Programable logic controllers (PLC) Essay Example | Topics and Well Written Essays - 750 words

Programable rationale controllers (PLC) - Essay Example On its site, Wikipedia says a PLC is utilized for the computerization of electromechanical procedures for instance controlling processing plant hardware or running beguilement rides. It says that its capacity is not normal for a PC that is worked for a broadly useful, and that it is intended to oblige numerous information sources and yield courses of action, impervious to vibrations, effect or temperature changes. The controlling projects are for the most part put away in a non-unstable memory as these controllers work in various types of condition, fitted into machines where the controlling system must be kept stable consistently. They are intended for constant use and are frequently exposed to outrageous situations where it can't bear to breakdown; its hardware keeps a beware of various sensor inputs which control the yield actuators, for instance, solenoids, lights and valves (Blacharski, 2003). The main Programmable Logic Controller to be created was by General Motors in 1968 when its Hydramatic Division needed to counter the taking off costs associated with the current resolute transfer controlled frameworks. The beginning PLCs had transfer usefulness, subbing the conventional hard-wired hand-off rationale which utilized electrically run gadgets to precisely switch circuits. They offered a ton of preferred position as they were far simpler to use in an industry; the establishment wasn’t intense, they required less space and they were re-usable. The advantage of PLCs immediately got on to different organizations like food, refreshment and producing and by 1971, they were giving hand-off substitution which was the initial step to control computerization (Bryan and Bryan 1997, 16-18). The CPU, comprising of the processor, memory framework and the force flexibly runs all PLC exercises. The I/O framework is genuinely associated with gadgets utilized in the control of a procedure or machine and its interface gives the association between the CPU, the data suppliers

Hemagglutination Assay Samples for Students †MyAssignmenthelp.com

Question: Talk about the Virology Hemagglutination Assay. Answer: Presentation The hemagglutination (HA) test is a straightforward and quantitative method of refined flu infection dependent on their capacity to join to particles present on the red platelets. If there should be an occurrence of research identified with the avian flu infection, the device is utilized for screening of the cell culture extricated from the emryonating chicken eggs with type A flu (1). The outside of the Influenza An infection comprise of hemagglutinin (HA) and neuraminidase protein (NA) (2). The hemagglutinin protein present on the Influenza An infection can possibly tie with N-acetylneuraminic corrosive, which contains the proteins, found on the avian and mammalian erythrocytes. If there should arise an occurrence of high grouping of the Influenza infection, blend of the protein prompts an agglutination response. This causes both the erythrocytes to connect together and subsequently structure a diffused cross section. Agglutination might be brought about by different infections as well, for example, paramyxovirus, adenovirus and microbes with hemaggutinating property (1). In this manner, HA can't be viewed as a distinguishing proof examine, hemagglutination hindrance test is to important to recognize the sort of infection present in mammalian cells. Conversation From the investigation of the outcomes acquired from HA measure, it very well may be said that it is a simple and touchy strategy that gives direct outcomes inside 30 minutes. Expected result was conceivable on the grounds that each progression in the trial was done precisely performed. Be that as it may, slight contrast in perusing was seen because of the temperature of the research facility, types of gear utilized, specialized aptitude of the experimenter and the nature of chicken erythrocytes got (3). The HA measure may not be productive in recognizing suitable infection, anyway live and inactivated infections are promptly identified from this method. The HA examine additionally can possibly recognize non-irresistible infection particles and inactivated or debased viral particles. During the analysis, it was discovered that erythrocytes didn't settle in charge wells much following 20-30 minutes. This may have occulted because of low quality of hemolysed erthyrocyte suspension or mistaken pH of PBS or defilement of the well with viral antigen. This could have been kept away from by playing out all the means in a Class II organic security bureau to forestall pollution. Also, vaporized safe tips and utilization of asecptic procedure while taking the aliquot from the infection containing cylinder may lessen the issue during the examination. Other protected and exact procedure is that HA measure plate ought to be perused just when the erythrocytes present in the control well have settled down well. Nonetheless, plates ought not be saved for longer time before perusing and perusing ought to be taken beyond what many would consider possible. The neuraminidase protein found on the outside of the Influenza infection can break infection bond cells and encourage breaking separated the cross section framed by the infection and erythrocytes. In some popular strains, there may be exceptionally high neuraminidase action, which may hamper legitimate haemagglutination process (4). End The report summed up the adequacy of HA test in recognizing sort of infection in culture cells. The subtype of infection is recognized based on agglutination response when erythrocytes join to frame a cross section. As different infection and microorganisms would likewise have hemagglutinating properties, the kind of infection is affirmed by hemagglutination hindrance measure. The conversation identified with explore uncovered that following precise and aseptic method is critical to maintain a strategic distance from blunder in perusing and distortion of the examination results. Reference Killian ML. Hemagglutination measure for the avian flu infection. Avian Influenza Virus. 2008:47-52. Flu Type A Viruses | Avian Influenza (Flu) [Internet]. Cdc.gov. 2017 [cited 3 May 2017]. Accessible from: https://www.cdc.gov/influenza/avianflu/flu an infection subtypes.htm Truelove S, Zhu H, Lessler J, Riley S, Read JM, Wang S, Kwok KO, Guan Y, Jiang CQ, Cummings DA. An examination of hemagglutination restraint and balance measures for portraying invulnerability to regular flu A. Flu and other respiratory infections. 2016 Nov 1;10(6):518-24. Monto AS, Petrie JG, Cross RT, Johnson E, Liu M, Zhong W, Levine M, Katz JM, Ohmit SE. Neutralizer to flu infection neuraminidase: a free correspond of security. Diary of Infectious Diseases. 2015 Apr 8:jiv195.

