Enhanced Role of EMA in EU Crisis Response

The regulation also sets out obligations on marketing authorization holders (MAHs) and medical devices manufacturers, authorized representatives, importers, distributors, and notified bodies duties to: * Provide information that will assist with the monitoring by the MSSG/MDSSG of shortages of medicinal products and devices contained in the critical medicines list and updating this when necessary * Provide a justification for any failure to provide the requested information by the established deadlines * Immediately provide any evidence of an actual or potential shortage of medicinal products or devices * Provide information to EMA by 2 Sep. 2022 that will enable the establishment of a Single Point of Contact (SPOC) network, and the industry Single Point of Contact (iSPOC) network, with mandates to updating this when necessary (7). Enhanced advisory role In addition to the measures designed to address medicinal and medical device shortages, an Emergency Task Force (ETF) will also be established within EMA to provide scientific advice and review evidence on medicines that have the potential to address public health emergencies, offer scientific support to facilitate clinical trials, and support existing EMA committees with their authorization and safety monitoring of medicines (8). According to the document published by EMA on Crisis Preparedness and Management, the key benefits for EMA of having these responsibilities include: * Accelerated evaluation and access to safe and effective medicines which could treat or prevent a disease causing, or likely to cause, a public health emergency * Improved quality of data and the effective use of resources through increased support at EU level towards the conducting of clinical trials in preparation for, and during a public health emergency * Improved coordination and harmonization at EU level in preparation for and during a public health emergency (7).

Revamping Site Feasibility as Trials Become Decentralized

[...]this critical step is receiving the attention it deserves, maybe even an overhaul, as the wave of clinical trial decentralization surges on. With this regulatory foundation, the site feasibility process involves choosing sites that not only conform to these requirements, but can also offer the best fit for specific studies, based on past performance, access to a database of appropriate patients, and the bandwidth to perform the study at hand. A recent article by Kurbegov et al. of the American Society of Cancer Oncology (ASCO) describes a Task Force that was convened to evaluate the burdens and challenges of site feasibility, which often lead to delayed study start-up and act as a barrier to site participation.6 With input from sites, sponsors, and CROs in the form of surveys and in-person meetings, the Task Force developed three recommendations for improvement, with a goal of speeding patient access to clinical trial participation, and ultimately, much needed new treatments, as shown in Table 1 on the facing page. According to Comis, "We now have 146,000 users of SIP, which represents 125,000 site researchers.

Can EMA's Regulatory Science Strategy Meet Medicine's Major Challenges?

[...]the report, which covers both human and veterinary medicines, devotes relatively limited space to ways of using regulatory science to deal with pandemics such as COVID-19, particularly the emergency development and mass-scale manufacture of vaccines. [...]to deal with the outbreak, EMA has implemented its 2018 Health Threat Plan by setting up a COVID-19 EMA Emergency Task Force (ETF), which will assist in the development, authorization, and safety monitoring of therapeutics and vaccines to deal with the pandemic (2). EMA, "Mandate, Objectives, Rules, and Procedure of the COVID-19 EMA Pandemic Task Force (COVID-ETF)," ema.europa. eu (Amsterdam, 31 March 2020).

Business on Hold? EMA's Full Recovery in Question

The EMA pandemic Task Force (COVID-ETF) helps EU member states and the European Commission (EC) to take quick and coordinated regulatory action on COVID-19 treatments and vaccines. Delayed submissions As a result of pressure on the work time of regulators from COVID-19 matters, pharmaceutical companies are thought to be holding back the application for marketing authorizations of their products or approval of variations of marketing authorizations. Regulators are not only worried about having to grapple with a rush of delayed submissions but also the extra burden of implementing new EU legislation in areas like veterinary medicine, medical devices, and personal data protection. A joint HMA/EMA Big Data Task Force recommended in December 2019 that the regulatory network set up a platform for access and analysis of healthcare data from across the EU (5).

2022 CCCC Chair's Letter

Hassel officially started his service as an elected CCCC officer on Dec 23, 2019, but for four years prior to that, he was an ex officio member of the CCCC Executive Committee (EC) by virtue of his role as editor of Teaching English in the Two-Year College. The editors of four of the college-level NCTE publications (TETYC, College Composition and Communication, Forum: Issues about Part-Time and Contingent Faculty, and the Studies in Writing and Rhetoric book series) are invited to attend meetings and participate in deliberations about issues affecting governance of the organization but do not have voting rights. During the nearly five years of service prior to his official elected role, he had many opportunities to observe how CCCC governance works (or doesn't): how committees and task forces are formed, appointed, and charged;how committees are constituted;how decisions are made;how nomination and election processes are conducted for the EC and other elected groups, such as the Nominating Committee. He even served on a subcommittee of the EC: the Subcommittee on Committees that produced the User's Guide to CCCC.

