Beaver’s Self-Report Family Inventory | Evaluation

Beaver’s Self-Report Family Inventory | Evaluation Contents (Jump to) Introduction Literature Review Psychological Test Beaver’s Self-Report Family Inventory Administration of SRFI Scoring and Interpretation of SRFI Validity and Reliability Strengths Limitations Conclusion References Introduction This write up is to analyze the effectiveness of an instrument used as a psychological test to gather information. The chosen instrument is Beaver’s Self-Report Family Inventory – Version II (SRFI). Parents and family environment or more appropriately family relationship plays a very important role in the well-being of children. (Lambert,M., 2010) In Malaysian context, discipline problem is an increasing phenomenon in primary schools as well as secondary schools. The root cause or the first and foremost reason behind those discipline problems is the family environment and relationship. SRFI is considered to be an instrument that can help the counselors and other helping professionals to identify the family functioning so that further plans can be done in order to help the children. Literature Review Previous literature on family assessment instruments for use in child welfare includes descriptions of instruments (Pinsof, 2009) and guides for developing comprehensive assessment strategies as part of community-based child welfare services reform (Pinsof, 2010). This structured literature review builds on these efforts by identifying the most valid and reliable instruments that address the following four federally-defined domains of family assessment: (1) patterns of social interaction, including the nature of contact and involvement with others, and the presence or absence of social support networks and relationships; (2) parenting practices, including methods of discipline, patterns of supervision, understanding of child development and/or of the emotional needs of children; (3) background and history of the parents or caregivers, including the history of abuse and neglect; and (4) problems in access to basic necessities such as income, employment, adequate housing, child care, t ransportation, and other needed services and supports (US, HHS, 2006). Several additional behaviors and conditions have been associated with child maltreatment, such as domestic violence, mental illness, poor physical health, disabilities, and alcohol and drug use. Ideally, a comprehensive family assessment instrument will address these conditions and indicate whether a need for more specialized assessment exists. An objective of this review was to identify measures that addressed these behaviors and conditions as part of a comprehensive family assessment strategy. However, the review of specialized instruments for these conditions and various disabilities was outside the scope of this review. A structured review on the assessment of children and youth in the child welfare system is the focus of a separate review. These major theoretical and disciplinary influences have given rise to several practical issues when considering the appropriateness of a family assessment measure and met hod. While there are many approaches, family assessment methods typically fall into three categories: client self-report, observation, and interviews. Each of these methods has its advantages and disadvantages. A key distinction is the degree to which the method is formalized. Formal methods, such as self-report questionnaires, tend to have procedures that are clearly outlined to facilitate consistently repeated administrations. By contrast, informal methods such as interviews may be less clear in their specification and more variable in terms of administration. Family assessment measures also vary in terms of the perspective obtained. Typically, child welfare practitioners will consider the perspectives of multiple individuals during the family assessment process, including â€Å"insider† reports from family members and children as well as â€Å"outsider† reports from school personnel, extended family members, and others that may be involved with the case. Integration of the assessment of multiple reporters with insider and outsider perspectives is reflected in the â€Å"multisystem-multi method† (MS-MM) approach (Greenberger, 2000) Self-report questionnaires provide a unique insider view of family life as well as reliable methods, simplified administration and scoring, and a measurable link between an individual’s perceptions or attitudes and behaviors. Given these advantages, they are by far the most commonly used method in research as well as in practice. Observation rating scales provide another cost-effective method of generating outsider information regarding family interaction patterns that can also be evaluated for reliability and validity. However, rating scales can also be limited in their usefulness by the competence of the rater and the psychometric quality of the scale. Raters must have a clear understanding of the concepts that are measured and the behaviors that represent the concepts in practice. They must also poss ess adequate knowledge of different populations in order to place observed behavior on a continuum, a concern that adequate training and clinical supervision can begin to address. However, as with self-report measures, evidence of the validity and reliability of an observational rating scale is critical in the instrument selection process, particularly with regard to specific stages of assessment. Psychological