Technical – organizational measures for classifying pyrotechnic articles

Pyrotechnic articles shall be classified by manufacturers according to their type of use, their purpose and their level of risk, including their noise level, and the notified bodies shall confirm the classification as part of the conformity assessment procedures. In accordance with the relevant national legislation, the national authority must take all appropriate measures to ensure that pyrotechnic articles do not endanger the health and safety of persons. If the national market surveillance authority has sufficient reasons to consider that a pyrotechnic article poses a risk to the health, safety of persons or other aspects of the protection of the public interest, it shall carry out an assessment of the pyrotechnic article concerned. INCD INSEMEX Petrosani is an accredited institution, to carry out such technical expertise according to the legislation in force harmonized with the European regulations, having also adequate modern facilities for fulfilling the requirements of the standards in the field. The paper also highlights the results of the modernization of the methodological and practical infrastructure as well as the technical facilities that underlie the substantiation of the new approach in terms of optimizing and increasing the quality of the process.

National strategy for development and protection of the sphere intellectual property

In recent years, Ukraine has received not only new legislation, a new regulator, but also a new National Intellectual Property Authority. On the initiative of the Ministry of Economy of Ukraine, the Cabinet of Ministers of Ukraine 13.10.2020 № 1267-r, in pursuance of subparagraph 1 of paragraph 7 of section II «Final and transitional provisions» of the Law of Ukraine of 16.06.2020 № 703-IX «On Amendments to Certain Laws of Ukraine on the Establishment of a National Intellectual Property Authority» determined that the state enterprise «Ukrainian Institute of Intellectual Property» performs the functions of the National Intellectual Property Authority. Given that the state structures considered six options for the formation of a new national body, the definition of a temporary state enterprise «Ukrainian Institute of Intellectual Property» as the National Intellectual Property Authority, on the one hand was the best solution, and on the other, the intellectual property protection system to some laws of Ukraine on the establishment of a national intellectual property body, has undergone significant changes, which could not affect the entire system of intellectual property protection in the state. Keywords: intellectual property, legislation, reorganization, national authority, system, structure

A Study on the Structure and Significance of the North Sanctuary at Western Prasat Top | ការសិក្សាអំពីរចនាសម្ព័ន្ធ និងសារៈសំខាន់ននតួប៉មខាងជ􀈹ើងជៅប្រាសា ទតុបខាងលិច

Western Prasat Top is located in the south-west quadrant of Angkor Thom. The Central, South, and North Sanctuaries, and the uposathāgāra are divided by sīmā stones and, along with a laterite boundary, form the temple precinct. In order to study the history of Western Prasat Top, the Nara National Research Institute for Cultural Properties (NABUNKEN), in collaboration with the Apsara National Authority (APSARA), began surveying in 2003. Our discoveries from the North Sanctuary have contributed new and important evidence to understanding the history of the late Angkor period. We will discuss this unearthed evidence from the perspectives of archaeology, archaeological science and iconography. ប្រាសាទតុបខាងលិចសិ្តជៅទិសនិរតីននប្រាសាទរាយនព័ អតីតប្ក្រុងអង្គរធំ។ បរជិ េណប្រាសាទតុបមានតួបម៉ ក្ណ្តា ល ខាងត្បូង និងខាងជ􀈹ើង ប្ពមទាងំ ជ􀈳ឿនឧជរាសថ (ប្ពរះេហាិ រ) ដែលមានសន្លឹក្សីមា៉ ថ្មភក្ជ់ ្្ រះមានប្រាបំ ីទិសជ􀉒ើយមានជាក្ប្មាលរបងប្ពំថ្មរាយជប្ក្ៀមពទព័ ្ធ􀈹ុំេញិ ដែលបជងើតក រានជាទប្មងប្់ រាសាទ។ ជែើម្សី ិក្សា􀈳្រះៗពីប្បេតិប្តា រាសាទតុបខាងលិច េទិ យាសា្ នប្សាេ ប្ជាេជាតិណ្រ៉សប្មាបស់ ម្តិេតា ប្ធម ៌ (NABUNKEN) រានស􀉒ការជាមយួ អាជាញា ធរជាតិអប្សរ ដែ លរានចាបជ់ ្ើមតា ជធើក្វ ិច្ចស􀉒ប្បតិបតិកាតា រប្សាេប្ជាេជៅឆ្នា ំ ២០០៣។ ការសិក្សាប្សាេប្ជាេជនរះរក្ជ􀈵ើ ញេតុ្មយួ ចំនួនជៅតួបម៉ ខាងជ􀈹ើងដែលជាភសុតាតាងែស៍ ំខាន ់ ក្ុងនា ការរមួ ចំដណក្រក្ជ􀈵ើញរបក្គំជ􀉒ើ ញថី្ម និង ជែើម្ដី សវងយល់អំពីប្បេតិសាតា សសតានាសមយព័ ចុងជប្កាយននអាណ្ចប្ក្អង្គរ។ ជយើងនលឹងពិ្ក្្ សាអំពីភសុតាតាងទាងំ អមបាលមានដែលរានរក្ជ􀈵ើញឲ្យរានសុី􀈹ជប្រៅ ជៅជលើទស្សនៈននបុរណេទិ យា,េ ទិ យាសាសសតាបុរណេទិ យា និងជទេក្ថា។

