Shadow Program Committee Initiative

The Shadow Program Committee (PC) is an initiative/program that provides an opportunity to Early-Career Researchers (ECRs), i.e., PhD students, postdocs, new faculty members, and industry practitioners, who have not been in a PC, to learn rst-hand about the peer-review process of the technical track at Software Engi- neering (SE) conferences. This program aims to train the next generation of PC members as well as to allow ECRs to be recog- nized and embedded in the research community. By participating in this program, ECRs will have a great chance i) to gain expe- rience about the reviewing process including the restrictions and ethical standards of the academic peer-review process; ii) to be mentored by senior researchers on how to write a good review; and iii) to create a network with other ECRs and senior researchers (i.e., Shadow PC advisors). The Shadow PC program was rst introduced to the SE research community at the Mining Software Repositories (MSR) confer- ence in 2021. The program was led by Patanamon Thongta- nunam and Ayushi Rastogi (Shadow PC Co-chairs) with support from Shadow PC Advisor Co-Chairs (Foutse Khomh and Serge Demeyer), PC Co-Chairs of the technical track (Meiyappan Na- gappan and Kelly Blincoe), and the General Chair of the con- ference, Gregorio Robles. To promote and facilitate the Shadow PC program at SE conferences in the future, this report provides details about the process and a re ection on the Shadow PC pro- gram during MSR2021. The presentation slides and video are also available online at https://youtu.be/ReUXwmtIEk8.

Manganese Encephalopathy Caused by Homemade Methcathinone (Ephedrone) Prevalence in Poland

Manganese encephalopathy is a known disorder in occupational medicine. A serious phenomenon has been the emergence of manganese encephalopathy in intravenous users of homemade methcathinone (ephedrone). A short survey was developed for clinical environments dealing with people who use psychoactive substances. The data were obtained from 72 rehabilitation therapy centers. Surveys carried out in about a third of Polish centers dealing with providing medical assistance to people addicted to substances other than alcohol and tobacco have shown that over 4% of people treated there had symptoms of manganese encephalopathy, of which more than half are people in whom the probability of a clinical diagnosis of this disorder is significant. It has been shown that knowledge of manganese encephalopathy is none or minimal in more than 70% of the surveyed institutions. An urgent need for personnel training in this field was pointed out. Attention was paid to the importance of disseminating good review articles on new and dynamically developing problem phenomena.

Book review: Nietzsche: filosofo della libertà

Nietzsche once opined that “a good review of a research book consists in better solving the problem that book advances” (KGW IV/2, 24 [53]). To some extent, Nietzsche’s ambitious conception of criticism aides in offering a review of Laura Langone’s Nietzsche: filosofo della libertà (Nietzsche: Philosopher of Freedom). Langone deals with a complex and centuries-old theme, as it appears and develops through the Nietzschean corpus: that of freedom. The book attempts to answer questions pertinent to this theme: can we become free? If so, how might we achieve this goal of freedom? What does being ‘free’ really mean, for Nietzsche? How might this freedom affect our lives?

Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward

Introduction: National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the review process to facilitate access to quality-assured medicines by their populations. One such collaboration is the Southern African Development Community (SADC) medicines registration collaborative initiative, ZaZiBoNa. Countries participate in the initiative by contributing to regulatory reviews and good manufacturing practices inspections. The aim of this study was to review and compare the registration processes of regulatory authorities of Mozambique, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe to identify strategies for better alignment.Methods: A senior member of the division responsible for issuing marketing authorisations completed an established and validated questionnaire, which standardises the review process, allowing key milestones, activities and practices of the six regulatory authorities to be identified and compared. The completed questionnaires were validated by the heads of the respective agencies.Results: The six countries vary in population and in the size of their respective regulatory agency and the resources allocated to regulatory reviews. The review processes of the six agencies were similar; however, differences were noted in the milestones recorded; for example, two of the countries did not record the start of the scientific assessment. Additionally, decisions for marketing authorisation were made by an expert committee in four of the countries and by the head of the agency and the Minister of Health in two countries. All six agencies implemented the majority of good review practices; however, the need for improvement in the areas of transparency and communication and quality decision making practices was a common finding for all six countries.Conclusions: Participation in the ZaZiBoNa initiative has improved the way in which the six agencies perform regulatory reviews in their countries, highlighting the realisation of one of the key objectives of the initiative, which was building the expert capacity of member countries. Other agencies in the SADC region and beyond can use the results of this study to identify best practices, which in turn, could improve their regulatory performance.

