scholarly journals Practical considerations for creating a strategic and proactive clinical safety and pharmacovigilance organization for the future

2021 ◽  
pp. 1-16
Author(s):  
Magnus Nord ◽  
Magnus Ysander ◽  
Tim Sullivan ◽  
Mayur Patel
Keyword(s):  
Decision Making ◽  
Patient Safety ◽  
Observation Time ◽  
Operating Model ◽  
Clinical Safety ◽  
Patent Expiry ◽  
Multiple Challenges ◽  
Set Up ◽  
Main Components ◽  
Future Business

OBJECTIVE: In 2012, Patient Safety (PS) in AstraZeneca was facing a situation with multiple challenges, scientifically and structurally. To meet these and support AstraZeneca’s ambition to return to growth after years of patent expiry, we undertook a project to fundamentally revisit ways of working to create an organisation set up to provide strategic safety in support of drug project decision-making. METHOD: In this paper, we describe the challenges we faced, the project to deliver changes to respond to them, and the methodology used. The project had two main components: creating a new operating model and simplifying the procedural framework. RESULTS: It was delivered in a focused effort by internal PS resources with cross-functional input. The framework simplification resulted in a 71% reduction in procedural documents and a survey of PS staff revealed an increase in satisfaction of 10%–20% across all scores. CONCLUSIONS: With >3 years of observation time, this project has provided AstraZeneca with a PS organisation able to provide strategic safety, supporting successful portfolio delivery, while ensuring patient safety and maintaining compliance with global pharmacovigilance regulations. It has driven efficiency and set the foundation for continued organisational evolution to meet future business needs in an everchanging environment.

Independent Environmental Regulation in India: Less an Authority and more a Process from Below

2018 ◽  
Vol 64 (4) ◽  
pp. 614-626
Author(s):  
Tishyarakshit Chatterjee
Keyword(s):  
Decision Making ◽  
Environmental Regulation ◽  
Regulatory Authority ◽  
Environmental Regulations ◽  
Political Support ◽  
Environmental Data ◽  
Primary Field ◽  
Environmental Laws ◽  
Field Level ◽  
Set Up

With India’s well-intentioned environmental laws and legal interpretations in place, there is still a perceptible weakness in the enforcement of her environmental regulations. This is ascribed to the centralised departmental structure and process of implementation, which prioritise clearances of developmental projects over monitoring and cleaning up of already polluted environments. Although in a democratic set-up, a lack of transparency and participation of knowledgeable stakeholders in decision-making are other process weaknesses noticed. Establishing an Independent Environmental Regulatory Authority has been tried repeatedly but given up mainly because its effectiveness depends on the same resources support as at present, on reliable primary field-level environmental data, not gathered regularly now and on sustained political support. Technically analysing the issues involved, this article suggests a process shift towards a locally relevant, transparent, decentralised, participative and area-science–value-based approach that can strengthen environmental regulation from below.

scholarly journals Implementation of the general principles of creating an information environment for the maintenance and repair of ship mechanisms in the Electronic Product Passport

2021 ◽  
pp. 54-59
Author(s):  
Е.Г. Бурмистров ◽  
Е.А. Давыдов ◽  
А.Б. Корнев ◽  
Е.П. Роннов
Keyword(s):  
Decision Making ◽  
Product Life Cycle ◽  
Information Environment ◽  
Maintenance And Repair ◽  
Registration Data ◽  
Electronic Product ◽  
Stage 4 ◽  
Passport Data ◽  
General Data ◽  
Main Components