test Psychological tests are administered by many different professionals to many different individuals, and the results of these tests are used in ways that significantly affect us and those around us. Psychological test is something that requires us to perform behaviour to measure some personal attribute, trait, or characteristic or to predict an outcome. Psychological tests can differ in terms of how they are administered and their format. A test can be administered in paper-and-pencil format (individually or in a group setting), on a computer, or verbally. Similarly, a psychological test may consist of multiple-choice items; agree/disagree items, true/false items, open-ended questions, or some mix of these. There are also tests that ask respondents to perform some behaviour such as sorting cards, playing a role, or writing an essay. Psychological tests can differ in terms of how they are scored and interpreted. Some tests are completed on scan able sheets and are computer scored. Some are hand-scored by the person administering the test. Others are scored by the test takers themselves. In terms of interpretation, some tests generate results that can be interpreted easily by the test taker, and others require a knowledgeable professional to explain the results to the test taker. Psychological tests have various similarities and many differences. All psychological tests require an individual to perform one or more behaviours, and these behaviours are used to measure some personal attribute, trait, or characteristic thought to be important in describing or understanding behaviour or to predict an outcome. However, psychological tests can and do differ in terms of the behaviours they require individuals to perform, the attributes they measure, their content, how they are administered and formatted, how they are scored and interpreted, and their psychometric quality. All good tests have three defining characteristics in common. First, they include a representative sa mple of behaviours. Second, they collect the sample under standardized conditions. Third, they have rules for scoring. When using psychological tests, we must make some assumptions. We must assume that a test measures what it says it measures, that any inferences that are drawn about test takers from their scores on the test are appropriate, that an individual’s behaviour (and therefore test scores) will remain stable over time, that individuals understand test items similarly, that individuals can and will report accurately about their thoughts and feelings, and that the test score an individual receives is equal to his or her true behaviour/ability in the real world plus some error. Testing professionals refer to psychological tests in various ways. Sometimes they refer to them as tests of maximal performance, behaviour observations, or self-report. Sometimes they refer to them as standardized or non-standardized. Other times they refer to them as objective or projective. P rofessionals also refer to tests based on the dimensions they measure. It is important to remember the distinctions among four commonly misunderstood terms: psychological assessment, psychological test, measurement, and survey. First, although both psychological assessments and psychological tests are used to gather information, a psychological test is only one of many tools in the psychological assessment process. Second, a psychological test can be considered to be a measurement when the sampled behaviour can be expressed in a derived score. Third, psychological tests are different from surveys in that psychological tests focus on individual differences and often report one overall derived score (or scaled scores), and surveys focus on group similarities and typically report results at the question or item level. Beaver’s Self-Report Family Inventory (SRFI) Version II The Self-Report Family Inventory: Version II (SRFI) is a 36-item measure of perceptions of family functioning in five domains: Health/Competence, Conflict, Cohesion, Leadership, and Expressiveness. The instrument is a screening device to assess a family member’s view of overall family competence, based on the Beavers Systems Model of family functioning. Each item is rated on a 5-point scale; for the first 34 items, the scale descriptors are 1 = YES: Fits our family very well, 3 = SOME: Fits our family some, and 5 = NO: Does not fit our family. The last two items have response scales specific to the items. Lower scores represent greater family competence. Administration of SRFI It is a paper pencil method of administration for children aged 12 and above and also for the adults in the family. Interview also can be done for those who are illiterate or have reading and writing problem. Time given is within 5 to 10 minutes. Scoring and Interpretation of SRFI Summary scores for each of the five subscales can be obtained as follows: (An â€Å"R† refers to an item score that must be reversed prior to summing). To reverse score, change all numbers where indicated to their opposite. For example, five becomes a one, four becomes a two, three stays the same, two becomes a four, and one becomes a five. Health/Competence: Items 2, 3, 4, 6, 12, 15, 16, 17, 18R, 19R, 20, 21, 24R, 25R, 27R, 28, 33, 35, and 36 Conflict: Items 5R, 6, 7, 8R, 10R, 14R, 18R, 24R, 25R, 30R, 31R, and 34 Cohesion: Items 2, 15, 19R, 27R, and 36 Expressiveness: Items 1, 9, 13R, 20, and 22 Leadership: Items 8R, 16, and 32 For each numbered item, fill in the score from the