Risk-Based Monitoring in Clinical Trials: 2021 Update.

Clinical trial quality depends on ensuring participant safety and data integrity, which require careful management throughout the trial lifecycle, from protocol development to final data analysis and submission. Recent developments-including new regulatory requirements, emerging technologies, and trial decentralization-have increased adoption of risk-based monitoring (RBM) and its parent framework, risk-based quality management (RBQM) in clinical trials. The Association of Clinical Research Organizations (ACRO), recognizing the growing importance of these approaches, initiated an ongoing RBM/RBQM landscape survey project in 2019 to track adoption of the eight functional components of RBQM. Here we present results from the third annual survey, which included data from 4889 clinical trials ongoing in 2021. At least one RBQM component was implemented in 88% of trials in the 2021 survey, compared with 77% in 2020 and 53% in 2019. The most frequently implemented components in 2021 were initial and ongoing risk assessments (80 and 78% of trials, respectively). Only 7% of RBQM trials were Phase IV, while the proportions of Phase I-III trials ranged 27-36%. Small trials (< 300 participants) accounted for 60% of those implementing RBQM. The therapeutic areas with the largest number of RBQM trials were oncology (38%), neurology (10%), and infectious diseases (9%). The 2021 survey confirmed a pattern of increasing RBM/RBQM adoption seen in earlier surveys, with risk assessments, which have broad regulatory support, driving RBQM growth; however, one area requiring further development is implementation of centralized monitoring combined with reductions in source data verification (SDV) and source data review (SDR).

Air pollution and its associated health risks before and after COVID-19 in Shaanxi Province, China.

Air pollution is a serious environmental problem that damages public health. In the present study, we used the segmentation function to improve the health risk-based air quality index (HAQI) and named it new HAQI (NHAQI). To investigate the spatiotemporal distribution characteristics of air pollutants and the associated health risks in Shaanxi Province before (Period I, 2015-2019) and after (Period II, 2020-2021) COVID-19. The six criteria pollutants were analyzed between January 1, 2015, and December 31, 2021, using the air quality index (AQI), aggregate AQI (AAQI), and NHAQI. The results showed that compared with AAQI and NHAQI, AQI underestimated the combined effects of multiple pollutants. The average concentrations of the six criteria pollutants were lower in Period II than in Period I due to reductions in anthropogenic emissions, with the concentrations of PM2.5 (particulate matter ≤2.5 µm diameter), PM10 (PM ≤ 10 µm diameter) SO2, NO2, O3, and CO decreased by 23.5%, 22.5%, 45.7%, 17.6%, 2.9%, and 41.6%, respectively. In Period II, the excess risk and the number of air pollution-related deaths decreased considerably by 46.5% and 49%, respectively. The cumulative population distribution estimated using the NHAQI revealed that 61% of the total number of individuals in Shaanxi Province were exposed to unhealthy air during Period I, whereas this proportion decreased to 16% during Period II. Although overall air quality exhibited substantial improvements, the associated health risks in winter remained high.

Optimal Unlabeled Set Partitioning with Application to Risk-based Quarantine Policies

We consider the problem of partitioning a set of items into unlabeled subsets so as to optimize an additive objective, i.e., the objective function value of a partition is equal to the sum of the contribution of each subset. Under an arbitrary objective function, this family of problems is known to be an N P -complete combinatorial optimization problem. We study this problem under a broad family of objective functions characterized by elementary symmetric polynomials, which are "building blocks” to symmetric functions. By analyzing a continuous relaxation of the problem, we identify conditions that enable the use of a reformulation technique in which the set partitioning problem is cast as a more tractable network flow problem solvable in polynomial-time. We show that a number of results from the literature arise as special cases of our proposed framework, highlighting its generality. We demonstrate the usefulness of the developed methodology through a novel and timely application of quarantining heterogeneous populations in an optimal manner. Our case study on real COVID-19 data reveals significant benefits over conventional measures in terms of both spread mitigation and economic impact, underscoring the importance of data-driven policies. [ FROM AUTHOR] Copyright of IISE Transactions is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Floating Structure Integrity Management Program (FSIMP) Towards Digitalization

