Training Efforts Research Articles

A Global Industry Survey on Post-Approval Change Management and Use of Reliance.

Post-approval changes (PACs) to the control and manufacturing processes of medicines and vaccines are routinely undertaken and critical to enable both innovation and secure sustained supply. In a world of global supply chains, the existence of divergent national PAC requirements (with additional countries introducing new requirements with potential differences) and other factors including document preparation and response timelines, can lead to long delays in approval (of up to 3-5years) increasing the risk of disruption and shortages.We undertook an Industry survey in 2023 to assess implementation of ICH Q12, PAC procedures (change categorisation and review timelines) and use of reliance mechanisms across different countries (9 selected ICH Members and 19 Observers). Although this survey revealed limited implementation of Q12 in ICH Member countries, when comparing the data collected with those of a previous survey performed in 2020, we observed a broader adoption of risk-based approaches to variation categorisation (in all countries). This, however, was not reflected in improved timelines for approval.With regards to ICH Q12 adoption, the uptake of Post-Approval Change Management Protocols (PACMPs) was unchanged (with only one country reporting in-use) and implementation gaps were evident for Established Conditions (EC) and the Product Life Cycle Management document (PLCM). The survey found greater awareness of ICH Q12 and its tools compared to 2020, potentially illustrating the positive impact of training efforts. This illustrates the challenges being faced to broaden its implementation and use globally.In the same Industry survey, we also assessed PAC processes across different international countries. Long unpredictable timelines were the major concern across the countries surveyed together with limited capacity of the regulators. Four different CMC changes were selected and categorized by the respondents according to current knowledge of national classifications and timelines in the selected countries and compared with a reference classification and timeline from the European Medicines Agency and the World Health Organisation. This highlighted the lack of harmonisation of many countries with EU/WHO requirements, especially within the ICH Observer group.Last, this survey showed that some use of unilateral forms of reliance to Reference Authorities for PACs is starting. This is a mechanism all countries can employ, regardless of convergence of requirements and expertise, to enhance capacity building and reduce duplication of reviews, streamline variations approval, whilst accelerating patient access to innovation and securing supply.

Rapid Deployment of a Pseudonymization Service in a Distributed Research Data Infrastructure - Lessons Learned.

The SARS-CoV-2 pandemic highlighted the importance of fast, collaborative research in biomedicine. Within the ORCHESTRA consortium, we rapidly deployed a pseudonymization service with minimal training and maintenance efforts under time-critical conditions to support a complex, multi-site research project. Over two years, the service was deployed in 13 sites across 11 countries to register more than 10,000 study participants and 15,000 biosamples. In this work, we present lessons learned as part of this process. Most importantly, we learned that common challenges can be overcome by creatively utilizing widely available tools and that having a dedicated partner to manage software rollout and pre-configure software packages for each site fosters the effective implementation.

From words to action (research): a new generation of workplace training

PurposeThis paper aims to explore how a new type of workplace training program can be created that truly enables participants to move from words to action. Recognizing the need to understand trainee–work environment dynamics the authors criticize training efforts that center on targeted learning events, instead highlighting the role of preparation and following up. In doing so, the authors tackle the lack of guidance practitioners experience when designing and implementing workplace training programs.Design/methodology/approachThe authors present action research on a pilot workplace training program focused on wellbeing in an academic work setting. The data collection draws from the case study tradition. The authors collect data through interviews (21), field notes of participant observation (3 occasions), participant-produced written materials and a feedback survey.FindingsThe authors find that restorative practices, workplace mediation and reteaming enhance the participants’ perceptions of self-efficacy and agency. Throughout the training program, facilitators observe the dynamics of the situation and take part in discussions to encourage exploration and reflection. Thus, facilitators likely need a coaching mindset.Originality/valueThe theoretical contribution stems from an in-depth exploration of trainee–work environment dynamics and novel insights brought to workplace training from adjacent fields of research. The authors introduce a framework for planning participatory workplace training and organizational development programs, which answers a call from practitioners.

