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Purpose: The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) launched a strategy to examine the public health impact of major regulatory interventions aimed at minimising risks of medicinal products. We conducted a lessons learnt analysis of impact studies completed between 2015 and 2023. Methods: We surveyed PRAC Sponsors and (Co‐)Rapporteurs involved in the evaluation of 12 impact studies (10 commissioned by EMA and 2 conducted collaboratively by Member States) to explore how these support regulatory decision‐making. Questions covered achievement of study objectives, risk minimisation effectiveness, added value for regulatory decision‐making, and recommendations for future impact studies. Themes were generated using thematic content analysis. Results: Survey responses from 15 PRAC Sponsors and (Co‐)Rapporteurs from 10 European Union Member States were included in the analysis. Among four cross‐sectional surveys and eight drug utilisation studies, 50% achieved all objectives, the other studies partially due to limitations. Two studies concluded that risk minimisation measures were overall effective, two were effective with variation across countries, two were partially effective and four studies showed limited effectiveness. Two studies were deemed inconclusive due to limitations. The reasons for the limited effectiveness of risk minimisation may be explored using mixed‐method approaches. Assessment of study feasibility and a priori discussion of effectiveness measurements is important. Conclusion: Despite limitations, impact research adds value to regulatory decision‐making by addressing knowledge gaps and providing additional information on unintended consequences of regulatory interventions. Our recommendations will help to improve planning, conducting and interpretating future impact studies. [ABSTRACT FROM AUTHOR]

Zimbabwe has received substantial external assistance for health since the early 2000s, including funding earmarked for, or framed as, health systems strengthening (HSS). This study sought to examine whether external assistance has strengthened the health system (i.e. enabled comprehensive changes to health system performance drivers) or has just supported the health system (by increasing inputs and improving service coverage in the short term). Between August and October 2022, we conducted in-depth key informant interviews with 18 individuals and reviewed documents to understand: (1) whether external funding has supported or strengthened Zimbabwe's health system since the 2000s; (2) whether the experience of COVID-19 fosters a re-examination of what had been considered as HSS during the pre-pandemic era; and (3) areas to be reconsidered for HSS post COVID-19. Our findings suggest that external funders have supported Zimbabwe to control major epidemics and avert health system collapse. However, the COVID-19 pandemic showed that supporting the health system is not the same as strengthening it, as it became apparent at that time that the health sector is plagued with several system-wide bottlenecks. External funding is fragile and highly unsustainable, which reinforces the oft-ignored reality that HSS is a sovereign mandate of country-level authorities, and one that falls outside the core interests of external funders. The key positive lesson from the pandemic is that Zimbabwe is capable of raising domestic resources to fund HSS. However, there is no guarantee that such funding will be maintained. There is a need, then, to reconsider government's stewardship for HSS. External funders need to re-examine whether their funding really strengthens the national health system or just supports the country to provide basic services in their areas of interest. [ABSTRACT FROM AUTHOR]

Background: HIV testing remains an entry point into HIV care and treatment services. In 2007, Nigeria adopted and implemented a two-test rapid HIV testing algorithm of three HIV rapid test kits, following the sequence: Alere Determine (first test), UnigoldTM (second test), and STAT-PAK® as the tie-breaker. Sub-analysis of the 2018 Nigeria HIV/AIDS Indicator and Impact Survey data showed significant discordance between the first and second tests, necessitating an evaluation of the algorithm. This manuscript highlights lessons learnt from that evaluation. Intervention: A two-phased evaluation method was employed, including abstraction and analysis of retrospective HIV testing data from January 2017 to December 2019 from 24 selected sites supported by the United States President’s Emergency Plan for AIDS Relief programme. A prospective evaluation of HIV testing was done among 2895 consecutively enrolled and consented adults, aged 15–64 years, accessing HIV testing services from three selected sites per state across the six geopolitical zones of Nigeria between July 2020 and September 2020. The prospective evaluation was performed both in the field and at the National Reference Laboratory under controlled laboratory conditions. Stakeholder engagements, strategic selection and training of study personnel, and integrated supportive supervision were employed to assure the quality of evaluation procedures and outcomes. Lessons learnt: The algorithm showed higher sensitivity and specificity in the National Reference Laboratory compared with the field. The approaches to quality assurance were integral to the high-quality study outcomes. Recommendations: We recommend comparison of testing algorithms under evaluation against a gold standard. What this study adds: This study provides context-specific considerations in using World Health Organization recommendations to evaluate the Nigerian national HIV rapid testing algorithm.