Chris Yeh talking about Blitzscaling

Chris Yeh talking about Blitzscaling In Palo Alto, we meet Chris Yeh who talks about how to blitzscale a company. Blitzscaling is very important for startups.Martin: Is your Start Up growing too slow? Maybe Blitzscaling can help. Today we talk about this with Chris. Chris, Hi.Chris: Glad to be here.Martin: Who are you and what do you do?Chris: So I’m Chris Yeh and I do a whole variety of things. But for today the most important thing is that I write books. So I Previously co-authored a book called ‘The Alliance’ with my friends Reid Hoffman and Ben Casnocha and that came out last year, 2014 and we are currently working on our next book which is going to be focused on the concept of Blitzscaling which is growing Start Ups extremely rapidly to an extremely large size.Martin: Besides being an author, what did you do before?Chris: So I have a classic sort of Silicon Valley background; I studied Engineering, but also Creative Writing when I was an undergraduate at Stanford. I worked in high tech industry since 1995 in various Starts Ups. I actually was actually in Boston for a while working D. E Shaw and Company which is the company just Jeff Bezos worked for before he started Amazon. Sadly, he had left before I arrived so I never got a chance to really work with him. But then, I had been out here in Silicon Valley since 2000, doing a variety of things starting companies, investing, advising, mentoring young entrepreneurs and the likes.Martin: Cool. Let’s talk about Blitzscaling, can you please elaborate on the concept of Blitzscaling.Chris: Sure, so the concept Blitzscaling really comes from the notion of there is something special about the kind of speed with which you can grow Start Ups, especially here in Silicon Valley and in certain others parts of the world like China. Everyone knows that companies want to grow, every company believes in growth but for the most companies that kind of growth is, “Hey can we grow 10% a year? Can we go 15% a year? Can we steadily climbed?”. And this is the classic way that a lot of companies have been successful in the past. But we increasingly see companies just grow to enormous scale incredibly quickly. So Facebook, for example, get started less than a decade later is the biggest website in the world. Google get started as a little obscure graduate student project and within 10 years it’s the world biggest media company. So we looked at this and say, “What is going here? What has changed to allow companies to grow so big, so quickly? And what are the characteristics that make it happen more often is Silicon Valley and in China than any other place?Martin: For what type of companies does Blitzscaling apply?Chris: So Blitzscaling is applied to an increasingly large number of companies, as you know a number of years ago Marc Andreessen came up with this thesis that ‘Software is eating the world’ and increasingly technology is becoming embedded in pretty much every industry. And while the book is going to focus primarily on high tech industry, there are industries that have gone through enormous changes in a very rapid way that have nothing to do with technology. So for example, in the oil and gas or energy industry, the shale oil boom over the past decade has just completely transformed the energy landscape in the United States that all took place because of a number of small Start Ups that very quickly became enormous. So I think it applies broadly and will apply to more and more industries as software continues to eat the world.Martin: Can you simplify that the Blitzscaling mainly applies to companies who can benefit from economies of scale or is there anything else involved in that?Chris: So what I would say is that Blitzscaling primarily focuses on companies where there are network effects and network effects mean that as you grow the number of nodes in the network, the value of the entire network grows far greater than the linear growth in the number of nodes. And one of the fundamental thesis we have about Blitzscaling is the reason why it has worked so well in Silicon Valley because of the incredible strength of the network here. There are only seven million people in the Metro Bay Area which is a tiny fraction of the world. There are seven million people here, there are seven billion in the world as whole but half of world’s most valuable Start Up companies are here in Silicon Valley and other half are in that other seven billion people. So like what’s going on here? It really is because there is a dense network of connections between investors, entrepreneurs, people who are employers, employees, professional service firmsâ€" all these people are able to come together very quickly in a way that you can’t in many other environments.Martin: And from my perception of what has changed over the last 20 years or so is, the world has become more connectedâ€"Chris: YesMartin: â€"because due to the fact that we have internet right now and the second thing is that here in th e Silicon Valley you have so much capital poured in so that you can fund the rocket ship, so to speak, and if you then change the mindset of the people, then it’s key ingredients for scaling companies faster.Chris: That’s Right. And the capital is obviouslyâ€"The two most important things are the capital and the talent. And this is where Silicon Valley has long held an advantage but if you look at what’s happening over in China for example with the kind of financing that is going into the Didi Kuadi and other sorts of companies that are there. That Capital is now becoming more available globally than ever before and I know that in Europe there is a lot more capital available than was available in the past. And so, what we see happening is Blitzscaling is becoming more and more common in places outside of Silicon Valley because that very fact that you mentioned, because the world is far more becoming connected than it was before.Martin: Imagine I am a Start Up or a CEO of a Sta rt Up outside of the Bay Area and I read about your book and said “Hey, I should Blitzscale”. How did I do it?Chris: So what you going focus on in terms Blitzscaling is picking the right moment to do so. So the Term ‘Blitzscaling’ comes from the term ‘Blitzkrieg’ and of course there is a bad history around that word and the folks who originallyâ€" the leadership that originally promoted it, but it is actually something very different than the traditional means of war. Blitzkrieg meant cutting loose from your supply lines and attacking far more quickly than anyone ever thought possible. In fact, during the battle of France and many people will say, ‘Well the French actually had better tanks than the Wehrmacht did, the Wehrmacht tactics and strategy overwhelmed them. So for us Blitzscaling is all about knowing when you have the right moment, when you are in the situation where all of a sudden you need to grow quickly, you have the opportunity to grow quickly, the capital is available the talent is available, being willing to make that decision.So here’s a great example, I was just reading about Google the other day, it’s a fascinating story. So Google is enormously successful today, once upon a time it was a little tiny Start Up. And one of the things that Google did in its infancy was that it reached a deal with America Online to monetize America Online’s search and advertising and page views alike. And at the time Google was a relatively smaller company they had only ever raised 25 million, basically one rounding of funding and they had only ten million dollar left in the bank. And they signed a deal with America Online where they said, “AOL we’re going to take over ad sales, we’re going to take 15% as our cut, you take 85% percent and we’re going to guarantee you 150 million dollars a year in minimum revenues”. So company with ten million in the bank, went and struck a deal with what was then, sort of the giant in the field and g uaranteed them 150 million dollars a year. Now that’s the kind of aggressiveness that is required in order to Blitzscale, it’s taking a risk, it’s doing things that feel uncomfortable, that don’t necessarily have 100% chance of succeeding but which are necessary in order to achieve the kind of scale that you need. Because once Google had that deal with AOL, once they have that vast volume of additional traffic, of course they were able to learn much more quickly, developed their monetization, ultimately in the end they never had any problems making those minimums.Martin: And is there some kind of checkbox or checklist or so where I can say, “Ok, if these conditions are fulfilled then I should Blitzscale.Chris: So there a couple of things the first of course, I think you referenced is the accessibility of Capital. A Capital is kind of the lifeblood of Blitzscaling. If you were able to scale up at this incredible rate and profits were just gushing in, that’s relatively eas y to do. In case of Google they we’re profitable but they took on a gigantic commitment that was far bigger than anything that had in the past. But in many cases it is based on saying, “well we’re going to grow faster than strictly speaking efficiency would call for but it’s because we believe that this is a decisive point in time in the history of this industry and we have a chance to grow to scale where we will eventually be one of the winner takes all winners.I think the other part of it besides the capital being available is looking at the overall situation around you. We are teaching a class on Blitzscaling at Stanford right now and we had a guest on Mariam Naficy who runs company right now called Minted and what was interesting is she chose not to scale the company very rapidly at the outset. So many years the company was relatively small, she only raised several single-digit millions and only in the past couple of years she raised another ninety million dollars to sca le the company up and it’s growing now with over 500 employees and it’s growing extremely rapidly. But one of the reason she did that is, as the company began to grow out of its