Hospital Preparedness Analysis in Disaster Management : Literature Review

Under Act No. 44 of 2009, hospitals have a responsibility to actively engage in disaster situations, provide services to victims as they can, and have an accident prevention and disaster management system. This research aims to find out how prepared some hospitals are in disaster management based on some library studies. The preparation of this article uses a method of systematic literature review using 10 articles from 2019 to 2024 from search databases, namely Google Scholar, Garuda, Sage Journals, and ScienceDirect. Although hospitals have policies and standard operational procedures to cope with disasters, the findings suggest that their implementation by health personnel is not optimal. Although disaster response teams, K3RS teams, and abuse teams have been formed, education and training efforts are still not at their maximum. Hospitals are important in disaster management, but many still need improvements such as special guidelines, infrastructure, and intensive training. Preparedness includes planning, organization, movement, control, and recovery. Ready hospitals have emergency response teams, training programs, and early warning systems.

Adapting the science teaching efficacy beliefs instrument to assess engineering teaching efficacy beliefs of pre-service elementary teachers: Rasch model and confirmatory factor analysis

<b>Background</b>: The next generation science standards (NGSS) (NGSS Lead States, 2013) place a particular emphasis on the integration of engineering into the science curriculum. Consequently, the NGSS calls on teachers to engage students in engineering practices to facilitate their experience with the engineering design process similar to engineers and develop a more contemporary view of engineering as a discipline. Since engineering education research in K-12 is still in its infancy, there is limited empirical evidence related to how teachers integrate engineering concepts into their classrooms. To assess the quality of teachers’ engineering teaching practices, teaching self-efficacy can be used as an indicator of their instructional practices because teaching efficacy beliefs are often associated with greater use of student-oriented instructional practices, increased teacher effort, and other positive instructional behaviors.<br /> <b>Purpose:</b> The main aim of this study was to validate an engineering teaching efficacy beliefs instrument (ETEBI) to measure pre-service elementary teachers’ engineering teaching efficacy beliefs.<br /> <b>Design/method</b>: The science teaching efficacy beliefs instrument version B was modified to develop the ETEBI. The instrument was administered to 561 pre-service elementary teachers. A Rasch model analysis and confirmatory factor analysis (CFA) were conducted on the data obtained from 561 pre-service elementary teachers to provide evidence supporting the validity of the instrument.<br /> <b>Results:</b> The Rasch model and CFA suggested a two-factor solution: personal engineering teaching efficacy and engineering teaching outcome expectancy. Also, Cronbach’s coefficient alphas for each subscale were measured to assess the internal consistency of the subscales. Based on the analyses, the study provided evidence supporting the reliability and validity of the ETEBI to assess pre-service elementary teachers’ engineering teaching efficacy.<br /> <b>Conclusions:</b> The ETEBI can be confidently utilized to assess pre-service elementary teachers’ engineering teaching efficacy beliefs. It is effective in gauging the current status of their beliefs and/or determining changes in their beliefs as a result of any teacher training and professional development effort.

We Must Consider Infrastructure when Attempting to Scale up Autism EBIs: A Case Example from Early Intervention Systems.

In the autism field, there is increasing interest in translating evidence-based interventions (EBIs) into systems that serve young autistic children and their families. Public Early Intervention systems have been a focal point of research-based implementation efforts given that these systems are federally mandated to provide services to children birth to three years of age with developmental delays under Part C of the Individuals with Disabilities Education Act. Although a growing number of research studies are now training Early Intervention providers to deliver autism EBIs, this work has been conducted on a relatively small scale and has only just begun to consider the alignment of these models with Early Intervention systems and whether sufficient infrastructure exists to scale up these training efforts and to sustain their public health impact. This commentary aims to address this gap by reviewing factors that have been found to uniformly impact the scale-up of EBIs across diverse public systems (Fagan 20, 1147-1168, 2019), and to extend this framework to the implementation of EBIs within public Early Intervention systems. These factors include developer and funder capacity, the public's awareness of and support for EBIs, the system's leadership support for EBI use, the capacity for community engagement in implementation efforts, the availability of a skilled workforce capable of delivering EBIs, and the capacity for data monitoring and quality improvement. This commentary discusses how these factors may specifically impact the scale-up of autism EBIs within EI systems to support toddlers and young, autistic children, and implications for autism researchers.