Many aspects of society changed due to the COVID-19 pandemic. As a result, many individuals experienced the introduction of travel bans and restrictions, COVID-19 related anxiety, greater risk to their health and an increased need for adaptive coping. Research has shown health-related quality of life was negatively affected during the time. However, the influence that these restrictions and experiences had on other various quality of life domains (physical, psychological, environmental, and social) is not yet known. Therefore, we aimed to examine the relationships between COVID-19-related variables, health variables, psychological variables and five domains of quality of life in Australian adults. Data was collected via cross-sectional online surveys from 264 Australian participants (Mage = 29.76 years, SD = 12.40). Five hierarchical multiple regression analyses were conducted. The findings showed better adaptive coping, decreased COVID-19 anxiety, and lower perceived health risk were all associated with better quality of life during this time. Neither having travel plans during 2020–2021 nor engaging in compensatory behaviours were associated with quality of life. During times of uncertainty, such as pandemics, natural disasters or war, providing anxiety-reducing coping strategies may be beneficial for reducing the negative impacts on quality of life. In line with these findings and similar research, we have provided several directions and recommendations for governments and media organisations for when future events, similar to COVID-19, occur. [ABSTRACT FROM AUTHOR]

Abstract Background Uganda implemented its third mass campaign to distribute long-lasting insecticidal nets (LLINs) in 2020 during the COVID-19 pandemic. This context necessitated modification of implementation guidelines. The mass campaign's objective was to ensure that at least 85% of the targeted population had access to LLINs. Methods Revised implementation guidelines were followed while conducting the LLIN distribution campaign. Lessons learned were captured from documented activities and reports. Results A total of 27,789,044 mosquito nets were distributed in 11,287,392 households, with an average of 5.1 persons per household. Household coverage of the LLIN distribution was 94.1%. The 2020/2021 campaign design was modified to follow COVID-19 Standard Operating Procedures (SOPs). These included using Personal Protective Equipment (PPE), e-platforms for training and briefing meetings, electronic data management systems and door-to-door household registration and distribution of LLINs. Conclusions Campaign modifications due to the COVID-19 pandemic were effective in implementing mass distribution of LLINs despite the disruptions and restrictions. The campaign’s net coverage far exceeded its objective. Electronic data management was critical in monitoring and reporting distribution activities.

Background: Uganda implemented its third mass campaign to distribute long-lasting insecticidal nets (LLINs) in 2020 during the COVID-19 pandemic. This context necessitated modification of implementation guidelines. The mass campaign's objective was to ensure that at least 85% of the targeted population had access to LLINs. Methods: Revised implementation guidelines were followed while conducting the LLIN distribution campaign. Lessons learned were captured from documented activities and reports. Results: A total of 27,789,044 mosquito nets were distributed in 11,287,392 households, with an average of 5.1 persons per household. Household coverage of the LLIN distribution was 94.1%. The 2020/2021 campaign design was modified to follow COVID-19 Standard Operating Procedures (SOPs). These included using Personal Protective Equipment (PPE), e-platforms for training and briefing meetings, electronic data management systems and door-to-door household registration and distribution of LLINs. Conclusions: Campaign modifications due to the COVID-19 pandemic were effective in implementing mass distribution of LLINs despite the disruptions and restrictions. The campaign's net coverage far exceeded its objective. Electronic data management was critical in monitoring and reporting distribution activities. [ABSTRACT FROM AUTHOR]