The objective of the paper is to demonstrate digitalization of Floating Structures Integrity Management Program (FSIMP) and its application for the structural integrity of floating structure assets. The framework of FSIMP is being developed by adopting Risk Based Inspection (RBI) methodology and complemented with technical know-how and industry best-practices. Implementing the methodology provides strategic planning for maintenance by reducing the anticipated risk. Hence, ensuring uninterrupted service of the floating structure assets throughout the service life. This paper presents a systematic approach for digitalization of the integrity management program for a nominated floating structure asset. The methodology offers a procedure to acquire necessary data management gathering, risk assessment, and RBI survey plan to maintain the structural integrity in the centralized web-based platform of FSIMP. RBI process is adopted into the FSIMP to investigate all deterioration and failure mechanisms. These structures will be identified by qualitative and quantitative risk assessment methods. The implementation of FSIMP offers a wide range of capabilities in structural integrity management such as integrating all floating structure fleet assets in a single dashboard of web-based platform, clear line of sight for reliable structural integrity, and an holistic overview across all levels of management. FSIMP with RBI methodology evaluates all data gathering to optimize inspection resources based on the risk assessment through an optimum combination of inspection methods and frequencies. The whole process is aligned to the requirements from Classification to ensure reliability for continuous operations. It also observes the essential need of digitalization for FSIMP during the time of post-COVID19 pandemic and the ever-expanding offshore oil, gas and energy frontiers that demand the adoption of new and advanced technologies, especially in the field of digitalization. It is shown that FSIMP has great potential as a digitalization tool and system to integrate with the RBI risk assessment that aligns to the requirements from Classification. It is strategically to maximize the effectiveness and improved efficiency for inspection and monitoring plan. The paper provides information on the solution of digitalization to the Floating Structures Integrity Management Program (FSIMP) in ensuring that the integrity of floating structure asset during the service life is intact for continuous operation and a holistic overview for all the assigned fleet assets in a centralized dashboard web-based platform. In addition to that, RBI is as added benefit to the FSIMP with its structure methodology of data evaluation and risk assessment in order to objectively optimizing inspection and maintenance resources. Copyright © 2023, International Petroleum Technology Conference.

Lessons learned from 11th September, 2001 (9/11): A comparison of aviation security and health crisis response

The terrorist attacks of 11th September, 2001 (9/11) triggered significant changes in the way aviation security is implemented all over the world. Despite many lessons learned in the industry, the response to the COVID-19 pandemic has been the same as those prompted by 9/11 — the imposition of prescribed, disproportionate to risk, one-size-fits-all measures with adverse impacts on operations. Taking the learning from a major world crisis such as 9/11 has shown how an intelligence-driven, risk-based, outcome-focused regulatory model enables the industry to determine how a known threat informed by intelligence might manifest in terms of likelihood and consequence that is unique to every airport. Together, ACI and Arup have identified the top ten lessons learnt from the security experience that can be directly applied to manage health risks in aviation. The paper explores the lessons learned for airports (recommendations 1–5) before identifying those learned for regulators (recommendations 6–10). [ FROM AUTHOR] Copyright of Journal of Airport Management is the property of Henry Stewart Publications LLP and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Impact of Risk Budgeting on Enhancing the Projected Growth of the Hotel Industry under the Conditions of Enduring Uncertainty Related to the COVID-19 Pandemic. Case Study by Republic of Kazakhstan

The article considers the possibility of using a risk budgeting approach in forecasting the development of the hotel business in the Republic of Kazakhstan. This study aims at elaborating three budget scenarios for the sales of services provided by accommodations with due regard to the possible risks associated with COVID-19. To attain this end, the authors used a set of budget planning methods, including expert assessments, scenario analysis, and Monte Carlo simulation. The results obtained allow the authors to determine the ranges of probable values and the most probable indicators for the budget items of hotel enterprises in the Republic of Kazakhstan. At the same time, the resulting model does not assess the simultaneous impact of other risks that the hotel industry is exposed to. The authors of the article believe that the construction of multi-factor risk budgeting models for the hotel business is the subject of further scientific research. © 2022 by ASERS® Publishing. All rights reserved.

Managing emerging pathogen risks in recycled water

The COVID-19 pandemic raised the public profile of wastewater-based infectious disease monitoring. General media coverage about wastewater detection of SARS-CoV-2 (the COVID-19 coronavirus) increased community awareness of the potential use of wastewater for the detection and surveillance of emerging diseases and also heightened recognition of the potential for wastewater to harbour and convey a variety of pathogens. This has also generated questions about the potential public health impacts of emerging pathogens, such as SARS-CoV-2 and mpox, in sewage and recycled water. To ensure water security in an era of climate change, water recycling is increasingly important in Australia and other water-stressed nations and managing disease risks in integrated water management is thus of critical importance. This paper demonstrates the existing risk management provisions for recycled water and explores potential issues posed by novel and emerging pathogens. First, a synopsis of some key emerging and re-emerging human pathogens is presented and the risks associated with these pathogens in the context of recycled water provision is considered. Then, an overview of the engineered treatment systems and regulatory framework used to manage these emerging risks in Australia is presented, together with a discusion of how emerging pathogen risks can be managed to ensure safe recycled water supply now and into the future.