В статье рассматриваются принципы формирования информационной среды обслуживания судовых механизмов. Показывается перспективность разработки для этих целей и ведения с актуализацией на всех основных этапах жизненного цикла изделия его Электронного паспорта. Обосновывается структура паспорта, включающая три основных составляющих: 1. Состояние изделия; 2. Эксплуатационный журнал; 3. История изделия и структура обслуживающей такой паспорт базы знаний, включающей в свою очередь следующие основные группы данных: 1) общие данные; 2) данные для принятия решений на этапе ремонта; 3) критерии для принятия решений на этапе эксплуатации; 4) регламенты. Отмечается, что обеспечение действительности данных Электронного паспорта должен осуществляться через единый Регистрационный центр, функции которого сводятся к проверке наличия регистрационных данных и их целостности, хранению последних действительных копий электронных паспортов изделий и хранению данных о этих паспортах. The article deals with the principles of formation of the information environment for the maintenance of ship mechanisms. the prospects of development for these purposes and maintenance with updating at all main stages of the product life cycle of its electronic passport are shown. The structure of the passport, which includes three main components, is justified: 1. Product status; 2. Operational log; 3. Product history and structure of the knowledge base serving such a passport, which in turn includes the following main data groups: 1) general data; 2) data for decision-making at the repair stage; 3) criteria for decision-making at the operational stage; 4) regulations. It is noted that ensuring the validity of Electronic Passport data should be carried out through a single Registration Center, whose functions are limited to checking the availability of registration data and their integrity, storing the latest valid copies of electronic product passports and storing data on these passports.

scholarly journals Controlling and the Use of UAVs as Important Components of Smart Logistical Operations

2021 ◽  
Vol 12 (1) ◽  
pp. 192-203
Author(s):  
Martin Holubčík ◽  
Jakub Soviar
Keyword(s):  
Decision Making ◽  
Internal State ◽  
Good Decision ◽  
Interdisciplinary Field ◽  
Different Types ◽  
Way Of Thinking ◽  
Set Up ◽  
Controlling Measures ◽  
A Company ◽  
The Way

Abstract Modern controlling is an interdisciplinary field that allows management to manage properly, thereby creating the basis for good decision-making. Logistics operations in smart companies need to be not only properly set up, but also properly controlled and improved. The purpose of the article is to analyze the controlling environment in a selected company and point out possible improvements in logistics activities and devices, with a view to preventing different types of problems. For this purpose, observations of the internal logistics processes in a selected company were used and quantified to assess its internal state. On the basis of the data, controlling measures are put forward to improve the management of the company’s logistics activities. The results of the research highlight the opportunities that exist through controlling activities to collect and analyze information about the logistics activities of a company. By doing so, employees can be given greater responsibility for the fulfilment of their tasks and contribute to the streamlining of logistics processes. For managers, the implementation of controlling represents a change in the way of thinking and managing a company.

scholarly journals Rancangbangun Starter Elektrik Portabel untuk Mesin Traktor Tangan

2020 ◽  
Vol 40 (1) ◽  
pp. 48
Author(s):  
Geraldo Adinugra Rimartin ◽  
Bambang Purwantana ◽  
Radi Radi
Keyword(s):  
Performance Test ◽  
Transmission Mechanism ◽  
Power Requirement ◽  
Rotating Speed ◽  
Turn On ◽  
Starter Motor ◽  
High Preference ◽  
Work Accident ◽  
Set Up ◽  
Main Components

Indonesian farmers used to utilize crank to turn on hand tractor machine till today. It may make operators weariness and potentially raised work accident. The purpose of this study was to design a portable electric starter for hand tractor machine. Moreover, the study was addressed to evaluate the performance of the design. The minimum rotational speed (n) and initial torque (T) in decompression and non decompression conditions were adopted to calculate the minimum power (P) requirement. The minumum power of decompression and non decompression were 572.78 watts (≈ 0.74 hp) and 841.75 watts (≈ 1.09 hp), respectively. These values used as a reference in determining the main components, namely the wet type 12 volt battery and the serial type direct current starter motor. The next step, set up additional components, transmission mechanism, as well as concept of portable electric starter. The design was realized by construction and assembly process. A performance test was carried out on the prototype. The performance test of non decompression showed 1.88 seconds for working time, 264.56 Joules for workload (operator), 363.20 rpm for rotating speed and 0.68 watt hours for power requirement. Overall, application portable electric starter indicated better performance than crank. This study proved a high preference of operator on application of portable electric starter in decompression conditions.