original niche it began to encounter other competitors and because there was now competition one of the things she said was, “Now I to be more aggressive growth. If I’m being ignored I might be willing to grow a little more quietly”, in her case she deliberately did that because it felt more comfortable but then when the competition was there she said, “Well I’m willing to feel uncomfortable in order to win” and that’s what the Blitzscaling came in.Martin: What type of pain points are you feeling when you are doing Blitzscaling, especially in terms of organization, if you are growing from like 10 to 100 people in six month or from 100 to 1000 in a year, there are some organizational challenge, etc.Chris: Absolutely, so one of the fundamental frameworks of Blitzscaling is that the organizati on changes radically at each stage and so we divided up into five different stages, we have a metaphor for this.So the first stage is what we call The family this is what we call when you have ones of employees, when you have 1- 10 or so. And the whole thing about a family is everyone knows each other or they’re all under one roof, it tends to be informal there’s not a very set structure. And that fine when you starting out, in fact it could be very efficient if you have a group of people who are used to working with each other.But as it grows, it eventually goes from family to A tribe, you may not have everyone under the same roof, everyone is not seeing each other every single day although everyone still knows each other. And now you’re starting to see some elements of organization, you may have some more specialization than before, “Hey I’m going to focus on engineering, I’m going to focus on operation, etc.” and that will take you from 10-100 employees or 10- 50 em ployees or something along those lines.The next level up is what we call The village. Once you get to the village stage you may not instantly be able to recognize everyone when you see them. You’ve been in a company before with like 100 to 150 people, you start to approach Dunbar’s number and it’s difficult to have that same kind of relationship that you had when you were a tribe or even a family and so the notion is now all of a sudden the organization begins take on more of the characteristics that we think of, of a kind of a company there are going to be a functional areas, there are going to be senior managers, there is going to be additional managers that are hired in to help coordinate everything and it becomes more pronounced as it continues to grow and scale.The next scale up after you get past the village stage is what we call The city phase. So if you think about a village everyone might â€" they see another village resident and be like, “Ok, yeah I kind of know th at guy, I’ve seen him before”. You get to the city phase which is to say thousands of employees and their employees will never meet. Now all of a sudden you’re dealing with something that is less a unitary body where you can just have a single all hands and the CEO can shake hands with everyone and now you’re dealing with a set of constituencies, you need to know govern it and governance becomes increasingly important.And that continues to level the next level up which is tens of thousands of employees which is A nationâ€"a nation all of a sudden. A city often just sort of looks to govern itself and looks to its immediate surrounding, a nation now has to be aware of your Geopolitcs, it has to be aware of adjacent nations, of others players and the game of great powers. When a company has reached that stage, all of a sudden now you’re Google and you’re like, “Well, we had been cooperating with Apple but now we’re competing with Apple on Android, we’re competing with Microsoft on search but we’re also competing with them because we have Google Docs and they have Microsoft office”. And all the sudden the notion of how these greats nations interact with each other becomes a critical part of what you do as you’re Blitzscaling.Martin: I totally agree, I think for every company no matter how fast it grows, if it gets really really big and will follow those 5 phases. The issue from my point of view for Blitzscaling is only that you are not doing this like ten, twenty years but maybe in one or two yearsâ€"Chris: Correct. And the reason why that’s so important is when a company grows to that scale, let’s say over a couple of decades, it’s never easy but it’s easier because people have the chance to scale and grows along with the company and there’s natural attrition, you bring in new people. When a company is scaling at this incredible rate from a couple of founders to thousands of employees and in less than a presidential administratio n of four years, the human being simply can’t scale that quickly and most human beings can’t. And so now you are trying to figure out how can I bring in new leaders and new managers and executives who have the experience to work at these higher levels of scale while still respecting the contribution of those who’ve come before, figuring out how to make sure people continue to have roles or if they no longer have roles, figuring out what the right transition and the right way to treat each other is. So that what makes that growth so challenging because you are scaling a rate that had faster than a human being can actually scale.Martin: So does this mean that you should look for managers or employees in general that could potentially work in each and every of those five phases?Chris: So that’s the interesting thing. A lot of people think, “well, let’s get somebody who has been able to do it all”, and that great. So if you can go out and hire Eric Schmidt or Larry Page in to your company to work for you, you should do that but it’s very difficult to find that. In fact what you instead get isâ€"there are people who will tend to specialize in bigger companies and people who tend to specialize in smaller companies. It is very rare that somebody’s going to have experience at all levels and even if they do have experience all levels they’re going to be better at one particular phase or another. So what we say instead is we have a couple of broad guidelines that you should follow. At the early stages of growth, during the family and tribal and village stages you’re probably going to hire a lot more generalist than specialists. Things are still very up in the air, things still need to shake out and having generalist allows you to have that flexibility within the organization, but as you grow and you reach these higher levels of scale you’re going to bring in more specialist because they have the right skills to manage that level.The other principl e we say is you really have focus at the current stage you’re at. A lot of companies have gone wrong by saying “Well I’ve only got ten people now but I’m going to be huge someday, let me hired somebody who’s already managed a thousand people”. The persons who’s managed a thousand people, those skills are completely different from the skill required to be a part of 10 person team. I am myself more of an early stage person. I tell people, “Listen if you need to figure out how to get your company on the map and you have no money I’m your guy. If you have a budget of a hundred million dollars that you need to spend, go find someone else because that’s a completely different set of skills”.Martin: Is there a methodology how you would manage this transition? You’ve mentioned, “I have hired somebody a generalist”, and I mean you don’t want to fire those people, you want to either develop some other skill or put them in some other place but I find it quite hard to imagine how to really do this.Chris: Yeah and it’s difficult and part of it is just being able to treat people with respect and treat people well even if it their role has to change. So for example, let’s say we bring in somebody as a manager, actually take the classic example of a founder of a company. Founder early on, founders are doing everything, this founder is running engineering, this founder is running all the business side of the world. Well, let’s say this founder who runs engineering as the company continues to scale doesn’t have experience running a hundred person engineering team and they’re not able to learn quickly enough.Well now you need to bring in somebody else, so now you have to say, “Well for this founder, what are they going to do either going to do? Are they going to become a manager who works for this person? Perhaps. Are they going to become more of a CTO or somebody who has more of a strategic portfolio and doesn’t do direct day to day m anagement? Perhaps. Are they going to focus on being a spokesperson or take on a completely different role that also a possibility. But the main thing is to say, “Look lets be explicit about what’s going on here we need a set of skills that are associated with a higher stage and you don’t currently have those skills. So you know if you want to grow into that you may want to work for someone and learn”. Take the example of Google for example, Larry Page was CEO of the company, he was the fellow who ran Google they brought in Eric Schmidt, the investor did as well, in order to have somebody who had experience managing a large organization, he’d help them grow but eventually after they’ve been doing this for long enough, Eric Schmidt and Larry Page and Larry can do it now, let’s bring him back as CEO, and then Eric gets to enjoy his well deserved respite as executive chairman, whereas Larry is now focuses on the day to day.Martin: Cool. Do you have any other examples wher e we can really vividly show what it is to Blitzscale a company?Chris: Absolutely. So a great example this is one that we’re actually going to probably use in the book comes from Reid’s days at paypal. This is a fascinating one. So paypal was growing incredibly rapidly, I think that the way they put it was the company was growing 5% a day, not a week, but a day. So it’s kind of nuts and because they were dealing with money any time something went wrong, people got very angry about it and so they would