Provisional Registration Research Articles

Psychometric properties of the multifactor leadership questionnaire when used in early-career pharmacists with provisional registration

BackgroundThe Multifactor Leadership Questionnaire (MLQ) is a validated instrument used to explore participants' perceptions of leadership and the Outcomes of leadership, participants' evaluation of and satisfaction with leadership and willingness to put in extra effort. The factor structure of MLQ varies across studies. The aim was to explore the psychometric properties of the MLQ for early-career pharmacists rating their preceptor's leadership. MethodsThe MLQ was administered to provisionally registered pharmacists during the final half of their 1 year of supervised practice. Confirmatory and Exploratory Factor Analysis (CFA & EFA) and Structural Equation Modeling (SEM) were used to analyse the data. ResultsResponses were obtained from 430 participants (25 % of all Australian pre-registration pharmacists at the time). CFA demonstrated that the original 9-factor model and a range of previously published models were poor fit for the data. EFA revealed that a good fit was a model with 4 factors named: Passive laissez-faire, Strategic visionary, Personalized, and Active management by exception. Passive laissez-faire and Active management by exception were consistent with previously published models. The Strategic visionary and Personalized factors were interpreted as 2 forms of transformational leadership that includes the provision of rewards depending on performance. A SEM of MLQ sub-scales predicting Outcomes of leadership explained 90.3 % of variance. Personalized leadership was highly predictive (β = 0.743, P < 0.001) while the three other factors had negligible effects. ConclusionThe psychometric analyses demonstrated overlap of the original 9-factors. A more parsimonious 4-factor model fit the data well.

Provisional registration ‘would require a stronger supervision plan'

Provisional registration ‘would require a stronger supervision plan'

무효등기유용의 효력 - 대전지방법원 2016. 12. 13. 선고 2016나105785 판결(대법원 2022. 7. 28. 선고 2017다204629 판결의 원심판결), 대법원 2009. 5. 28. 선고 2009다4787 판결 -

Traditional precedents and the prevailing view hold that regarding the usefulness of invalid registrations, if there is a third party with an interest in the registration before the agreement on its usefulness, the agreement is not effective in relation to that third party, and within that scope, the registration made useful is considered invalid as it does not correspond to the actual legal relationships.&#x0D; The decisions in question judged that in cases where a provisional registration, which is invalid, has been utilized to complete a final registration or a provisional transfer registration, (a) the utilization of the registration cannot be claimed against a third party with an interest in the registration, such as a provisional seizure creditor, but (b) among the parties to the agreement of utilization, the validity of the utilization agreement and the registration made useful can still be claimed. However, in the situations addressed by these decisions, the provisional seizure creditor, who is a third party with an interest in the registration, can only request the cancellation of such provisional registrations on behalf of the debtor (one of the parties to the utilization agreement) and therefore, cannot claim the invalidity of the utilization agreement and the registration made useful against the parties to the invalid registration utilization who cannot oppose them.&#x0D; However, the conclusion of (b) is incorrect, and therefore, the conclusions of the decisions in question cannot be considered correct. That is, the conclusion that in the presence of a third party with an interest in the registration, the agreement of utilization and the registration made useful are invalid only in relation to that third party, and the validity of the utilization agreement and the registration made useful can still be claimed among the parties to the utilization is not acceptable as it acknowledges the relative effect of real rights. When there is a third party with an interest in the registration, the utilization of an invalid registration should not be recognized. It is not that the validity of the agreement of utilization and the useful registration “cannot be claimed only against the third party with an interest in the registration” and “within that scope,” but rather, “in cases where there is a third party with an interest in the registration,” the agreement of utilization and the useful registration, not corresponding to the actual legal relationships, should be considered “invalid against everyone.” Here, “everyone” includes the parties to the agreement of utilization (the counterpart).