Towards Diagnosing and Mitigating Behavioral Cyber Risks

A company’s cyber defenses are based on a secure infrastructure and risk-aware behavior by employees. With rising cyber threats and normative training efforts showing limited impact, raising cyber risk awareness is emerging as a challenging effort. The review of the extant literature on awareness diagnosis shows interdisciplinary but mainly theoretical approaches to understanding attitudes and influencing risk behavior. We propose and test a novel methodology to combine and operationalize two tools, deep metaphor interviews and the IDEA risk communication model, to apply them for the first time in the context of behavioral cyber vulnerabilities. The results show a link between diagnosed attitudes and effective risk behavior in a real-life organizational setting, indicating the potential for an expanded diagnostic effort. We propose to develop a broader diagnostic and intervention set to improve cyber awareness and a toolkit to support the business practice of cyber risk management.

Personnel Selection in a Coffee Shop Company Based on a Multi-Criteria Decision-Aiding and Artificial Intelligence Approach

Human capital management is a strategic element for companies in a globalized world. Therefore, they must use strategies and methods to recruit and select personnel assertively to focus their training, strengthening, and business growth efforts. Personnel selection can be seen as a decision problem and can be addressed in a multi-criteria decision-making context. This work aims to present the selection process of a barista in a Mexican coffee shop. The baristas could be the face of the company to customers, and they could significantly impact their overall experience. The personnel selection process included eleven candidates and three criteria. This process was performed using the ELECTRE-III to model the preferences of a decision-maker and RP2-NSGA-II+H, a multi-objective evolutionary algorithm that exploits fuzzy outranking relations to derive multi-criteria rankings. The ordering obtained with the algorithm did not have any inconsistency concerning the integral preference model, and it allowed for the selection of a candidate to occupy the barista position. The results show the relevance of combining preference modeling with multi-criteria analysis methods for decision-making and artificial intelligence techniques.

Rapid, easy, sensitive, low‐cost and on‐site detection of environmental DNA and RNA using CRISPR‐Cas13

Abstract Environmental DNA (eDNA) monitoring of species distribution has become a critical tool in ecology, conservation biology and fisheries for identifying the presence and distribution of diverse organisms, including important, threatened and invasive species. However, eDNA detection still has room for improvement in sensitivity, requiring time‐consuming real‐time polymerase chain reaction (qPCR) steps and costly machines. In this study, we report a CRISPR‐Cas13‐based method for rapid, easy, sensitive, low‐cost and on‐site detection of eDNA. The assay for the detection of common carp (Cyprinus carpio) and medaka (Oryzias latipes) nucleic acid employs a two‐step process, starting with recombinase polymerase amplification (RPA) and followed by cleavage using Cas13 nuclease, to effectively identify mitochondrial DNA or RNA. Our results showed that the Cas13‐based method has a higher sensitivity than the qPCR‐based method in detecting tiny amounts of eDNA. When combined with reverse transcription of environmental RNA (eRNA), our method increased detection sensitivity by approximately one order of magnitude. Cas13‐based detection could achieve on‐site detection of eDNA using a quick nucleic acid extraction solution and lateral flow strips. Cas13‐based detection of eDNA and eRNA requires minimal training efforts and can be performed in 1 h, without the need for centrifugation and qPCR machines. The portability of the Cas13‐based method, along with its accuracy and relative ease in designing primers and CRISPR RNA (crRNA), underscores its potential to broaden the application of eDNA and eRNA in various fields, including biodiversity conservation.

Enhancing digital access and inclusion for SMEs in the financial services industry through Cybersecurity GRC: A pathway to safer digital ecosystems

This research paper explores the enhancement of digital access and inclusion for Small and Medium Enterprises (SMEs) in the financial services industry by implementing Cybersecurity Governance, Risk Management, and Compliance (GRC) frameworks. It begins by analyzing the current state of digital access for SMEs, highlighting the significant benefits of digital transformation, including operational efficiencies, enhanced customer experiences, and new market opportunities. The paper identifies key barriers to digital access, such as cybersecurity risks, regulatory compliance challenges, financial constraints, and the lack of digital expertise. The study then reviews existing initiatives aimed at enhancing digital access for SMEs, including government programs, industry collaborations, cybersecurity awareness and training efforts, and fintech solutions. The paper argues that while these initiatives are beneficial, they often fail without a comprehensive GRC framework to address underlying security and compliance issues. A detailed conceptual model is proposed, comprising digital strategy and planning, a robust cybersecurity framework, effective governance and compliance practices, proactive risk management, continuous training and awareness, technological innovation, and collaboration and partnerships. Each component systematically addresses the identified barriers and facilitates a safer, more inclusive digital ecosystem for SMEs. The implementation of this model is outlined in four phases: initiation, implementation, operational, and evaluation, ensuring a structured approach to digital transformation. The paper concludes with recommendations for SMEs to adopt this model, emphasizing the importance of stakeholder engagement, resource allocation, and continuous evaluation. Keywords: Digital Transformation, SMEs, Cybersecurity, GRC, Financial Services, Digital Access.