start emailing, the number of customer service tickets just kept getting bigger and bigger and bigger. And the way Reid puts it is, there were enough people who are trying to reach us that they went into Palo Alto phonebook, discovered the line for Paypal and just randomly dialed the extension in order to reach someone. At any given time, every single phone in the office was ringing and if you picked it up there was an angry customer on other end. So well, what do you do? Well yo u know what you’re now in a situation where efficiency is not the primary concern, just dealing with this volume is the primary concern, so what actually happened was Paypal made a deal with the state of Nebraska and flew out to Omaha, Nebraska, shook hands with the governor, got a building and they flew basically the entire team of the company and they were not that many people in the company at that point to do group interviews to hire a hundred customer service in people in two weeks.Martin: And they didn’t have any customer service agents before?Chris: No.Martin: Wow, okay.Chris: This was inefficiency right, so it was enormously inefficient. I think that the statistic was of the people they hired in that first frantic wave, 70% had left within a month, either because they didn’t work out or because they said, “This is insane I can’t deal with this”. But they actually grew that customer call center in Omaha, Nebraska and that became the customer call center for Payal that was there all the way through the IPO and acquisition by Ebay and as we put it, they took one of Paypal’s early employees and center out to Omahaâ€"a gentle, young, young smart generalist and said, “ Figure out the problem, make it happen, none of us knows anymore than you do”. But she did make it happen as it turns out she also met her husband while she was out there so it all worked out in the end.Martin: I guess not every Blitzkrieg or Blitzscaling is successful, do you have any stories of Blitzscaling who have failed?Chris: There are definitely some cautionary tales. Just recently in the news for example is a company called Home Joy that was a service that allow you to go online and book people to come clean your house. There was some debate about whether or not that good service or good business model as a whole. But what was definitely true and what the founders will tell you is that they try to scale up too quickly. They decided, you know, this is the right time to Blitzscale, we’re going to go into multiple cities we’re going to open up different offices and there’s has been plenty of other companies who follow the same path, basically they said, “We figured this out now let’s expand everywhere”. And often times that ends badly. In the case of Home Joy, just too many commitments, fundamental unit economic problems and ultimately the company went under despite six months before being hailed as one of the hottest companies on the internet.Martin: But do you think this was a problem due to Blitzscaling or scaling in general or was it just that even the scaling would not have to helped the unit economics?Chris : So that’s the interesting point, so I think that the point is the scaling wouldn’t have necessarily helped the unit economics. You have to recognize that when your unit economics are poor enough it is not a time where you can successfully Blitzcale. Their thesis presumably was that this is a land grab and we need to get a s much market share as possible and scale will provide returns and we talk in the book about we call the first scalar advantage; the first person to reach massive scale at any given industry has a significant advantage. It’s not the first person to enter, if early entry allows you to become the first person to reach scale, then great. But if you’re not the first person to reach scaleâ€"and the example use is as I recall the first social network that I remember was called Ryze, well guess what they’re not around anymore. I think they actually are but obviously there not important. What mattered was being the first to reach the scale and different levels of scale. Friendster were the first to sort of reach scale, but fell upon hard times. Myspace reached another level of scale but again they were some fundamental problems. What that shows you is that Blitzscaling is not a panacea. Just growing is not enough to make a business successful. The business underlying has to be success ful, but in order to take full advantage of the market place that rapid growth can be a key tool.Martin: Great, Chris thank you so much for your time.Chris: My pleasure.Martin: And maybe next time if you’re thinking about starting a company, just check whether at some point in your start up journey that you try to Blitzscale as well. Thank you so much, Great.Chris: Thank you,Martin: Thank you, Chris.Chris: It such a pleasure.

New Jersey Colleges and Universities Pursuing Online and Campus Based Education in New Jersey 2019

The Garden State of New Jersey has the highest population density of any U.S. state. Its proximity to New York and Philadelphia make it an ideal location for working professionals and full-time students. With one of the highest median incomes in the entire nation, students of New Jersey colleges and universities can expect to enter lucrative careers following graduation. 50 New Jersey Fortune 500 Companies Offer Employment Opportunities to Graduates of New Jersey Universities and Colleges 50 of the nations Fortune 500 companies are headquartered in, or conduct business from New Jersey. New Jersey college students find employment with some of the states top employers in the printing, pharmaceuticals, biotechnology, telecommunications, finance, and industrial research industries. Some of New Jerseys most prominent employers include: Johnson Johnson headquartered in New Jersey. Merck Co. headquartered in New Jersey. Nabisco headquartered in New Jersey. Wyeth headquartered in New Jersey. Creative Manager Pro headquartered in New Jersey. North Jersey Media Group headquartered in New Jersey. Quest Diagnostics headquartered in New Jersey. Prudential Financial headquartered in New Jersey. .u90d42d8ac866297573b5da23617e0b59 { padding:0px; margin: 0; padding-top:1em!important; padding-bottom:1em!important; width:100%; display: block; font-weight:bold; background-color:#eaeaea; border:0!important; border-left:4px solid #34495E!important; box-shadow: 0 1px 2px rgba(0, 0, 0, 0.17); -moz-box-shadow: 0 1px 2px rgba(0, 0, 0, 0.17); -o-box-shadow: 0 1px 2px rgba(0, 0, 0, 0.17); -webkit-box-shadow: 0 1px 2px rgba(0, 0, 0, 0.17); text-decoration:none; } .u90d42d8ac866297573b5da23617e0b59:active, .u90d42d8ac866297573b5da23617e0b59:hover { opacity: 1; transition: opacity 250ms; webkit-transition: opacity 250ms; text-decoration:none; } .u90d42d8ac866297573b5da23617e0b59 { transition: background-color 250ms; webkit-transition: background-color 250ms; opacity: 1; transition: opacity 250ms; webkit-transition: opacity 250ms; } .u90d42d8ac866297573b5da23617e0b59 .ctaText { font-weight:bold; color:inherit; text-decoration:none; font-size: 16px; } .u90d42d8ac866297573b5da23617e0b59 .post Title { color:#000000; text-decoration: underline!important; font-size: 16px; } .u90d42d8ac866297573b5da23617e0b59:hover .postTitle { text-decoration: underline!important; } READ Earning a Master's Degrees in Computer Science OnlineFemale Graduates of New Jersey Colleges and Universities have the Highest Earnings in the Nation A 2017 Newark Star-Ledger article reported that women earn the highest per capita income in the nation in New Jersey. College graduates of all backgrounds enter a strong local economy. The most recent U.S. Department of Labor and U.S. Census Bureau data reveal: The 2017 New Jersey gross state product was $416 billion. The 2016 2017 New Jersey median household income was $60,246, $14,000 above the national average. The September, 2017 New Jersey unemployment rate was 5.4%. 4,246,100 people are employed in New Jersey. Working Professionals Combine Campus-based and Online Programs at New Jersey Universities and Colleges Working professionals have more flexibility than ever before at New Jersey colleges and universities. Unique combinations of online and campus-based learning programs are available through New Jersey schools, such as: Kaplan University: New Jersey Online Programs. University of Phoenix: Jersey City College Campus and Online Programs. 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Social Problems with Smartphones Free Essay Example, 5250 words

It is evidently clear from the discussion that the smartphone market is increasing and exploding in complexity and therefore, it can never be considered as a single segment which has a specific market and requirements as needed for its technology. This segmentation has created large differences in the hardware requirements. The underlying technologies have become smaller, cheaper and more powerful. The stakeholders are well-known for the new technologies in mobile phones and the way they are handling multi-media. A generation of stakeholders has grown up by using smartphones and PDAs in their private life. In the present day s university and high school students represent the new generation of stakeholders. They are the present and the future customers. Stakeholders will be happy to give the feedback in order to enhance the system for which they are using by themselves. While the stakeholders wait for a system reaction or for a service, for example, at an ATM counter, there is an oc casion to get a feedback. The lack of interconnectedness standardized and widely accepted procedures of payment which are needed for successful m-payments and also for the commercialization of smartphones. We will write a custom essay sample on Social Problems with Smartphones or any topic specifically for you Only $17.96 $11.86/page Over the years, communication and storytelling have changed a lot. In the present days, there is instant sharing of news and information. With the help of internet and smartphones, one can receive an abundant and instant flow of information.