생부의 친생부인권과 임시출생신고에 관한 입법론

In this article, the author proposes legislation that would recognize the biological father’s right to deny paternity for a child born within wedlock, and allow the biological father to seek a provisional birth registration for such a child. The main points of the proposed legislation can be summarized as follows:&#x0D; On the biological father’s rights to deny paternity:&#x0D; 1. Ⓐ Within 2 years from the date of the child’s birth, or Ⓑ within 1 year from the date the plaintiff discovers that he is the biological father, provided there is no social parenthood between the legal father and the child, and if the adult child consents to the denial themselves, the biological father may file for the denial of paternity against the legal father and the child/the mother with parental authority.&#x0D; 2. Although the above requirements are met, the court may dismiss the biological father’s request for denial of paternity if such denial significantly harms or is likely to harm the welfare of the child.&#x0D; 3. Any person who files for denial of paternity while aware that he is not the biological father will be subject to criminal punishment.&#x0D; On the provisional birth registration by biological father of the child:&#x0D; 1. The biological father who has already filed for denial of paternity may apply for a provisional birth registration listing himself as the father of the registered child, by attaching test results conducted through scientific methods proving that he is the biological father.&#x0D; 2. A provisional birth registration has the same effect as a formal one, except for matters regarding the child's legal father. Even if a provisional birth registration is made listing himself as the father of the registered child, the child’s legal father remains the mother’s husband until the court’s judgment denying the presumed paternity of the husband, and confirming the biological father's acknowledgment of his paternity is finalized.&#x0D; 3. Upon finalization of the judgment in the lawsuit filed by the biological father for denying paternity, or termination of the legal proceedings for other reasons, the legal father and mother responsible for the birth registration, and the biological father who applied for the provisional birth registration are obligated to correct the provisional birth registration in accordance with the final judgment or parental law.

PP30 The Fast Track In Drug Registration By ANVISA – Brazil And Possible Consequences

IntroductionThe fast track in drug registration by the Brazilian Health Regulatory Agency, ANVISA, began in 2017 and is intended to prioritize analysis related to drugs relevant to public health. This process is appropriate in situations where there are no therapeutic alternative available or for technologies show significant improvement in safety, efficacy, or adherence to treatment.MethodsThe Brazilian public administration has a tool for accessing information called Transparency Portal. Thus, data on the number of drugs approved by fast track between 2018 and 2021 were requested through this tool and evaluated.ResultsThe data received by the Brazilian transparency portal shows that the number of requests for fast track had an increase from one in 2018 to 32 in 2021. There is an important increase of registrations, being drugs with phase II trials and with single-arm clinical trials. With registration based on a phase II trial, these patients are in fact receiving drugs in a context similar to clinical trials, but with funding from the healthcare system. Given that phase II studies are conducted in a limited population, there has been an increase in the registration of drugs with suboptimal efficacy and safety concerns. This scenario of uncertainty leads to non-adherence to treatment and a discrepancy in real-world outcomes in comparison to the clinical trial. About 70 percent of phase II trials, show no benefit, and only 30 percent proceed to later phases. It is noteworthy that about 50 percent of the studies that move on to later phases fail to show benefits. Nowadays the number of drugs approved by the fast track has increased, many probably with phase II studies and no comparator group.ConclusionsGiven the uncertainties in the efficacy and safety of a drug registered via fast track, often based on phase II studies, implementing provisional registration with real-world evaluation of outcomes, and coupled with financing based on risk-sharing agreements, may be a sustainable alternative for health systems.

