Gangs Of Gangs - 1136 Words

Youth gangs and the violence around them has grown in America. The gang related crimes committed by these youth gangs has risen and the age of these members had dropped. The youth are turning to the gang life at a younger age than ever before. In this essay I will dive into the different geographic types and their youth gangs. We will also take a look at age, gender, and the race of these gang members. Gang related crimes and local gang violence factors will also be discussed in this essay. Gangs can be identified by the colors that they wear along with other things such as, clothing and tattoos. The well known gangs around the nation are the Bloods and the Crips. The Bloods can be identified by the color red that they wear and also by the†¦show more content†¦Rural counties reported juvenile gang activity at 58.9 percent and adult gang activity at 41.1 percent (National Youth Gang Survey Analysis. (n.d.). Retrieved September 18, 2017, from https://www.nationalgangcenter.gov/Survey-Analysis/Demographics). The gender of the youth in these gangs has not changed much but there has been a spike in the number of females joining gangs and/or creating gangs of their own. In a study conducted by the NYGS, lasting from 1998 to 2010 the percent of juvenile males has always been higher than the females but the percentage for females has increased. Law enforcement agencies have reported a greater percentage of male than female gang members but despite the concern of female s joining gangs, there is still little to no change in the percentage change in the observed survey years. One fourth of the agencies that participated in the NYGS could not provide much information regarding the presence of female membership in gangs and that it is not an issue. The agencies that could provide the study with information (less that fifteen percent) did however report that none of the gangs in their jurisdiction have female gang members. Close to half of the gangs outside of large cities are reported to have female compared to the twenty five percent in larger cities. In 2009 a study shows that rural counties have the largest report of female members involved with gangs coming inShow MoreRelatedGang Report On Gang Groups840 Words   |  4 Pages2013 National Gang Report, gangs continue to flourish, progress, and develop criminal tradecrafts (p. 3). Based on state, local, and federal law enforcement reporting, the National Gang Intelligence Center (NGIC) calculated t hat the US gang composition is approximately 88 percent street gang members, 9.5 percent prison gang members, and 2.5 percent outlaw motorcycle gang (OMG) members. Street gangs pose the most violent and significant threat in most communities, while prison gangs are viewed asRead MoreCharacteristics Of Chicago Gang Gangs988 Words   |  4 Pagescharacteristics of Chicago’s gangs of the 1920 was the division across ethnic lines. In other words, representatives of the same ethnic group stuck together and frowned upon the inclusion of outsiders into their gangs. Of course, larger gangs were often multiethnic, but their core was predominantly monoethnic. The same tendency prevailed across the country, as gangs in New York and Philadelphia were also increasingly homogenous. Asian triads, Italian mafia, Irish and Jewish gangs were all incestuous organizationsRead MoreGangs: Crime and Gang Violence1549 Words   |  7 PagesGangs Gangs are a violent reality that people have to deal with in today s cities. What has made these groups come about? Why do kids feel that being in a gang is both an acceptable and prestigious way to live? The long range answer to these questions can only be speculated upon, but in the short term the answers are much easier to find. On the surface, gangs are a direct result of human beings personal wants and peer pressure. To determine how to effectively end gang violence weRead MoreAfrican American Gang Gangs1943 Words   |  8 Pagesis relative in space and time. Gangs are a seen as a deviant subculture within itself. While not all gang members have a criminally deviant agenda, many do perform deviant acts such as graffiti, robbery, larceny, assault, drug deals and homicide. Regardless of what the intentions of joining are, becoming a gang member is considered a deviant behavior in our society. There are different types of gangs such as street gangs, prison gangs, motorcycle gangs, ethnic gangs etc. For this paper, the focusRead MoreGangs And Gang Crimes All Together2177 Words   |  9 PagesI have chosen to write my paper on Gangs and Gang crimes all together. I want to explain the history and reasoning of modern gangs and how and why they came about. I also want to give examples of some of the most common gangs known world wide and examples of the crimes they commit. I will also include insight on the reasoning behind the joining of gangs. Lastly, I would like to go into some detail about the criminal investigation of gang crimes. I have chosen this topic because I believe it is oneRead MoreDo Gang Behavior And Gang Affiliation?1845 Words   |  8 Pagesacknowledge and challenge communities to recognize gang behavior and gang affiliation. This paper will also describe the culture and what it means to be in a gang; key findings of the research; recommendations the commu nity can employ to remedy the need; and discussions and implications for further study. Keywords: African-American, Black men, Hip hop, Rap music, Nigga â€Å"There are approximately 27,900 gangs, with 774,000 members, impacting towns, cities, andRead MoreGang Activity Of A Gang1893 Words   |  8 PagesFor decades there have been an abundance amount of gang activity going on around the world and it continues to grow. Every year there is an increasing amount of teenagers over 600,000 that are rushed to the emergency rooms and taken into hospital care due to gang related injuries (Forster, Grigsby, Unger Sussman, 2015). Most of these children are very young and have not even enter high school, and others have not even completed middle school. Many of the teens that have been rushed to the hospitalRead MoreThe Violence Of Gangs And Gangs1377 Words   |  6 PagesGangs have become one of the nation’s fastest growing problems within recent history. According to the Federal Bureau of Investigation about 33,000 violent street gangs, motorcycle gangs, and prison gangs with about 2.4 million members are criminally active in the U. S. today. They use violence to control neighborhoods and boost their illegal moneymaking activities, which include but are not limited to: robbery, drug and gun trafficking, fraud, extortion, and prostitute rings. With as much researchRead MoreU.s. Gangs And The Gangs1317 Words   |  6 Pagesoriginated with U.S. gangs in an effort for drug cartels to amp up and focus on their production, leaving the logistics to the gangs. The drug cartels have chosen to align with U.S. gangs based on similar philosophies of honor, allegiance, and loyalty combined with similar business practices and levels of hierarchy. The largest U.S. gangs are structured similarly to giant corporations that succeed with levels of management teams with the ultimate goal of profit, U.S. gangs are no different as theyRead MoreClassification of Gangs847 Words   |  4 PagesClassification of Gangs Introduction The problem of classifying gangs has interested both sociologists and law enforcement. For the purpose of law enforcement, a gang is generally defined as an organized group among the members of which there is well-designed communication. This paper evaluates classification schemes from current research for gangs. The objective is to discover the issues and problems in creating classifications for gangs including a definition which delineates what constitutes a gang and differentiates