The importance of pharmacovigilance in risk management Free Essays

Introduction OBJECTIVE Every medicinal product has its own risk-benefit ratio. The products, whose benefits to the patients overweigh its risk, are approved by the Competent Authorities (CA). The approved products do not mean that they have no side effects. We will write a custom essay sample on The importance of pharmacovigilance in risk management or any similar topic only for you Order Now Actually every medicinal product has some side-effects and it’s very important to identify the side-effects throughout its lifecycle. The process of constant monitoring of the medicinal product throughout the product lifecycle is called Pharmacovigilance. The aim of pharmacovigilance is to protect people by identifying, detecting, characterising, monitoring and communicating risk for rational and safe use of medicines.1 These benefit-risk findings helps to take decision regarding safety of the medicinal product by regulators, company, physicians and patients.2 BACKGROUND In 1961, after disaster of thalidomide, it has been brought forward that post-authorisation data was not sufficient to detect early warning signs of the drug safety.3 If Pharmacovigilance system were in place during that time; such a disaster would be minimised. To avoid any such disaster in future Marketing Authorisation Holder (MAH) Competent Authority (CA) work together to ensure that pharmacovigilance system is maintained and patient’s safety is not compromised. CONCEPT OF PHARMACOVIGILANCE In general, pharmacovigilance have no boundaries and it should be performed to all medicinal products throughout its lifecycle. Rapid and effective assessment of drug safety is achieved by early information of any unintended effect. Innovative and generic companies have to follow the same requirements with regards to updating the safety specification.4 Currently, the pharmacovigilance system is set as per guidance, Regulation EC/726/2004 Directive 2004/27/EC. Volume 9A and ICH guidelines PHARMACOVIGILANCE RESPONSIBILITY Marketing Authorisation Holder (MAH): In current situation, it’s very difficult to identify a new product and new product application is expensive and time-consuming process. To make a blockbuster product; MAH focus thoroughly on Pharmacovigilance system to avoid any disappointment at the later stage of the product lifecycle as it’s very essential for survival of the company. The importance of Pharmacovigilance is that if successful product fails to detect early signals, company also fails to protect its brand identity. The first step initiated by MAH is to ensure that proper pharmacovigilance system is set up to detect signal of any adverse effect and risk management plans should be in place to minimise its impact.3 To perform above activities, MAH appoints a QPPV who is responsible for,5 Collecting and collating all suspected adverse effects globally and establish benefit-risk balance to submit to CA. Preparing and submitting Periodic Safety Update Review (PSUR), Individual Case Safety Review (ICSR), pre post-authorisation studies to the CA through electronic reporting. Reviewing safety issues and product defects. Conducting internal audit of pharmacovigilance system and ensure management of database. Along with Pharmacovigilance team, company also build Risk Management Team or Crisis Management Team who plays a vital role in minimising the impact of any adverse reactions on the product and the company. Competent Authorities (CA) Along with MAH, CA also develop their Pharmacovigilance team who performs studies like MAH to evaluate the safety performance of the medicinal product. It is also the responsibility of MAH to provide timely and correct information of any signal detected to the CA. CA also evaluate Pharmacovigilance system of the MAH by routine inspections conducted by national authorities to check the system and facilities are in accordance as mentioned in Detailed Description of Pharmacovigilance System (DDPS)6. Apart from routine inspections, certain factors that triggers the inspections are,5 Delays in carry out safety reporting Incomplete or poor quality reporting Inconsistency between reports Changes in benefit-risk balance and failure to communicate to CA. Hence considering the importance of Pharmacovigilance, both MAH and CA take joint responsibility to safeguard public health. KEY STEPS IN PHARMACOVIGILANCE Once the MAH Pharmacovigilance system is set, the key factors are, Signal detection Signal detection is initiated by MAH as well as CA. At any stage during the product lifecycle, if unintended effect is detected, it prompts to evaluate the reason for its happening. Generally MAH should be first to detect any signal, but if is detected by CA, it means that MAH pharmacovigilance system is not efficient and inspections are required to verify the pharmacovigilance set up. The adverse effect signal can be detected by: Constant monitoring in-house studies conducted by MAH. Spontaneous ADR reporting: where a healthcare professional reports any adverse effect to the MAH or CA from patients experiences as well as from his own studies.5 MAH evaluates if a casual or suspected relationship is determined between adverse reaction and medicinal product. Once it is confirmed that relationship exists, MAH should inform CA within 15 days of the occurring of the adverse reaction.5 For cases where patient contacts the MAH directly regarding any adverse reaction, MAH should advice the patient to contact the healthcare professional. Once the adverse reactions are confirmed by healthcare professional, it should be documented by MAH as spontaneous adverse reactions. Prescription Event Monitoring (PEM): It is a hybrid method of data collection from surveillance as well as spontaneous adverse effects. Here all the prescriptions when dispensed are collected and analysed to give an idea of which patients are exposed to which medicines, time of exposure and any signal detected during their therapy.3 Worldwide reports published for ICSR published on Medline or Embase etc helps MAH to be aware of the incidents and can get prepared for such adverse reaction incidents.5 Such literature or internet references should be reviewed atleast once or twice fortnight. If the product is authorised by CP, it should be reported to Eudravigilance, but if the product is authorised through MRP or DCP, CA of the RMS should be reported. Here RMS takes the leading role and contacts respective CMS regarding of reporting any such adverse reaction.25 All the regional wise signals detected are collected by local affiliates and then they are reported to the main office The MAH collects this information globally through local affiliates and reporting to the central office as well as collecting information through websites. Benefit-risk Assessment Once the signal is detected, benefits of medicinal product are assessed on the information of cure or improve rate of the symptoms, the response rate and quality of life. The risk involved is assessed as spontaneous adverse reactions, frequency and presence of risk factors, epidemiological data as well as overdose, misuse or medication errors.5 MAH should try to improve the benefit-risk balance to optimise safe use of the medicines. To effectively monitor the safety performance of the medicine by the CA, it is decided to report periodically which is known as Periodic Safety Update Review (PSUR). Pharmacovigilance during pre-authorisation From drug discovery till the application is submitted, MAH performs several non-clinical and clinical studies to establish benefit-risk balance. Once the product is in application but not granted, if any unintended effect is seen, MAH evaluate the impact of unintended effect and inform to the CA. But there are several limitations to pre-authorisation stages like, 5 limited people population, limited time of exposure of medicine, limited age sex, geographical, ethnicity people limited scope of interactions with other medicines. Pharmacovigilance during post-authorisation But when the product is authorised, it is widely prescribed in different class of patients. This gives more opportunity to identify any unintended risk or potential risk which was not identified during pre-authorisation studies. Hence post-authorisation studies are very essential to detect any such changes in benefit-risk balance and its reporting is through PSUR. To make the post-authorisation robust, MAH maintains the list of information regarding safety, indications, dosing and pharmacology which is called Company Core Data Sheet (CCDS). CCDS proves as a reference to evaluate the change in benefit-risk balance. If any new adverse reaction is reported, CCDS data is updated to reflect changes.27 PHARMACOVIGILANCE REPORTING Periodic Safety Update Reports (PSUR) PSUR is intended to review worldwide safety profile of the product and ensure that SmPC, labelling and leaflet are up-to-date. It is performed to