Access to Medicine in Developing Countries: Elevating State Obligations Over Corporate Profit

This paper investigates the divergence between the objectives of the state in ensuring citizens' right to health and the profit-maximization objective of pharmaceutical corporations in relation to, access to, and supply of medicine. This divergence is pertinent given both the rising cost of medicines and unmet needs, particularly in developing countries. This paper analyses the correlation between pharmaceutical corporations' profit drive and the state's welfare obligation. There is a need to bridge the gap between business and human rights, which can be achieved by combining the concepts of "business ethical responsibility" and corporations' contributions to "common good" with the jurisprudence on the right to health. This is imperative in view of the impact of the business of pharmaceutical corporations on vulnerable populations, particularly in, but not limited to, developing countries.

Trinidad and Tobago and money laundering control: a country committed to strengthening the link

PurposeIn 2008, the author wrote on the Concept of "Money Laundering Control: The Missing Link in Trinidad and Tobago. Now, approximately two years after that seminal assessment, the author has re-assessed the domestic anti-money laundering (AML) framework, with particular reference to the controls in place to address money laundering (ML) and the confiscation of the proceeds of crime. This paper aims to assess the efficiency and effectiveness of the newly implemented regime and considers whether it meets international standards.Design/methodology/approachThis analysis embraces a pluralist approach. Within this assessment, a case study method is used with contextual qualitative analysis. Empirical data is analyzed and causal connections are linked to the analysis.FindingsThis research highlights catalytic change and creativity in addressing deficiencies within the AML architecture in Trinidad and Tobago. Upon analysis, it is pellucid that a radically altered criminal justice landscape has emerged and a more aggressive and targeted approach to address ML and the confiscation of the proceeds of crime is apparent. The result is a shift in paradigm with tangible outcomes to suggest that the strategies have borne fruit and that the twin island Republic is indeed committed to strengthening the link.Research limitations/implicationsFindings are limited to Trinidad and Tobago and to the period ended April 2020.Originality/valueAs a country with a medium to high ML risk, the possible negative socio-economic effects of ML cannot be underscored. Disruption of ML and the confiscation of the proceeds of crime are, therefore, imperative. This paper considers the progress made in addressing these pertinent issues and assists in assessing the effects of the reformation efforts undertaken by Trinidad and Tobago.

FROM THE Chair

[...]the commitment of the CJS Council and past chairs, our committee and task force members, the dedication and support of Section staff, and the consistent participation of the CJS membership have all contributed to CJS continued struggle for justice reform. When we consider the worldwide COVID-19 pandemic and its devasting impact on marginalized communities, the similar deleterious and disparate impact of social and criminal legal systems on the poor and black and brown people in this country, the continued demise of unarmed black men and women at the hands of the police, the social unrest and activism that captured the conscience of a nation and the world, and even the politicized debate about the COVID-19 vaccine and climate change, it is clear. [...]the ever-present professional and membership goals: continue serving, supporting, and growing the CJS membership.

Reflections on AORN's Progress During My Presidential Term: The Official Voice of Perioperative Nursing

Our strategic goals were: 1. Invest in and transform AORN membership through new programs and initiatives. 2. Reduce financial reliance on Expo through revenue growth and continued development of products, services, and partnerships. 3. Invest in technology and digital innovations to give our members engaging and innovative online education and networking capabilities. 4. Advance AORN's commitment to diversity, equity, and inclusion (DEI). 5. Ensure financial sustainability to safeguard our organization for the next 70 years.

The Current State of the Role of the Nephrology Registered Nurse in Home Dialysis Therapies and Future Implications

With an increased emphasis on home dialysis therapies (HDTs), and to ensure nephrology nurses have a voice in health policy discussions and decisions, the American Nephrology Nurses Association (ANNA) initiated the Home Dialysis Therapies Task Force. ANNA fully supports the increased utilization of HDTs and wants to ensure every individual has the option of HDT and deserves an RN in their care. Careful consideration must be given to the impact of legislative initiatives aimed at the nursing shortage and increasing the use of HDTs on delivery of safe care and RN practice. The HDT Task Force implemented a Think Tank to explore and delineate the role of nephrology RNs in HDT to ensure a safe and informed transition to HDT for individuals with kidney failure. The mission was to gather and analyze information on the role of the nephrology RN in HDTs, clarify RN-specific tasks versus tasks that may be delegated to support staff, and gather and gain insight into barriers to HDTs.