Strategic plan of Riordan Plastics Example

Essays on Strategic plan of Riordan Plastics PowerPoint Presentation Riordan Manufacturing is one of the leading plastic products manufacturing company in a global plastic industry business. The main products that are manufactured by Riordan include appliance manufacturers, automotive parts, defense development, beverage makers, health care and aircraft manufacturers. Riordan is considered as the leading producers of plastic products and serving a wide range of industries. Although the company is in a sustainable situation but the ever changing competitive business world has forced almost all companies and industries to revolutionize and develop their management strategies that would cope with the current economical demands and trends. To capture the global market, an organization needs a comprehensive strategic management plan that should be followed successively to ensure the conformity with global business rules and requirements (Kiechel, 2010). Strategic management of a company is a process by which a company can successfully exploit minimum amount of resources available to maximize the profits and enjoy the greater market shares (Dess, 2009). Ideally, the strategic management includes the knowledge of competitors, analysis of strengths and weaknesses of a company and meeting all the goals and objectives of the company. The SWOT analysis will allow the company to design the strategic management plan. Riordan Manufacturing Company needs the strategic management plan to motivate the employees and management at every level along with formulating strategies that would allow maximum profits (Dess, et. al., 2009). The strategic management plan for Riordan Manufacturing should have the following components: 1) Development of mission statement along with formulation of measurable and time specified objectives of the company. 2) SWOT analysis is the second step in this plan to evaluate the internal strengths of the company. Analyzing the external threats like industry, social, political, regulatory, technological and macro-economic threats along with internal threats including marketing, financial etc. Based on this analysis, the company would be in a better position to capitalize on best possible opportunities available in the market 3) The factors that might affect the strategy itself are also acknowledged. It includes regulatory forces, society forces, company’s culture and personal managerial ambitions. 4) The most important part of the strategic plan is the implementation of the strategy. This includes the implementation in an organization by changing its environment with the help of budgeting, marketing, feasible work environment, reward structure and information systems. 5) Lastly, observation of the outcomes and adjusting the process in terms of mission, objectives, processes and goals. Ethical and social responsibility in the strategic management plan for Riordan Manufacturing is considered important from the view point of investors, creditors and stakeholders. If a company fails in considering these facts in the strategic management plan, it would soon lose its worth in the public eyes. The stakeholders not only involve the investors and shareholders but it also includes the people living in the environment that might or might not be affected by the business processes of the company. The business ethics are an important part of this plan to conduct the business and act responsible for the stakeholders. The management of the company is responsible to contribute towards charity and social causes to develop trust among the people. It is also the responsibility of a company to offer job opportunities to permanently unemployed people. Last but not the least, accuracy of the financial statements of the firm is also a social and ethical responsibility of the company. References: Dess, G. (2009) Strategic Management. 4th Edition. Non Basic Stock line. Dess, G., Lumpkin, G.T. and Eisner, A. (2009) Strategic Management: Creating Competitive Advantage. New Jersey: McGraw-Hill/Irwin. Kiechel, W. (2010) The Lords of Strategy: The secret intellectual history of the new corporate world. Harvard Business School Press.