Decision-making under duress: the treatment of churches in the City of London during and after World War II

Urban History ◽  
2012 ◽  
Vol 39 (2) ◽  
pp. 285-309 ◽  
Author(s):  
PETER J. LARKHAM ◽  
JOE L. NASR
Keyword(s):  
Decision Making ◽  
World War Ii ◽  
World War ◽  
Post War ◽  
Set Up ◽  
The Uk ◽  
Multiple Experts ◽  
City Of London ◽  
The City ◽  
The Church

ABSTRACT:The process of making decisions about cities during the bombing of World War II, in its immediate aftermath and in the early post-war years remains a phenomenon that is only partly understood. The bombing left many church buildings damaged or destroyed across the UK. The Church of England's churches within the City of London, subject to a complex progression of deliberations, debates and decisions involving several committees and commissions set up by the bishop of London and others, are used to review the process and product of decision-making in the crisis of war. Church authorities are shown to have responded to the immediate problem of what to do with these sites in order most effectively to provide for the needs of the church as an organization, while simultaneously considering other factors including morale, culture and heritage. The beginnings of processes of consulting multiple experts, if not stakeholders, can be seen in this example of an institution making decisions under the pressures of a major crisis.

The Empirical Research for the Expansion of Chain into the Third and Fourth Tier Cities in Guangdong Province

2012 ◽  
Vol 433-440 ◽  
pp. 1967-1970
Author(s):  
Jun Chen ◽  
De Shan Tang
Keyword(s):  
Decision Making ◽  
Factor Analysis ◽  
Empirical Research ◽  
Power Index ◽  
Guangdong Province ◽  
County Level ◽  
Scientific Choice ◽  
Retail Chain ◽  
The Third ◽  
Set Up

The Retail Chain Enterprises implement the strategy of channel to sink to set up shops in third and fourth cities. A reasonable and scientific choice of order of priority must be made when the enterprises entering those cities. This article adopts the approach of the Factor Analysis and duster Analysis the analysis 72 cities (including county-level cities) according to purchasing power index, and to explore how Retail Chain Enterprises to make the market of third and fourth their cities in Guangdong province. The conclusion that is the order of decision ——making to enter into the third and fourth tier cities, which has important guiding significance.

Combined data mining techniques based patient data outlier detection for healthcare safety

2016 ◽  
Vol 9 (1) ◽  
pp. 42-68 ◽  
Author(s):  
Gebeyehu Belay Gebremeskel ◽  
Chai Yi ◽  
Zhongshi He ◽  
Dawit Haile
Keyword(s):  
Data Mining ◽  
Decision Making ◽  
Patient Safety ◽  
Outlier Detection ◽  
Clinical Data ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Healthcare Services ◽  
Content Type ◽  
Outliers Detection

Purpose – Among the growing number of data mining (DM) techniques, outlier detection has gained importance in many applications and also attracted much attention in recent times. In the past, outlier detection researched papers appeared in a safety care that can view as searching for the needles in the haystack. However, outliers are not always erroneous. Therefore, the purpose of this paper is to investigate the role of outliers in healthcare services in general and patient safety care, in particular. Design/methodology/approach – It is a combined DM (clustering and the nearest neighbor) technique for outliers’ detection, which provides a clear understanding and meaningful insights to visualize the data behaviors for healthcare safety. The outcomes or the knowledge implicit is vitally essential to a proper clinical decision-making process. The method is important to the semantic, and the novel tactic of patients’ events and situations prove that play a significant role in the process of patient care safety and medications. Findings – The outcomes of the paper is discussing a novel and integrated methodology, which can be inferring for different biological data analysis. It is discussed as integrated DM techniques to optimize its performance in the field of health and medical science. It is an integrated method of outliers detection that can be extending for searching valuable information and knowledge implicit based on selected patient factors. Based on these facts, outliers are detected as clusters and point events, and novel ideas proposed to empower clinical services in consideration of customers’ satisfactions. It is also essential to be a baseline for further healthcare strategic development and research works. Research limitations/implications – This paper mainly focussed on outliers detections. Outlier isolation that are essential to investigate the reason how it happened and communications how to mitigate it did not touch. Therefore, the research can be extended more about the hierarchy of patient problems. Originality/value – DM is a dynamic and successful gateway for discovering useful knowledge for enhancing healthcare performances and patient safety. Clinical data based outlier detection is a basic task to achieve healthcare strategy. Therefore, in this paper, the authors focussed on combined DM techniques for a deep analysis of clinical data, which provide an optimal level of clinical decision-making processes. Proper clinical decisions can obtain in terms of attributes selections that important to know the influential factors or parameters of healthcare services. Therefore, using integrated clustering and nearest neighbors techniques give more acceptable searched such complex data outliers, which could be fundamental to further analysis of healthcare and patient safety situational analysis.