An expanded role for blood donor emerging pathogens surveillance: CMAJ

From May 2020 (continuing until March 2023), Canadian Blood Services, in partnership with the COVID-19 Immunity Task Force, tested samples from all Canadian provinces (not Quebec and the territories) for SARS-CoV-2 antibodies.2,3 Monthly reports were openly and routinely distributed to provincial and national public health professionals, posted on the COVID-19 Immunity Task Force website (https://www.covid19immunitytaskforce.ca /seroprevalence-in-canada) and used to estimate the population prevalence of SARS-CoV-2 in mathematical models. Canadian Blood Services is undertaking a pilot study to link SARS-CoV-2 seroprevalence data to administrative data from at least 1 province. Canadian Blood Services has a long history of contributing to public health surveillance for vectorborne pathogens such as West Nile virus and Babesia microti, and food-borne illnesses such as hepatitis E.4 We believe it makes sense for blood donor surveillance to take on an expanded role in surveillance for emerging and re-emerging pathogens.

COVID-19 PANDEMIC AND ADMINISTRATION OF CRIMINAL JUSTICE IN NIGERIA: A CALL FOR A BETTER APPLICATION

The world is moving into an uncertain future and one does not need a crystal ball to agree that uncertainty stares the whole world in the face;one only need reference the global pandemic caused by the dreaded corona virus. Famously, for a long time it has been known that when America sneezes the whole world catches a cold, but this time china Coughed and the whole globe was affected. Nigeria was not spared and neither were its security apparatus spared nor the Criminal Justice Administration (CJA) which struggled to cope with the new challenges that surfaced due to the pandemic. In this entire viral hurricane witnessed globally how did the Criminal Justice Administration (CJA) and its attendant legal framework in Nigeria fare? This paper has as its focal point to review said legal framework viz a viz attendant challenges leading to a call for better application of the legal framework to the administration of criminal justice in Nigeria hoping that lessons were learnt from mistakes made.

Global Remittances and COVID-19: Locked Down but Not Locked Out

What happens to remittances, an important feature of the global financial system, when a pandemic strikes? Despite early predictions of significant drops in volumes, flows have been affected less than expected. This commentary explains that this outcome is attributable in part to a renewed focus on the infrastructure of global finance and an accelerated development and use of digital solutions, but that it is mostly a result of the individual efforts and resilience of migrants.

AMA House of Delegates Holds Virtual Annual Meeting

The 2021 Annual Meeting of the AMA House of Delegates (HOD), normally several days in Chicago, was held as a virtual "special" meeting from June 11 through June 16. James Madiera, MD, Executive Director, praised physicians for "standing tall," advocating for physicians and patients and supporting good science and our public health system. Resolutions called for improvements in personal protective equipment, for strengthening public health services, for universal access to public health services for modernization of reporting data systems. On issues ranging from banning "ghost guns" to waiving patent protection for vaccines, the HOD advocated policies of the current Federal administration, even where those policies were only marginally related to medicine and public health.

COVID-19 Pandemic: Impact on Healthcare in Missouri

Most elective and non-essential procedures and in-person visits were deferred in Missouri based on CDC and CMS recommendations in order to preserve PPE, and free up equipment, ORs, hospital beds, ICUs and ventilators for an expected surge of COVID-19 cases (as was seen in Italy and New York City), and to prevent the spread of the virus in the healthcare setting. A trip to the supermarket, hardware store, or gas station may well be riskier than going to the doctors office or an outpatient surgery center, which are much better controlled environments. By having a detailed, written COVID-19 pandemic preparedness plan in place, we have been able to bring back staff who were leery of working during these uncertain times. [...]there is a vaccine or some highly effective treatment, COVID-19 will be with us.

Laundering Coercion: Restart Planning, “Pandemic Task Forces,” and the Dismantling of Shared Governance

In this chapter, we show how an already severely weakened commitment to academic shared governance was further undermined during COVID-19 through the workings of “pandemic task forces” established on campuses around the country that often served as vehicles to carry management agendas under the guise of “faculty consultation.” We examine a disturbing set of illustrations of both the implicit and also explicit allocation of COVID response team authority to campus executives in student affairs and athletics, as opposed to faculty-supported leaders in academic affairs. We explore the various manifestations of these exercises in the manufacture of consent, including those that are entangled with local and state officials. We discuss the consequences for faculty power, control over curriculum, and the conditions of teaching and learning. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

