Regulatory Perspective Research Articles

Trend of pharmaceuticals 3D printing in the Middle East and North Africa (MENA) region: An overview, regulatory perspective and future outlook

The traditional method of producing medicine using the “one-size fits all” model is becoming a major issue for pharmaceutical manufacturers due to its inability to produce customizable medicines for individuals’ needs. Three-dimensional (3D) printing is a new disruptive technology that offers many benefits to the pharmaceutical industry by revolutionizing the way pharmaceuticals are developed and manufactured. 3D printing technology enables the on-demand production of personalized medicine with tailored dosage, shape and release characteristics. Despite the lack of clear regulatory guidance, there is substantial interest in adopting 3D printing technology in the large-scale manufacturing of medicine. This review aims to evaluate the research efforts of 3D printing technology in the Middle East and North Africa (MENA) region, with a particular emphasis on pharmaceutical research and development. Our analysis indicates an upsurge in the overall research activity of 3D printing technology but there is limited progress in pharmaceuticals research and development. While the MENA region still lags, there is evidence of the regional interest in expanding the 3D printing technology applications in different sectors including pharmaceuticals. 3D printing holds great promise for pharmaceutical development within the MENA region and its advancement will require a strong collaboration between academic researchers and industry partners in parallel with drafting detailed guidelines from regulatory authorities.

Intention to adopt a blockchain-based halal certification: Indonesia consumers and regulatory perspective

Intention to adopt a blockchain-based halal certification: Indonesia consumers and regulatory perspective

Approval of Mycophenolate Mofetil for Prophylaxis of Organ Rejection in Pediatric Recipients of Heart or Liver Transplants: A Regulatory Perspective.

On June 6, 2022, the FDA expanded the indications for mycophenolate mofetil (MMF) to include the prophylaxis of organ rejection in combination with other immunosuppressants in pediatric recipients of allogeneic heart or liver transplants aged 3 months and older. The approved oral dosing regimen for these patients was a starting dose of 600 mg/m2 with titration up to a maximum of 900 mg/m2 twice daily. Data to support efficacy in pediatric patients were derived from established pharmacokinetic (PK) relationships across approved populations, a PK study in pediatric liver transplant recipients, and information from the Scientific Registry of Transplant Recipients database. Information supporting safety was based on comparing mycophenolic acid (MPA) exposure with that in pediatric kidney transplant recipients, the published literature, and post-marketing safety reports. Efficacy in pediatric patients was established based on extrapolation of efficacy from studies in adult liver, adult heart, and pediatric kidney transplant populations, and similarity in MPA exposure between pediatric and adult patients. Review of the data supported an oral dosing regimen for pediatric heart transplant and liver transplant recipients consisting of a starting dose of 600 mg/m2 up to a maximum of 900 mg/m2 b.i.d. A dosage range for MMF is recommended recognizing that the MMF dose may be modified in clinical practice for myriad factors. The dosage recommendations in the labeling for pediatric liver and pediatric heart transplant patients are intended to permit individualized dosing based on clinical assessment of these factors.

Perlindungan Hukum Anak Korban Perkosaan Inses dalam Sistem Peradilan Pidana

This article discusses the legal issue of protecting the rights of children who are victims of incest rape after abortion in the law enforcement process. The crimes that occur should be resolved by the criminal justice system. In fact, child victims of incest rape have not received protection at every stage of the examination, from the investigation, prosecution to court decision. The importance of protecting child victims can be seen as a form of protection by the state in the form of administering justice. Apart from the completeness of statutory regulations regarding the protection of child victims, (the Witness and Victim Protection Agency), law enforcement officials, related government agencies and other relevant parties, the function of the judiciary plays an important role. This article aims first, to analyze the regulations regarding forms of protection for victims of incest rape in the criminal justice system. Second, it aims to analyze the enforcement of legal protection for child victims of incest rape in the judicial system. The method used in this article is a normative juridical research type using a statutory approach, conceptual approach and case approach. Analysis of legal materials, namely legal materials and literature that have been collected through systematic methods and then analyzed by inventorying, systematizing and interpreting all legal regulations and concepts according to the problems discussed. Substantially, from a regulatory perspective, a lot has been regulated regarding legal protection for child victims of incest, but in law enforcement it has not been able to provide protection, because the regulations for victim protection are still partially regulated. Studies of court decisions have not been able to accommodate the values of legal efficacy and the value of legal justice in providing legal protection to child victims of incest rape, especially in the criminal justice system. This study is important to carry out so that in the future there will be legal harmonization regarding legal protection for child victims of incest in the future.