During the COVID-19 vaccination campaign, Germany, like other high-income countries, introduced mass vaccination centers for administering vaccinations. This qualitative study aimed to examine the role that these novel, temporary government healthcare structures played in a mass immunization roll-out and how they can be optimally deployed. In addition, learnings for general emergency preparedness were explored. A total of 27 high-level policymakers responsible for planning and implementing the COVID vaccination campaign at the national and state level in Germany were interviewed in May and June 2022. The semi-structured interviews were analyzed using thematic analysis. Interviewees indicated that mass vaccination structures played an essential role with respect to controllability, throughput, accessibility and openness in line with the key success criteria vaccination coverage, speed and accessibility. In contrast to the regular vaccination structures (private medical practices and occupational health services), public administration has direct authority over mass vaccination centers, allowing for reliable vaccine access prioritization and documentation. The deployment of vaccination centers should be guided by vaccine availability and demand, and vaccine requirements related to logistics, as well as local capacities, i.e., public-health-service strength and the physician density, to ensure effective, timely and equitable access. Improvements to the capacity use, scalability and flexibility of governmental vaccination structures are warranted for future pandemics. [ABSTRACT FROM AUTHOR]

Breeding programs involving either centralized nucleus schemes and/or importation of exotic germplasm for crossbreeding were not successful and sustainable in most Africa countries. Community-based breeding programs (CBBPs) are now suggested as alternatives that aim to improve local breeds and concurrently conserve them. Community-based breeding program is unique in that it involves the different actors from the initial phase of design up until implementation of the programs, gives farmers the knowledge, skills and support they need to continue making improvements long into the future and is suitable for low input systems. In Ethiopia, we piloted CBBPs in sheep and goats, and the results show that they are technically feasible to implement, generate genetic gains in breeding goal traits and result in socio-economic impact. In Malawi, CBBPs were piloted in local goats, and results showed substantial gain in production traits of growth and carcass yields. CBBPs are currently being integrated into goat pass-on programs in few NGOs and is out-scaled to local pig production. Impressive results have also been generated from pilot CBBPs in Tanzania. From experiential monitoring and learning, their success depends on the following: 1) identification of the right beneficiaries; 2) clear framework for dissemination of improved genetics and an up/out scaling strategy; 3) institutional arrangements including establishment of breeders' cooperatives to support functionality and sustainability; 4) capacity development of the different actors on animal husbandry, breeding practices, breeding value estimation and sound financial management; 5) easy to use mobile applications for data collection and management; 6) long-term technical support mainly in data management, analysis and feedback of estimated breeding values from committed and accessible technical staff; 7) complementary services including disease prevention and control, proper feeding, and market linkages for improved genotypes and non-selected counterparts; 8) a system for certification of breeding rams/bucks to ensure quality control; 9) periodic program evaluation and impact assessment; and 10) flexibility in the implementation of the programs. Lessons relating to technical, institutional, community dynamics and the innovative approaches followed are discussed. [ABSTRACT FROM AUTHOR]

An accident database is an excellent data source if appropriately leveraged along with domain expertise. However, a proper framework and tools are required to extract data from a database. The current work aims to develop such a framework by systematically introducing a unique approach to integrate three techniques. First, Natural Language Processing (NLP) is used to extract causal and contributing factors from an accident database. Second, an Interpretive Structural Model (ISM) establishes the interrelationship and hierarchy of the extracted factors. Third, a probabilistic method for quantitative reasoning and accident analysis is employed. This integrated approach is applied to the US Chemical Safety and Hazard Investigation Board (CSB) oil and refining (downstream) incident database to develop a generalized accident causation model. The model provides insight into the factors responsible for accidents (i.e., commonalities among casualties), interactions, and accident pathways. It can also be used to develop strategies for preventing accidents. The model is tested on ten scenarios from the CSB and verified on six incidents from the IChemE database. The results are promising in establishing the model's efficacy in predicting adverse events. Sensitivity analysis shows that management of change and lack of procedure and training have the highest sensitivity towards fire and explosion, and therefore need proper attention. This approach will be an essential tool for Safety 4.0, enabling process safety in the digitalization process. [ABSTRACT FROM AUTHOR]

