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Good Post-Marketing Study Practice (GPSP) changed in April 2018, allows pharmaceutical companies to use a real-world data for pharmacovigilance activity. On the other hand, it is known that there are 3 major dimensions of pharmacovigilance： “Monitoring, vigilance, and science：building the best evidence” ,“Regulation, industry, and legal system：ensuring public health” and “Medicine, medicines, and uncertainty : doing good to patients” . Therefore, in this article, we consider how the change of GPSP reflects on the 3 features of pharmacovigilance.In general, it is thought that the change of GPSP contributes pharmacovigilance, considering the 3 features of pharmacovigilance. On the other hand, there are some points to improve pharmacovigilance system：1) how a safety question for pharmacovigilance should be addressed, 2) how information of routine pharmacovigilance should contribute to a safety question to be addressed, 3) how a feasibility assessment (assessment of data source before conducting a formal comparative activity) should be conducted, and 4) a necessity of a variety of methodology and data sources such as descriptive studies and disease registry. These improvements will contribute to global standardization and give us global competence.Overall, it is very difficult to consider the best safety question, data source and methodology from many options. However, it is thought that keep considering them in order to accumulate experiences is important for our ultimate goal, which is to help our patients. We expect more discussions among all the stakeholders together.
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Objective To summarize the clinical experience and effect analysis of liver transplantation from donation after citizen’s death. Methods Clinical data of 76 donors and 78 recipients of liver transplantation from donation after citizen’s death completed in Liver Transplantation Center of West China Hospital,Sichuan University from March 2012 to November 2015 were analyzed retrospectively.The functional recovery of early allografts in liver transplant recipients was observed and the risk factors causing early allograft dysfunction (EAD)were analyzed.In addition,long﹣term survival of allografts and recipient as well as complications was observed. Results The incidence of postoperative EAD was 36%(28 /78)in 78 recipients.High total bilirubin (TB)and long cold ischemia time constituted the risk factors of EAD. Survival rate of the recipients was 92% (72 /78)during perioperation,and 6 cases died,of which 4 cases died of primary graft dysfunction,1 case of upper gastrointestinal hemorrhage and 1 case of pulmonary infection.Postoperative abdominal infection occurred in 5 cases,with biliary stricture in 3 cases and vascular thrombosis in 2 cases.One case died,and the rest were improved after corresponding treatment.The 1﹣year survival rate of the recipients was 84.2% and 2﹣year survival rate was 80% after operation. Conclusions Liver transplantation from donation after citizen’s death realizes favorable short and long﹣term effects,which can be regarded as a good source of donor livers.Important measures such as controlling the preoperative quality of donor liver and shortening the cold ischemia time can improve the clinical effect.
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O artigo objetiva investigar como está sendo realizado o estudo na contemporaneidade. Segue dois caminhos. Inicialmente opera uma inflexão no campo dos estudos sobre o estudo. Ao invés de conceber o estudo como entidade objetiva e naturalizada propõe, com a ajuda das abordagens construtivistas da cognição, como as de J. Piaget, L.Vigotski, F. Varela e H. Maturana e dos trabalhos de M. Foucault e R. Chartier, analisar o problema a partir da noção de práticas de estudo. O estudo passa a ser resultado das ações concretas dos estudantes, deixando de ser concebido como atividade mental supostamente invariante, voltada para aquisição de um saber. Em seguida, apresenta e discute uma pesquisa de campo, na qual foram entrevistados 15 estudantes de Psicologia do primeiro ao nono período de quatro instituições de ensino superior do município do Rio de Janeiro, sendo duas públicas e duas privadas. As entrevistas seguiram a técnica da entrevista de explicitação. A conclusão aponta para a importância do uso do computador-internet nas práticas de estudo contemporâneas e analisa alguns de seus efeitos, como a grande quantidade de informação, o estudo em circulação, a fragmentação e composição de partes e a coexistência do estudo com o texto digital e impresso...
This paper aims at investigating how study is being accomplished in contemporaneity. It follows two main paths: Initially, it operates an inflection in the study field of studies. Instead of conceiving study as an objective and naturalized entity, it proposes to analyze the issue from notions of practices of study, with the support of constructivist approaches of cognition such as those by J. Piaget, L.Vygotski, F. Varela and H. Maturana, as well as the work of M. Foucault and R. Chartier. The study becomes the result of concrete actions of students, instead of being conceived as an allegedly invariant mental activity aiming at knowledge acquisition. Secondly, it presents and discusses a field research in which fifteen psychology students were interviewed. The interviewees belong to four different institutions from the city of Rio de Janeiro, two public and two private, where they were between the 1st and 9th semesters. Interviews were carried out following the explanation technique. The conclusion points out the importance of the use of internet-computer in contemporary study practices, and analyzes some of its effects, such as the great amount of information, the study in circulation, the fragmentation and composition of parts, and the coexistence of study with the digital and printed texts...