D Minus Months: Strategic Planning for Weather-Sensitive Decisions

2021 ◽  
Author(s):  
Eva D. Regnier ◽  
Joel W. Feldmeier
Keyword(s):  
Decision Making ◽  
Decision Analysis ◽  
Weather Forecasting ◽  
Decision Makers ◽  
Strategic Decisions ◽  
Sequential Decisions ◽  
Weather Forecasts ◽  
Current State ◽  
Set Up ◽  
Made In

General Eisenhower’s decisions to postpone and, one day later, to launch the “D-Day” invasion of Normandy are a gripping illustration of sequential decisions under uncertainty, suitable for any introductory decision analysis class. They’re also the archetypal example of weather-sensitive decision making using a forecast. This paper develops a framework for analyzing weather-sensitive decisions with a focus on the less-familiar strategic decisions that determine how forecasts are produced and what operational alternatives are available so that decision makers can extract value from forecasts. We tell the story of the decisions made in the months before D-Day regarding how to set up the forecasting process and the myriad decisions implicating nation-level resources that prepared Allied forces not just to invade, but to hold open that decision until the last possible hour so that Eisenhower and his staff could use the critical forecasts. Finally, we overview the current state of the weather-forecasting enterprise, the current challenges of interest to decision analysts, and what this means for decision analysts seeking opportunities to help the weather enterprise improve forecasts and to help operational decision makers extract more value from modern weather forecasts.

Setting Up Education-Based “Crosswalk Analyses” on an Online Survey Platform

2019 ◽  
pp. 90-102
Keyword(s):  
Decision Making ◽  
Online Survey ◽  
Collaborative Work ◽  
Program Planning ◽  
Distributed Team ◽  
Set Up ◽  
Team Setting ◽  
Cross System

Practically, crosswalk analyses in education may be used to identify gaps for decision making and program planning, enable cross-system comparisons, promote cross-disciplinary work, and others. Often, crosswalk analyses require the expertise of a cross-disciplinary and/or distributed team. Setting up a crosswalk analysis on an online survey platform stands to benefit this collaborative work in ways that are more powerful than a co-edited shared online file. This chapter describes some ways to set up education-based crosswalk analyses on an online survey platform and highlights some online survey features that can enhance this work.

Balancing Green ICT Business Development with Corporate Social Responsibility (CSR)

2011 ◽  
pp. 607-620
Author(s):  
Marco Garito
Keyword(s):  
Decision Making ◽  
Co2 Emission ◽  
Industrial Revolution ◽  
Positive Impact ◽  
Business Decision ◽  
Personal Level ◽  
Overall Performance ◽  
Green Ict ◽  
Set Up ◽  
Corporate Social

The debate over green ICT has been triggered by media during the climate change summit in Kyoto in 2007. This was when the industry tried to build up a clean and non-polluting image. While the Copenhagen summit on the environment failed to produce a conclusive decision, it is now clear that its carbon footprint is a remarkable factor in all business decision making. Governments around the world have set up defined programs and targets that companies have to reach. ICT is aimed at achieving reduction in the 2% of CO2 emission levels. The advantage of the positive impact of Green ICT initiatives would be seen in the clear results in management‘s decision making. However, the adoption of green ICT programs gives the opportunity to fully rethink over current business process and develop new solutions. The benefit of environmental friendly companies can also affect the overall performance and deliver measurable results in terms of customer‘s preference, brand value, ROI, not to count the needed change of behaviour at individual and personal level (such as waste disposal). The chapter wants to outline those topics and properly address the issues behind what the author considers as equivalent to the next industrial revolution.

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