Breeding programs involving either centralized nucleus schemes and/or importation of exotic germplasm for crossbreeding were not successful and sustainable in most Africa countries. Community-based breeding programs (CBBPs) are now suggested as alternatives that aim to improve local breeds and concurrently conserve them. Community-based breeding program is unique in that it involves the different actors from the initial phase of design up until implementation of the programs, gives farmers the knowledge, skills and support they need to continue making improvements long into the future and is suitable for low input systems. In Ethiopia, we piloted CBBPs in sheep and goats, and the results show that they are technically feasible to implement, generate genetic gains in breeding goal traits and result in socio-economic impact. In Malawi, CBBPs were piloted in local goats, and results showed substantial gain in production traits of growth and carcass yields. CBBPs are currently being integrated into goat pass-on programs in few NGOs and is out-scaled to local pig production. Impressive results have also been generated from pilot CBBPs in Tanzania. From experiential monitoring and learning, their success depends on the following: 1) identification of the right beneficiaries; 2) clear framework for dissemination of improved genetics and an up/out scaling strategy; 3) institutional arrangements including establishment of breeders’ cooperatives to support functionality and sustainability; 4) capacity development of the different actors on animal husbandry, breeding practices, breeding value estimation and sound financial management; 5) easy to use mobile applications for data collection and management; 6) long-term technical support mainly in data management, analysis and feedback of estimated breeding values from committed and accessible technical staff; 7) complementary services including disease prevention and control, proper feeding, and market linkages for improved genotypes and non-selected counterparts; 8) a system for certification of breeding rams/bucks to ensure quality control; 9) periodic program evaluation and impact assessment; and 10) flexibility in the implementation of the programs. Lessons relating to technical, institutional, community dynamics and the innovative approaches followed are discussed.

"Failure" is recognised as being vital for success in many fields but is seldom embraced in primate conservation or conservation more generally. In this paper, we use examples from the literature, particularly around reintroduction, to reflect on failure and consider the contribution it can make to primate conservation success. Barriers to acknowledging failure are highlighted and include concerns regarding reputational damage that impact on communication with funders, publishing, and discussing our projects more widely. We also discuss the need for a broader and adaptive approach to include multiple steps of experimentation, reflection, and subsequent learning. This process, which necessarily includes failures and the results of unintended consequences, will require primatologists to use a collaborative, interdisciplinary, and reflective approach to effectively address factors that contribute to failure, including those external to the traditional focus of primatologists. The paper concludes with specific recommendations for progressing in this area, including (i) Funding—funders to incorporate greater flexibility in response to project change and to specifically ask grantees to consider risk, failure, and lessons learnt, and funders and grantees to improve dialogue; (ii) Publishing—journals to have a section that considers failure and lessons learnt and, along with societies, to further engage with researchers from the Global South about the best ways to support with publishing; and (iii) Communication—primate conservationists to lead by example and reflect/discuss failure openly and to create spaces that encourage sharing of these topics. Whilst not exhaustive, we hope that these recommendations will contribute to developing a culture of constructive discussion around failure in primate conservation. [ABSTRACT FROM AUTHOR]

There are three main regional human rights tribunals (HRTs) in Africa, namely the African Commission, the African Court and the African Committee of Experts on the Rights and Welfare of the Child. In addition to these, there are political bodies within the African Union responsible for implementing human rights mandates as well as several sub-regional courts established for the primary purpose of adjudicating trade disputes and facilitating political integration which have issued notable human rights decisions and judgments. Accordingly, Africa is not lacking in human rights jurisprudence. What is lacking, however, is genuine commitment on the part of state actors to implement the decisions and judgments of the various human rights bodies. This article examines the factors responsible for slowing down the pace and rate of state compliance in Africa. It argues, among other things, that compliance with HRTs' decisions in Africa has been limited due to poor supervision mechanisms, weak domestic infrastructures, weak state institutions caused by 'strong men syndrome' and poor observance of the rule of law, poor institutional designs of regional and sub-regional HRTs, lack of awareness and erroneous perceptions about international human rights system, ineffective follow-up as well as a poor system of governance in many states in Africa among other factors. The article notes that attitudinal barriers and erroneous perceptions about international human rights system are central to the various barriers and thus adequate attention should be given to changing negative attitudes and perceptions among states actors and members of the public in the various African states. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve replacement (TAVR) has become an accepted modality of treatment in intermediate and high surgical risk patients of symptomatic severe calcific aortic stenosis (AS). We herein report Indian data of 84 intermediate and high-risk patients who underwent TAVR at two Armed Forces cardiac centres. Most of the patients underwent TAVR in cardiac catheterization lab by percutaneous transfemoral approach, under conscious sedation. Patients were followed up and echocardiographic parameters were assessed after six months of procedure. Total of 84 intermediate and high-risk patients underwent TAVR between Jan 2017 and June 2021. Mean age of population was 71.5 ± 8.4 years; 28.5% of patients had bicuspid aortic valve and Mean STS score was 6.34 ± 2.08. Majority (92.8%) patients underwent the procedure under conscious sedation. Self-expanding valves were used in 72.6% and balloon expandable in 27.4% of patients. Predilatation was done in 64% patients while 13% cases underwent post dilatation. Procedural mortality was 2.3%. Rate of permanent pacemaker implantation was 4.9%. Ischemic stroke occurred in 1.1% of patents. There was no case of severe paravalvular leak. Emergency surgical aortic valve replacement was done in 2.4% patients. Procedural success in this study was 97.6%. All-cause mortality was 9.5% at 6 months. TAVR is an effective treatment modality in intermediate and high-risk Indian patients with severe aortic stenosis. Patients with bicuspid or previous bio prosthetic aortic valves also have a good outcome post TAVR. [ABSTRACT FROM AUTHOR]