evaluate the data of latest safety reports and to conclude that safety benefit-risk balance is not changed. If there is any change in safety data, appropriate actions should be taken for amendments of current information through increased market surveillance.7 Single PSUR is required to be submitted per MA which include all indications, dosage forms and route of administration. The main contents of PSUR are,5 Executive summary Introduction Worldwide market authorisation status Update to regulatory authority Changes to reference safety information Patient exposure Individual case histories Overall safety evaluation Conclusion Appendix: company core data PSUR reporting to CA is derived from the date of birth of the medicinal product. The date when the medicinal product was approved is call International Birth Date (IBD).5 Considering IBD, PSUR is submitted, Every six months from authorisation until it is placed in the market Every six months for first two years Annually for next two years and thereafter every 3 years Product submitted for renewal In certain cases, where PSUR is not submitted on time, additional 30 days are allowed to submit PSUR. For generic and well established product, PSUR submission dates can be amended depending on the benefit-risk profile of the product. But in all cases, prior permission should be taken from CA.5 During renewal submission, the PSUR report should cover 4 years and 4 months. Renewal can be submitted before 6 months.5 As PSUR submission is calculated as per IBD, renewal should not be affect by PSUR reporting and similar reporting cycle should be followed. RISK MANAGEMENT PLAN (RMP) As all actual or potential side-effects are not identified during studies, so along with pharmacovigilance activities which detect any unintended effects, there should also be Risk Management Plan (RMP) to minimise the impact of any such unintended effects. RMP identifies the risk, clarifies the safety profile and decide alternative ways to minimise risk to the patients.15 As every product has different pharmacological actions and differ in safety profiles, separate RMP should be designed for each product. RMP should also identify multiple risks. RMP comprised of 4 steps:5 Risk detection Risk assessment Risk minimisation Risk communication EU Risk Management Plan All products authorised within the EU should have approved EU-RMP maintained throughout the product lifecycle. EU RMP contains, Safety Specification – These are certain data which are not clearly addressed during non-clinical and clinical trials like toxicity, drug interactions, pharmacology pharmacological class, population not studied, epidemiology and adverse events. Hence it is the summary of important identified risks, potential risk and some missing information.13 It should also highlight the population at risk and highlights the requirement for further study. The safety specification is itself a stand-along document along with pharmacovigilance plan and the specific elements are incorporated in CTD.5 A Pharmacovigilance Plan – It is based as per safety specifications. For certain products where less risk is expected, routine Pharmacovigilance plan is designed. For certain product which involves more complexity and were less safety specifications are available, additional steps are taken to ensure that any signal detected is evaluated in early stages. Action plans are prepared depending on the safety issue. The main points for action plan are safety issue, objective of proposed action, action proposed, rational for proposed action, monitoring and finally evaluating reporting.5 Risk minimisation activities – It can be achieved through knowledge of Safety Specifications by restricting adding suitable warning on the labelling and package leaflet. Medication errors should also be considered with respect to brand names, presentations instructions for use.5 Appropriate warning should also be mentioned if it can be life-threatening due to improper use of route of administration or due to mixing of different strength. Risk can be minimised through additional studies, legal status of medicines, control at pharmacy level and prescription size and validity. Risk communication – Risk communication is a much appreciated step for risk minimisation. Risk should be communicated to healthcare professionals through literatures, educational trainings and informative internet sources so that they can take corrective steps while prescribing to the patient and can minimise the risk.5 EU-RMP is required to be submitted for,5 Application for new active substance, paediatric product, biological product or generic product where more information is required for reference medicinal product. Application for significant change in MA like new dosage forms, route of administration or change in manufacturing process On request of CA or if any safety issue arises of the product. EU-RMP plan is submitted in Module 1.8.2 for evaluation by pharmacovigilance and risk management experts.5 PHARMACOVIGILANCE PENALTIES Every MAH has to adhere to pharmacovigilance system. Non-compliance in the UK will have fine upto ?5000 or if it is conviction it is unlimited fine and imprisonment for upto 2 years to QPPV or company management. As per EU laws, if non-compliance is intentional or negligent, the fine is upto 5% of the annual sales or 2.5% per day average or if it is failure to co-operate or providing misleading information, the fine is upto 0.5% of total annual or per day average sales. Apart from fine, it gives a signal that company is not looking about patient’s safety, putting their profits first and an embarrassment in the industry. EUDRAVIGILANCE From November 2005, electronic reporting became mandatory. The reporting of European pharmacovigilance activities is supported by software called Eudravigilance. Eudravigilance maintains the database of adverse reactions reported for any medicinal product which are subject to clinical trials.8 Eudravigilance provides access of adverse reactions to CA, healthcare professionals, patients as well as pharmaceutical industry. It also maintains the data of ICSR and other suspected adverse reactions. While reviewing the pharmacovigilance system, it helps to identify adverse events to the rapporteur by creating regular overview of adverse events throughout the lifecycle of medicinal product. Also Eudravigilance interfaces with EU-RMP in providing systemic description of risk in terms as defined by MEDdra.8 It is found that 40% of safety issues can be detected earlier if Eudravigilance is used in addition to other PV sources.9 The typical flow of information from PV and EU risk management st rategy implication are, PRACTICAL APPROACH TO PHARMACOVIGILANCE Pharmacovigilance system is dependent on reporting and analysis of unintended effects. But all the side effects cannot be classified as unintended effects. Hence its MAH decision to classify which they consider as serious unintended effects. As physician did not get any feedback of their reporting of unintended effect which ends up in reluctance to report to the MAH.10 In the EU as the products are granted through different procedures, the requirements for labelling are different which makes it difficult to understand benefit-risk balance which pose a risk to public health.10 MAH along with manufacturers should responsible for overall detecting and evaluating the adverse effects of the medicinal product. Duplication of work is involved for reporting by both generic and innovator companies for same medicinal product and lack of communication between them.10 Important safety information should be treated as priority instead of documenting, validating, evaluating and reporting all experiences with the same degree of urgency. PSUR reporting is complex as it involves different presentations, different approval times and country specific labelling.10 As per innovation in healthcare technology, Pharmacovigilance system should be developed to identify the potential association of side effect with a comparison of patient who was given medicine v/s patient who has not taken the medicine.10 NEW 2010 PHARMACOVIGILANCE LEGISLATION The current legislation will amended by Regulation EU/1235/2010 and Directive 2010/84/EC from July 2012.39 The new legislation aims to minimise duplication of reporting system simplifies reporting of adverse drug reactions and PSUR. It also aims to inform patients about benefit-risk aspects and encourage patient to report any effects through online forms, have explanatory wordings on patient leaflet and SmPC for special safety monitoring medicines. The main implications are,40 MAH have to submit ADR reports only to Eudravigilance and not required to submit to individual national CAs. PSUR will have single assessment for same active substance hence all variations; maintenance should be done through union procedure to maintain harmonisation. PSUR reporting is not required for low risk or established molecules