Submission Of Application Research Articles

Evidence-Based Review and Discussion Points

Evidence-Based Review and Discussion Points

Deadline-based dynamic resource allocation and provisioning algorithms in Fog-Cloud environment

The Fog computing paradigm is becoming prominent in supporting time-sensitive applications that are related to the smart Internet of Things (IoT) services, such as smart city and smart healthcare. Although Cloud computing is a promising paradigm for IoT in data processing, due to the high latency limitation of the Cloud, it is unable to satisfy the requirements for time-sensitive applications. Resource allocation and provisioning in the Fog-Cloud environment, considering dynamic changes in user requirements and limited available resources in Fog devices, is a challenging task. Among dynamic changes in the parameters of user requirements, the deadline is the most important challenge in the Fog computing environment. Current works on Fog computing address the resource provisioning without considering the dynamic changes in users’ requirements. To address the problem of satisfying deadline-based dynamic user requirements, we propose resource allocation and provisioning algorithms by using resource ranking and provision of resources in a hybrid and hierarchical fashion. The proposed algorithms are evaluated in a simulation environment by extending the CloudSim toolkit to simulate a realistic Fog environment. The experimental results indicate that the performance of the proposed algorithms is better compared with existing algorithms in terms of overall data processing time, instance cost and network delay, with the increasing number of application submissions. The average processing time and cost are decreased by 12% and 15% respectively, compared with existing solutions.

Bringing the Security Analyst into the Loop: From Human‐Computer Interaction to Human‐Computer Collaboration

This case study examines how one Artificial Intelligence (AI) security software team made the decision to abandon a core feature of the product – an interactive Knowledge Graph visualization deemed by prospective buyers as “cool,” “impressive,” and “complex” – in favor of one that its users – security analysts – found easier to use and interpret. Guided by the results of ethnographic and user research, the QRadar Advisor with Watson team created a new knowledge graph (KG) visualization more aligned with how security analysts actually investigate potential security threats than evocative of AI and “the way that the internet works.” This new feature will be released in Q1 2020 by IBM and has been adopted as a component in IBM's open‐source design system. In addition, it is currently being reviewed by IBM as a patent application submission. The commitment of IBM and the team to replace a foundational AI component with one that better aligns to the mental models and practices of its users represents a victory for users and user‐centered design, alike. It took designers and software engineers working with security analysts and leaders to create a KG representation that is valued for more than its role as “eye candy.” This case study thus speaks to the power of ethnographic research to embolden product teams in their development of AI applications.Dominant expressions of AI that reinforce the image of AI as autonomous “black box” systems can be resisted, and alternatives that align with the mental models of users proposed. Product teams can create new experiences that recognize the co‐dependency of AI software and users, and, in so doing, pave the way for designing more collaborative partnerships between AI software and humans.

ACTERIA prizes to benefit more young researchers from 2020

ACTERIA prizes to benefit more young researchers from 2020

THE EFFECTIVENESS OF THE TKA ONLINE APPLICATION PROCESS WITH THE VISA APPROVAL APPLICATION IN THE APPLICATION OF LIMITED STAY VISA APPROVAL FOR FOREIGN WORKERS

Manpower Being one of the aspects driving the open market economy, the entry of foreign workers into Indonesian territory is regulated in Indonesian government regulations. Use of visas and residence permits given to prospective foreign workers who will enter Indonesia through an online application submission process. However, in practice, the guarantor from foreign workers often encounter problems in the process of applying for a work visa for the Republic of Indonesia. Inhibiting factors in the process of applying for an RI work visa affect immigration services at the Visa Sub-Directorate.

