3rd Colombian educational workshop on regulatory assessment of biosimilars 2019 – Report

2020 ◽  
Vol 9 (3) ◽  
pp. 132-144
Author(s):  
John-Joseph Borg ◽  
Yolanda Elias Gramajo ◽  
Andrea Laslop ◽  
Robin Thorpe ◽  
Jian Wang
Keyword(s):  
Best Practice ◽  
Panel Discussion ◽  
Access To Medicines ◽  
Current Status ◽  
Regulatory Guidelines ◽  
The Us ◽  
Regulatory Assessment ◽  
Educational Workshop

Introduction: Biosimilars have the potential to improve access to medicines for many across the globe. However, work is required to ensure adequate regulation, pharmacovigilance and education about biosimilars. Colombia implemented biosimilars regulation in 2017 and a 3rd Colombian Educational Workshop was organized by GaBI and the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in 2019 to follow up on progress and provide a forum for further discussion. Methods: The 3rd Colombian Educational Workshop on Regulatory Assessment was held in Bogotá, Colombia on 30 April 2019. The format included expert speaker presentations, a panel discussion, Q&A sessions and case study workgroup discussions. Participants included regulators, clinicians, pharmacists, academics and healthcare professionals from Colombia who are involved in biological/ biosimilar medicines evaluation, and expert speakers from Canada, Europe and the US. Results: Presentations and topics of discussion included the current status of biosimilars regulation in Colombia, how to carry out a quality assessment of a biological/biosimilar, pharmacological and clinical studies, and extrapolation of indications. Conclusion: The meeting helped to clarify many regulatory concepts and concerns, and highlighted Colombia’s initial successes since the implementation of its regulatory guidelines. In addition, the meeting acted as a forum to exchange knowledge on best practice, and to discuss pharmacovigilance and the future plans for education regarding biosimilars in Colombia. Several key action points were concluded following the discussions.

scholarly journals Distilling and Applying Criteria for Best Practice EIA Follow-Up

2019 ◽  
Vol 21 (02) ◽  
pp. 1950008 ◽  
Author(s):  
Elise Pinto ◽  
Angus Morrison-Saunders ◽  
Alan Bond ◽  
Jenny Pope ◽  
Francois Retief
Keyword(s):  
Impact Assessment ◽  
Best Practice ◽  
International Association ◽  
Management Communication ◽  
Five Dimensions ◽  
Eastern Australia ◽  
Under Construction ◽  
Document Review

Follow-up is an essential component of Environmental Impact Assessment (EIA) if the success of EIA in improving the sustainability of a project once implemented is to be determined. This paper aims to establish universally-applicable criteria for EIA follow-up to evaluate project performance once assessed and underway. A suite of 24 criteria is derived from EIA follow-up best practice principles published by the International Association for Impact Assessment. The criteria are categorized according to the five dimensions of EIA follow-up: monitoring, evaluation, management, communication and governance. Posed as questions, the criteria support qualitative assessments of EIA follow-up performance for a project. Through application of the criteria to a case study currently under construction (the Shell Cove Marina project in eastern Australia), we found they provided an effective basis for a document review process delivering a short but informative account of the follow-up performance of the case study. The more robust evaluation of some of the criteria, particularly in the governance category, would require supplementary techniques such as interviews.

Improvisation in Dance and the Movement of Everyday Life

2019 ◽  
pp. 52-64
Author(s):  
Libby Worth
Keyword(s):  
Cognitive Development ◽  
Everyday Life ◽  
Best Practice ◽  
The Us ◽  
Dance Improvisation ◽  
The Uk ◽  
Insight Into

Dance improvisation, as developed in the UK and the US in particular, has become associated with a number of tropes that apparently offer means of best practice. By attending to a few of these, I examine how they might offer insight into dance improvisation. This incorporates research into ways in which improvisation is a part of everyday life, as demonstrated most clearly in examples of infant movement and cognitive development. Taking Henry Montes and Marcus Coates’s dance film A Question of Movement as a case study example, I consider how their innovative way of dancing responses to life questions connects with the infant’s reliance on ‘thinking in movement’, a term offered by Maxine Sheets-Johnstone. Finally, I consider what dancers can learn from people living with chronic dementia-related diseases who forge ways to live in a perpetual present and, conversely, what insight dancers might offer through integration of dance improvisatory processes in caregiving.