Tuberculosis: Common Questions and Answers

Approximately 10 million people worldwide were infected with tuberculosis (TB) in 2019, resulting in 1.4 million deaths. In the United States that same year, there were nearly 9,000 reported cases of TB disease and up to 13 million people were living with latent TB infection (LTBI), which is an asymptomatic, noncommunicable infection caused by Mycobacterium tuberculosis. Without treatment, LTBI will progress to active TB disease in approximately 5% to 10% of affected people. Individuals with symptoms of TB disease warrant testing. The U.S. Preventive Services Task Force recommends testing individuals at increased risk of LTBI with an interferon-gamma release assay or tuberculin skin testing. Because the incidence of LTBI in health care professionals is similar to that of the general population, periodic retesting is not recommended. After a positive test result, chest radiography should be performed and, in patients with suspected pulmonary TB disease, sputum collected for diagnosis. Both suspected and confirmed cases of LTBI and TB disease must be reported to local or state health departments. Preferred treatment regimens for LTBI include isoniazid in combination with rifapentine or rifampin, or rifampin alone for a duration of three and four months, respectively. Treatment of drug-susceptible TB disease includes an eight-week intensive phase with four drugs (isoniazid, rifampin, pyrazinamide, and ethambutol), followed by a continuation phase lasting 18 weeks or more, with two drugs based on susceptibility testing results. Consultation with a TB expert is necessary if there is suspicion or confirmation of drug-resistant TB. (Am Fam Physician. 2022;106(3):308–315. Copyright © 2022 American Academy of Family Physicians.)

Science, Rulemaking, and COVID-19 in the Philippines : Evaluating the Scientific Basis of the Motorcycle Pillion Shield Regulation

This article evaluates the Philippine government’s science-based response to the COVID-19 pandemic, particularly in the field of administrative rulemaking. Specifically, it evaluates the effectiveness of the Motorcycle Pillion Shield Regulation (MPSR) to implement social distancing and prevent COVID-19 infections in motorcycle back-riding. Applying Max Weber’s view on the necessity of scientific expertise in rulemaking, and using government and media reports, the article analyzes the scientific foundation of the MPSR rulemaking by the Philippine Inter-agency Task Force on Emerging Infectious Disease (IATF-EID) and National Task Force (NTF), the country’s top task forces against COVID-19. It argues that a truly science-based approach to rulemaking must be based on sound scientific evidence and consultation with scientists, experts, interest groups, and motorcycle riding public, before crafting and implementing a regulation. Results showed that use of shield in motorcycle back-riding can cause the spread of the virus instead of preventing it, especially in motorcycle taxis. The use of common helmet and the inevitable physical contact between the driver and the back-rider may cause infection if one rider is positive, as scientific studies indicate that touching contaminated surfaces can cause a transmission. It is also an added expense, unsafe, and prone to accident as the shield obstructs the motorcycle’s aerodynamics and balance. Lastly, no comprehensive scientific study and consultations with experts and riders before the MPSR was crafted and implemented by the NTF. Ultimately, this article contends that the government’s claim to a science-based strategy against COVID-19 can remain elusive if it fails to address the country’s lack of a reliable scientific advisory group and if it fails to amend the new Philippine Administrative Code to require regulators to strictly follow sound science in rulemaking.

Enforcing Double Materiality in Global Sustainability Reporting for Developing Economies: Reflection on Ghana’s Oil Exploration and Mining Sectors

While the development of globally accepted sustainability reporting standards initiated by the IFRS Foundation has largely engaged stakeholders in developed economies, the stakes for developing economies could be compromised without an explicit consideration of their sustainability issues within this standard-setting framework. This paper examines the need to develop global sustainability reporting standards based on the principle of double materiality to warrant that both the target towards carbon net-zero by 2050 under the Paris Agreement and the subsequent promise to accelerate under COP26 are achieved with efficacy. Adopting a multiple-case study approach, this paper reveals the limitations of existing sustainability reporting in the absence of double materiality in a developing economy. Specifically, the analyses reveal limited climate-related disclosures among selected cases in Ghana. Available disclosures connote increasing GHG emissions over the period under consideration. This study also shows weak disclosure comparability across the companies following similar reporting standards. Overall, it argues that enforcement of double materiality to embrace sustainability issues impacting both developed and developing economies is necessary for an effective transformation towards a low-carbon global economy. It contributes to the existing body of knowledge by elucidating double materiality as a pertinent interdisciplinary concept and devising a holistic framework for the emerging global sustainability reporting system to underscore governance accountability for external costs to the environment. Global sustainability reporting standards with a myopic focus on conventional financial matters in the absence of double materiality remain a disclosure system with implausible impact on climate change.