Background: HIV testing remains an entry point into HIV care and treatment services. In 2007, Nigeria adopted and implemented a two-test rapid HIV testing algorithm of three HIV rapid test kits, following the sequence: Alere Determine (first test), Unigold TM (second test), and STAT-PAK ® as the tie-breaker. Sub-analysis of the 2018 Nigeria HIV/AIDS Indicator and Impact Survey data showed significant discordance between the first and second tests, necessitating an evaluation of the algorithm. This manuscript highlights lessons learnt from that evaluation., Intervention: A two-phased evaluation method was employed, including abstraction and analysis of retrospective HIV testing data from January 2017 to December 2019 from 24 selected sites supported by the United States President's Emergency Plan for AIDS Relief programme. A prospective evaluation of HIV testing was done among 2895 consecutively enrolled and consented adults, aged 15-64 years, accessing HIV testing services from three selected sites per state across the six geopolitical zones of Nigeria between July 2020 and September 2020. The prospective evaluation was performed both in the field and at the National Reference Laboratory under controlled laboratory conditions. Stakeholder engagements, strategic selection and training of study personnel, and integrated supportive supervision were employed to assure the quality of evaluation procedures and outcomes., Lessons Learnt: The algorithm showed higher sensitivity and specificity in the National Reference Laboratory compared with the field. The approaches to quality assurance were integral to the high-quality study outcomes., Recommendations: We recommend comparison of testing algorithms under evaluation against a gold standard., What This Study Adds: This study provides context-specific considerations in using World Health Organization recommendations to evaluate the Nigerian national HIV rapid testing algorithm., Competing Interests: The authors declare that they have no financial or personal relationships that may have inappropriately influenced them in writing this article., (© 2024. The Authors.)

On the occasion of the 20th anniversary of International Environmental Agreements: Politics, Law & Economics, we conduct an extensive review of papers published in this journal that address the economic dimensions of international environmental agreements (IEAs). We focus particularly on the lessons learnt from this body of literature and the implications for the assessment and design of IEAs in relation to goals such as efficiency, effectiveness, and equity. Our key conclusions run as follows. First, at the international level, universal coalitions are more cost-efficient and effective than fragmented regimes, but more difficult to negotiate and less stable. Second, in developing countries, there is need for substantial external funding to cover the short-run costs of environmental compliance. Third, market-based solutions have been increasingly applied in international agreements but with mixed results. For example, cap-and-trade systems have the potential to achieve greenhouse gas emissions reductions and least economic cost. But in the provisioning of water services, private sector solutions often result in outcomes that are unaffordable for low-income groups or nonviable for businesses, suggesting well-designed public–private partnerships. At the international level, Green Bond markets can attract investors for climate and environmental projects, but implementation failures tend to weaken outcomes. Finally, in practical politics, economically optimal designs are rarely achieved. Future applied economic research should therefore critically investigate institutions and the scope for their reform. Gains in knowledge are expected to come from economic analyses taking a broader perspective on "the economy", taking institutions and social and ecological relations into account from the start. [ABSTRACT FROM AUTHOR]