scholarly journals The current status of community drug testing via the analysis of drugs and drug metabolites in sewage

2011 ◽  
Vol 21 (1) ◽  
Author(s):  
Malcolm J. Reid ◽  
Christopher Harman ◽  
Merete Grung ◽  
Kevin V. Thomas
Keyword(s):  
Drug Use ◽  
Drug Testing ◽  
Best Practice ◽  
Current Status ◽  
New Techniques ◽  
Monitoring Centre ◽  
The Past ◽  
Time Estimates ◽  
The Us ◽  
Promising Development

Over the past few years the analysis of drug residues in sewage has been promoted as a means of estimating the level of drug use in communities. Measured drug residue concentrations in the sewage are used to determine the load (total mass) of the drug being used by the entire community. Knowledge of the size or population of the community then allows for the calculation of drug-use relative to population (typically drug-mass/day/1000 inhabitants) which facilitates comparisons between differing communities or populations. Studies have been performed in many European countries, including Norway, as well as in the US and Australia. The approach has successfully estimated the use of cocaine, amphetamine, methamphetamine, MDMA, cannabis, nicotine and alcohol. The analysis of biomarkers of drug use in sewage has great potential to support and complement existing techniques for estimating levels of drug use, and as such has been identified as a promising development by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA; www.emcdda.europa.eu/wastewater-analysis). The approach is not without its challenges, and ongoing collaboration across Europe aims at agreeing upon best-practice and harmonising the methods being used. In Norway development is being performed through the NFR RUSMIDDEL funded DrugMon (www.niva.no/drugmon) project that has led to the development of many new techniques, significantly improved our understanding of the uncertainties associated with the approach and allowed the coordination of Europe wide collaboration which has included all important intercalibration exercises. Application of the technique can provide evidence-based and real-time estimates of collective drug use with the resulting data used to improve the much needed estimates of drug use and dependency.

Global Edge

2018 ◽  
Author(s):  
Alejandro Portes ◽  
Ariel C. Armony
Keyword(s):  
Metropolitan Areas ◽  
Global City ◽  
Political Transformation ◽  
Us South ◽  
Cultural Economic ◽  
Process Of Change ◽  
The Social ◽  
The Us

Over the last quarter of a century, no other city like Miami has rapidly transformed into a global city. This book charts the social tensions and unexpected consequences of this remarkable process of change. Acting as a follow-up to City on the Edge, this book examines Miami in the context of globalization and scrutinizes its newfound place as a stellar international city. The book examines Miami's rise as a finance and banking center without parallel in the US South to the simultaneous emergence of a highly diverse but contentious ethnic mosaic. The book serves as a case study of Miami's present cultural, economic, and political transformation, and describes how its future course can provide key lessons for other metropolitan areas throughout the world.

Paradata and dashboards in PIAAC

2018 ◽  
Vol 26 (2) ◽  
pp. 263-277 ◽  
Author(s):  
Leyla Mohadjer ◽  
Brad Edwards
Keyword(s):  
Monitoring System ◽  
Best Practice ◽  
Field Work ◽  
Process Data ◽  
Content Type ◽  
Survey Quality ◽  
The Us ◽  
Field Data Collection ◽  
Quality Production

Purpose This paper aims to provides a brief review of the dashboard literature, an account of the development of performance dashboards for field data collection at Westat, and more specifically for the first cycle of the Programme for the International Assessment of Adult Competencies (PIAAC). A brief concluding section offers suggestions for improvements in survey dashboards for PIAAC’s next cycle. Design/methodology/approach To manage field work at Westat, the authors create views into various paradata databases and present them in a dashboard, showing key performance indicators at a glance. Users can drill down from the dashboard into underlying databases to investigate potential problems. The US PIAAC dashboard is a monitoring system that supports daily review of many activities. For example, it provides overnight alerts to the field supervisor when global positioning system (GPS) data from an interviewer’s smartphone shows the interview occurred far from the respondent’s home. Findings Performance dashboards may represent best practice for monitoring field activities. Paradata sources and systems vary greatly across the PIAAC countries, but a multitude of process data exists in every country and can be used to create quality indicators and a monitoring system. PIAAC can establish standards/guidelines to improve visualization of quality metrics and management data, regardless of the local survey infrastructure. Originality/value The core of the paper is a case study of the experiences on the US PIAAC implementation of dashboards to monitor survey quality, production and costs, with special attention to the issue of fabrication.