unless there is some safety concern. So generic companies will be benefitted by not submitting PSUR unless requested. Currently DDPS will be replaced by Pharmacovigilance System Master File (PSMF) which should be permanently available for submission or inspection on request of national CA. All pharmacovigilance referrals will be discussed by Pharmacovigilance Risk Assessment Committee (PRAC) and to avoid duplication CMDh should agree on the single opinions for all member states. Environmental risk factors should be considered as safety of the people in the particular area of the EU. SUCCESS EXAMPLES OF PHARMACOVIGILANCE In last few years, there were certain medicinal products which were showing positive benefit-risk balance during approval, but on constant monitoring for 5 to 10 years, their safety profile has changed and they started to show negative benefit-risk balance. The few products are, Avandia Avandamet Acomplia Vioxx etc. Avandia and Avandamet have shown good management of diabetes, but along with that they also pose a risk of cardiovascular events which were unintended adverse effects. MAH have provided extensive research documents to support their product, but finally it was found that benefits were less compared to risks imposed. Hence considering the public safety, these products are withdrawn at their maturity stages. As a part of pharmacovigilance studies, it was found that due to long exposure time of the medicine, it has shown adverse effects which were not possible during pre-authorisation studies. Also it proved the strength of pharmacovigilance studies, which has avoided any such disaster among the patients. CONCLUSION Pharmacovigilance plays very important part in healthcare system. As the new molecules are complex with limited reports, pharmacovigilance is the tool to monitor the safety benefits. Though it creates more and more hurdles to the MAH with respect to provide more data and justification, it actually provides more safety towards the public health. Without accurate pharmacovigilance system, it may end up with lot of life-threatening incidence globally. New legislation from July 2012 will bring a major change in current pharmacovigilance system, but it is more acceptable in terms of avoiding duplication of work, systematic reporting and monitoring and harmonised approach. LIST OF REFERENCES Primary reference: World Health Organisation. The importance of Pharmacovigilance. Safety monitoring of medicinal products. 2002. Secondary reference: Carol Tsang, Pharmacovigilance: Is there a difference between innovative and generic industriesPart I: Analysis of spontaneous reporting practice in innovative and generic companies, TOPRA Regulatory Rapporteur, Issue January 2007:p2 Primary reference: Meyboom RH, Egberts AC, Gribnau FW, Hekster YA. Pharmacovigilance in perspective. Drug Saf. 1999 Dec;21(6): 429-47. Secondary reference: Carol Tsang, Pharmacovigilance: Is there a difference between innovative and generic industriesPart I: Analysis of spontaneous reporting practice in innovative and generic companies, TOPRA Regulatory Rapporteur, Issue January 2007:p2 Pharmacovigilance, 2nd Edition by Ronald D. Mann Elizabeth B. Andrews, John Wiley Sons Ltd., p.3 Available from URL: http://www.compsci.googlecode.com/files/Pharmacovigilance,%202nd%20edition.pdf (accessed on 9th May 2011) Carol Tsang, Pharmacovigilance: Is there a difference in perceived practices between innovative and generic industriesPart 2: Seriousness criteria for ADR reporting by innovative and generic companies, TOPRA Regulatory Rapporteur, Issue March 2007:p8-11 Volume 9A of the Rules governing medicinal products in the European Union: Guidelines on Pharmacovigilance for medicinal products for human use; September 2008. Available from URL: http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf (assessed on 9th May 2011) Jackie Roberts, Chief Regulatory Officer and QPPV, Jenson Pharmaceuticals Services Ltd, Devon, UK, Detailed Description of the Pharmacovigilance System (DDPS), MHRA Conference, London, 22 April 2010, TOPRA Regulatory Rapporteur, Vol 7, No 6, June 2010:p25 Carol Tsang, ApoPharma Inc, Toronto, Canada ([email protected]), Pharmacovigilance – PSUR preparation and submission by innovative and generic companies, TOPRA Regulatory Rapporteur September 2007,p. 10-19 Thomas Goedecke, Sabine Brosch, Peter Arlett, EMEA: EudraVigilance – the common EU database to support pharmacovigilance activities, TOPRA Regulatory Rapporteur, Vol 6, No 2, February 2009: p6-11. Carol Hynes, Director, Global Regulatory Affairs, Strategic policy and support, Johnson Johnson Pharmaceuticals Group, The 4th EMEA/TOPRA meeting on medicines legislation 2009: Evaluation to the next step – the needs of the future, Session 2 – Pharmacovigilance and risk management, TOPRA regulatory rapporteur, Vol 7, No 3, March 2010: p 22. Paolo Biffignandi, EU Vigilance, UK, Germany and Italy, The complexity of Pharmacovigilance, TOPRA Regulatory Rapporteur – Vol 6, No. 2, February 2009, p.4-5 New 2010 Pharmacovigilance legislation. Available from URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000492.jspmurl=menus/regulations/regulations.jspmid=WC0b01ac058033e8ad (assessed on 9th May 2011) 2010 Pharmacovigilance legislation: strengthening the monitoring of medicines. Available from URL; http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000491.jspmurl=menus/special_topics/special_topics.jspmid=WC0b01ac058033e8ac (accessed on 9th May 2011) Hoss A Dowlat, Principle Consultant, Regulatory Affairs (Biologics), Freiburg, Germany ([email protected]), The Importance and Impact of the EU-RMP and US-REMS to risk-benefit assessments, TOPRA Regulatory Rapporteur – Vol 8, No. 2, February 2011,p.20-23 Directives: Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010. Available from URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF (assessed on 9th May 2011) Regulations: Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010. Available from URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF (assessed on 9th May 2011) ICH Harmonised Tripartite Guideline, Pharmacovigilance Planning E2E, Current Step 4 version dated 18 November 2004. Available UTL from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2E/Step4/E2E_Guideline.pdf (assessed on 9th May 2011) EMA Document Ref EMEA/CHMP/96268/2005, Guideline of Risk Management for Medicinal Products for Human Use, Date coming into effect 20 November 2005. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004888.pdf (assessed on 9th May 2011) EMA Document Ref EMEA/187439/2006/Final, Draft Eudravigilance Access Policy for Medicines for Human Use, Date 19 December 2008. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500006344.pdf (assessed on 9th May 2011) MHRA Frequently asked questions for Good Pharmacovigilance Practice. Available from URL: http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodPharmacovigilancePractice/Frequentlyaskedquestions/index.htm (assessed on 9th May 2011) How to cite The importance of pharmacovigilance in risk management, Essay examples

Financial Accounting of JB Hi-Fi Limited Australia †Free Samples

Question: Discuss about the Financial Accounting JB Hi-Fi Limited. Answer: Introduction JB Hi-Fi Limited is a publicly-listed company on the Australian Stock Exchange and a fast growing retailer of consumer goods and home appliances which include hardware and electronics. Its head office is in Melbourne and has 112 stores in the whole of Australia and New Zealand. Its competitors include Target Australia, Big W, Harvey Norman and David Jones (JB-Hifi, 2016). The Annual Report for the financial year ending 30 June 2016 has been referred to for the purpose of this assignment. Total value in the consolidated financial statements the following items at the end of the year Account Head Total Value as on 30 June 2016 ($000) Cash Cash Equivalents 51,884 Inventories 546,437 Sales Revenue 3,954,467 Other Income 546 Plant Equipment 183,570 Interest Expense 3,857 Sales Marketing expenses 404,575 Occupancy expenses 173,792 Trade Other payables 384,928 Borrowings (Non-current) 109,736 Normal balance for each of the accounts Account Head Normal Balance Affect on decrease Cash Cash Equivalents Debit Balance Credit Side Inventories Debit Balance Credit Side Sales Revenue Credit Balance Debit Side Other Income Credit Balance Debit Side Plant Equipment Debit Balance Credit Side Interest Expense Debit Balance Credit Side Sales Marketing expenses Debit Balance Credit Side Occupancy expenses Debit Balance Credit Side Trade Other payables Credit Balance Debit Side Borrowings (Non-current) Credit Balance Debit Side Accounts that are affected Apart from the dual impact of debit and credit, the multiple impacts of this debit and credit on other accounts has also been analyzed and presented below. Cash Cash Equivalents Increasing Cash and Cash Equivalents is possible by increasing the revenues, other incomes or