• Informatization Policy
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• v.29 no.3
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• pp.26-47
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• 2022

"The certification of compliance of new products of industrial convergence" (hereinafter referred to as "certification of compliance") is a legal certification system in accordance with the Industrial Convergence Promotion Act through which a convergence new product can be officially certified without legislation when the certification standards applicable to the product are not yet provided. Unlike other certification systems, the certification of compliance is characterized by the role of resolving the certification difficulties driven by the regulatory lag of convergence new products. Nevertheless, studies that analyzed the certification of compliance in detail from the viewpoint of regulatory improvement were surprisingly rare. Through the sequential matching of the steps of certification of compliance with the process from the occurrence of a regulatory problem to resolution, our study provided clear understanding as to how the regulatory lag could be reduced by the procedure for certification of compliance. Furthermore, we divided the perspective on regulatory lag management into quantitative and qualitative, and the structures and practices of certification of compliance were then analyzed from the two perspectives. By doing this, the present study emphasized that the fundamental reason the certification of compliance could effectively solve the regulatory lag problem of convergence new products was not only the quantitative elements such as legal deadlines for each step but also several qualitative approaches to securing the quality of every stage.

• Korean Journal of Clinical Pharmacy
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• v.31 no.1
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• pp.1-11
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• 2021

Objective: This study aimed to overview and assess the effectiveness of the policies and regulations that have governed new drug access in Korea, and to propose policies to enhance patient access to drugs, particularly for new innovative medicines. Methods: We approached drug access issues in two perspectives: approval lag (or availability) and reimbursement lag (or affordability). The issues were identified and evaluated through the review of literature, public documents, reports published by the government agencies and private organizations, and news articles. Results: To shorten approval lag, it is recommended to hire and train more reviewers at the Ministry of Food and Drug Safety. Increasing user fees to a realistic level can facilitate this process. To reduce reimbursement lag, flexible incremental cost-effectiveness ratio threshold, alternative cost-effectiveness evaluation, and establishment of funding source other than the national health insurance are identified as the areas to be improved. Conclusion: The current policies and regulations had to be supplemented by new systems to drastically promote patient accessibility to new drugs, consequently in order to promote national public health.

• The Journal of Korean Institute of Communications and Information Sciences
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• v.31 no.2B
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• pp.154-163
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• 2006

The importance of R & D investment has dramatically been increased as industrial paradigm rapidly changes to knowledge-based economy. In order to preserve recent economic growth and reinforce competitive advantage, government policy and regulatory framework needs to be reshaped in ways that minimize the distorted use of limited resources and maximize the efficiency of R & D investment. In this regards, this paper aims to investigate the influence of R & D investment in national economic growth and to compare the effectiveness of IT R & D investment with other industries, in respect to the time lag.

• Journal of Microbiology and Biotechnology
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• v.16 no.6
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• pp.993-998
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• 2006

We earlier suggested a hierarchical regulatory network using defined modeling symbols and weights in order to improve the flux balance analysis (FBA) with regulatory events that were represented by if-then rules and Boolean logic. In the present study, the simulation results of the models, which were developed and improved from the previou model by incorporating a hierarchical regulatory network into the FBA, were compared with the experimental outcome of an aerobic batch growth of E. coli on glucose and tryptophan. From the experimental result, a diauxic growth curve was observed, reflecting growth resumption, when tryptophan was used as an alternativee after the supply of glucose was exhausted. The model parameters, the initial concentration of substrates (0.92 mM glucose and 1 mM tryptophan), cell density (0.0086 g biomass/1), the maximal uptake rates of substrates (5.4 mmol glucose/g DCW h and 1.32 mmol tryptophan/g DCW h), and lag time (0.32 h) were derived from the experimental data for more accurate prediction. The simulation results agreed with the experimental outcome of the temporal profiles of cell density and glucose, and tryptophan concentrations.

• Journal of the Korean Medical Association
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• v.61 no.12
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• pp.702-705
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• 2018

Advances in technology lead to advances in medical devices, and these advances have the positive effect of creating opportunities for beneficial developments in healthcare, such as innovating traditional healthcare processes or expanding opportunities for diagnosing and treating diseases. Nonetheless, device developers, suppliers, users, insurers, and patients all face the challenge of balancing patient safety and health effectiveness with a reasonable profit. In Korea, the New Health Technology Assessment system aims to introduce safe and effective health technology, but this is only effective for the entry of devices onto the healthcare market. This system is not enough for creating a healthy ecosystem in which high-quality technologies and devices survive in the market and naturally exit from the market if not successful. The nation must not lag in the rapid development of medical devices, but the concomitant requirement for patient safety is like two rabbits moving in different directions. There is not enough time to resolve each source of uncertainty for both developers and users. The early adoption of health technologies, including medical devices, offers new opportunities for treatment and diagnosis, but also poses unexpected health risks. Thus, we need to design a plan to generate scientific evidence related to medical devices after they introduced into practice. Additionally, regarding the use of individual medical devices, we believe that the creation of a healthy ecosystem for medical devices by implementing medical device surveillance culture is a way to manage the opportunities and risks of the early introduction of innovative medical devices.

