cyproterone acetate (CPA) is a synthetic progesterone derivative introduced in the 1970s and prescribed as antiandrogenic therapy for inoperable prostate cancer, sexual deviations in men, and signs of androgenization in women. In 2020, the CPA summary of product characteristics (SmPC)was revised to include an updated special warning and precaution about (1) the risk of meningioma with increasing cumulative dose and (2) contraindication in patients with meningioma or history of meningioma. A Direct Healthcare Professional Communication(DHPC) was distributed. The European Medicine Agency's Pharmacovigilance Risk Assessment Committee requested that marketing authorization holders in Europe conduct a survey to assess physicians' knowledge of the updated key safety information. The primary objective of this study was to measure physicians' awareness (i.e., did they receive and review the revised SmPC and DHPC) and level of knowledge and understanding of the key safety information pertaining to the restricted use of CPA monotherapy because of the risk of meningioma. This cross-sectional web-based survey was administered to dermatologists, endocrinologists, gynecologists, urologists, oncologists, psychiatrists, and general practitioners in France, Germany, Poland, Spain, and the Netherlands who had prescribed CPA monotherapy in the previous 12 months to assess awareness of the risk of meningioma associated with CPA monotherapy. Of the 613 physicians who participated, 85% correctly indicated that CPA monotherapy should be prescribed with the lowest effective dose, 75% correctly indicated that the risk of meningioma increases with increasing cumulative CPA monotherapy doses, and 73% correctly indicated that treatment with CPA-containing products must be stopped permanently if a patient is diagnosed with meningioma. Overall, 40% of physicians reported having received the DHPC, and 42% reported having received the revised SmPC. Despite low recall of receipt of the updated SmPC and DHPC, most physicians surveyed are aware of the meningioma risk and actions to mitigate the risk.

1910년대 한반도 중북부 지역 상점 상인의 존재형태와 동향

Based on the list of stores listed in the appendix to the “Chosun Commercial comprehensive book”, this paper examines the existence and trends of store merchants in the 1910s. The store merchant in the “Chosun Commercial Comprehensive Book” were largely emerging merchant forces, who differed from traditional merchants. The first characteristic that is noteworthy in the existence of store merchants in the 1910s is the bias by industry. Looking at the composition of the detailed industry, four types, commission agency business, general store, trade store, and cloth store, accounted for about 71% of all commercial-based stores. In the case of industrial-based stores, manufacturing pharmacies and shoe manufacturing stores accounted for nearly half of all handicraft stores. This industry bias phenomenon was due to the survival strategy of Korean commercial and industrial capitalists to respond to the impact of colonialism. The second characteristic that is noteworthy in the existence of store merchants is that there were several types surrounding the supply and demand of products and sales channels. It can be classified into five main types. First, the type that is produced in Chosun and sold in Chosun. Second, the type that is produced in Chosun and sold to Japan. Third, the type that is produced in Chosun and sold to China. Fourth, the type that is produced in Japan and sold to Chosun. Fifth, the type that is produced in China and sold to Chosun. It can be seen that small and medium-sized capitalists were also gradually dividing their economic existence due to colonial economic policy. Meanwhile, some of the store merchants have expanded their economic activities by establishing modern companies or factories or investing in other industries such as mining and agriculture based on the capital earned from store management. This aspect can be said to show that the path of personal economic growth was not completely impossible even for small and medium-sized capitalists, at least until this period.