A plea for urgent action: Addressing the critical shortage of cardiothoracic surgical workforce in the COSECSA region.

The College of Surgeons of East, Central, and Southern Africa (COSECSA) comprises 14 countries, many of which currently grapple with an increasing burden of cardiothoracic surgical (CTS) diseases. Health and economic implications of unaddressed CTS conditions are profound and require a robust regional response. This study aimed to define the status of CTS specialist training in the region (including the density of specialists, facilities, and active training posts), examine implications, and proffer recommendations. A desk review of COSECSA secretariat documents and program accreditation records triangulated with information from surgical societies was performed in May 2022 and September 2023 as part of education quality improvement. A modified nominal group process involving contextual experts was used to develop a relevant action framework. Only 6 of 14 (43%) of COSECSA countries offered active training programs with annual intake of only 18 trainees. Significant training gaps existed in Burundi, Botswana, Malawi, Rwanda, South Sudan, Zambia, and Zimbabwe. Country specialist density ranged from 1 per 400,000 (Namibia) to 1 per 8,000,000 (Ethiopia). Overall, the region had 0.2 CTS specialists per million population as compared with 7.15 surgeons per million in High-Income Countries. Surgical education experts proposed an action framework to address the training crisis including increasing investments in CTS education, establishing regional centers of excellence, retention incentives and opportunities for women, and leveraging international partnerships. Proactive investments in infrastructure, human resources, training, and collaborative efforts by national governments, regional intergovernmental organizations, and international partners are critical to expanding regional CTS training.

Advancing Community Well-being through innovative Pharmacies: A European Perspective

The project’s goal is to gain knowledge of how European pharmacies integrate technology and personalized healthcare in order provide better health care services to the community. To identify patterns and trends, descriptive statistics were utilized to make assumptions about the data from various trees. The principal finding is that important takeaways underscore the importance of tailored services and technology deployment in current medical practice, indicating that both of them have the greatest influence on improving patient outcomes and community health. The report’s suggestions emphasize techniques for promoting pharmacy practice innovation. The measures also include the promotion of worker training and collaborative efforts to address sector-specific issues.

Integrating TQM into organizational culture for the success of the one Indonesian data (SDI) in the East Java

This study evaluates the implementation of Total Quality Management (TQM) in supporting the One Data Indonesia (SDI) policy at the East Java Provincial Communication and Information Agency (Kominfo). Employing a qualitative descriptive approach, the study well elaborates on challenges such as the lack of coordination between government agencies and the lack of regulatory support from the regional government. Despite these challenges, the implementation of TQM at the Communication and Information Agency has brought about well-described benefits, including increased data accuracy and relevance, as well as resource efficiency. However, obstacles such as the shortage of trained human resources and differences in data standards between agencies persist. The implementation of TQM has also fostered collaboration between government agencies and the private sector, enhancing the quality of public services. In conclusion, the implementation of TQM at the Communication and Information Agency supports the SDI policy by improving data service quality and strengthening organizational work culture. Further efforts in HR training and data standardization are necessary to optimize the SDI policy and improve public services.

National implementation of advanced training in the safety planning intervention in the Department of Veterans Affairs health care system.