Ted Rogers School Of Management

Question: What is the impact on the crashing solution increased from seven to nine weeks? Answer: After the preparation of schedule in MS Project, with the provided sequences between the activities is coming to 40 weeks. Start date considered is Monday (March 27, 2017) and End date arrived at Friday (December 29, 2017). Attached snapshot of MSP program without crashing, here we can observe the Total Slack of Activity B is 16 weeks, that is it I not in critical path. Then after crashing the schedule by using the data in Exhibit 2 has reduced from 40 weeks to 33 weeks. Accordingly, total slack of Activity B has reduced to 13 weeks, but still it is not in critical path. End date has prepended to Friday (November 10, 2016) from Friday (December 29, 2017). Now, after increasing the duration of activity B to 9 weeks in MS project, the total slack of activity B has reduced from 13 to 10 weeks. Because the activity B is not in critical path of crashed schedule and have total slack of 13 weeks, so by increasing the duration by 3 weeks the available total slack will be correspondingly reduced by 3 weeks only. here shall be no impact by increasing the duration of activity B by 3 weeks on overall crashed schedule. So, I suggest not to spend any amount to crash the activity B Market Assessment.

Raven Culver Essays (861 words) - Indian Films, The Guide

Raven Culver EN-229 Dr. Laoye 3 March 2017 The Guide R.K. Narayan's novel, "The Guide" , deals with a man named Raju who recently was released from prison. After being spotted in a temple and mistaken for a Swami, Raju has now taken on that role and is pretending to be this holy man in Malgudi. In this novel, I had analyzed chapters six and eleven. In chapter six, the people are worshipping Raju as a Swami or saint. Because of his "role" as a religious leader, people bring gifts to his templeand Raju's love for food makes it easy to accept them. From all the abundance of gifts, Raju stopped becoming interested in these gifts and began handing them back out to the women and children at the end of the day. Based on the gifts given to him, Raju could tell what season it was so there was no need to keep a calendar. During one season, the rain had stopped half way through the season and crops began to dry up. Though the people were going through all these difficulties with their crops, they still continued to bring Raju gifts, though they we re smaller in, "size and volume" ( Narayan 71). The lack of rains began to effect the animals who no longer could plow the fields or produce milk. The people kept running the Raju for answers about the lack of rain, failing crops, and dying cattle; each for which he had made up some reason. As the days went on and more and more animals died and wells dried up, the townspeople began to become frustrated. They started fighting from the high food cost and stress. Upon seeing this, Raju thought of leaving town, but knew the people would look for him. Instead, he declared that he would fast until the people stopped fighting and the rains came. The people compare Raju to Ghandi and the pressure begins to overwhelm Raju. One night, Raju sits Velan down and tells him, "I am not a saint, Velan, I'm just an ordinary human being like anyone else. Listen to my story" ( Narayan 87), and reveals who he truly is. In chapter 11, Raju finishes narrating his life story to Velan about his childhood up until his release from jail. In the village, government officials sent a commission to observe the conditions of the drought and remedies; with this commission came newspapers. The newspapers began to spread word about the Swami and his fasting for the drought. These newspapers brought this to public interest. Raju was never left alone. He constantly had villagers outside of the temple protecting him. He finally vouched that he would stop thinking about food for the next ten days. He was finally making a true effort to be the Swami everyone saw him as and maybe this was his new dharma. Concentrating on something other than money and love gave him a new trill to actually keep with his promiseto fast in order to end the draught. Soon enough, Raju attracted attention from all over that he was being interviewed and appointed doctors by the government. By his tenth day of fasting, Raju's heal th was declining drastically, but tomorrow would be his last day of fast. On the eleventh day, Raju went down to the river, stepped into his basin, looked towards the mountains, said a prayer, and then opened his eyes. He said to Velan, "it is raining in the hills. I can feel it coming up under my feet, up my legs" (Narayan 196). In the beginning of the novel, we see that Raju is greedy and accepts all gifts given to him, though he knows that the villagers are suffering from the failing crops and lack of rain. When villagers had asked him questions, Raju came up with answer s that the people had believed because of his prestigious role in their caste system . He was pretending to be the swami to save the hopes of the people. At the end of chapter six, he finally feels guilty and admits his true dharma to Velan. Going forward to chapter eleven, we get Velan's reaction, which is not much