SITANOS EFFECTIVENESS IN IMMIGRATION SERVICES IN THE NON-TPI TANGERANG CLASS I IMMIGRATION OFFICE

The launch of an innovation by the Immigration Office Class I Non-Border Control of Tangerang in the form of a web-based information technology system. This system is a simple system in bridging the immigration application submission process. Sitanos (Immigration TANgerang Online Service) was created to support better immigration services to the community, where this innovation is expected to make it easier for applicants to apply for immigration services by cutting their application flow. This study uses a quantitative method that aims to determine the effectiveness of using Sitanos in immigration services at the Immigration Office Class I Non-Border Control of Tangerang. Therefore the hypothesis of this research is that Sitanos is effectively used in the service of immigration documents for foreigners at the Immigration Office Class I Non-Border Control of Tangerang. The population of this study were employees of the Immigration Office Class I Non-Border Control of Tangerang. The research population is saturated in nature where all respondents are used as samples because the population is relatively small, amounting to 14 people. In determining the effectiveness of using Sitanos, using the system effectiveness test model from DeLone and McLean (2015). The results of the correlation coefficient analysis obtained a significance value of 0.000 and a correlation value of 0.956. In the simple linear regression test, it shows that the t value of the Sitanos variable is 11.297 with a significance of 0.000. Then it can be concluded that the research hypothesis (H1) is accepted and proven correct. So it can be proven that there is an influence between the use of Sitanos on immigration document services at the Immigration Office Clas I Non-Border Control of Tangerang and it can be stated that Sitanos is effectively used to support immigration document services for foreigners at the Immigration Office Class I Non-Border Control of Tangerang.

Generalizabilty Probability: Importance in Clinical Research

International conference on harmonization (ICH) suggested that bridging study is important to extrapolate clinical results. and also us food and drug administration requires Substantial evidences regarding safety. The review explains about different approaches that are necessary for obtaining clinical results, various clinical results were performed between similar patient population within same or different regions. moreover no criteria on the evaluation of similarity of clinical results between regions is given .It is important in regulatory submission of new drug application .Mainly this review explains about how clinical results are reproducible.
 Keywords: ICH, Generalizability, probability Reproducibility, clinical trails, bridging study.

Zmiana preferencji wyborczych w Szwecji w wyniku kryzysu migracyjnego

The migration crisis influenced the internal situation in Sweden to a great extent. Owing to an intensive migrant inflow and a massive submission of asylum applications, the topic of immigration became an integral part of the political discourse. Therefore, a question should be asked, whether intensified migration will cause any visible changes in Sweden, especially in the field of politics and social attitudes towards foreigners. Sweden, until now, has been perceived as a tolerant and open state and society. The aim of the article is to test the hypothesis assuming that there is a correlation between the migration crisis, the radicalisation of the Swedish society and the growing support for the Sweden Democrats, the only anti-immigration political party in Sweden.

Notary Role In The Process Of Establishment Limited Liability Company (PT)

The purpose of this study were 1) To determine the role of the notary in the process of setting up a Limited Liability Company (PT), 2) To determine whether the obstacles faced by the notary in the process of setting up a Limited Liability Company (PT) and the solution.The method used in this research is empirical juridical approach, juridical (legal viewed as the norm or das sollen), because in discussing the problem of research using legal materials (both the written law and the unwritten law or good legal materials primary or secondary law). Specifications research used in this research is descriptive, as explained, describe or disclose the legislation in force associated with the theories of law and positive law enforcement practice concerning these issues.Based on the results of this study concluded that 1) According to the Minister of Justice of the Republic of Indonesia No. M.01-PR.08.01 1996 on Procedures for Submission of Application and Approval of Deed of Establishment of the Limited Liability Company, that pengesahaan establishment of PT may be made by the founders together or proxies , can also by a notary, so there is no necessity notaries as public officials who approve their establishment of limited liability companies, but these roles can be carried out by the founder of the company. 2) Barriers faced delay problems often arise.For the notary, will make the process inefficient. Probes for the ongoing process difficult because of the lack of an online system that can monitor the manufacturing process. Solutions to overcome the obstacles faced by the notary in the legalization of the establishment Company Limited is a Limited Liability Company in the legalization of the establishment can be overcome with the Legal Entity Administration System electronically, as a matter of time and efficiency in monitoring the rights to this process.Keywords: Role; Notary Public; Limited Liability Company (PT)

Assessment of Applications of Design of Experiments in Pharmaceutical Development for Oral Solid Dosage Forms