Can quality management drive evidence generation?

Recent guidance documents from international regulators emphasize the importance of thoughtful trial design and risk-based oversight in delivering reliable results. In practice, these recommendations are often implemented in a fragmented manner, reducing their effectiveness. We argue that collaborative, cross-stakeholder engagement that prioritizes both optimal trial design and tailored oversight are a necessary and effective approach to modernize quality management. This practice is at the core of Quality by Design, an approach that involves identifying important errors that could undermine trial credibility or participant safety and addressing them proactively. While Quality by Design is well suited for clinical trials supporting regulatory approval of a new medicinal product, we describe how the approach is equally relevant for pragmatic trials, including those conducted in the context of a pandemic.

Meeting a Planetary Launch Window in a Pandemic

L'Ralph is the primary science instrument on the Lucy mission to encounter the Trojan asteroids at the Jupiter L4 and L5 Lagrange points. In December of 2019, the main instrument subassemblies were finishing their build-up and testing. The team was getting ready for integration and testing with comfortable schedule margin to our required delivery date in support of the planetary launch window. When COVID-19 started to spread, the flight hardware ground to a halt but the planets kept moving. The L'Ralph team used a risk-based process to strategically descope activities from the integration and test flow and to negotiate a late delivery to the spacecraft. They changed the entire risk posture, investing in infrastructure to allow more remote test support to protect the team's health and reduce the schedule risk in case of an outbreak. Despite multiple technical hurdles, the team was able to make an on-time delivery to the spacecraft, and Lucy was successfully launched in October 2021. © 2022 IEEE.

Standardized Risk Mitigation Measurement in Extended Reality Environments Utilizing the IEEE Experience API (xAPI) Standard

Recent reports indicate increased organizational appetite and spend in the energy industry in both the areas of operational risk management training and enablement and in extended reality hardware and software, as part of larger automation and digital transformation initiatives. Furthermore, recent advances in immersive technology, along with more dispersed, asynchronous working conditions due to COVID, have resulted in scalable, immersive simulations that more and more closely resemble real world environments. While recent standards have defined JSON syntax appropriate for tracking and measuring human behavior data in generic learning environments (IEEE P9274.1) and in a manner that more closely approximates human behavior in the workplace, as typically tracked in operational risk management systems, no risk-based ontology has yet been defined that more closely crosswalks and correlates data from simulated environment systems to those in operational environments. Thus, the true efficacy of extended reality-based risk mitigation training cannot be fully measured. In this effort, a risk-based ontology and matrix was constructed in accordance with the xAPI standard syntax and allowable extensions and was utilized to transform a subset of historical data from simulated operational risk-based scenarios from the energy industry. Transformed data from this initial subset closely approximated operational risk reporting data and provided insights into human behavior data in simulated environments that can be easily compared and correlated to existing operational excellence and risk mitigation KPIs. Implications for mapping of additional advanced data from simulated environments in larger, more complex datasets, such as eye tracking and biometrics, were also considered and explored. © 2022 IEEE.

Determinants Affecting Internal Audit Effectiveness

This study tries to identify the determinants that affect the effectiveness of internal auditing for listed firms in India. A sample of 300 listed companies was drawn. Questionnaires were mailed to the head of audit department, internal audit managers, internal auditor and head of accounts of each company. The overall response rate was 28.3%. The results were derived by applying multiple regression method and the three determinants turned out to be significant. The three determinants are risk-based planning, usage of Big Data and Analytics, and frequency of meetings of internal auditor (IA) with audit committee (AC) respectively. The model explains 42.8% of variations in the dependent variable (IA effectiveness). The study indeed encourages internal auditors to develop their core skills and competencies in the area of risk assessment and Big Data and Analytics for delivering better services to the auditees, the board of directors and the AC members. The implications of these findings may be of importance to internal audit professionals, accounting professional bodies and the regulators. Direction for future research is also provided.

