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. ITT Technical Institute: New Jersey Online Programs. .u14b146f1793bf339431354702f5a8eff { 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; } .u14b146f1793bf339431354702f5a8eff:active, .u14b146f1793bf339431354702f5a8eff:hover { opacity: 1; transition: opacity 250ms; webkit-transition: opacity 250ms; text-decoration:none; } .u14b146f1793bf339431354702f5a8eff { transition: background-color 250ms; webkit-transition: background-color 250ms; opacity: 1; transition: opacity 250ms; webkit-transition: opacity 250ms; } .u14b146f1793bf339431354702f5a8eff .ctaText { font-weight:bold; color:inherit; text-decoration:none; font-size: 16px; } .u14b146f1793bf339431354702f5a8eff .post Title { color:#000000; text-decoration: underline!important; font-size: 16px; } .u14b146f1793bf339431354702f5a8eff:hover .postTitle { text-decoration: underline!important; } READ Criminal Justice Associate Degree Jobs 7 Exciting Career Opportunities from Court Services to Detective JobsMore New Jersey colleges and universities are available through College-Pages.com, the leading education and career resource website. Prospective students will also find links to informative articles about making education and career decisions in the state of New Jersey. Related ArticlesPennsylvania Colleges and Universities Pursuing Online and Campus Based Education in PennsylvaniaNew York Colleges and Universities Pursuing Online and Campus Based Education in New York, the Empire StatePursuing Online and Campus Based Education in Washington D.C.The Human Resources DepartmentConnecticut Colleges and Universities Pursuing Online and Campus-based EducationHealth Care Employment Opportunities

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