SFI. For items , reverse the score and enter the reversed score on the score sheet. Lower scores represent greater competence and higher scores indicate greater problems within the system. Validity and Reliability of SRFI Validity was measured by correlating the SRFI with the observational scales of the Beavers System Model. The results indicate a high degree of convergence of family constructs across the two methods at .62 or above (Beavers Hampson, 2000). The authors claim that this indicates that the SRFI is roughly equivalent to observations (Drumm, M. Carr, 2000). The authors of the instrument report high internal consistencies reliability with Cronbach alphas between .84 and .93 and test-retest reliabilities of .85 or better (Beavers Hampson, 2000). Strengths The great advantage of SRFI is that it gives the respondents’ own views directly. It gives access to phenomenological data, i.e., respondents’ perceptions of themselves and their world, which are unobtainable in any other way. Furthermore, self-report methods can be used to obtain information in situations where observational data are not normally available. Able to study large samples of people fairly easy. Able to examine a large number of variables. Can be carried out relatively cheaply. Limitations The main disadvantage of self-report is that there is a number of potential validity problems associated with it. The data are personal and idiosyncratic and thus may bear little relationship to ‘‘reality,’’ as seen by you or others. More importantly, people are not always truthful. Furthermore, research participants may not be able to provide the level of detail, or use the concepts, that the researcher is interested in. People may not respond truthfully, either because they cannot remember or because they wish to present themselves in a socially acceptable manner. We cannot establish cause and effect relationships from survey data as other variables which could have had an effect may not have been considered in the questionnaire or interview. It may be difficult to obtain a random sample of the population because some people who are selected refuse to answer questions or it may be difficult to obtain a full list of the population from which to select a random sample. Conclusions SRFI is best use for a quick access of information and it is easy to administer. To have a comprehensive assessment of family the same SRFI can be used as a tool for interview for a qualitative research. More information can be gathered if it is used while observing the family with their consent. Teachers, counsellors and discipline masters in school can use SRFI to plan future programs in order to help the children with complicated family background. It will be a very helpful tool in school environment. References Beavers, R., Hampson, R. B. (2000). The Beavers System Model of Family Functioning. Journal of Family Therapy, 22(2), 128-143. Drumm, M., Carr, A., Fitzgerald, M. (2000). The Beavers, McMaster and Circumplex clinical rating scales: A study of their sensitivity, specificity and discriminant validity. Journal of Family Therapy, 22(2), 225-258. Greenberger, E., Chen, C., Beam, M., Whang, S. M., Dong, Q. (2000). The perceived social contexts of adolescent misconduct: A comparative study of youths in three cultures. Journal of Adolescent Research, 10(3), 365–388. Johnson, L., Ketring, S., Anderson, S. (2010). The Intersession Report: Development of a short questionnaire for couple’s therapy. American Journal of Family Therapy, 38, 266–276. Kim, S. Y., Ge, X. (2000). Parenting practices and adolescent depressive symptoms in Chinese American families. Journal of Family Psychology, 14, 420–435. Lambert, M. (2010). Prevention of treatment failure: The use of measuring, monitoring, and feedback in clinical practice. Washington, DC: American Psychological Association. Miller, S., Duncan, B., Brown, J., Sorrell, R., Chalk, M. (2006). Using outcome to inform and improved treatment outcomes: Making ongoing, real-time assessment feasible. Journal of Brief Therapy, 5, 5–23. Pinsof, W., Chambers, A. (2010). Empirically informed systemic psychotherapy: Tracking client change and therapist behavior during therapy. In J. Bray M. Stanton (Eds.), The Wiley-Blackwell handbook of family psychology (pp. 431–446). Oxford, UK: Blackwell. Pinsof, W., Zinbarg, R., Lebow, J., Knobloch-Fedders, L., Durbin, E., Chambers, A., et al. (2009). Laying the foundation for progress research in family, couple, and individual therapy: The development and psychometric features of the initial systemic therapy inventory of change. Psychotherapy Research, 19, 143–156. U.S. Department of Health and Human Services. (2006). Comprehensive Family Assessment Guidelines for Child Welfare. Washington, DC: Administration for Children and Families Childrens Bureau. www.ets.org www.pearsonassessments.com www.hoganassessments.com www.ipat.com www3.parinc.com www.psytech.co.uk www.psionline.com www.testagency.com www.upress.umn.edu/tests/default.html Should The Abortion Be Encouraged? Should The Abortion Be Encouraged? Abortion is a process of termination of pregnancy. The classic definition of abortion is the expulsion of the fetus before it is viable. This could include spontaneous abortion, which is a miscarriage, or induced abortion such as a doctor, the woman herself, or a layperson causes the abortion. Before modern methods of abortion, this sometimes meant the introduction of foreign objects like catheters into the uterus to disrupt the