RISKS OF BECOMING INFECTED WITH SARS-COV-2 FOR MEDICAL PERSONNEL IN A LARGE INDUSTRIAL CITY DURING THE PANDEMIC: COMPARATIVE ASSESSMENT

The COVID-19 pandemic has produced its effects on functioning of all the state institutions, the public healthcare sys-tem being a peculiar one among them. Medical personnel have become an unprotected population group that was actively involved into the epidemic process. Results produced by several studies indicate that relative risks to become infected with COVID-19 are by up to 11.6 times higher for medical personnel than in population at large. A share of medical personnel among patients with COVID-19 varies in different countries, from 4.2 % in China to 17.8 % in the USA. According to official statistics, in 2020 a share of medical personnel who became infected with COVID-19 in in-hospital foci amounted to 68.6 % in the RF regions located in the Urals and Siberian Federal Districts. High epidemic potential of the virus and intensive mass contacts between medical personnel and their patients make for rapid SARS-CoV-2 spread and infection among them. It is vital to examine all the range of risk factors that cause SARS-CoV-2 infection among medical personnel. The present study involved using “The map of epidemiological investigation focused on the incidence of the new coronavirus in-fection (COVID-19) in medical personnel”. The map was located on Google Cloud Platform. Overall, 613 medical workers from dif-ferent medical organizations took part in the research. We applied sociological, epidemiological and statistical research techniques. We established that work in an infectious diseases hospital increased a relative risk of SARS-CoV-2 infection by 1.8 times (RR = 1.78;95 % CI [1.65–1.93]). The total risk of SARS-CoV-2 infection was insignificant for workers employed at a medical organization that provided scheduled medical assistance to population (RR = 1.02;95 % CI [1.00–1.04]). However, certain factors created elevated risks of infection. Any contacts with COVID-19 patients who were close relatives, friends or neighbors were established to be significant (RR = 1.13;95 % CI [1.04–1.228]). The research results should be used when organizing work procedures and anti-epidemic activities in infectious diseases hospi-tals and medical organizations providing scheduled assistance to population. The focus should be on providing medical personnel with personal protective equipment as well as on calculating relevant duration of a work shift relying on the risk-based approach. © Smirnova S.S., Egorov I.А., Zhuikov N.N., Vyatkina L.G., Kharitonov А.N., Semenov А.V., Morova О.V., 2022

Maintaining trust in a technologized public sector

Emerging technologies permeate and potentially disrupt a wide spectrum of our social, economic, and political relations. Various state institutions, including education, law enforcement, and healthcare, increasingly rely on technical components, such as automated decision-making systems, e-government systems, and other digital tools to provide cheap, efficient public services, and supposedly fair, transparent, disinterested, and accountable public administration. The increased interest in various blockchain-based solutions from central bank digital currencies, via tokenized educational credentials, and distributed ledger-based land registries to self-sovereign identities is the latest, still mostly unwritten chapter in a long history of standardized, objectified, automated, technocratic, and technologized public administration. The rapid, (often) unplanned, and uncontrolled technologization of public services (as happened in the hasty adoption of distance-learning and teleconferencing systems during Corona Virus Disease (COVID) lockdowns) raises complex questions about the use of novel technological components, which may or may not be ultimately adequate for the task for which they are used. The question whether we can trust the technical infrastructures the public sector uses when providing public services is a central concern in an age where trust in government is declining: If the government's artificial intelligence system that detects welfare fraud fails, the public's confidence in the government is ultimately hit. In this paper, we provide a critical assessment of how the use of potentially untrustworthy (private) technological systems including blockchain-based systems in the public sector may affect trust in government. We then propose several policy options to protect the trust in government even if some of their technological components prove fundamentally untrustworthy.

Predicting the trends and cost impact of COVID-19 OSHA citations on US construction contractors using machine learning and simulation

Purpose Occupational Safety and Health Administration (OSHA) of the U.S. government ensures that all health and safety regulations, protecting the workers, are enforced. OSHA officers conduct inspections and assess fines for non-compliance and regulatory violations. Literature discussion on the economic impact of OSHA inspections with COVID-19 related citations for the construction sector is lacking. This study aims to investigate the relationships between the number of COVID-19 cases, construction employment and OSHA citations and it further evaluates the total and monthly predicted cost impact of OSHA citations associated with COVID-19 violations. Design/methodology/approach An application of multiple regression analysis, a supervised machine learning linear regression model, based on K-fold cross validation sampling and a probabilistic risk-based cost estimate Monte Carlo simulation were utilized to evaluate the data. The data were collected from numerous websites including OSHA, Centers for Disease Control and the World Health Organization. Findings The results show that as the monthly construction employment increased, there was a decrease in OSHA citations. Conversely, the cost impact of OSHA citations had a positive relationship with the number of COVID-19 cases. In addition, the monthly cost impact of OSHA COVID-19 related citations along with the total cost impact of citations were predicted and analyzed. Originality/value The application of the two models on cost analysis provides a thorough comparison of predicted and overall cost impact, which can assist the contractors to better understand the possible cost ramifications. Based on the findings, it is suggested that the contractors include contingency fees within their contracts, hire safety managers to implement specific safety protocols related to COVID-19 and request a safety action plan when qualifying their subcontractors to avoid potential fines and citations.