INEA has featured many articles covering the dilemmas, puzzles, and tensions related to global biodiversity governance; this coverage was infrequent in earlier issues but has steadily increased as both environmental diplomacy and international law on biodiversity conservation and environmental justice have expanded. Using the definition found in the Convention on Biological Diversity, we scanned INEA articles and derived several lessons learnt over the 2000–2020 period. These include: implementation remains a central challenge, but challenge should not be conflated with ineffectiveness; multilateral environmental agreements are vital for success; coordination and policy coherences are often lacking, insufficient, or superficial; institutional change and policy reform within existing institutions are incremental at best; understanding local political dynamics is critical; equity concerns remain central to biodiversity policy development at all levels; the role of non-state actors and private voluntary standards fluctuates; tensions over state sovereignty and collective action and the commons have often been visible but as often lurk in the shadows of environmental diplomacy and most ongoing discussions of global biodiversity governance. After elaborating on each of these lessons, we offer some insights on research gaps and potential thematic directions for future contributors to INEA. [ABSTRACT FROM AUTHOR]

In addition to revealing the cracks in global health care, emergency preparedness, and response systems, COVID-19 also exposed the lack of capacity to run chemical plants safely under such conditions. On 7th May 2020, self-polymerization runaway reaction from an atmospheric storage tank in a polymer facility triggered the release of styrene to the atmosphere, resulting in 12 fatalities and hospitalization of more than 1000 individuals. A similar incident had happened 35 years back at Bhopal involving the release of methyl isocyanate resulting in one of the deadliest process safety incidents to date. Therefore, it is very important to understand the causal factors so that such high-risk incidents can be prevented in future. This paper presents a comprehensive investigative study of styrene gas leak at Vizag with special emphasis on probabilistic risk analysis of the loss of containment. Hazard perception study was performed to understand the possible hazardous scenarios in bulk styrene storage facilities for preventing such catastrophic recurrences. Energy barrier analysis was performed to study the inadequacy of pro-active and reactive barriers with respect to the accident case study. The analysis also considers the escalation factors resulting from extremities of COVID-19 lockdown. The self-polymerization reaction that resulted in toxic styrene dispersion was preventable owing to the advancements in safety engineering and loss prevention since Bhopal Gas Tragedy (1984). Based on the investigative analysis, it can be pointed out that this accident would have occurred even in the absence of COVID-19 restrictions, mainly due to negligence and complacency shown towards safety by the company's management. [ABSTRACT FROM AUTHOR]

This article is dedicated to doing a detailed review of the aforementioned book entitled Life Under Lockdown: Lived Experiences and Lessons Learnt by Professor Sanjai Bhatt, Department of Social Work, University of Delhi,3, University Road, Delhi 110007, India; Immediate Past President, National Association of Professional Social Workers in India; Immediate Past President,(South Asia), International Council on Social Welfare, Alliance Ambassador, GSSWA.

Abstract Background Following the West Africa Ebola virus disease (EVD) outbreak (2013–2016), WHO developed a preparedness checklist for its member states. This checklist is currently being applied for the first time on a large and systematic scale to prepare for the cross border importation of the ongoing EVD outbreak in the Democratic Republic of Congo hence the need to document the lessons learnt from this experience. This is more pertinent considering the complex humanitarian context and weak health system under which some of the countries such as the Republic of South Sudan are implementing their EVD preparedness interventions. Main text We identified four main lessons from the ongoing EVD preparedness efforts in the Republic South Sudan. First, EVD preparedness is possible in complex humanitarian settings such as the Republic of South Sudan by using a longer-term health system strengthening approach. Second, the Republic of South Sudan is at risk of both domestic and cross border transmission of EVD and several other infectious disease outbreaks hence the need for an integrated and sustainable approach to outbreak preparedness in the country. Third, a phased and well-prioritized approach is required for EVD preparedness in complex humanitarian settings given the costs associated with preparedness and the difficulties in the accurate prediction of outbreaks in such settings. Fourth, EVD preparedness in complex humanitarian settings is a massive undertaking that requires effective and decentralized coordination. Conclusion Despite a very challenging context, the Republic of South Sudan made significant progress in its EVD preparedness drive demonstrating that it is possible to rapidly scale up preparedness efforts in complex humanitarian contexts if appropriate and context-specific approaches are used. Further research, systematic reviews and evaluation of the ongoing preparedness efforts are required to ensure comprehensive documentation and application of the lessons learnt for future EVD outbreak preparedness and response efforts.