South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access

Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to the timelines historically achieved by the Medicines Control Council (MCC). This study also aimed to evaluate the regulatory review processes and the good review practices that have been implemented by SAHPRA to support the assessment of new chemical entities and generic product applications for market authorization in the business-as-usual and backlog process streams.Methods: A questionnaire was completed and verified by SAHPRA to describe the structure of the organization, the resources available, the process for regulatory review of new chemical entities and generic products and the level of implementation of good review practices and regulatory decision-making practices for market authorization. Data were collected and analyzed on the overall approval timelines for new chemical entities and generic products registered by SAHPRA in 2020 in the business-as-usual and backlog process streams.Results: A full, independent scientific review was conducted for all new chemical entities and generic product applications in the business-as-usual stream. Facilitated regulatory pathways were introduced for the review of new chemical entities and generic products in the backlog stream. As a result, the timelines for approval of applications in the backlog stream were 68% quicker for both new chemical entities and generics, using facilitated regulatory pathways, such as abridged and verification review models.Conclusion: The comparisons made through this study provided insight into the improvements that have been made through the establishment of SAHPRA and the transition in 2018 from the MCC. The re-engineered processes that have been developed and implemented by SAHPRA to address the backlog in the review of the applications for market authorization have demonstrated a decrease in the overall median approval times. The expansion of these processes into the routine review of medical products will contribute to the enhanced regulatory performance of SAHPRA and patients’ access to new medicines.

Recent progress of ceramic electrolytes for post Li and Na batteries

Recently, post Li batteries have been intensively researched due to high cost and localization of Li sources, especially for large-scale applications. Concurrently, ceramic electrolytes for post Li batteries also gain much attention to develop all-solid-state post Li batteries. The most intensively researched post Li battery is Na battery because of chemical and electrochemical similarities between Li and Na elements. Many good review papers about Na battery have been published including Na-ion conductive ceramic electrolytes. Contrary, ceramic electrolytes for other post Li batteries like K, Mg, Ca, Zn and Al batteries are hardly summarized. In this review, research on ceramic electrolytes for K, Mg, Ca, Zn and Al batteries is analyzed based on latest papers published since 2019 and suggested future research direction of ceramic electrolytes for post-Li batteries.

Evaluation of the Regulatory Review Process in Zimbabwe: Challenges and Opportunities

Purpose The aims of this study were to assess the current regulatory review process of the Medicines Control Authority of Zimbabwe (MCAZ), identify key milestones and target timelines, evaluate the overall performance from 2017 to 2019, identify good review practices, evaluate the quality of decision-making processes, and identify the challenges and opportunities for improvement. Methods A questionnaire was completed by the MCAZ. The agency has participated in the Optimising Efficiencies in Regulatory Agencies (OpERA) program, a multinational endeavor to characterize assessment procedures and metrics associated with regulatory agencies and regional regulatory initiatives. Data identifying the milestones and overall approval times for all products registered MCAZ from 2017 to 2019 were collected and analyzed. Results The MCAZ conducts a full review of quality, safety, and efficacy data for generics and biosimilars not approved by a reference agency, an abridged review for products approved by a reference agency and a verification review for World Health Organization prequalified products under the collaborative registration procedure. The highest number of reviewed products is generics manufactured by foreign companies. There has been an improvement in review times for all categories of products over the three-year period. Guidelines, standard operating procedures, and review templates are in place and the majority of indicators for good review practices are implemented. Although quality decision-making practices are implemented, there is no formal framework in place. Conclusion The MCAZ successfully implements three types of review models in line with international standards. Overall, target timelines are realistic and what is achievable with the current available resources. Recommendations made such as the review of available human resources, separation of agency and company time when setting and measuring targets, review of the templates and benefit-risk framework used for abridged review, and development of a decision-making framework present opportunities for an enhanced regulatory review process.

Management of Facial Scars

Scar formation is a very complicated process, which is outlined in this chapter. As oral and maxillofacial surgeons we have a duty to produce unsightly scars. Scar management includes prevention, pre-injury treatments during the healing period and definitive treatment once the scar is established. This chapter outlines multiple non-surgical remedies that can be used to manage scars including: steroid, 5 FU, dermabrasion, subcision, fillers, lasers, radiation and emulsified scar rejuvenation. Furthermore, we explain surgical techniques that can be incorporated in the scar management including Z-plasty, W plasty, irregular line closures and V-Y plasty and Y-V plasty. The algorithm at the end of this chapter is used to summarise method or combination of methods that is used to treat different scars including invisible scars, stretched scars, depressed scars, hypertrophic scars and keloid scars. This algorithm provides a good review of all different treatment modalities used in scar management.

Agricultural Mobile Apps used in India: Current Status and Gap Analysis

Background: Agriculture plays a significant role in economic and social development in India. With the rapid development of Information and Communication Technologies, information and data can be effectively generated, stored and used by farmers to improve agricultural productivity. For this, smart farming technologies using mobile applications (apps) that help reduce costs, maximize yields and increase profits are being employed. Here, we present an overview of several mobile apps available for traceability in agricultural sectors, discuss their features, functions and how they are lacking in some domains.Methods: In this study during Aug 2019-Sep 2019, several online databases were used for the survey according to the guidelines for Transparent Reporting of Systematic Reviews and Meta-Analyses. 73 agriculture mobile apps were selected based upon the hits using keywords like “mobile apps, agriculture mobile app, animal husbandry, etc. and with the inclusion criteria of a good review and proper up to date information. These apps were found to be used in different agriculture allied sectors in India.Result: Among these 73 mobile apps used by Indian farmers in various agricultural sectors viz. farm management, fisheries, poultry, livestock and animal husbandry, food traceability and pure agriculture sectors; the respective availability percentage of apps were 12, 14, 14, 23, 23 and 14%. These apps are discussed here in detail along with their gap analysis and a new traceability mechanism has been proposed as well.