African Agency and Colonial Committees at Fourah Bay College

Fourah Bay College was the first Western-style university to be established along the West African coast in 1827. Primarily used to train missionaries and traders operating in British West Africa, it remained one of the premier educational establishments, overlooking the docks of Cline Town in Freetown, Sierra Leone. Following the Colonial Development and Welfare Acts and civil unrest in the aftermath of World War II, British colonial policy began to fund a series of secondary and tertiary education institutions. Modeled on the new University of the West Indies, these new universities adopted the residential college dorm typology coupled with the latest modernist architecture designed to enhance climatic comfort.A new campus was proposed for Fourah Bay, and in contrast to earlier precedents, the architectural approach was to be more humble and less monumental. Following a masterplan by London-based architects Norman and Dawbarn, the much smaller and relatively unknown British practice of Frank Rutter was appointed to design most of the campus buildings. The centerpiece is a large concrete tower named after John F. Kennedy, symbolic of the shifting political posturing for control and influence. Following Independence in 1961 and with increasing technical aid offered to neighboring Ghana and Nigeria from Socialist Eastern European powers, Fourah Bay College demonstrated how these political attempts for influence were directly played out through these newly formed institutions. Fourah Bay College also reveals the African agency in appointing architects and who was able to control the procurement processes and design teams. Rutter was dismissed as ‘college architect’ by a small contingent of newly qualified Sierra Leonean architects eager to ensure local appointments and architectural expressions were given opportunity. The campus, with its impressive architectural structures and innovative solutions, mirrors the political flux and shifting global power structures of the late 1950s and early 1960s, along with the local agency of Freetown architects and their quest to shape the future.

Less is more? Channel separation to mitigate triple competition and combat copycats in agency e-commerce

In practice, agency e-commerce, also known as e-marketplace, faces the challenges of copycat products with nearly identical “consumption quality” to genuine products. The e-marketplace may lack incentives to combat copycat sellers, leading many brands to adopt a novel “Channel Separation” strategy to protect their brand image. Under this strategy, although the brand seems to lose profit from stopping product sales in the e-marketplace, copycat products will be successfully revealed and the channel competition will be softened. We then investigate the brand's strategy choice by examining the tradeoffs among three factors: triple competition under a co-existing strategy (the brand decides co-selling with the copycat sellers in the e-marketplace), dual-channel competition under a channel separation strategy (the brand sells genuine products exclusively through the self-operated channel), and the value of revealing copycat products to eliminate their free-riding of brand image. Our findings indicate that a high agency commission rate and/or intensified channel competition may lead to a surge in copycat product sales under the co-existing strategy. Only the brand with a significant image advantage could benefit from channel separation. Interestingly, our results suggest that copycat sellers and the e-marketplace could also benefit from the brand's channel separation when channel competition is adequately alleviated and the brand's image advantage is not very pronounced.

The European landscape for gene therapies in orphan diseases: 6-year experience with the EMA Committee for Orphan Medicinal Products

In 2000, the European Union (EU) introduced the orphan pharmaceutical legislation to incentivize the development of medicinal products for rare diseases. The Committee for Orphan Medicinal Products (COMP), the European Medicines Agency committee responsible for evaluation of applications for orphan designation (OD), received an increasing flow of applications in the field of gene therapies over the last years. Here, the COMP has conducted a descriptive analysis of applications regarding gene therapies in non-oncological rare diseases, with respect to (a)targeted conditions and their rarity, (b) characteristics of the gene therapy products proposed for OD, with a focus on the type of vector used, and (c)regulatory aspects pertaining to the type of sponsor and development, by examining the use of available frameworks offered in the EU such as protocol assistance and PRIME. It was noted that gene therapies are being developed by sponsors from different backgrounds. Most conditions being targeted are monogenic, the most common being lysosomal disorders, and with a very low prevalence. Generally, adeno-associated viral vectors were being used to deliver the transgene. Finally, sponsors are not frequently using the incentives that may support the development and the reasons for this are unclear.