The concept of quality by design (QbD) was introduced to the pharmaceutical industry about a decade ago. Design of experiments (DoE) is an excellent and important tool for a QbD approach. This project’s aim is to obtain an overview of how DoE is being applied to assist pharmaceutical development in New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) submissions for oral solid dosage forms including immediate release (IR) tablet, extended release (ER) tablet, IR capsule, and ER capsule. A total of 131 NDA submissions and 606 randomly selected ANDA submissions with submission dates between 2012 and 2016 were chosen based on the Biopharmaceutics Classification System (BCS) of drug substances. The ratios of applying DoE studies in NDA and ANDA submissions were calculated and compared based on the BCS classes of the active pharmaceutical ingredients (APIs). For the Reference Listed Drug (RLD)-based cluster ANDA submissions, the percentage of applying DoE studies in BCS II ANDA submissions is statistically higher than those of the ANDA submissions in the other three BCS classes. Some common issues of the DoE studies were found in the selected submissions. DoE has been used as an important tool for QbD approach in NDA submissions but has not yet become a routine common practice to assist the implementation of QbD approach during the pharmaceutical development for NDA and ANDA submissions for oral solid dosage forms. By conducting DoE studies, researchers can gather critical information (i.e., CMAs, CQAs, CPPs, potential interactions) during the pharmaceutical development which can help to improve the quality of applications.

Meteor: Optimizing spark-on-yarn for short applications

Abstract Due to its speed and ease of use, Spark has become a popular tool amongst data scientists to analyze data in various sizes. Counter-intuitively, data processing workloads in industrial companies such as Google, Facebook, and Yahoo are dominated by short-running applications, which is due to the majority of applications being mostly consisted of simple SQL-like queries (Dean, 2004, Zaharia et al, 2008). Unfortunately, the current version of Spark is not optimized for such kinds of workloads. In this paper, we propose a novel framework, called Meteor, which can dramatically improve the performance for short-running applications. We extend Spark with three additional operating modes: one-thread, one-container, and distributed. The one-thread mode executes all tasks on just one thread; the one-container mode runs these tasks in one container by multi-threading; the distributed mode allocates all tasks over the whole cluster. A new framework for submitting applications is also designed, which utilizes a fine-grained Spark performance model to decide which of the three modes is the most efficient to invoke upon a new application submission. From our extensive experiments on Amazon EC2, one-thread mode is the optimal choice when the input size is small, otherwise the distributed mode is better. Overall, Meteor is up to 2 times faster than the original Spark for short applications.

Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology.

Generic drug products are approved by the US Food and Drug Administration (FDA) through Abbreviated New Drug Applications (ANDAs). The ANDA review and approval involves multiple offices across the FDA. Forecasting ANDA submissions can critically inform resource allocation and workload management. In this work, we used machine learning (ML) methodologies to predict the time to first ANDA submissions referencing new chemical entities following their earliest lawful ANDA submission dates. Drug product information, regulatory factors, and pharmacoeconomic factors were used as modeling inputs. The random survival forest ML method, as well as the conventional Cox model, was used for ANDA submission predictions. The ML method outperformed the conventional Cox regression model in predictive performance that was adequately assessed by both internal and external validations. In conclusion, it can potentially serve as an effective forecasting tool for strategic workload and research planning for generic applications.

The Internet's impact on trademark applications

AbstractThis article assesses empirically the impact of Internet access on the number of trademark applications submitted by countries' residents. The analysis suggests that promotion of access to the Internet influences positively the submission of trademark applications by residents. Greater access to the Internet exerts a stronger positive effect on trademark submissions in developed countries than in developing ones. This positive effect is enhanced when countries further liberalise their trade regimes.

Administrative guidance on the submission of applications for renewal of authorisation of genetically modified food and feed under Articles 11 and 23 of Regulation (EC) No 1829/2003

Administrative guidance on the submission of applications for renewal of authorisation of genetically modified food and feed under Articles 11 and 23 of Regulation (EC) No 1829/2003

Exploring Professional Development for New Investigators Underrepresented in the Federally Funded Biomedical Research Workforce.