Definition of Regulatory Targets for Electricity Default Rate in Brazil: Proposition of a Fuzzy Inference-Based Model

The current electricity default rates in continental countries, such as Brazil, pose risks to the economic stability and investment capabilities of distribution utilities. This situation results in higher electricity tariffs for regular customers. From a regulatory perspective, the key issue regarding this challenge is devising incentive mechanisms that reward distribution utilities for their operational and investment choices, aiming to mitigate or decrease electricity non-payment rates and avoid tariff increases for regular customers. Despite adhering to the principles of incentive regulation, the Brazilian Electricity Regulatory Agency (ANEEL) uses a methodological approach to define regulatory targets for electricity defaults tied to econometric models developed to determine targets to combat electricity non-technical losses (NTLs). This methodology has been widely criticized by electricity distribution utilities and academics because it includes many ad hoc steps and fails to consider the components that capture the specificities and heterogeneity of distribution utilities. This study proposes a fuzzy inference-based model for defining regulatory default targets built independently of the current methodological approach adopted by ANEEL and aligned with the principles of incentive regulation. An empirical study focusing on the residential class of electricity consumption demonstrated that it is possible to adopt a specific methodology for determining regulatory default targets and that the fuzzy inference approach can meet the necessary premises to ensure that the principles of incentive regulation and the establishment of regulatory targets are consistent with the reality of each electricity distribution utility.

Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology.

Early inclusion of Japan in the global development program could be a key factor in reducing the drug lag, making participation in phase I multiregional clinical trials (Ph. I MRCTs) an important consideration for oncology drug development in Japan. We aimed to investigate the factors associated with the inclusion of Japan in Ph. I MRCTs in oncology. We compared the trial design, target population, type of primary tested drug, trial conduct profile, and sponsor profile for Ph. I MRCTs with or without Japan conducted by the top 20 companies in more than two countries and started between January 1, 2011, and December 31, 2020. One hundred and ninety-seven Ph. I MRCTs included Japan, and 697 did not. Detailed features of the Ph. I MRCTs in oncology were summarized, and several factors (trial design, target population, trial conduct profile, and sponsor profile) associated with inclusion of Japan in the Ph. I MRCTs were identified. It is important for Japanese subsidiaries within global pharmaceutical companies to closely communicate with the headquarters based on medical practice and unmet needs in Japan to join global development from an early stage. In addition, further efforts to attract emerging biopharmaceutical companies to Japan from the regulatory and/or political perspectives would be needed, thereby preventing drug lag in Japan.

A regulatory focus theory perspective on the dynamics between action and power.

Building on the strong consensus that the experience of power motivates individuals to take action, prior research postulates a positively reinforcing cycle wherein taking action leads to power, which in turn leads to subsequent actions. Applying regulatory focus theory, we differentiate between promotion-oriented and prevention-oriented actions to develop a within-person theory of when and why promotion-oriented and prevention-oriented actions should relate to power, and vice-versa. Across two studies, we find that when employees engaged in promotive voice behaviors, they were more likely to experience a sense of power; this effect was amplified for employees with trait promotion focus. When employees engaged in prohibitive voice behaviors, employees with trait prevention focus were less likely to experience a sense of power. The experience of power subsequently motivated employees to engage in promotive voice behaviors, but not prohibitive voice behaviors. By elucidating the differences between promotion and prevention pathways of action and power, our research challenges the notion that action and power positively reinforce each other. We discuss the theoretical and practical implications of our findings. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Nanostructured Medical Devices: Regulatory Perspective and Current Applications.

Nanomaterials (NMs) are having a huge impact in several domains, including the fabrication of medical devices (MDs). Hence, nanostructured MDs are becoming quite common; nevertheless, the associated risks must be carefully considered in order to demonstrate safety prior to their immission on the market. The biological effect of NMs requires the consideration of methodological issues since already established methods for, e.g., cytotoxicity can be subject to a loss of accuracy in the presence of certain NMs. The need for oversight of MDs containing NMs is reflected by the European Regulation 2017/745 on MDs, which states that MDs incorporating or consisting of NMs are in class III, at highest risk, unless the NM is encapsulated or bound in such a manner that the potential for its internal exposure is low or negligible (Rule 19). This study addresses the role of NMs in medical devices, highlighting the current applications and considering the regulatory requirements of such products.