The Safety Planning Intervention (SPI) is an evidence-based therapeutic intervention designed to mitigate suicide risk by providing a suicidal individual with a written, personalized safety plan. The Department of Veterans Affairs (VA) has implemented safety planning, but research found variability in the quality of safety plans. To improve quality, the VA developed an Advanced Training in the Safety Planning Intervention (ASPI) that went beyond previous didactic training efforts by emphasizing experiential learning. The aim of this article is to describe the procedures and initial results of VA's competency-based ASPI Training Program. Before training, providers participating in this program uploaded a written, deidentified safety plan completed with a Veteran. Providers then completed four training components, including evaluation of fidelity of written safety plans and competency in SPI during live, standardized roleplays at the conclusion of training, and at a 3-month follow-up evaluation. Of the 409 providers who initiated training, 367 (90%) completed training, 26 (6%) dropped out of training, and 16 (4%) did not meet the competency requirements for training completion. Relative to pretraining, there was a medium to large increase in the effect size of the quality of written Safety Plans at the end of training that was maintained at the 3-month follow-up. Using a standardized, observational measure of SPI competency, 383 of 391 (98%) providers met competency criteria following the training, and 367 of 375 (98%) providers met competency at 3-month follow-up. Findings suggest that ASPI training is effective in helping providers achieve and maintain fidelity in safety planning. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Implementation of Adaptive Core Value

This research aims to describe how the Adaptive Core Value learning process can explain the Adaptive performance profile of Basic Training participants for Agenda II Civil Servant Candidates using the classical training model. The learning process for participants aims to understand the concept of Adaptiveness and actualize adaptive values in carrying out their job duties. From the concept findings and implementation, the learning process achieved will be put into practice and described; in addition to that, an instrument will be developed to see the participant's adaptive performance profile. This research used descriptive quantitative and qualitative methods with purposive random sampling involving participants from Batch I and XVII of 2022 at the Personnel and Human Resources Development Agency of Bali Province. The results of the book review found that the Adaptive Core Value concept leads to adaptive performance, which contains the dimensions: 1) handling emergency/crisis situations; 2) managing work stress; 3) solving problems creatively; 4) facing an uncertain work situation; 5) training and learning efforts; 6) interpersonal adaptation; 7) work culture adaptation; and 8) physical adaptation. The findings in this research show that all dimensions of Adaptive performance have emerged in the learning process in Adaptive training courses. In line with this, the participant's Adaptive performance profile is high. Thus, there is a match between the achievements in the learning process and the participants' adaptive performance profiles. Learning is not limited to concepts and theories but how they can actualize these Adaptive values in the form of Adaptive performance in the learning process. It is hoped that the results of this research can be a reference in learning Agenda II Core Values of ASN with AKHLAK on Adaptive values and can develop other Core Values of ASN with AKHLAK.

Resource-constrained narrowband optoelectronic oscillator-based reservoir computing for classification of modulated signals.

We experimentally investigate the performance of narrowband optoelectronic oscillator (OEO) reservoir computers using the standard 10th-order nonlinear autoregressive-moving-average (NARMA10) task. Because comparing results from differently parameterized photonic time-delay systems can be difficult, we introduce a new, to the best of our knowledge, metric that accounts for system size, computational accuracy, and training effort overhead in order to provide an "at-a-glance" method to holistically determine a reservoir computer's performance. We then demonstrate the first experimental effort of narrowband OEO-based reservoir computing for the RADIOML dataset, which consists of recognizing and classifying IQ-modulated radio signals including analog and digital modulations. Our results indicate that narrowband OEOs are capable of achieving reasonable accuracies with exceptionally small training sets, thereby paving the way to real-time machine learning for radio frequency signals.

Review of Management Accounting in a Digital Economy

The paper gives an overview of the transformation in management accounting practices in a digital economy. Advanced technologies such as big data analytics, cloud computing, artificial intelligence, and blockchain digitised traditional accounting ways by providing real-time data processing, enhanced decision-making, and strategic insights. The review focuses on how technological innovations have changed data collection, analysis, and reporting links, moving attention away from record-keeping to predictive and prescriptive analytics. Discussions are the automation of routine tasks, real-time financial reporting developments, and increased involvement of management accountants in strategic planning and risk management. The review talks about cloud accounting systems, machine learning in managing costs, blockchain for financial transparency and security, and how digital transformation opens up some critical challenges related to data privacy concerns, security risks, and massive upskilling on the part of accounting professionals. The paper addresses these issues by examining strategies to mitigate identified risks and bridging skill gaps through specific training and educational efforts. It further reviews the emerging trends in predictive and prescriptive analytics and discusses their potential applications in Management Accounting. The review sheds light on changing regulatory scenarios that will impact digital practices in accounting. The implications of this digital transformation are huge and thus require a rethink in the role of management accounting within organisations. It calls for management accountants to reposition themselves in the field and stay relevant by embracing new technologies while attaining strategic competencies, enabling them to drive value creation against the drastic changes in the digital age.