OECD/NEA R&D priorities for loss-of-cooling and loss-of-coolant accidents in Spent-Fuel-Pools

Motivated by the 2011 accident at the Fukushima Daiichi Nuclear Power Station, the Nuclear Energy Agency (NEA) Committee on the Safety of Nuclear Installations (CSNI) of the Organisation for Economic Cooperation and Development (OECD) launched several activities with the aim to support the post-Fukushima accident decision making process. One of these activities, discussed in the present paper, consisted in the production of a Phenomena Identification and Ranking Table (PIRT) in order to systematically highlight Spent-Fuel-Pool (SFP) accident-related phenomena that are of both high importance and high uncertainty, and thus of primary interest for further experimental or modeling activities. For that purpose, an international panel of experts identified and ranked more than a hundred physical phenomena with regard to their safety importance and current level of knowledge. Altogether eighteen unique phenomena were identified as having priority research needs. About half of these phenomena are related to thermal-hydraulics and heat transfer in the SFP, and they are judged to be important to the coolability of the spent fuel in loss-of-cooling and/or loss-of-coolant accidents. The other half comprises fuel-related phenomena such as fuel volatilization, cladding oxidation in mixed steam–air environment and nitrogen-assisted oxide breakaway at moderate temperature, judged as important and poorly modeled in the scope of SFP accidents. The final part of the paper discusses the research programmes performed on Spent Fuel Pool loss-of-cooling and loss-of-coolant accidents since the publication of the PIRT report in 2018 and the remaining R&D needs.

The EMA Assessment of Asciminib for the Treatment of Adult Patients With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase Who Were Previously Treated With At Least 2 Tyrosine Kinase Inhibitors.

Asciminib is an allosteric high-affinity tyrosine kinase inhibitor (TKI) of the BCR-ABL1 protein kinase. This kinase is translated from the Philadelphia chromosome in chronic myeloid leukemia (CML). Marketing authorization for asciminib was granted on August 25, 2022 by the European Commission. The approved indication was for patients with Philadelphia chromosome-positive CML in the chronic phase which have previously been treated with at least 2 TKIs. Clinical efficacy and safety of asciminib were evaluated in the open-label, randomized, phase III ASCEMBL study. The primary endpoint of this trial was major molecular response (MMR) rate at 24 weeks. A significant difference in MRR rate was shown between the asciminib treated population and the bosutinib control group (25.5% vs. 13.2%, respectively, P = .029). In the asciminib cohort, adverse reactions of at least grade 3 with an incidence ≥ 5% were thrombocytopenia, neutropenia, increased pancreatic enzymes, hypertension, and anemia. The aim of this article is to summarize the scientific review of the application which led to the positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use.

Kenya Elections Trail: East African Roads Lead To Nairobi Anew

Purpose: Elections in Kenya since 1992 have had an uneven experience with some in which the results were contested only in the end to be accepted by the citizens on the one hand. On the other, in some elections there were crises but which resulted in a workable democratic compromise. This time around, in 2022, Kenya’s Supreme Court confirmed William Ruto winner of the country’s 2022 disputed national vote and the gesture did not put an end to political instability. The Opposition, Azimio coalition, continued to take the government head on over the high cost of living, issues of constitutional review, the appointment of a new electoral agency commission and the buying off of opposition members of parliament, among others. After two weeks of street protests by the Opposition and in an unexpected turn of events, Ruto (the sitting President) extended an offer of peace calling for dialogue. This study examines whether what is unfolding is yet another reason to believe that Kenya is setting a model for democracy in the East African region bedeviled with some election democracy troubled spots.
 Methodology: To attain up-to-date and reliable information, engagements have been done in debates, discussions and interviews with personnel who have had different roles and mandates at the level of intervention in the electoral process such as observing, monitoring and supervising; political analysts, political scientists, ruling party personnel, main opposition party personnel and civic educators in the office of the Registrar of Political Parties. Complementing were media tools in its various forms: tabloids (daily or weekly), newsreels, electronic media and others.
 Findings: Preliminary results from such avenues portray that in what appears as ceding ground from hard stance earlier adopted by the government, the reconciliatory tone stuck by the President is a step going along way to cool down the temperatures that have characterized the country’s political space over the last few months. In a similar vein, the gesture by the Opposition to give dialogue a chance is a window of opportunity to get the country back in the course of stability.
 Unique Contribution to Theory, Practice and Policy: While it remains to be seen how the talks between the two sides will progress, it also remains to be seen as to whether the jargon defining the process, ‘bi-partisan’ differs from other wordings like cooperation, grand-coalition, and handshake earlier applied when such situations determined the then defining political atmosphere.