scholarly journals BEST PRACTICE PENJAMINAN MUTU LULUSAN BERBASIS IASP 2020 DI SEKOLAH MENENGAH KEJURUAN

2021 ◽  
Vol 4 (2) ◽  
pp. 178
Author(s):  
Enung Hasanah
Keyword(s):  
Quality Assurance ◽  
Best Practice ◽  
Gap Analysis ◽  
Case Study Research ◽  
Quality Performance ◽  
Purposive Sampling ◽  
Quality Assurance Process ◽  
Assurance Process

Abstract: Tahun 2020, instrument akreditasi sekolah/madrasah mulai menggunakan Instrumen Akreditasi Satuan Pendidikan 2020 (IASP 2020). Dalam konteks IASP 2020, komponen mutu lulusan merupakan komponen yang memiliki bobot nilai paling tinggi dibandingkan dengan komponen lainnya. Penelitian ini bertujuan untuk mengeksplorasi proses penjaminan mutu lulusan berbasis akreditasi di Sekolah Menengah Kejuruan dengan menggunakan IASP 2020. Penelitian ini menggunakan metode penelitian studi kasus. Partisipan dalam penelitian ini ditentukan dengan metode purposive sampling, dengan kriteria: seluruh warga SMK yang telah mengalami proses penjaminan mutu lulusan dengan menggunakan IASP 2020. Jumlah partisipan dalam penelitian ini sebanyak 16 orang guru dan karyawan. Hasil penelitian menunjukan bahwa proses penjaminan mutu lulusan berbasis akreditasi dilakukan melalui program: 1) Persiapan: pemahaman IASP 2020, pembentukan tim penjamin mutu lulusan; 2) Melakukan EDS mutu lulusan berbasis IASP 2020; 3) Analisis kesenjangan antara hasil EDS dengan kondisi ideal; 4) Pemenuhan gap melalui perbaikan kinerja pada komponen mutu lulusan; 5) Evalusi program ketercapaian kinerja mutu lulusan dan tindak lanjut. Keywords: mutu lulusan; akreditasi; IASP 20203; Sekolah Menengah Kejuruan. Abstrak: In 2020, the school accreditation instrument began to use the 2020 Education Unit Accreditation Instrument (IASP 2020). In the context of the 2020 IASP, the component of graduate quality is the component that has the highest value weight compared to other components. This study aims to explore the process of quality assurance for accreditation-based graduates in Vocational High Schools using the IASP 2020. This study uses a case study research method. Participants in this study were determined by purposive sampling method, with the criteria: all SMK citizens who have undergone a graduate quality assurance process using IASP 2020. The number of participants in this study was 16 teachers and employees. The results showed that the accreditation-based graduate quality assurance process was carried out through the following programs: 1) Preparation: understanding IASP 2020, forming a graduate quality assurance team; 2) Conducting the 2020 IASP-based graduate quality EDS; 3) Gap analysis between EDS results and ideal conditions; 4) Fulfilling the gap through improving the performance of the graduate quality component; 5) Evaluation of the program for the achievement of the quality performance of graduates and the follow-up. Keywords: graduated qualities; accreditation; IASP 2020; Vocational Senior High School.

scholarly journals School Libraries in Istanbul, Turkey

2010 ◽  
Vol 11 (2) ◽  
pp. 459-470
Author(s):  
Sevim Mccutcheon
Keyword(s):  
Mixed Method ◽  
Practical Purpose ◽  
School Library ◽  
School Libraries ◽  
Current Status ◽  
Functional Level ◽  
Educational Mission

Libraries are important in supporting the curriculum and educational mission of schools. The purpose of this study was to describe and evaluate the current status of a private primary school’s library in Istanbul, Turkey, and to formulate recommendations for improvement. This case study was accomplished through a mixed method involving questionnaires and observation. A survey with semi-structured questions was administered to students, teachers, and the librarian regarding their perceptions of the school library and their desires for the school library. Questionnaires administered to teachers and the librarian of its sister school provide a counterpoint. Observations provided information about the current functional level and nature of usage of the library. The survey was administered in 2007 with a follow-up visit in 2008. The research achieved the specific, practical purpose of identifying areas for development and potential challenges to that development in the school’s library, taking into account the input of its constituents. It also provides suggestions for those who might pursue broader research about the needs and future possibilities for school libraries in Turkey.