Cryptocurrency Adoption and Financial Innovation

The advent of cryptocurrencies and blockchain technology has sparked a revolutionary Shift in the financial sector. This study sets out on a wide-ranging investigation to understand the nuanced dynamics, repercussions, and potential future paths of this shifting environment in the UK and USA. The primary goals of the research are to examine how cryptocurrencies affect financial markets and conventional banking systems; to examine how blockchain technology might be used in the financial sector; to assess policy and regulatory considerations; and to predict and plan for the future. This research digs into how cryptocurrencies have revolutionized the banking and finance sectors. Analysis of adoption rates, market volatility, and integration methods sheds light on the changing position of cryptocurrencies in investment portfolios, reconfiguration of asset classes, and coping mechanisms of conventional financial institutions. When looking at the financial sector as a whole, the transformational potential of blockchain technology becomes clear. The advent of DeFi, smart contracts, and asset tokenization offers new prospects to improve financial transactions, increase transparency, and broaden participation in the investment market. The research analyzes cryptocurrencies and blockchain technology from a policy and regulatory perspective. The delicate balancing act between stimulating innovation and guaranteeing consumer protection, market integrity, and financial stability is highlighted by a comparison of the regulatory methods adopted in the United Kingdom and United States, as well as proposals from international organizations. The research identifies potential future paths for these technologies and their implications. Opportunities and challenges that will influence the future of finance emerge, with a focus on central bank digital currencies (CBDCs), sustainable blockchain solutions, and interdisciplinary collaborations. As this deep dive comes to a close, the transformational power of cryptocurrencies and blockchain technology is highlighted. It sheds light on the forces that are altering the structures of the world’s financial markets, conventional banking structures, and regulatory frameworks. The findings and critical assessment stress the need for well-considered choices, ethical innovation, and interdisciplinary cooperation in order to succeed in an ever-changing environment. To further democratize access, improve transparency, and reshape the economic fabric of our planet, the future of finance resides at the confluence of tradition and innovation, where cryptocurrencies and blockchain technology exist. Cryptocurrency adoption has catalyzed changes in consumer behavior and investment patterns. While some view digital currencies as speculative assets, others embrace them as alternative forms of money and store of value. This diversity of perspectives underscores the need for a nuanced understanding of cryptocurrency adoption and its implications for financial systems. The significance of this study lies in its contribution to our understanding of the evolving relationship between cryptocurrency adoption and financial innovation. By elucidating the drivers, challenges, and implications of this phenomenon, policymakers, industry stakeholders, and researchers can make informed decisions to harness the transformative potential of digital currencies while mitigating associated risks. Cryptocurrency adoption and the financial innovations it has spurred are transforming the way we think about money and financial services. While challenges remain, the potential benefits of a more decentralized, efficient, and inclusive financial system are significant. As the technology matures, regulatory frameworks adapt, and user confidence grows, cryptocurrency adoption is likely tocontinue its upward trajectory. Cryptocurrency adoption and its associated financial innovations have the potential to usher in a paradigm shift in the way we manage and exchange value.

Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.

Physiologically based biopharmaceutics modeling (PBBM) is used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models are based on the integration of physiological, pharmacological, and pharmaceutical data to simulate and predict drug behavior in vivo. Effective utilization of PBBM requires a consistent approach to model development, verification, validation, and application. Currently, only one country has a draft guidance document for PBBM, whereas other major regulatory authorities have had limited experience with the review of PBBM. To address this gap, industry submitted confidential PBBM case studies to be reviewed by the regulatory agencies; software companies committed to training. PBBM cases were independently and collaboratively discussed by regulators, and academic colleagues participated in some of the discussions. Successful bioequivalence "safe space" industry case examples are also presented. Overall, six regulatory agencies were involved in the case study exercises, including ANVISA, FDA, Health Canada, MHRA, PMDA, and EMA (experts from Belgium, Germany, Norway, Portugal, Spain, and Sweden), and we believe this is the first time such a collaboration has taken place. The outcomes were presented at this workshop, together with a participant survey on the utility and experience with PBBM submissions, to discuss the best scientific practices for developing, validating, and applying PBBMs. The PBBM case studies enabled industry to receive constructive feedback from global regulators and highlighted clear direction for future PBBM submissions for regulatory consideration.