• The Journal of Asian Finance, Economics and Business
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• v.6 no.1
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• pp.59-69
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• 2019

The auditor, an important instrument of corporate governance, ensures the transparency and accountability of the firm to the stakeholders. The objective of this paper is to explore the impact of audit characteristics on firm performance. In this study, external audit quality (BIG4), frequencies of audit committee meetings, and audit committee size are used as the proxies of audit characteristics and firm performance is measured through ROA, profit margin and EPS. A total of 503 firm years are considered as sample size from the listed manufacturing firms of Dhaka Stock Exchange (DSE) during the period of 2013 to 2017 to find out the impact of audit characteristics on firm performance. In this study, multivariate regression analysis is conducted using the pooled OLS method. Moreover, time dummy and lag model of multivariate analysis are also analyzed as robust check. The multivariate regression results find that external audit quality (BIG4) and audit committee size are significantly positively associated with firm performance. This study also finds that there is a significant negative relationship between audit committee meeting and firm performance. This study recommends that the regulatory authority and audit committee should review the frequencies of audit committee meeting to make it more effective to ensure better firm performance.

• STI Policy Review
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• v.9 no.1
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• pp.133-157
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• 2018

The divide between the "digital" economy and the traditional "physical" economy is outdated. In fact, we are in a transition to a singular economy. This paper classifies economic objects (including actors) as either physical or virtual and argues that due to emerging technologies, these objects are interacting with each other in both physical and increasingly digital spheres in tandem. This paper recognizes the elemental difference between atoms and bytes but argues that physical and digital economic activities are becoming inseparably intertwined. Furthermore, arbitrarily dividing the economy into two categories - one "physical" and the other "digital" - distorts the overall view of the actual execution of economic activity. A wide range of innovations emerging concurrently is fueling the transition to a singular economy. Often referred to as the elements of the Fourth Industrial Revolution (4IR), four emerging technological areas are reviewed here: distributed ledger technology, artificial intelligence/machine learning/data sciences, biometrics and remote sensor technologies, and access infrastructure (universal internet access/electricity/cloud computing). The financial services sector is presented as a case study for the potential impact of these 4IR technologies and the blurring physical/digital line. To reach the potential of these innovations and a truly singular economy, it requires the concurrent development of social, organizational, and regulatory innovations, though they lag in terms of technological progress thus far.

• The Journal of Asian Finance, Economics and Business
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• v.8 no.5
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• pp.325-334
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• 2021

This study aims to investigate whether economic growth is elevated by banking industry development in Jordan. The study adopts time-series econometric methodologies, which comprise the bounds testing approach within the autoregressive distributed lag (ARDL) and the conditional causality analysis. Consistent with the assumptions of the adopted methodology, the study utilized annual time-series data for a relatively long period of thirty-nine years, between 1980 and 2018. The empirical results show that Jordan's economic growth is strongly responsive in respect to any changes in banking industry development. Also, the results reveal the harmful impact of rising lending interest rate; as this rate increases, economic growth will decrease. The findings are in line with the conceptual arguments of the supply-leading hypothesis, which confirmed that banking development is considered as one of the main pillars that have stimulating effects on economic growth. The evidence of the current study may provide important implications for policymakers and bankers. Those professionals should work to maintain a stable regulatory system that enhances the banking system function in activating economic growth. Also, a considerable focus should be placed on designing a steady interest rate policy to avoid the inherently undesirable impacts of high-interest rates on the Jordanian economy.

• Korean Journal of Food Science and Technology
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• v.37 no.5
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• pp.850-855
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• 2005

Model was developed to predict the growth of Listeria monocytogenes in raw pork. Experiment condition for model development was full 5-by-7 factorial arrangements of temperature (0, 5, 10, 15, and $20^{\circ}C$) and time (0, 1, 2, 3, 18, 48, and 120 hr). Gompertz values A, C, B, and M, and growth kinetics, exponential growth rate (EGR), generation time (GT), lag phase duration (LPD), and maximum population density (MPD) were calculated based on growth increased data. GT and LPD values gradually decreased, whereas EGR value gradually increased with increasing temperature. Response surface analysis (RSA) was carried out using Gompertz B and M values, to formulate equation with temperature being main control factor. This equation was applied to Gompertz equation. Experimental and predictive values for GT, LPD, and EGR, compared using the model, showed no significant differences (p<0.01). Proposed model could be used to predict growth of microorganisms for exposure assessment of MRA, thereby allowing more informed decision-making on potential regulatory actions of microorganisms in raw pork.

• The Korean Journal of Air & Space Law and Policy
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• v.30 no.2
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• pp.373-401
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• 2015

The UAV(Unmanned Aerial Vehicle, Drone) technology has been undergoing rapid progress, accompanied with a growth in the market. However, domestic industry standards and technology lag behind such progress happening on the international scene, and in particular in developed countries. Related regulations are also deemed lacking to address the issues that arise with such developments. Meanwhile, as the rise of UAV technology is a fairly recent phenomenon, the gap between Korea and developed countries is not too big. As this technology has high relevance to information and communication technologies, it also offers ample leeway for Korea to catch up in the field of UAV. As such, this paper seeks to provide a survey of the overall technology, market and regulations concerning UAV to identify possible measures on how to address any issues that may arise through proper policies. Due to the progress made in the field of UAV technology and increased penetration rate, striking a right balance between putting in place a proper regulatory system and establishing policies that foster growth in the field has risen as a very important issue. While the importance of establishing a legal system that helps prevent possible risks is indeed important, it must also be acknowledged that excessive regulation can also hinder technological progress. This, in turn would stagnate the market and dampen the entrepreneurial spirit in the society. In the case of new, practical technologies such as UAV, a prompt establishment of regulatory systems and policy measures in terms of policies is a requisite. In brief, in order to promote progress in the UAV industry and at the same time, for public safety and the protection of privacy, there should be an appropriate level on the easing and tightening of the regulation.