Ugovor o komisionu – neka otvorena pitanja

A particularity of commission agency is that the commission agent acts in its own name, but for the account of the principal. The provisions of the Law on Obligations leave certain practical issues conclusively unresolved, and such issues have been encountered both in doctrinal analysis and in case law. The article analyzes some of the issues that, while being relevant in practice, have not been subject to scrutiny recently, such as the content and reach of the obligation of the commission agent to act in accordance with the instructions of the principal, the principals rights over chattels, and claims acquired by the commission agent or held by it, implications of the provisions of the law regulating the rights of the principal in case of bankruptcy of the commission agent, and the consequences of commission agent’s belated transfer of monies received or even unauthorized use of monies belonging to the principal.

RWD132 Suitability of Nordic Real-World Data to Support EU Regulatory Decision Making

On September 16, 2021, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) approved guidelines for use of patient registries by marketing authorisation applicants and holders (MAAs/MAHs) to support regulatory decision-making. The Nordic countries are globally renowned for the depth, breadth, and quality of local real-world data (RWD). This research aims to assess the suitability of Nordic RWD to support EMA regulatory decision making.

Possible accident scenarios related to the Spent Fuel Pool operating events

After the accident in Fukushima Daiichi NPP, the Nuclear Energy Agency Committee on the Safety of Nuclear Installations (OECD/NEA CSNI) initiated activities to address some technical issues. As a one of results, the Status report on Spent Fuel Pools (SFPs) under Loss of Cooling Accident Conditions was created. To give a valuable contribution to the post-Fukushima accident decision making process, brief summaries were produced on:
 - The status of SFP accident and mitigation strategies;
 - Assessment of current experimental and analytical knowledge about loss of cooling accidents in SFPs and their associated mitigation strategies;
 - The strengths and weaknesses of analytical methods used in codes to predict SFP accident evolution and assess the efficiency of different cooling mechanisms for mitigation of such accidents;
 - Identification of additional research activities required to address gaps in the understanding of relevant phenomenological processes, where analytical tool deficiencies exist, and to reduce the uncertainties in this understanding.
 The final report was approved by OECD/NEA CSNI in December 2014 with the reference NEA/CSNI/R(2015)2 and it is available for download on the OECD website http://www.oecdnea. org/nsd/docs/2015/csni-r2015-2.pdf. Joint Research Centre of European Commission took the leading role in creation of the chapter about possible accident scenarios, past accidents and precursor events. Evaluations of past events where SFP cooling has been lost show that malfunctions of the SFP cooling system are in most cases caused by inoperable cooling pumps. The other important causes are inadvertent diversion of coolant flow and Loss of ultimate heat sink. This paper is providing short general report overview and more details about JRC contribution.

The Juncker Commission as a Politicising Bricoleur and the Renewed Momentum in Social Europe

AbstractThis article analyses the Juncker Commission's strategy to revitalize the legislative aspects of social Europe. Given the inherent obstacles to forging agreements in the field the Commission was required to operationalize a strategy of being a politicalising bricoleur: a bricoleur in the sense it revisited and revised existing tools with the aim of generating change and building an integration moment in social Europe; politicizing in the sense that the Commission exercised social acuity, built broad teams to mobilize for change, and deployed a distinctive discursive strategy. The analysis finds that the Commission had some success, but continued obstacles resulted in reforms being focused on revisions to relatively non‐contentious policies rather than new legislative agreements. The analysis draws attention to the creativity of Commission agency and the constraints within which it operates.