The National Research Mentoring Network (NRMN) is a strategic partnership whose goals include remedying documented disparities by race and ethnicity in the awarding of National Institutes of Health research grants. Our objectives were to offer a profile of early-career investigators who applied to NRMN's Grantsmanship Coaching Programs (GCP) and test for differences in the research productivity, professional obligations, research resources, and motivations of applicants from underrepresented groups (URGs) compared with applicants from well-represented groups (WRGs). We also evaluated how employment at a minority serving institution (MSI) influenced access to research resources and professional obligations. 880 investigators who submitted online applications to join an NRMN GCP between August 1, 2015 and February 1, 2018. We used two-sample tests of proportions and logistic regression to explore differences in applicants' characteristics and local research environment by group (URG vs WRG) and institution type (MSI vs Other). URG and WRG applicants did not differ in grant application submission history. However, URG applicants had published fewer articles than WRG peers (9.8 vs 15.3, P<.001) and fewer articles as first/last author (4.4 vs 6.9, P<.001). URG applicants reported less access to core facilities to conduct research (74% vs 81%, P<.05). Investigators at MSIs reported less access to collaborators (P<.01) and departmental colleagues with federal funding (P<.001) and spent less time on conducting research (P<.001). URGs were more motivated to seek professional development support to expand their peer networks (P<.05) and advance their careers (P<.001). Our findings identified several points of intervention to help applicants from URGs to improve their future chances of obtaining competitive funding.

Exploring Professional Development for New Investigators Underrepresented in the Federally Funded Biomedical Research Workforce

Objective: The National Research Mentor­ing Network (NRMN) is a strategic partner­ship whose goals include remedying docu­mented disparities by race and ethnicity in the awarding of National Institutes of Health research grants. Our objectives were to offer a profile of early-career investigators who applied to NRMN’s Grantsmanship Coach­ing Programs (GCP) and test for differences in the research productivity, professional obligations, research resources, and motiva­tions of applicants from underrepresented groups (URGs) compared with applicants from well-represented groups (WRGs). We also evaluated how employment at a minority serving institution (MSI) influenced access to research resources and profes­sional obligations.Participants: 880 investigators who submit­ted online applications to join an NRMN GCP between August 1, 2015 and February 1, 2018.Methods: We used two-sample tests of pro­portions and logistic regression to explore differences in applicants’ characteristics and local research environment by group (URG vs WRG) and institution type (MSI vs Other).Results: URG and WRG applicants did not differ in grant application submission history. However, URG applicants had published fewer articles than WRG peers (9.8 vs 15.3, P&lt;.001) and fewer articles as first/last author (4.4 vs 6.9, P&lt;.001). URG appli­cants reported less access to core facilities to conduct research (74% vs 81%, P&lt;.05). Investigators at MSIs reported less access to collaborators (P&lt;.01) and departmental colleagues with federal funding (P&lt;.001) and spent less time on conducting research (P&lt;.001). URGs were more motivated to seek professional development support to expand their peer networks (P&lt;.05) and advance their careers (P&lt;.001).Conclusions: Our findings identified several points of intervention to help applicants from URGs to improve their future chances of obtaining competitive funding.Ethn Dis. 2019;29(Suppl 1): 123-128; doi:10.18865/ ed.29.S1.123.

"If It wouldn't be Made So Difficult for Us" - Barriers on Access to Pediatric Rehabilitation and Potential for Optimization from the Pediatricians' Perspective

The study explores barriers impeding the access to pediatric rehabilitation and potential for optimization from the pediatricians' perspective. Semi-structured expert interviews (N=25) and focus groups (N=3) with pediatricians were conducted and analyzed according to the method of Meuser & Nagel. The results were discussed within an expert group consisting of representatives of the statutory pension insurance and the professional association of pediatricians. Barriers appear due to information deficits regarding carrier-oriented access criteria. A perceived time-consuming application, high refusal rates with insufficient reasons and a lack of feedback from the carrier to the physician inhibit the application motivation. Mentioned improvements refer to a direct feedback of the application decision to the physician, case-specific reasons for refusal, physician oriented information as well as an increased presence of rehabilitation at pediatric congresses and medical trainings. To strengthen the role of rehabilitation in pediatric care improved information and knowledge in the allocation and submission of rehabilitation applications of primary care physicians is needed as well as an enhanced communication between rehabilitation carriers and physicians.

Assessment of genetically modified oilseed rape T45 forrenewal of authorisation under Regulation (EC) No1829/2003 (application EFSA-GMO-RX-012).

Following the submission of application EFSA‐GMO‐RX‐012 under Regulation (EC) No 1829/2003 from Bayer CropScience N.V., the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified oilseed rape T45, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in oilseed rape T45 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in the renewal application EFSA‐GMO‐RX‐012 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape T45.