The Influence Mechanism Analysis of Online Public Opinions on Pork Import Customs Risk-Based on LDA-GRA Model

China is the world's largest consumer and importer of pork. In the context of COVID-19, countries have implemented strict import inspection and quarantine standards, and pork imports are facing more complicated customs clearance procedures, resulting in a sharp increase in customs risks. Pork, as a basic livelihood product, has always been a sensitive topic on the Internet. Their public opinions often have an important impact on customs policies and are one of the important sources of customs risks. Based on Internet text big data mining and LDA-GRA analysis method, this paper classifies online public opinion on pork import during the COVID-19 pandemic into different topics, and conducts correlation analysis on public opinion text and customs policy, investigates the correlation between online public opinion, customs policy and customs risk, as well as its correlation strength. The results show that the online public opinion of pork import has a significant impact on the implementation of the customs policy, and causes a variety of potential customs risks of pork import. Pork import-related enterprises should strengthen public opinion monitoring to reduce losses caused by customs risks. © 2021 ACM.

Research monitoring practices in critical care research: a survey of current state and attitudes.

BACKGROUND/AIMS: In 2016, international standards governing clinical research recommended that the approach to monitoring a research project should be undertaken based on risk, however it is unknown whether this approach has been adopted in Australia and New Zealand (ANZ) throughout critical care research. The aims of the project were to: 1) Gain an understanding of current research monitoring practices in academic-led clinical trials in the field of critical care research, 2) Describe the perceived barriers and enablers to undertaking research monitoring. METHODS: Electronic survey distributed to investigators, research co-ordinators and other research staff currently undertaking and supporting academic-led clinical trials in the field of critical care in ANZ. RESULTS: Of the 118 respondents, 70 were involved in the co-ordination of academic trials; the remaining results pertain to this sub-sample. Fifty-eight (83%) were working in research units associated with hospitals, 29 (41%) were experienced Research Coordinators and 19 (27%) Principal Investigators; 31 (44%) were primarily associated with paediatric research. Fifty-six (80%) develop monitoring plans with 33 (59%) of these undertaking a risk assessment; the most common barrier reported was lack of expertise. Nineteen (27%) indicated that centralised monitoring was used, noting that technology to support centralised monitoring (45/51; 88%) along with support from data managers and statisticians (45/52; 87%) were key enablers. Coronavirus disease-19 (COVID-19) impacted monitoring for 82% (45/55) by increasing remote (25/45; 56%) and reducing onsite (29/45; 64%) monitoring. CONCLUSIONS: Contrary to Good Clinical Practice guidance, risk assessments to inform monitoring plans are not being consistently performed due to lack of experience and guidance. There is an urgent need to enhance risk assessment methodologies and develop technological solutions for centralised statistical monitoring.

Towards Zero Trust: The Design and Implementation of a Secure End-Point Device for Remote Working

COVID-19 pandemic and lockdowns forced employees across the world to work from home. Remote working has become a necessity rather than a choice. However, in order to meet this increasing demand, the most pressing security concerns of organizations should be addressed. In this paper, we present the design and implementation of ProGun, an end-point device (a USB dongle) for remote working. We present the hardware/software co-design of ProGun, by which most security risks due to lack of physical protection could be mitigated. We also discuss choices we made among many alternatives for user authentication and their security and usability implications in a remote working environment. © 2021 IEEE.