reducing the expenses. The impact of this is seen by the way of increase in the profits which is further attributed to the owners in the form of Reserves and Retained Earnings (JB-Hifi, 2016). The increase in Cash and cash equivalents can also be invested in current or noncurrent assets and utilized in acquiring tangible assets like Inventories and Plant and Equipment (Horngren, 2013). Similarly, the increase in Cash and Cash Equivalents can also be utilized to pay off the current liabilities like Trade and other payables or noncurrent liabilities like Borrowings. Inventories The increase in inventories will decrease the balance of Cash and Cash Equivalents due to the investment required for the same (Portor Norton, 2014). In the Statement of Profit and Loss Account, the balance in Closing Stock will also increase. If the inventories have been acquired on borrowed money, then the finance costs in the form of interest expenses will also increase. If the inventories have been purchased on credit, then the balance of Trade and other payables will increase accordingly. Sales Revenue Sales Revenue increase has a direct impact on shooting up the profits. But there will be additional costs involved to achieve this increased revenue in the form of an increase in the cost of sales, selling and marketing expenses, administration expenses, and other expenses (JB-Hifi, 2016). This increase in profits will lead to increase in the balance of retained earnings and reserves. If the increased sales revenue has been achieved in cash and cash equivalents, then the cash balance will increase (Berk et. al, 2015). Else if the increased sales revenue is achieved on credit basis, then the balance of trade and other receivables will increase to the corresponding extent. Other Income Other income comprises of the items that are not directly sales revenue. But the nature and impact of an increase in other income is similar to that of sales revenue. There are not much direct and indirect costs involved for increasing other income as it is mostly earned in connection with the other business activities. If some nominal expenses are incurred, then this increase in other income will lead to an increase in such expenses (Subramanyam Wild, 2014). The profits will increase to reflect the impact of increased other income and the balance of Reserves and Retained Earnings will increase accordingly. In most cases, the other income is earned in cash (Brealey et. al, 2011). So the balance of Cash and Cash Equivalents will also increase accordingly. Plant and Equipment Plant and Equipment forms a part of the Non-Current Assets. To acquire plant and equipment, the cash balance is required, so the Cash and Cash Equivalents will decrease to that extent. The increase in plant and equipment will also lead to increase in depreciation expense. The related expenses are occupancy expenses, administration expenses which cover insurance expenses and the running costs involved. If more staff is required to be employed for operation of the Plant and Equipment, then these costs will increase accordingly. If the Plant and Equipment have been acquired on credit, then the borrowings will increase and the associated finance costs in the form of interest expenses will also increase (Berk et. al, 2015). The immediate impact of this increased investment in Plant and Equipment cannot be seen but the long term impact is seen by the increase in revenues and profits. Interest expense (Financial costs) Interest expenses increase when additional capital is required for the business and borrowings have been opted for the same (Guerard, 2013). Hence the increase interest expenses can be directly linked to the increased borrowings. Interest is also levied on the taxes due which are included in the current taxation liabilities. If this additional capital and increased interest expenses have turned out to be favorable for the business, then the increased sales revenue is seen. Else the increased interest expenses will bring down the profits. Sales and Marketing expenses Sales and marketing expense are incurred to achieve a higher sales revenue and in turn higher profitability for the business. Hence increase in these expenses will lead to increase in Sales Revenue (JB-Hifi, 2016). As expenses are incurred, the payment for the same is either in cash or on credit basis. This will lead to a reduction in the balance of cash and cash equivalents or an increase in the balance of the trade and other payables which include all the current and short-term liabilities payable by the company. Occupancy expenses This refers to the costs incurred for acquiring additional office spaces or such other areas of business operation. The increase in occupancy expenses leads to a decrease in the balance or cash and cash equivalents and an increase in the balance of trade and other payables (Christensen, 2011). Apart from this, all the other administration and operational expenses are set to increase due to the additional costs to be incurred for running a business from the additional spaces. The impact of this can be seen by the increase in the revenue due to the increased sales achieved and the corresponding increase in profits if the additional business spaces turn break even and get converted into profitable areas of operation (Deegan, 2011). Trade and other payables Trade and other payables increase due to the purchase of goods or acquisition of services on credit. It reflects the balances outstanding and payable by the company (Graham Smart, 2012). As payables have increased, the cost of sales which includes the purchases will also increase. Apart from this, every other item of expenses or cost which is kept outstanding like employment expenses or marketing expenses or administration expenses will all get reflected as an increase in the other payables (Davies Crawford, 2012). The benefit of this is that the immediate cash balance will not get impacted as the payment has to be made in intervals and so the balance of cash and cash equivalents will be relatively higher to this extent (JB-Hifi, 2016). Borrowings (Non-current) The increase in borrowings will increase the cash balance in the first place as it is similar to the introduction of additional capital and finance for the business (Shah, 2013). This additional cash can be utilized by the business in many ways which are either the acquisition of current assets like inventories and noncurrent assets like plant and equipment or such other investments (Albrecht et. al, 2011). Accordingly, the balance in each of these accounts will increase based on its utilization. The cash can also be used to incur expenses like occupancy expenses, selling and marketing expenses, so on and so forth and based on the utilization, these account balances will increase accordingly. Apart from this, every additional capital comes at a cost; hence the increase in borrowings will increase the finance costs in the form of interest expenses (Choi Meek, 2011). Thus increase in borrowings has the impact of increasing or decreasing the profits based on the matching of the incomes and expenses for which it is used. Conclusion As the financial statements are connected, every business transaction has dual impact namely debit and credit. So the impact of increase or decrease in each of the items mentioned above is seen both in the Statement of Profit and Loss and in the Statement of Financial Position. Every account is connected to other accounts both directly and indirectly. But it is difficult to trace the direct impact of the increase to any specific account and hence the impact and various possibilities in each case have been discussed. References Albrecht, W, Stice, E. Stice, J 2011, Financial accounting, Mason, OH: Thomson/South-Western. Berk, J, DeMarzo, P Stangeland, D 2015, Corporate Finance, Canadian Toronto: Pearson Canada. Brealey, R, Myers, S Allen, F 2011, Principles of corporate finance, New York: McGraw-Hill/Irwin. Choi, R.D Meek, G.K 2011, International accounting, Pearson . Christensen, J 2011, Good analytical research, European Accounting Review, vol. 20, no. 1, pp. 41-51 Davies, T Crawford, I 2012, Financial accounting, Harlow, England: Pearson. Deegan, C. M 2011, In Financial accounting theory, North Ryde, N.S.W: McGraw-Hill. Graham, J Smart, S 2012, Introduction to corporate finance, Australia: South-Western Cengage Learning. Guerard, J. 2013,Introduction to financial forecasting in investment analysis, New York, NY: Springer. Horngren, C 2013, Financial accounting, Frenchs Forest, N.S.W: Pearson Australia Group. JB-Hifi 2016, JB-Hifi Annual report accounts 2016, viewed 11 May 2017 https://www.jbhifi.com.au/Documents/2016%20JB%20Hi-Fi%20Annual%20Report_ASX.pdf Porter, G Norton, C 2014, Financial Accounting: The Impact on Decision Maker, Texas: Cengage Learning Shah, P 2013, Financial Accounting, London: Oxford University Press Subramanyam, K Wild, J 2014, Financial Statement Analysis, McGraw Hill