OP310 Challenges Raised By The Economic Evaluation Of CAR-T-cell therapies: The Review By The French National Authority For Health

IntroductionSince 2013, the coverage of innovative and expensive drugs by the French National Health Insurance considers cost-effectiveness and budget impact, as assessed by the National Authority for Health (HAS) on the basis of an evaluation submitted by the firm. First CAR-T cell therapies were subject to economic evaluation in 2019 in France. We aim at describing the process and results of the economic evaluation of tisagenlecleucel and axicabtagene ciloleucel and the challenges these evaluations raised.MethodsPrimary evaluations were submitted by the firms to be reviewed by HAS. The final analyses were submitted to the Committee of Economic Evaluation and Public Health (CEESP), composed of independent economists, clinicians and patients’ representatives. The CEESP issued Opinions related to i) the methodological quality of economic evidence and ii) the cost-effectiveness and budget impact of the drugs under review.ResultsThe estimated incremental cost-utility ratio (ICUR) of tisagenlecleucel were rejected, being based on insufficient clinical evidence to estimate and extrapolate the long-term progression and to compare tisagenlecleucel with alternatives. Thus, the CEESP concluded that tisagenlecleucel was not proved cost-effective. The estimated ICUR of axicabtagene ciloleucel at 114,509EUR/QALY vs. chemotherapies was associated with an acceptable level of evidence despite being based on a frail indirect comparison and limited data on quality of life. In a context where France has no official cost-effectiveness threshold, the CEESP considered axicabtagene ciloleucel ICUR to be “very high” and questioned the collective acceptability of the claimed price.The CEESP stressed that the main source of uncertainty surrounding the ICUR estimates of both drugs was related to the lack of hindsight on effectiveness, especially in terms of overall survival and safety.ConclusionsThe economic evaluation of CAR-T cell therapies highlights the sources of uncertainty underlying the decision and the risk of inefficient resource allocation driven by limited clinical data. It calls for payment schemes accounting for the uncertainty, and effective collection of relevant post-marketing data.

Controlling the State in the Political Theory of Hamas and Palestinian Islamic Jihad

Existing scholarship has largely focused on the violence of Hamas and Palestinian Islamic Jihad (PIJ) when analyzing their response to the Oslo Agreement and the establishment of the Palestinian National Authority (PA) in the 1990s. The Islamist opposition’s contribution to Palestinian political thought has largely been ignored, however, although the prospects of Palestinian self-rule confronted the two movements with fundamental questions about social organization, governance, and the permissibility of democracy. I offer an analysis of key Hamas and PIJ texts from this period to demonstrate that Hamas and PIJ fundamentally differ in their analysis of the state and the organization of just society. While Hamas outlines a state-centric approach to governance through which Islamic values are enforced from above, PIJ perceives the state to be the greatest threat to the just organization of society. This article consequently dispels the myth that the two Palestinian Islamist movements had no significant ideological differences in the 1990s.

How to Realize the Benefits of Point-of-Care Testing at the General Practice: A Comparison of Four High-Income Countries

Background: In some countries, such as the Netherlands and Norway, point of care testing (POCT) is more widely implemented in general practice compared to countries such as England and Australia. To comprehend what is necessary to realize the benefits of POCT, regarding its integration in primary care, it would be beneficial to have an overview of the structure of healthcare operations and the transactions between stakeholders (also referred to as value networks). The aim of this paper is to identify the current value networks in place applying to POCT implementation at general practices (GPs) in England, Australia, Norway and the Netherlands and to compare these networks in terms of seven previously published factors that support the successful implementation, sustainability and scale-up of innovations. Methods: The value networks were described based on formal guidelines and standards published by the respective governments, organizational bodies and affiliates. The value network of each country was validated by at least two relevant stakeholders from the respective country. Results: The analysis revealed that the biggest challenge for countries with low POCT uptake was the lack of effective communication between the several organizations involved with POCT as well as the high workload for GPs aiming to implement POCT. It is observed that countries with a single national authority responsible for POCT have a better uptake as they can govern the task of POCT roll-out and management and reduce the workload for GPs by assisting with set-up, quality control, training and support. Conclusion: Setting up a single national authority may be an effective step towards realizing the full benefits of POCT. Although it is possible for day-to-day operations to fall under the responsibility of the GP, this is only feasible if support and guidance are readily available to ensure that the workload associated with POCT is limited and as low as possible.