Challenges and Future State for Mycotoxin Analysis: A Review From a Regulatory Perspective.

Mycotoxins are naturally occurring toxins produced by certain fungi. Exposure to mycotoxins may occur through the consumption of contaminated foods or from animals that are fed contaminated feed. To safeguard the nation's food supply, the U.S. Food and Drug Administration (FDA) utilizes a comprehensive mycotoxin program which samples and analyzes foods for surveillance and compliance purposes, including enforcing action levels. Mycotoxin analysis is at the center of the mycotoxin program, as concentration data are needed for data analysis, scientific assessments, and risk management. This review focuses on the Agency's continuous efforts to develop and incorporate fit-for-purpose analytical tools for mycotoxin analysis with particular focus on the relationship between analytical methodologies and scientific assessments. The discussion further highlights challenges and advancements in analytical methods and discusses future possibilities to develop analytical tools and preventative risk management approaches to meet the evolving regulatory needs.

A Regulatory Perspective: Have We Done Enough on Grasping Automation Failure?

This paper responds to Skraaning and Jamieson’s target paper “The Failure to Grasp Automation Failure.” We acknowledge that the target paper made important contributions to automation research in the human factors community. It analyzed automation failure events in complex operational systems in contrast to the vast majority of laboratory research on human-automation interaction. The paper presented a taxonomy of automation failure. The analysis and taxonomy demonstrate the integration of approaches to grasping automation failures from system instrumentation and controls, human factors engineering, and human reliability analysis. We reviewed the regulatory framework related to use of automation in nuclear power plants and examined whether the framework elements adequately address “Failure to Grasp Automation Failure” using the taxonomy in the target paper. Overall, we believe that the target paper could enhance the consideration for potential automation failures in the design and regulatory review process of automation technologies.

Corporate Social Responsibility in Mining Companies: Regulation and Business Role in Indonesia

This study aims to examine the role of mining business actors concerning community development in Indonesia from a regulatory perspective related to corporate social responsibility (CSR) programs. This research used qualitative methodologies using interviews and literature reviews were used. Mining companies share the common objective of profitability with other business sectors. However, CSR program within companies mandates that mining companies play a developmental role as community agents in the vicinity of their operations. In Indonesia, the national ideology of Pancasila and the 1945 Constitution, serves as the highest legal document, which firmly establishes that mining resources are under the control of the state. These resources are used to achieve social justice for all Indonesians through equitable development carried out by companies. This study explores CSR programs in the Indonesian mining sector by conducting a special role regulated by the ideology and constitution of the nation.
 Keywords: CSR, regulation, mining companies

Exploring a mechanism-based approach for the identification of endocrine disruptors using Adverse Outcome Pathways (AOPs) and New Approach Methodologies (NAMs) : A perfluorooctane sulfonic acid case study

Endocrine disruptors (EDs) pose a serious threat to human health and the environment and require a comprehensive evaluation to be identified. The identification of EDs require a substantial amount of data, both in vitro and in vivo, due to the current scientific criteria in the EU. At the same time, the EU strives to reduce animal testing due to concerns regarding animal welfare and sensitivity of animal studies to adequately detect adverse effects relevant for human health. Perfluorooctane sulfonic acid (PFOS) is a persistent organic pollutant that is suspected to be an ED based on academic research, however it is not identified as such from a regulatory perspective. It has previously been shown that PFOS has the potential to cause neurotoxicity as well as affect the thyroid system, and it is known that specific thyroid hormone levels are critical in the development of the brain during. In this work, the aim was to evaluate a mechanism-based approach to identify ED properties of PFOS based on the Adverse Outcome Pathway (AOP) framework and using New Approach Methods (NAMs), by comparing this approach to an ED assessment based on the currently available guidance document. An AOP network (AOPN) was generated for the thyroid modality, and AOPs leading to developmental neurotoxicity (DNT) were identified. A literature search and screening process based on the AOPN, and systematic review methodology, was performed, followed by a rigorous Weight-of-Evidence (WoE) assessment. Evidence was mapped back onto the AOPN used for the literature search, to identify possible endocrine Modes-of-Action (MoAs) for PFOS and data gaps in the two assessments. It could be concluded that PFOS fulfils the criteria for ED classification in the standard ED assessment, but not in the mechanism-based assessment. The need for quantitative information, such as quantitative AOPs, for the mechanism-based approach is discussed. The possibility of a directly neurotoxic alternative MoA was also highlighted based on available in vitro data. Opportunities and challenges with implementing AOPs and NAMs into the regulatory assessment of EDs, and assessing hazard in the Next Generation Risk Assessment, is discussed. This case study exploring the mechanism-based approach to ED identification represents an important step toward more accurate and predictive assessment of EDs based on AOPs and NAMs, and to the Next Generation Risk Assessment (NGRA) concept.