Assessing the impact of fast-track drug registration by Anvisa in Brazil: A descriptive study of new drug registrations from 2017 to 2022

Prompt release of novel pharmaceuticals is very much sought after during critical circumstances to aid patients and society in need. Nonetheless, the expeditious availability of these medications may jeopardize the well-structured investigations and observations. To tackle this concern, regulatory agencies globally have implemented expedited registration procedures. In Brazil, the National Health Surveillance Agency (Anvisa) has likewise implemented an expedited registration process to cater to patients who cannot afford to wait. The objective of this study is to evaluate the impact of Anvisa&amp;rsquo;s accelerated drug registration on the challenging regulatory environment in Brazil. Data pertaining to medications registered by Anvisa from 2017 to 2022 through the expedited process were procured from the Federal Government&amp;rsquo;s transparency portal and the medication consultation portal. The registration of novel drugs by Anvisa through both standard and expedited processes during this timeframe was analyzed. The introduction of the accelerated registration regulation by Anvisa in 2017 led to a substantial rise in registration requests utilizing this regulatory modality. Furthermore, the data concerning drug registration through all channels unveiled a noteworthy reduction in average response time. Despite concerns pertaining to the effectiveness and safety of drugs registered through the expedited process, often reliant on Phase II studies, the utilization of this process is on the rise worldwide, including in Brazil. To ensure the sustainability of health-care systems, it may be advantageous to implement provisional registration in conjunction with subsequent evaluation through real-world studies and financing based on risk-sharing agreements. In conclusion, the accelerated drug registration process implemented by Anvisa in Brazil has exhibited promising results in terms of reduced response times. Nevertheless, the effectiveness and safety of drugs registered through this process necessitate meticulous evaluation. The implementation of provisional registration and the integration of real-world studies, alongside managed entry agreements, could offer a sustainable alternative for health-care systems.

Acquisitive prescription for self-owned real property acquired by rehash of the invalid provisional registration and the status of a third party with an interest in the registration- Korea Supreme Court Decision 2017Da204629 Decided July 28, 2022 -

Acquisitive prescription for self-owned real property acquired by rehash of the invalid provisional registration and the status of a third party with an interest in the registration- Korea Supreme Court Decision 2017Da204629 Decided July 28, 2022 -

Glyphosate and human health

At this time of environmental crisis, pesticides represent a major threat to the environment and to human health alike. The widely used herbicide glyphosate is suspected of acting as a mutagen, a carcinogen as well as a neurotoxic substance for the professionals who use it. This possibly also holds true for the population at large. Despite increasing warnings from the independent scientific community, this product was granted provisional registration for Europe in 2017, and the decision has been postponed to 2022 with a report on the decision by that date. In fact, EU and US public authorities - who in theory are guarantors of public health - seem to put up with biased expert committees, falsification of science and attacks against a WHO health protection agency, as they keep relying on administrative pseudo-science as a basis for their decisions.

Approach to Study the Efficacy and Safety of New Complementary and Alternative Medicine Formulations: Lesson during COVID-19 from Sri Lanka.

COVID-19 affected Sri Lanka from early 2020, a time of considerable ignorance accompanied by wide media coverage of a devastating epidemic in Italy and Europe. Many were attracted to complementary and alternative medicine (CAM) or traditional medicine (TM) in this desperate situation. Several preparations were claimed to be effective against COVID-19 globally. Dammika Bandara Syrup© was one such preparation promoted for preventing and treating SARS-CoV-2 infection. It was based on bees' honey, pericarp and mace of Myristica fragrans (nutmeg), the seed of Foeniculum vulgare and fresh rhizome of Zingiber officinale, all believed to have anti-viral properties. Following an unpublished clinical study claiming efficacy, Dammika Bandara Syrup© gained wide media publicity and political patronage. The producer claimed of Goddess Kali revealing the formula added an anthropological, cultural, and religious complexity to the issue. The demand for the product increased rapidly as a debate raged both in public and in the parliament on utilizing such products in combating COVID-19. The Department of Ayurveda, which is statutorily responsible for regulating CAM/TM had to respond to the situation. The legislation to regulate such indigenous medicinal products was weak, and the crisis deepened as thousands converged to the production facility, defying mobility restrictions introduced to control COVID-19. This led to the Ministry of Health requesting academics to form a team and conduct a clinical trial to prove its efficacy. This paper outlines the process and issues faced during the regulatory approval for the trial in a polarized political environment. Some health professionals accused the researchers of bowing to political pressure and questioned the scientific justification for the trial. However, the team considered this as an opportunity to streamline a path for research into CAM/TM therapies in situations such as COVID-19. Several processes were identified and addressed, such as the provisional registration of CAM preparations, assessing the potential efficacy of a CAM product, confirmation of authenticity and safety, standardization and supervision of production respecting cultural identities, obtaining approval for human use, choice of comparators, and ethical issues. We believe the study has helped set standards and a benchmark for CAM and TM research in Sri Lanka.