The COVID-19 pandemic has been persistent with a huge demand for human health resources which is a vital component of its preparedness and response. Globally, the public health workforce through field epidemiology and laboratory training programme (FELTP) has been instrumental to global health security. We determined the status of FELTP in the region and its contributions to the COVID-19 pandemic response in the ECOWAS region. We conducted a desk review, shared a questionnaire among member states and organized a two-day online regional consultative meeting on field epidemiology training on 30 th -31 st March 2022 during which there were presentations, group discussions and deliberations on the status and contribution of FETP during the COVID-19 pandemic. Data collected were analyzed in themes. All countries in the ECOWAS region had established at least one tier of FELTP, 11 (73.3%) had established two tiers of FELTP and only 3 (20.0%) had established all three tiers of the program. Despite the pandemic, the cumulative number of graduates increased from 2996 to 4271 frontline, 41 to 380 intermediate, and 409 to 802 for advanced FELTP between 2019 and 2022. However, the progress has been disproportionate across countries. The key activities supported through FELTP graduates included pandemic response coordination, surveillance, data collection/management, laboratory support, case management, risk communication, infection prevention and control, COVID-19 vaccination, and research. Despite improvements in the FELTP in the Economic Community of West African States (ECOWAS) region, there is a need for continuous stakeholder engagement for its implementation, resource mobilization for sustainability, and leveraging critical partnerships., Competing Interests: The authors declare no competing interests., (Copyright: Virgil Kuassi Lokossou et al.)

• CMC lessons learnt, key CMC regulatory issues and use of risk-based approach for COVID-19 vaccine dossiers. • Need for early, continuous engagement of vaccine developer with the Regulator for COVID-19 vaccines. • Increased international regulatory cooperation for CMC/GMP during pandemic, more future collaboration expected • Very early investment in GMP, for production and testing sites for COVID-19 vaccines needed. • Early CMC Lifecycle, post-approval planning for COVID-19 vaccines needed. The European Medicines Agency (EMA) has approved five pandemic COVID-19 vaccines (prior to April 2022) and many others are in the pipeline. The commentary describes how timely approval and rapid manufacturing capacity scale up could be achieved from our perspective. The commentary considers the need for: early, continuous engagement with the regulator for COVID-19 vaccines; understanding key Chemistry, Manufacturing and Controls (CMC) challenges in order to build a successful COVID-19 vaccine CMC dossier; investing in production and testing site readiness for COVID-19 vaccines; CMC Lifecycle and post-approval planning for COVID-19 vaccines as well as future directions including international regulatory cooperation. EMA's experience of the CMC scientific considerations, which facilitated both timely approvals (as Conditional Marketing Authorisations) and rapid increase in production capacity and supply, is of interest to healthcare professionals, academia, pharmaceutical industry and global regulators to communicate the flexibility and agility applied to COVID-19 vaccines by the EU regulatory system and how these activities can be optimised while complying with the strict quality standards in the EU. [ABSTRACT FROM AUTHOR]

COVID-19 being a rapidly evolving pandemic, early lessons from the first deaths must be learnt to help feed into the public health guidelines. This article, therefore, aims to present the first two deaths due to COVID-19 in Uganda and their public health relevance. This is a case study of the first two COVID-19 deaths reported in Uganda, and the events were prospectively documented. The first case was a 34-year-old female and support staff at a health center II. She first presented with COVID-19 like symptoms before dying on 21st July 2020. The second case was an 80 years old female, who also presented with COVID-19 like symptoms before dying on 24th July 2020. The postmortem samples of both cases were confirmed positive for COVID-19. This study identifies a need for timely identification and testing of COVID-19 suspects, strengthening of health center capacity, as well as more awareness for effective prevention and control of COVID-19. [ABSTRACT FROM AUTHOR]

