Converting laws to programs

In highly regulated industries, it is critical that laws are translated precisely into code that reflects their intent.

A supply chain resilience model for business continuity: The way forward for highly regulated industries

The COVID-19 outbreak is a black swan event that has uncovered the delicateness of global supply chains and business architecture. Underpinned by the agency theory and institutional theory, a proposition for business continuity in the highly regulated pharma industry is presented in this paper. A cross-sectional quantitative study was carried out on a sample of 102 pharma supply chain executives in Malaysia. The primary data were gathered by administering a self-administered questionnaire and analyzed using the partial least squares structural equation modelling (PLS-SEM). The result reveals that supply chain orientation directly influences supply chain resilience. Also, introducing collaborative regulation as a mediator in this relationship shows partial mediation. The notion of collaborative regulation as a behavioral governance mechanism is relatively new, thus, presenting interesting opportunities for further exploration of the subject matter.

Serious Injuries and Fatalities: A Study of Data and Prevention Strategies

Serious injuries and fatalities (SIFs) occurring in the workplace have become a significant focus in the field of safety. Over the past 20 years there has been a steady decline in the prevalence of all injuries, however the rates of SIFs have plateaued in recent years, contrary to Heinrich's Triangle. In one of the largest studies of its kind, we set out to identify trends and common factors of SIF incidents to identify strategies to reduce the risk of SIF incidents occurring. We have studied OSHA log records and OSHA recorded fatalities of over 50,000 companies over multiple years broken down by numerous different indicies including industry, age, day of the week, body part affected, type of incident and severity of incident to give a picture of SIF prevalence and trends. This data has also been cross referenced against qualititive information of these companies to identify trends, commonalities and disparities in order to identify causes and opportunities for improvement. The data reported on has shown different risk groups for SIF incidents occurring, that 60% of companies are at low risk of SIF incidents occurring and identifying the highest risk injuries for SIF events occurring (drilling and construction work). In addition, seemingly random factors such as day of the week and month of they year are found to statistically vary, presenting opportunities for targetted outreach based on this data in order to reduce risk. Furthermore, the study reveals companies who work with chemicals, performing welding work and work at heights should be the top targets for SIF prevention intervention, whilst the impact of heavily regulated industries (e.g., PSM facilities) and ensuring organisations have good safety procedures are linked to lower risks of SIF events occuring. This information is of valuable use for all organisations who are interested in truly understanding the root causes of incidents and learning techniques to achieve a Vision Zero of a reduction of incidents, particularly serious injuries and fatalities, to the lowest possible level. A no-blame culture to the accurate reporting of incidents is also vital to a deeper understanding of causation and prevention.

Product Complexity and Strategic Alliance on Drug Approval

Management of the business-government relationship is critical for firm performance in regulated industries. In this paper, we predict a U-shaped relationship between product complexity and the time to approval by the US Food and Drug Administration (FDA). Moreover, we argue that this association is contingent on the types of strategic alliances (i.e., R&D alliance, Marketing alliance) of the focal firm in that those alliances help FDA and pharmaceutical companies achieve harmony. Using the approved drugs by FDA from 1999 to 2016 as the sample, our hypotheses are supported by the empirical analysis on US pharmaceutical firms. The findings have important implications to achieving harmony between pharmaceutical firms and regulatory agencies.

Lawsuits raise cost and existential risks for US tech

Significance Plaintiffs range from users, customers, app developers, investors, competitors, employees (current and former), law enforcement and tax agencies. They are seeking redress for alleged harm across a gamut of the companies’ business practices, creating financial risks for many firms and existential risks for a few. Impacts Losing privately brought lawsuits will disadvantage tech companies’ efforts to rebuff enhanced regulatory oversight. Some tech companies will initiate litigation to contest laws and regulations they consider a restraint on their businesses. As app platforms penetrate regulated industries such as finance and healthcare, liability risks will rise.

An Investigation of the Readability of Sustainability Reports

Requirement of G4 standards as common practice in sustainability reporting makes it important to understand the readability of such reports. This study contributes to the extant body of literature by assessing the readability of sustainability reports. We investigate several factors such as company size, company age, complexity, domestic versus international, and audited versus unaudited reports and how they contribute to the readability of sustainability reports. We apply text analytics to U.S. and Global firm issued sustainability reports. We also provide evidence about factors that may contribute to the readability of sustainability reports. We find that reports of companies in regulated industries are less readable than other firms' reports. We also find that less complex firms have more readable sustainability reports. This study should provide some insights to users of sustainability reports, standard setters for reporting standards, and for future researchers.