COMPARATIVE ANALYSIS OF REGULATORY FRAMEWORK OF PHYSIOTHERAPY IN INDIA WITH THAT OF AUSTRALIAAND NEW ZEALAND

The study aims at studying the Regulatory framework of Physiotherapy in India (NCAHP) as compared to Australia (HPRNL) and New Zealand (HPCAA). The study highlights the similarities and differences in the regulations of the two countries with India (NCAHP) with respect to 1) registrations of professionals and 2) Practice Standards for the profession and come up with recommendations that may be incorporated in future amendments in the NCAHP. The research methodology used is Rapid Appraisal literature review. On comparative analysis it is found that the Provisions on General, Provisional, Specialty, Limited and student Registration, scope of practice, Fitness to practice and Health and Competence Performance are not observed in NCAHP and are key requirements to ensure that health professionals are competent and t to practice their professions and hence come out as key recommendations for inclusions in the future amendments of NCAHP

Casirivimab/Imdevimab: First Approval.

Casirivimab/imdevimab (Ronapreve™; REGEN-COV™) is a co-packaged combination of two neutralizing immunoglobulin gamma 1 (IgG1) human monoclonal antibodies (casirivimab and imdevimab) against the spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19). Casirivimab/imdevimab received its first emergency use authorization for the treatment of COVID-19 in November 2020 in the USA, with similar authorizations subsequently granted in various other countries, including India, Canada, and Switzerland. In February 2021, casirivimab/imdevimab was granted a positive scientific opinion in the EU for the treatment of COVID-19. In July 2021, casirivimab/imdevimab received its first approval in Japan for the treatment of mild or moderate COVID-19, followed in August 2021 by its conditional approval for the prophylaxis and treatment of acute COVID-19 infection in the UK. The combination was also granted provisional determination in Australia in August 2021, indicating its eligibility to be considered for provisional registration for COVID-19 treatment and prevention. This article summarizes the milestones in the development of casirivimab/imdevimab leading to these first approvals for COVID-19.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40265-021-01620-z.