Significant differences on submission lag following regulation reform for registration of novel therapeutic drugs in Taiwan.

Drug lag, which delays patients' access to medicinal products, is typically associated with pharmaceutical regulations. To shorten drug lag, health authorities may establish new policies to liberalize the regulations, a step that is important in countries, such as Taiwan, with consumer demand for imported novel therapeutic agents. Taiwan's government enacted Articles 38-1 and 38-2 of Regulations for Registration of Medicinal Products to relax the regulatory barriers for new drug submission, thus conditionally exempting the requirement for the Certificate of Pharmaceutical Product (CPP). This study examined whether the enacted regulations reduce submission lag by analyzing the time gap of submission between Taiwan and the United States during 2014-2017. The results indicated that the enacted regulations substantially affected submission lag. Submission lag was significantly shorter for applications not requiring a CPP than those requiring one CPP, which in turn was significantly shorter than those requiring two CPPs. This conclusion can be applied to biological, chemical, non-orphan, and oncology drugs and also applications filed by subsidiary companies, but not orphan drugs and applications filed by contract agents. Among applications requiring one CPP, oncology drugs showed the shortest submission lag. Certain factors, such as clinical studies recruiting over-threshold Taiwanese participants and those performed before the submission of new drug application in the United States, may shorten submission lag. In summary, this study justifies the policy of the exemption from CPP requirements, which supports the hypothesis that relaxing regulatory barriers can reduce submission lag in Taiwan.

PDA Biosimilars Workshop Report (September 27-28, 2018)-Getting It Right the First Time for Biosimilar Marketing Applications.

This workshop report summarizes the presentations, the breakout session outcomes, and the speaker panel discussions from the PDA Biosimilars Workshop held September 27-28, 2018, in Washington, DC. This format was deliberately selected for the workshop with the expectation of delivering a post-workshop paper on current best practices and existing challenges for sponsors. The event, co-chaired by Dr. Stephan Krause (AstraZeneca Biologics) and Dr. Emanuela Lacana (CDER/FDA), was attended by 140 agency and industry representatives. The workshop was separated into three major sessions P1: Regulatory Perspective, P2: Challenges in Biosimilar Development, and P3: Demonstrating Analytical Similarity. Each of the three sessions started with agency and industry presentations. Participants then split into two concurrent roundtable discussion groups to hear the answers to questions that had been provided to all participants one week prior to the event. The sessions were recorded. This paper provides consolidated answers to specific case studies for current challenges to sponsors and agencies. In addition, the panel discussion notes following each breakout roundtable session, as well as brief talk summaries of all speakers, are provided. The first session explored the challenges encountered with submission of biosimilar marketing applications from the perspectives of regulatory agencies. Expectations for a successful submission of the chemistry, manufacturing, and controls (CMC) information were described. The second session addressed high-level technical challenges and how to avoid pitfalls frequently encountered during biosimilar candidate development, including data quality expectations, creation of the final control strategy, and strategic choices necessary for candidate selection and development. Both regulatory perspectives and industry experience were shared. The last session explored the use of statistical tools to provide meaningful contributions to the demonstration of analytical similarity. The presentations highlighted common issues and practical challenges that arise during the application of statistical tools.LAY ABSTRACT: Significant challenges are still-remaining for sponsors and agencies to successfully develop and license Biosimilars. A Biosimilars Workshop was therefore held on 27-28 September 2018 in Washington, DC, to find practical solutions to the remaining challenges. The workshop planning committee with members from industry and agencies prepared specific case studies focused on some of most difficult situations. The workshop was separated into three major sessions (P1 - Regulatory Perspective; P2 - Challenges in Biosimilar Development; P3 - Demonstrating Analytical Similarity) and each session attempted to provide practical solutions to the relevant case studies. This first session explored the challenges encountered with submission of biosimilar marketing applications from the regulatory agencies' perspectives. Expectations for a successful submission of the CMC information were described. The second session addressed high-level technical challenges frequently encountered during biosimilar candidate development, including data quality expectations, the creation of the final control strategy, and strategic choices necessary for candidate selection and development. The last session explored the use of statistical tools to provide meaningful contributions to the demonstration of analytical similarity and practical challenges that arise during the application of statistical tools.