Background: Following the West Africa Ebola virus disease (EVD) outbreak (2013–2016), WHO developed a preparedness checklist for its member states. This checklist is currently being applied for the first time on a large and systematic scale to prepare for the cross border importation of the ongoing EVD outbreak in the Democratic Republic of Congo hence the need to document the lessons learnt from this experience. This is more pertinent considering the complex humanitarian context and weak health system under which some of the countries such as the Republic of South Sudan are implementing their EVD preparedness interventions. Main text: We identified four main lessons from the ongoing EVD preparedness efforts in the Republic South Sudan. First, EVD preparedness is possible in complex humanitarian settings such as the Republic of South Sudan by using a longer-term health system strengthening approach. Second, the Republic of South Sudan is at risk of both domestic and cross border transmission of EVD and several other infectious disease outbreaks hence the need for an integrated and sustainable approach to outbreak preparedness in the country. Third, a phased and well-prioritized approach is required for EVD preparedness in complex humanitarian settings given the costs associated with preparedness and the difficulties in the accurate prediction of outbreaks in such settings. Fourth, EVD preparedness in complex humanitarian settings is a massive undertaking that requires effective and decentralized coordination. Conclusion: Despite a very challenging context, the Republic of South Sudan made significant progress in its EVD preparedness drive demonstrating that it is possible to rapidly scale up preparedness efforts in complex humanitarian contexts if appropriate and context-specific approaches are used. Further research, systematic reviews and evaluation of the ongoing preparedness efforts are required to ensure comprehensive documentation and application of the lessons learnt for future EVD outbreak preparedness and response efforts. [ABSTRACT FROM AUTHOR]

Since the emergence of Corona Virus Disease 19 (COVID 19) in China in December 2019, a lot of significant decisions have been taken by the World Health Organization (WHO) and several countries across the globe. As the world reels under the threat of rapid increase in the number of cases and is planning strategies with the limited information available on the virus, it is essential to learn from the experience of countries across the globe. Hence, we selected a few countries in five WHO regions based on their COVID 19 caseload, management strategies and outcome and compared some of the important measures taken by them to contain the spread of infection. Strategies like extensive testing and contact tracing, strict quarantine and isolation measures, Hospital preparedness, complete restriction of non-essential travel, strict border control measures and social distancing measures play a vital role in containment of the spread. All the countries faced the novel strain of virus and implemented similar strategies as per the guidance of WHO, but the extent of preparedness, swiftness with which the decisions were made and the scale of measures made the difference. [ABSTRACT FROM AUTHOR]

Background: The use of mobile phone technology for reporting adverse drug reactions (ADRs) in pharmacovigilance is relatively new.The objective of the study was to explore challenges and facilitators for the use of the Med Safety App for reporting ADRs in Ghana. A comparative evaluation of ADR reports received through the app and the standard paper-based form was also conducted., Methods: This was a cross-sectional study with a purposive sampling technique. The study population was persons who had downloaded the Med Safety App launched in Ghana 18 months before the study., Results: Of the 350 participants, 121 provided answers to the questionnaire sent as a Google form, representing a response rate of 34.6%.Ninety-five (78.5%) of the participants were healthcare professionals, and the remaining were patients. Seventy-five (64.7%) of the participants were using the app after initial installation because they thought it had helpful features. However, only 33 (27.3%) participants used the app to report ADRs, and of these, seven (21.2%) participants indicated that they would continue to use the app because it was easier than the other means of reporting ADRs. Most of the respondents, 109 (94%), indicated that they would recommend the app to someone else. There were some differences between the reports received through the app and between the paper-based Council for International Organizations of Medical Sciences (CIOMS) 1 form and the app, which warrant further exploration., Conclusion: Most participants indicated that the app is a useful tool and easy to use, and they were satisfied with the features of the app. Given that only just under one-third of participants had used the app to report ADRs, more time and training may be required to fully evaluate the feasibility of the use of the app going forward. The findings will help improve introduction of the app in other countries., Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2023.)