A Legal Cause at the Transfer Security

양도담보는 소유권 이전의 방식에 의하여 채권을 담보하는 제도이다. 양도담보에서 채무자는 금전채권의 담보를 목적으로 채권자에게 소유권을 이전하는데, 이때 문제가 되는 것은 ‘소유권 이전’의 법적 원인을 무엇으로 볼 것인가이다. 소유권의 이전은 대표적인 출연행위로서, 모든 출연행위는 법적 원인을 필요로 하고, 이것에 의해서 출연이 정당화된다. 양도담보는 채권담보라는 경제적 목적을 넘어서서 ‘소유권’이라는 법적 권능을 채권자에게 이전한다. 이러한 경제적 목적과 법적 형식 사이의 괴리 때문에 이것이 허위표시로서 무효가 아닌가라는 의심이 제기된 적도 있다. 이에 대해 독일에서는 이를 신탁행위이론으로 설명하는 견해가 제시되었다. 이는 우리의 학설과 판례에도 영향을 미쳐 양도담보를 ‘신탁적 소유권 이전’으로 보는 것이 판례와 다수설이었다. 그러나 가등기담보 등에 관한 법률이 제정되면서 신탁행위이론을 통해 해결해 왔던 양도담보의 원인문제에 대해 새로운 상황이 생겼다. 가등기담보법에서 채권자에게 인정하는 권리를 담보권으로 보는 견해가 현재 다수를 이루고 있다. 그러나 담보권으로 보는 경우에는 물권법정주의와 충돌을 일으키므로 타당하지 않다. 그리고 신탁행위이론에 의하더라도 가등기담보법은 충분히 설명가능하고, 이렇게 보는 것이 물권법정주의 및 당사자의사에도 부합할 것이다. 가령 판례가 인정하고 있는 ‘담보목적에 의한 제한’, 혹은 ‘종국적, 확정적이지 않은 소유권 이전’은 채무자와 채권자 사이의 채권적 관계로 해결하면 족하다. 그리고 악의의 제3자가 소유권을 상실하는 것은 가등기담보법에 의해 강행성이 인정되는 ‘정산절차의 합의내용’이 소유권 이전의 법적 원인인 담보약속에 영향을 미쳐서 생긴 효과로 보면 될 것이다.A Transfer security is the security of bonds by means of transfer of ownership. In transfer security, the debtor transfers ownership to the creditor for the purpose of collateralizing the monetary claim. At this point, the question is what to consider the legal cause of the ‘transfer of ownership’. A transfer of ownership is a typical act of contribution, and every act of contribution requires a legal cause, thereby justifying the contribution. A transfer security goes beyond the economic purpose of security for bonds and transfers the legal power of “ownership” to the creditor. Due to the discrepancy between the economic purpose and the legal form, doubts have been raised that this is invalid as a false statement. In Germany, a view was proposed to explain this as a theory of trust transfer of ownership. This had an impact on our theories and precedents, and there were many precedents and theories that viewed transfer security as a trust transfer of ownership . However, as the Provisional Registration Security Act was enacted, a new situation arose regarding the legal cause of transfer security, which had been solved through a trust theory. Currently, the majority view that the right granted to creditors in the Provisional Registration Security Act is a security right. However, in the case of a security right, it is not valid because it conflicts with the numerus clausus of property rights. And even according to a trust theory, the Provisional Registration Security Act is sufficiently explanatory, and this view would also be consistent with the numerus clausus of property rights and the intention of the parties. For example, ‘restriction by the purpose of security’ or ‘indefinitive transfer of ownership’ recognized by precedents is sufficient to resolve with the obligatory relationship between the debtor and the creditor. And the loss of ownership by a malicious third party can be seen as the result of the agreement of adjustment procedure enforced by the Provisional Registration Security Act affecting the promise of security, the legal cause of transfer of ownership.

Altered trunk and lower extremity movement coordination after neuromuscular training with and without external focus instruction: a randomized controlled trial

BackgroundThis study sought to determine the effects of a 6-week neuromuscular training (NMT) and NMT plus external focus (NMT plus EF) programs on trunk and lower extremity inter-segmental movement coordination in active individuals at risk of injury.MethodsForty-six active male athletes (controls = 15, NMT = 16, NMT plus EF = 15) participated (age = 23.26 ± 2.31 years) in this controlled, laboratory study. Three-dimensional kinematics were collected during a drop vertical jump (DVJ). A continuous relative phase (CRP) analysis quantified inter-segmental coordination of the: (1) thigh (flexion/extension)—shank (flexion/extension), (2) thigh (abduction/adduction)—shank (flexion/extension), (3) thigh (abduction/adduction)—trunk (flexion/extension), and (4) trunk (flexion/extension)—pelvis (posterior tilt/anterior tilt). Analysis of covariance compared biomechanical data between groups.ResultsAfter 6 weeks, inter-segmental coordination patterns were significantly different between the NMT and NMT plus EF groups (p < 0.05). No significant differences were observed in CRP for trunk-pelvis coupling comparing between NMT and NMT plus EF groups (p = 0.134), while significant differences were observed CRP angle of the thigh-shank, thigh-trunk couplings (p < 0.05).ConclusionsTrunk and lower extremity movement coordination were more in-phase during DVJ in the NMT plus EF compared to NMT in active individuals at risk of anterior cruciate ligament injury.Trial registration: The protocol was prospectively registered at UMIN_RCT website with ID number: UMIN000035050, Date of provisional registration 2018/11/27.