Money Laundering as an Organized Crime: The Legal and Institutional Measures for Controlling Money Laundering in Pakistan

Combating money laundering is not an easy job since it is world phenomena and world’s societies are supposed to cope with it. The Financial Action Task Force and other anti-money laundering initiatives have been devised in order to tackle the menace of money laundering. Pakistan, being the victim of money laundering, has also devised many prevention strategies in order to control money laundering. These include Anti money Laundering Ordinance 2007, Anti Money laundering Act 2010, Anti Money laundering Regulations 2015 and the Anti Money laundering Act 2015. The Federal Investigation Agency and National Executive Committee are some of the measures being devised in order to control and prevent money laundering. This literature-based paper is intended to describe the process, nature, effects and the legal and institutional measures for controlling money laundering in Pakistan.

Investigating Anzali Wetland Sediment Estimation Using the MPSIAC Model

The adverse effects of upland erosion impact the Anzali Wetland in Iran. The Modified Pacific South-west Inter Agency Committee model (MPSIAC) was used to estimate the sediment yield in the watershed. The watershed was divided into twelve sub-watersheds based on the geomorphologic features and waterway orientations (Sw0-Sw11). To investigate the effect of different factors on erosion and sedimentation, data were digitized using ArcGIS software. The effective factor weights were determined using the MPSIAC model, and the total sediment yield was calculated for each sub-watershed. Results showed that the amount of particulate sediment in the critical sub-watersheds Sw6and Sw9was 777.9 and 730.2 t km−2. yr−1, respectively. Based on erosion and sedimentation results, the sub-watershed erosion was prioritized as Sw6> Sw9> Sw4> Sw1> Sw0> Sw5> Sw2> Sw8> Sw3> Sw11> Sw7> Sw10. Both model inputs (precipitation) and outputs (sediment) at different parts of the watershed were assessedviapoint observations data. Comparison of correlation values reveals that the correlation between the simulated and sampling values was strong in sub-watershed 1 (R2< 0.8). EF, RMSE, nRMSE, CRM, and MAE were 0.23, 16.74 tons per year, 5.05%, 0.55, and −3.6, respectively, which indicates the model’s high performance in Sw0. Areas with insufficient cover and bare soil showed a high correlation with the final erosion model. Thus, land-use classes, such as dense vegetation and good pastures, correspond to areas with low erosion. Conversely, bare soils and poor pastures were located on the eroded flats.

Compensating for the effects of emigration. Eastern Europe and policy response to EU freedom of movement

ABSTRACT Freedom of Movement (FoM) has paradoxical implications for Central and Eastern European (CEE) countries: it facilitates brain drain and general population loss but also enjoys continuously high appreciation from Eastern Europeans. Against this background, the article addresses the question: how do FoM-driven expectation gaps— gaps between FoM policy design and outcomes – trigger policy responses? Borrowing from institutional change theories the article identifies new institutions that are added to FoM at the EU level. It argues that these new institutions, called ‘layers’, are established alongside the existing EU principle for the purpose of addressing critique that arises from gaps. To preserve the status quo of the FoM principle and its function for the single market, the layers define incremental changes to the overall policy framework of FoM. They introduce a compensation mechanism for population loss and Commission agency on demographic change and migrant return.

Price Sensitivity Measurement: A Yield Management Approach

The purpose of this paper is to investigate and identify the potential revenue losses, at price points determined by price sensitivity measurement, between actual revenue and potential revenue that can be gained, in terms of yield management. A case study was carried out in a 5 star hotel business in Aydın, Turkey. In the study, a questionnaire was conducted to determine price resistance levels, price threshold limits, price sensitivity levels and price perceptions based on the room quality perceptions of the tourists visiting the hotel business. Also, an interview was performed with the accounting manager and the front office manager about the room prices determined. Hotel businesses can determine the optimal price by depending on the quality and value perception of the customers; thus they can use their limited capacity more efficiently so that they can maximize yield. This study showed that the hotel business lost room revenue at all points calculated. The hotel business suffered a potential loss of 35-40% because of the high occupancy rate in July and August. The hotel industry could have room sales revenues much more than the actual room sales revenues, especially if the agency commission expenses can be reduced.