COVID-19 health management and business continuity

Considering the world faces an unprecedented challenge with economies everywhere affected by the COVID-19 pandemic there was an extreme need for coming together to combat the COVID-19 pandemic bringing governments, organizations from across industries and individuals together to manage this global outbreak. From the early stages of pandemic escalation, SOCAR AQS realized that only diversified measures would minimize risks, fulfil the duty of care responsibilities and promote workforce resilience. The establishment of the COVID-19 crisis management team ensured the continuous application of a proactive risk-based approach aligned with governmental regulations on the ground of the most up to date local and international information including the industry best practices. Access to the offices for all relevant staff and visitors was minimized, and the specific procedure for work from home was developed. A combination of preventive measures at all worksites and transportation facilities is held through regular effective disinfection, health checks, continuous access to the required personal protection and hygiene facilities, maintaining social distancing, and careful tracing close contacts for all suspected cases. Health promotion to all staff is conducted through various communication means. Two-stage pre-mobilization COVID-19 screening was implemented through a comprehensive health questionnaire prior to commuting at the entrance of quarantine facilities. There was a week of individual isolation in the designated controlled quarantine facilities with optimal detectability of the virus by the fifth day followed by highly-specific PCR testing before entering operational worksites enables early revealing of an infection prior to its manifestation in the human body. Specific post-illness medical assessment is a key for individual healthy return to work is carried out. Considering vaccines as a critical new tool in the battle against COVID-19, vaccination of all offshore personnel is implemented. As an outcome, the entire process provided a prudent way to ensure the continuation of uninterrupted operations resulted in zero COVID-19 detection at the quarantine worksites by follow-up of suspected cases during first eight months of the pandemic fight in Azerbaijan. In conclusion, the abovementioned statement provides the guidelines for the workforce working on worksites or in offices, and clear expectations of the measures to be taken to ensure COVID-19 health management and smooth business continuity are maintained. Copyright 2021, Society of Petroleum Engineers

How to accelerate the supply of vaccines to all populations worldwide? Part II: Initial industry lessons learned and detailed technical reflections leveraging the COVID-19 situation.

Vaccine discovery and vaccination against preventable diseases are one of most important achievements of the human race. While medical, scientific & technological advancements have kept in pace and found their way into treatment options for a vast majority of diseases, vaccines as a prevention tool in the public health realm are found languishing in the gap between such innovations and their easy availability/accessibility to vulnerable populations. This paradox has been best highlighted during the unprecedented crisis of the COVID-19 pandemic. As part of a two series publication on the vaccine industry's view on how to accelerate the availability of vaccines worldwide, this paper offers a deep dive into detailed proposals to enable this objective. These first-of-its-kind technical proposals gleaned from challenges and learnings from the COVID-19 pandemic are applicable to vaccines that are already on the market for routine pathogens as well as for production of new(er) vaccines for emerging pathogens with a public health threat potential. The technical proposals offer feasible and sustainable solutions in pivotal areas such as process validation, comparability, stability, post-approval changes, release testing, packaging, genetically modified organisms and variants, which are linked to manufacturing and quality control of vaccines. Ultimately these proposals aim to ease high regulatory complexity and heterogeneity surrounding the manufacturing & distribution of vaccines, by advocating the use of (1) Science and Risk based approaches, (2) global regulatory harmonization, (3) use of reliance, work-sharing, and recognition processes and (4) digitalization. Capitalizing & collaborating on such new-world advancements into the science of vaccines will eventually benefit the world by turning vaccines into vaccination, ensuring the health of everyone.

How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation.

The COVID-19 pandemic has shown itself to be an unprecedented challenge for vaccines which are widely recognized as the most important tool to exit this pandemic. We have witnessed vaccine scientists, developers, manufacturers, and stakeholders deliver several vaccines in just about a year. This is an unprecedented achievement in an environment that was not ready to manage such a global public health crisis. Indeed, the pandemic has highlighted some hurdles that need to be addressed in the system in order to streamline the regulatory processes and be in a situation where life-saving pharmaceutical solutions such as vaccines can be delivered quickly and equitably to people across the globe. More precisely, trade-offs had to be made between the need for regulatory flexibility in the requirements for manufacturing and controls to enable rapid availability of large volumes of vaccines vs the increased stringency and the lack of harmonization in the regulatory environment for vaccines globally. It is also characterized by a high heterogeneity in terms of review and approval processes, limiting equitable and timely access. We review and highlight the challenges relating to several topics, including process validation, comparability, stability, post-approval-changes, release testing, packaging, genetically modified organisms and variants. We see four areas for accelerating access to vaccines which provide solutions for the regulatory concerns, (1) science- and risk-based approaches, (2) global regulatory harmonization, (3) use of reliance, work-sharing, and recognition processes and (4) digitalization. These solutions are not new and have been previously highlighted. In recent months, we have seen some progress at the health authority level, but still much needs to be done. It is now time to reflect on the first lessons learnt from a devastating pandemic to ultimately ensure quick and wide access to medicines and vaccines for the citizens and patients.