The Case that the Titleholder of a Provisional Registration according to a Fictitious Declaration of Intention in Collusion Arbitrarily Completed a Main Registration and the Third Party in Article 108 Subparagraph 2 of the Civil Act

The Case that the Titleholder of a Provisional Registration according to a Fictitious Declaration of Intention in Collusion Arbitrarily Completed a Main Registration and the Third Party in Article 108 Subparagraph 2 of the Civil Act

Provisional register extended until January 2022

Provisional registration will be extended until January 2022, the General Pharmaceutical Council (GPhC) has announced. The register, which was originally due to close in July 2021, will be extended to allow preregistration trainees from the 2020–2021 cohort to apply to join the provisional register, subject to completion of their training. In a statement published on 12 […]

무효인 가등기의 유용에 있어서 제3자의 지위 - 본등기에 따라 촉탁으로 말소된 경매기입등기의 회복을 중심으로 - (대상판결 : 대법원 2019. 5. 16. 선고 2015다253573 판결)

무효인 가등기의 유용에 있어서 제3자의 지위 - 본등기에 따라 촉탁으로 말소된 경매기입등기의 회복을 중심으로 - (대상판결 : 대법원 2019. 5. 16. 선고 2015다253573 판결)

The impact of online death literacy education on psychology students to have better end‐of‐life conversations

ObjectiveThe role of psychologists is relatively invisible at end‐of‐life (EOL) and lack of training has been cited as one important reason for this. Contrasting the medicalisation of death, a new term Death Literacy references communities regaining knowledge and familiarity with the dying process. The aim of this study is to assess the impact on postgraduate students participating in a voluntary Online Death Literacy Education Module (ODELM).MethodsUsing a mixed methods, quasi‐experimental, repeated measure design, the current research paper measures the self‐reported Death Literacy of 86 post‐graduate psychology students.ResultsThe results found that psychology students' overall Death Literacy increased significantly, in addition, to the specific dimensions of knowledge and comfort in having EOL conversations. Further, exposure to Death Literacy training significantly increased participants' interest in EOL concerns and enhanced their perceptions of its relevance to the role of psychologists. Qualitative findings support a high level of engagement and interest in this sensitive and emotionally challenging topic for students, particularly in having EOL conversations with children.DiscussionThis study shows that online delivery is an effective way to deliver Death Literacy content, particularly for fifth‐year psychology students, who benefited most from gaining professional development hours towards provisional psychologist registration. Case studies and videos stimulated reflections on both the personal and professional dimensions of EOL supporting increased Death Literacy of participants.ConclusionThe strong interest and positive engagement in EOL expressed by emerging psychologists augurs well for their increased involvement in EOL care across the lifespan.

FiY101: A quick guide for newly qualified doctors

Final-year medical students in the UK have been allowed to voluntarily apply for early provisional registration in response to the COVID-19 pandemic, allowing these foundation interim year-1 (FiY1) doctors to assist in service provision in hospitals where resources and staffing may be strained. The authors, as recently qualified foundation year-1 (FY1) doctors, use this article to draw on their own experiences, and those of their colleagues, to provide advice on key topics that may not have been covered, or not covered sufficiently, in medical education, such as prescribing, rotas, wellbeing, and useful apps and websites.

What provisional registration will mean for the pharmacy profession

What provisional registration will mean for the pharmacy profession

Prospective Evaluation of Alternative Donor from Unrelated Volunteer Donor and Cord Blood in Adult Acute Leukemia and Myelodysplastic Syndrome: No Difference between Unrelated Donor and Cord Blood

Prospective Evaluation of Alternative Donor from Unrelated Volunteer Donor and Cord Blood in Adult Acute Leukemia and Myelodysplastic Syndrome: No Difference between Unrelated Donor and Cord Blood