Paper Proposal Research

Paper Proposal Research Paper Proposal Research Paper Proposal Research: Think before Writing Writing of a paper proposal is the first step you should take before getting down to your paper project. You may wonder whether it is really necessary to write this paper proposal. Yes, it is! But it should be noticed that many students do not understand why they have to write any additional papers except their assignment paper. So, lets explain you the issue. Actually, you support your prospective paper project by writing a paper proposal. You should convince your audience that the topic your have chosen is actual. Besides, you should prove that it is not studied completely; that is why your investigation is worth making. Thus, you see that the success of your paper project depends on a paper proposal considerably. That is why you should think over your paper proposal well and make a kind of paper proposal research. That means that you should think over what points you will highlight in your paper proposal and in what way you will put them. Paper Proposal Research Writing Steps Speaking about the paper proposal research one can point out the following steps you should take to write a convincing paper proposal: Topic. It is obvious that any paper proposal research should begin with studying of the topic you are going to write your paper project on. What kind of study should it be? You should answer the following questions:What are the matter points of the topic? Is the chosen topic actual? Who investigated it before? Of course, you should also provide the background information in your paper proposal. So, you should study informational materials on the topic properly. Literature. You should review informational sources that your paper will be based on. State works of researchers who investigated the issue. This part of your paper proposal research should prove that, firstly, your project has the solid basis and, secondly, you have already studied some information on the topic. Research question. What ex actly are you going to study? You should determine a point of the topic that is the most interesting for you and state it in your paper proposal. Methodology. In what way are you going to make your investigation? You should determine what methods you will apply in your study. Forecasts. How can you catch the interest of your audience? Of course, by making some predictions. So, what results of your study do you expect? Giving some forecasts at the end of your paper proposal will make it intriguing. Paper Proposal Research: Get Help! Thus, these are the main steps of the paper proposal research that will help you write a good paper proposal. If you have any difficulties with your paper project proposal writing, you may look for help in any paper project proposal sample placed in the Internet or contact us! We guarantee you professional help!

The importance of pharmacovigilance in risk management The WritePass Journal

The importance of pharmacovigilance in risk management Introduction The importance of pharmacovigilance in risk management IntroductionOBJECTIVEBACKGROUNDCONCEPT OF PHARMACOVIGILANCEPHARMACOVIGILANCE RESPONSIBILITYMarketing Authorisation Holder (MAH):Competent Authorities (CA)KEY STEPS IN PHARMACOVIGILANCESignal detectionBenefit-risk AssessmentPharmacovigilance during pre-authorisationPharmacovigilance during post-authorisationPHARMACOVIGILANCE REPORTINGPeriodic Safety Update Reports (PSUR)RISK MANAGEMENT PLAN (RMP)EU Risk Management PlanPHARMACOVIGILANCE PENALTIESEUDRAVIGILANCEPRACTICAL APPROACH TO PHARMACOVIGILANCENEW 2010 PHARMACOVIGILANCE LEGISLATIONSUCCESS EXAMPLES OF PHARMACOVIGILANCECONCLUSIONLIST OF REFERENCESRelated 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. 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  Ã‚   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 strategy 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 industries? Part 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 industries? Part 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: 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 industries? Part 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 ([emailprotected]), 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: 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; 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 ([emailprotected]), 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: 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: 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: 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: mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodPharmacovigilancePractice/Frequentlyaskedquestions/index.htm (assessed on 9th May 2011)

Network Topology Design Assignment Example | Topics and Well Written Essays - 250 words - 1

Network Topology Design - Assignment Example Major emphasis has been laid on the use of a three-layer hierarchical model. The company’s initial network configuration revolved around ten (10) users. This lays the foundation for the first network topology. By the end of the first twelve months, the number of users or employees rose to one hundred. Consequently, this rise in the number of employees acts as the building for the second network topology design. Lastly, it is projected that in the second year, the number of employees will again rise by one hundred. As indicated in the network topology diagram below, the initial computer network configuration at the company is composed of ten user computers. This is to offer services to the company’s ten employees. For efficiency and smooth connectivity, a three-layer hierarchical network model has been applied. This is to promote successful execution of the day-to-day company operations. In essence, the model provided a quality platform for flexibility, which is a key requirement for the aggressive expansion in the company’s networking operations. The assumption for this initial model is that, virtual private network connectivity is the main security mechanism. This is because, as indicated in the diagram, all operations are within a network that has been well integrated into one coherent unit (Karris, 2009). It is essential to clarify that the second diagram below provides an extended version of the initial company network. This is because the number of employees has increased to one hundred. The main assumption for this network configuration is that it is divided into two virtual local area networks (VLANS). That is, each router is composed of its own local area network. This is to promote efficient management of each segment of the company network where one of them connects to the company warehouse. It has also been assumed that, each of the switches has a minimum