El artículo tiene el objetivo de investigar cómo se realiza el estudio en el mundo contemporáneo. Toma dos caminos: De inicio realiza una inflexión en el campo de los estudios sobre el estudio. En vez de entender el estudio como una entidad objetiva y natural propone, con ayuda de abordajes constructivistas de la cognición como los de J. Piaget, L. Vygotski, F. Varela y H. Maturana, y de los trabajos de M. Foucault, R. Chartier, analizar el problema partiendo del concepto de prácticas de estudio. El estudio empieza a ser entendido como resultado de las acciones concretas de los estudiantes, dejando de ser comprendido como actividad mental supuestamente invariable, orientada para obtener un saber. Después presenta y discute una investigación de campo, en la que se entrevistaron a 15 estudiantes de psicología del 1º al 9º período de cuatro universidades de la capital de Río de Janeiro, siendo dos públicas y dos privadas. Las entrevistas siguieron la técnica de entrevista de explicitación. La conclusión indica la importancia del uso del ordenador-internet en prácticas de estudio contemporáneas y analiza algunos de sus efectos: la gran cantidad de informaciones, el estudio en circulación, la fragmentación y composición de partes y la coexistencia del estudio con el texto digital e impreso...
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Humans , Male , Female , Young Adult , Knowledge Bases , Psychology , Students , Technology , Electronic Data Processing , Diagnosis, Computer-Assisted , Therapy, Computer-AssistedABSTRACT
The reform of regulation is proposed to implement the Pharmacovigilance Planning (PVP) based on the ICH E2E guidelines as indicated in the notification of Risk Management Plan (J-RMP). Even after the J-RMP is enforced, the pharmacovigilance method still heavily depends on the traditional methods like “drug use results surveys”. The “Good Post-marketing Study Practice (GPSP)” ordinance and related notifications are the root causes of the malfunctioned operation of the system. Specifically, 1) the GPSP ordinance does not encourage the investigations according to the ICH E2E notification and 2) it is believed that the pharmacovigilance method should be limited to one of the three options only, namely, “drug use results surveys”, “specific use surveys” and “post-marketing clinical studies”. The followings are proposed: <br>• The GPSP ordinance should be revised to encourage referring the annex “pharmacovigilance methods” in “Pharmacovigilance planning”.<br>• The use of the early post-marketing phase vigilance (EPPV) should be restricted to the drugs marketed at the same time in the world or marketed for the first time in Japan.<br>• The notification connecting the “Good Vigilance Practice (GVP)” and GPSP ordinances (March 11, 2013, No 0311-7) should be revised to include a prescription that the “Safety Control Manager encourage the Post-marketing Surveillance Control Manager to develop a pharmacovigilance plan according to the ICH-E2E guidelines”.<br>• Forms attached to the individual RMP submissions should be revised according to the J-RMP notification.<br>• The notification on the RMP development (No.0426-1 and No.0426-2, on April 26, 2012) should be revised to indicate that the study design is acceptable to the health professionals.<br>• It should be clarified that the additional pharmacovigilance activities may be conducted by the divisional cooperation in the world or may be conducted as a non-clinical study, if appropriate.
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Introduction: An assortment of learning styles is adopted by medical students. Some like to learn by seeing, some by hearing and some by demonstration. Understanding their preferred learning styles as visual, auditory, read-write or kinesthetic learners will help improve the teaching methods adopted. Objective and Goal: role of the educator necessitates making the most of each teaching opportunity by understanding the characteristics of the learning audience and incorporating demonstrated principles of adult educational design, with a focus on collaborative learning and variety in presentation techniques. The goal is to provide student oriented education, producing efficient doctors. Design and participants: A cross-sectional study among 214 medical students of the AIMST University, conducted in 2008. Main outcome measures were: 1. Learning style {visual (V), auditory (A), readwrite( R), kinesthetic (K)} 2. Preferred study practice (alone, in pairs or in groups). Results and Discussion: Preference for different learning styles were, visual (V) 9%, auditory (A) 28%, reading/writing (R) 38% and kinesthetic (K) 35%. 51.4 % of the total 214 students preferred a single mode of information presentation (either V, A, R, or K). Of the 104 students (48.6 % of the total 214 ) who preferred multiple modes of information presentation, some preferred two modes (bimodal, 25%), some preferred three modes (tri-modal, 12%), and some preferred four modes (quadri-modal, 67%). Practical implications: With growing interest in learning styles, an awareness of students’ preferences will be of particular value in designing course delivery strategies which combine an appropriate mix of lectures, Problem based learning (PBL) sessions and practical hours. Originality/value: Multiplicity exists in the learning styles of students and the accomplishment of teaching goals is based on the ability to understand the complexity and to use the knowledge of these differences to balance these disparities among the students in a class.