Examining where to go: pediatric psychology trainees' perception of their graduate training in culture and diversity.

Culture and diversity-related training is critical to the development of competent pediatric psychologists. Evaluation of training efforts have been conducted at the program level, yet evaluation of trainee experiences in culture and diversity-related training remains unassessed. This trainee-led study was the first formal assessment of pediatric psychology trainee experiences of culture and diversity-related training and the impact of training on their own cultural humility. Study overview and a survey link was distributed across 2 listservs associated with the American Psychological Association (Division 53, Division 54) and sent directly to directors of graduate, internship, and fellowship training programs with a request to share with trainees. Surveys assessing integration of cultural training and trainee cultural humility were completed. Trainees also provided qualitative feedback regarding their multicultural training and development. Pediatric psychology trainees (N = 90) reported inconsistent integration of culture and diversity topics into their training. Of the 34 training areas assessed, 10 were perceived as thoroughly integrated into formal training by at least half of the respondents. Trainees often sought independent cultural training outside of their programs, and no relationship was detected between perceived integration of cultural training and trainee cultural competence. Results indicate room for improvement regarding integration of cultural training and a need to better understand driving forces behind trainees independently seeking training outside of their formal training programs. Moreover, understanding the aspects of training that are most contributory to trainee development is needed given that no relationship between training and development emerged in the current study.

Predictive Model on Leadership Skills of School Heads towards School Climate in Cluster 3, Davao City Division

The purpose of the study was to determine which combination of leadership skills (administrative skills, interpersonal skills, and conceptual skills) best predicts the school climate in Sta. Ana District, Davao City Division. A total of Seventy-four teachers were utilized as the respondents of the study using Tabachnick and Fidell (2007) calculation of sample size in running regression analysis. The study utilized a descriptive-correlational design. An adapted survey questionnaire was utilized, which centered on the leadership skills of school heads and the school climate. The results showed that school heads' administrative leadership skills were moderate, their interpersonal skills received a high mean rating, and their conceptual skills received a moderate mean rating. Moreover, the school climate in Cluster 3, Davao City Division, received a high mean rating for protecting instructional time, maintaining high visibility, and promoting professional development. Meanwhile, developing and enforcing academic standards has a mean score equivalent to moderate. According to the analysis results, the school head's leadership skills, namely administrative skills, interpersonal skills, and conceptual skills, best predicted the school climate in Cluster 3, Davao City Division. Further, the result indicates that for every unit increase in the three domains of leadership skills of school heads, the school climate will increase by holding other factors constant. Thus, this study recommends school heads prioritize improving their resource allocation abilities through targeted training and development efforts. They should also continue to build a friendly and collaborative classroom atmosphere, drawing on their demonstrated interpersonal skills.

Exploring DNA Analysis Methods and Genetic Research Applications in Low and Middle-Income Nations: A Study of Sri Lanka

Using Sri Lanka as a case study, the paper explores how DNA analysis has transformed genetic research, particularly in low and middle-income countries (LMICs). It discusses various DNA analyzing techniques, from traditional methods like Sanger sequencing to advanced techniques such as next-generation sequencing (NGS) and CRISPR-Cas9, highlighting their applications in disease research, population genetics, and forensic science. Sri Lanka's advancements in genetic research, including DNA sequencing, typing, and recent developments in X-chromosome-based DNA typing, are emphasized. The paper also examines challenges and opportunities in LMICs regarding genetic research and underscores the importance of DNA analysis in advancing personalized medicine and understanding genetic diversity. Additionally, it discusses Sri Lanka's efforts in education and training in molecular biology. It explores the country's rich genetic diversity and demographic history, focusing on ethnic studies and historical interactions among different population groups. Overall, the paper highlights the significance of DNA analysis in genetic research and its potential implications for LMICs. Sri Lanka is a notable example of progress in the field.