Water Extracts from Industrial Hemp Waste Inhibit the Adhesion and Development of Candida Biofilm and Showed Antioxidant Activity on HT-29 Colon Cancer Cells.

The evolution of regulatory perspectives regarding the health and nutritional properties of industrial hemp-based products (Cannabis sativa L.) has pushed research to focus on the development of new methods for both the extraction and formulation of the bioactive compounds present in hemp extracts. While the psychoactive and medicinal properties of hemp-derived cannabinoid extracts are well known, much less has been investigated on the functional and antimicrobial properties of hemp extracts. Within the hemp value chain, various agricultural wastes and by-products are generated. These materials can be valorised through eco-innovations, ultimately promoting sustainable economic development. In this study, we explored the use of waste from industrial light cannabis production for the extraction of bioactive compounds without the addition of chemicals. The five extracts obtained were tested for their antimicrobial activity on both planktonic and sessile cells of pathogenic strains of the Candida albicans, Candida parapsilosis, and Candida tropicalis species and for their antioxidant activity on HT-29 colon cancer cells under oxidative stress. Our results demonstrated that these extracts display interesting properties both as antioxidants and in hindering the development of fungal biofilm, paving the way for further investigations into the sustainable valorisation of hemp waste for different biomedical applications.

Commercial spaceflight: Regulatory framework assessment and safety perspectives

Recent years are witnessing the rapid technological development in airspace domain, actually paving the way to the development of a commercial space market. Until the recent past, space operations have been essentially performed by research centers or military agencies, in usually segregated areas to ensure third parties’ safety, governed by launch base regulations and organized in an unscheduled manner. However, with the entry of private companies into the space domain, a new market niche is being created: that of commercial space transportation. For example, a promising area is the one related to operations performed by commercial suborbital flights, whether aimed at space tourism or simply transporting things and/or passengers from one point to another on the Earth's surface. The traffic volumes are supposed to increase in next years and segregating airspace does not represent a sustainable solution for the future.The present paper will first assess the state of the art of the regulatory framework currently applicable to operators in order to obtain authorization to perform space missions for commercial use, then propose a comparison between the United State of America and European regulatory frameworks. Main challenges related to regulatory aspects will be identified and perspectives on possible higher airspace operations integration in the medium-long term will be derived. Finally, safety considerations deriving from a seamless accommodation of higher airspace operations in current Air Traffic Management will be derived for the medium-long term. In conclusion, this work reveals that neither the United States nor Europe has formally approved a legal framework establishing certification procedures for sub-orbital space transport systems. Currently, the US legislation is the most applicable as it has comprehensive rules to allow operators to obtain flight authorization ensuring compliance with requirements through a compliance matrix periodically updated.

Design Strategy and Consideration for Oncology Dose-Optimization: An Industry Perspective

ABSTRACT The conventional more-is-better dose selection paradigm is often inappropriate for novel molecularly targeted agents. In response, the US Food and Drug Administration (FDA) initiated Project Optimus to reform the dose optimization and dose selection paradigm in oncology drug development. Furthermore, the FDA recently also published draft guidance “Optimizing the dosage of human prescription drugs and biological products for the treatment of oncologic diseases guidance for industry”, providing overviews on the rationale, importance, and principles of dose optimization from the regulatory perspective. However, detailed guidance on how to design dose optimization trials is still lacking; it is a key issue faced by drug developers. The article discusses statistical and design strategies of dose optimization in oncology by sharing current industry practice on dose-finding, delineating key statistical components for dose optimization trials, describing available design strategies, and providing recommendations and future directions. This article is a joint work of the Statistical Methods in Oncology Scientific Working Group (Dose-Optimization Workstream) of the American Statistical Association Biopharmaceutical Section.