scholarly journals Injectable Botulinum Toxin as a Treatment for Plantar Hyperhidrosis

2008 ◽  
Vol 98 (2) ◽  
pp. 156-159 ◽  
Author(s):  
Tracey C. Vlahovic ◽  
S. Patrick Dunn ◽  
Jill C. Blau ◽  
Caroline Gauthier
Keyword(s):  
Botulinum Toxin ◽  
Botulinum Toxin Type A ◽  
Type A ◽  
Botulinum Toxin Type ◽  
Sweat Glands ◽  
Plantar Aspect ◽  
The Us ◽  
Eccrine Sweat Glands

Hyperhidrosis is defined as excessive and uncontrollable sweating due to overactivity of the eccrine sweat glands. The first line of treatment for plantar hyperhidrosis consists of conservative therapies such as topical solutions (ie, antiperspirant applications and aluminum chloride preparations) and iontophoresis. When the patient has failed these standard treatments, the other available medical options are rather limited and not well tolerated. Botulinum toxin type A (Botox, Allergan Inc, Irvine, California) is a purified neurotoxin complex approved by the US Food and Drug Administration in 2004 for multiple medical conditions, including severe primary axillary hyperhidrosis that failed conservative topical therapies. Few recent clinical studies have suggested that botulinum toxin is effective in the treatment of plantar hyperhidrosis. In this case study, two patients received intradermal injections of botulinum toxin type A into the plantar aspect of both feet. A 3-month follow-up evaluated the efficacy of botulinum toxin type A by subjectively assessing the amount of residual sweating. In these two patients, botulinum toxin type A was an effective and safe treatment for plantar hyperhidrosis. (J Am Podiatr Med Assoc 98(2): 156–159, 2008)

Intensive Stuttering Therapy With Telepractice Follow-up: A Case Study

2011 ◽  
Vol 21 (1) ◽  
pp. 11-21 ◽  
Author(s):  
Farzan Irani ◽  
Rodney Gabel
Keyword(s):  
Case Report ◽  
Therapeutic Intervention ◽  
Intensive Therapy ◽  
Positive Outcome ◽  
Eclectic Approach

This case report describes the positive outcome of a therapeutic intervention that integrated an intensive, residential component with follow-up telepractice for a 21 year old male who stutters. This therapy utilized an eclectic approach to intensive therapy in conjunction with a 12-month follow-up via video telepractice. The results indicated that the client benefited from the program as demonstrated by a reduction in percent stuttered syllables, a reduction in stuttering severity, and a change in attitudes and feelings related to stuttering and speaking.

Psychological Resilience Provides No Independent Protection From Suicidal Risk

Crisis ◽  
2016 ◽  
Vol 37 (2) ◽  
pp. 130-139 ◽  
Author(s):  
Danica W. Y. Liu ◽  
A. Kate Fairweather-Schmidt ◽  
Richard Burns ◽  
Rachel M. Roberts ◽  
Kaarin J. Anstey
Keyword(s):  
Risk Factors ◽  
Well Being ◽  
Current Status ◽  
Psychological Resilience ◽  
Cross Sectional ◽  
Life Project ◽  
Resilience Factors ◽  
First Time

Abstract. Background: Little is known about the role of resilience in the likelihood of suicidal ideation (SI) over time. Aims: We examined the association between resilience and SI in a young-adult cohort over 4 years. Our objectives were to determine whether resilience was associated with SI at follow-up or, conversely, whether SI was associated with lowered resilience at follow-up. Method: Participants were selected from the Personality and Total Health (PATH) Through Life Project from Canberra and Queanbeyan, Australia, aged 28–32 years at the first time point and 32–36 at the second. Multinomial, linear, and binary regression analyses explored the association between resilience and SI over two time points. Models were adjusted for suicidality risk factors. Results: While unadjusted analyses identified associations between resilience and SI, these effects were fully explained by the inclusion of other suicidality risk factors. Conclusion: Despite strong cross-sectional associations, resilience and SI appear to be unrelated in a longitudinal context, once risk/resilience factors are controlled for. As independent indicators of psychological well-being, suicidality and resilience are essential if current status is to be captured. However, the addition of other factors (e.g., support, mastery) makes this association tenuous. Consequently, resilience per se may not be protective of SI.

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