On the use of RWD in support of regulatory submission in drug development

ABSTRACT For the approval of a drug product, the United States Food and Drug Administration requires substantial evidence (SE) regarding effectiveness and safety of the test drug to be provided. In recent years, the use of real-world data in support of regulatory submission of pharmaceutical development has received much attention, and real-world evidence (RWE) is treated as complementary to SE by evaluating the real-world performance of the test treatment. In this article, we start by summarizing current regulatory perspectives on drug evaluation and some potential challenges in using RWE. To test for superiority in co-primary endpoints, a two-stage hybrid RCT/RWS adaptive design that combines randomized control trial for providing SE and real-world study for generating RWE is proposed. We use superiority in effectiveness and non-inferiority in safety as an example to illustrate how to implement this design. Numerical studies have shown that the proposed design has merits in reducing the required sample size compared with traditional co-primary endpoint tests while maintaining statistical power and controlling type I error inflation. The proposed design can be implemented in drug development considering co-primary endpoints, especially for oncology and rare disease drug development.

Drug shortages in Israel, revisited: a bitter pill to swallow.

In 2017, we published an article addressing drug shortages (DS) in Israel, exploring regulatory perspectives, challenges, and potential solutions. Since then, DS remain a significant concern for patients, healthcare providers, and policymakers globally. In this updated article, we revisit the topic, providing new insights, data, and analysis on the current DS landscape in Israel, efforts to mitigate them, and propose strategies to combat this escalating issue. We conducted a comprehensive search of the Israeli Ministry of Health (MOH) DS database, spanning from 2014 to the present. We extracted DS numbers and theirreasons. Further searches on the Israeli MOH website, pharmaceutical division archives, and the internet yielded official MOH publications and correspondence regarding regulatory responses to DS from 2017 onwards. Additionally, two specific cases of DS were examined to analyze their handling. Recent activities and publications from the Israeli MOH aimed at reducing DS were also reviewed. Between 2014 and 2022, DS surged 2.66-fold. Total DS were 3228; 672 due to commercial reasons, and 2556 to operational reasons (20.5% and 79.5% respectively). The average duration of intermittent DS increased 1.56-fold, from 85 to 133days. Manufacturers informed the MOH 22days prior to actual shortage on average. Analyzing 2022's DS (640) by ATC groups, prominent categories included nervous system drugs (18%), drugs acting on the alimentary tract and metabolism (14%), and dermatologicals (11%). Operational DS in 2022 (n = 564) were primarily due to stock delivery delays (38%), stock over-utilization (12%), and raw material shortages (9%). Sixteen official MOH publications on DS were identified from 2017 onwards. Moreover, two high-impact DS case studies were examined. Despite routine monitoring by the Israeli MOH and updating the DS policy throughout this period, DS persist, intensifying annually and posing serious health risks. This trend mirrors international patterns, affecting countries globally. In Israel's uniquely structured healthcare system, with its swift stakeholder cooperation and implementation capabilities, more effective DS management is conceivable. We propose ten universally applicable rules to address DS challenges.

Human performance and automated operations: a regulatory perspective

Increased levels of digitalisation present major opportunities for efficiency in the oil and gas industry but can also contribute to new risks and vulnerabilities. Based on developments in the industry, the Norwegian Ocean Industry Authority (HAVTIL) has in recent years pursued targeted knowledge development and follow-up of company’s digitalisation initiatives. This paper explores data collected through HAVTIL’s audits of the development and use of automated systems within well operations. The analysis of the data resulted in the identification of five main topics related to the implementation of digital technologies. The five main topics were organisational complexity, follow-up and implementation of technology, analysis and documentation, user-interface and alarms and competence and training. Overall, the results support research findings within human factors and technology development, pointing out that there is a lack of focus on human factors in both development projects and in operations. In addition, this paper provides insight into how digitalisation initiatives are followed-up and explores the results from the analysis in light of the current developments in the industry.