placenta and embryo (or fetus) so that a miscarriage would result (Family Jrank 2002). Abortion can be carried out by few ways such as taking pills and operation. Statistical information and cases. According to the report prepared by the Better Health Channel, in the year 1990, 23 percent of all pregnancies in Australia were terminated. This makes abortion become one of the most common surgical in the country with around 80,000 women undergoing abortion every year. Our current ratio of one abortion in every four pregnancies is an improvement over the estimated one in three recorded in Australia in the 1930s. Australias abortion rate is reasonably low by international standards compare to the United States of America has a 30 percent abortion rate. The majority of the Australians support the idea of the safe and legal abortion. The typical profile of a woman who is seeking abortion includes the ages in the 20s, single, educated and childless. Thesis statement This study has been carried out to determine whether abortion should be encouraged to the public. This study investigates the advantages and the disadvantages of the abortion to conclude that whether abortion should be encouraged to the public. This study draws on information gathered from International articles, World Wide Web sites, books and a survey. Abortion should be encouraged. First, abortion should be encouraged because an unwanted childs future will be affected. The young parent such as the teenager who has the unplanned pregnancy, they are unable to provide a good environment for the child. The teenager which is still studying and they do not have a job which causing them could not give a good environment to the child. Most of the juvenile crime happened is because of the children did not grow up in a good environment. Children who not grow in a good environment will cause them to do illegal things for getting attention from the others (Associated Content 2006). An unwilling parent is unlikely to be a good parent so the unwanted child is far more likely to drop out of school or commit acts of violence than children who are wanted, nurtured and well parent. The young parents are unable to take care of the child because they are immature. Parents play an important role in the childs education but the young parents have an immature mind so they can not give a good example for their child. When the young parents did something that is immature w ould affect the child do to the same mistake too. The young parents can not give accurate information that parents should give because their immature mind can not differentiate the rights and wrongs. If their children had done some mistake, the young parent could not give the right punishment and guide the child to the right pathway. In an addition, abortion should be encouraged because the future of the young parent would be affected if there is an unplanned pregnancy. According to the book, Should abortion rights be restricted? (2003), when a teenager is pregnant she has to face social problems, such as reduced education and employment opportunities. They are forced to stop their education because they have to spend more time on the child. For example, the young parent has to work hard to earn money for feeding the child. And due to the low education of the young parent, jobs with higher salaries may not want to hire them. There are only low salary jobs that would hire the low education teenager, which are typically hard-working employment types. The teenager could not afford to that job which is too heavy work. This will cause them to do illegal things to earn more money for their family such as become a robber, a thief, drug dealer and so on. And they will have to take the risk of getting caught by the police and going to jail. They also may be influenced by criminal associates and addicted to bad habits, such as smoking and gambling. So if they have an abortion, their future might include a  high standard of education, working with a high salary job and live happily. Furthermore, abortion should be encouraged because it can prevent the unwanted child. There are some cases such as rape or the incest pregnancy which is an unwanted pregnancy. The trauma will follow all of her life after the raping case, therefore, abortion is the right way to solve this problem or else an unwanted child would be the nightmare for the mother. We can not force a girl in her early age to become a mother after being raped. Abortion should be done toward the mother whom she does not know who is the father of the child. It will be a very hard life for the mother and the child which without a father. The mother is not ready to enter the parenthood yet. It is not easy to bring up a child by a single mother. The mother has to work hard for the child and have to spend time on taking care of the child at the same time. If a child grew up as a homely and because of it an unloved child, he or she will remember those painful experiences for the rest of your life (Associated Content 2007). Abortion should not be encouraged. On the other hand, abortion should not be encouraged because of the humans right. It is a process that is too cruel to a baby. The most basic human right of the human is the right to life there is no doubt which everyone knows it. The Catholic Bishop of the United States stated that since human life is sacred from conception until natural death, they contend, abortion is immoral. A person who did abortion is a murder because this action is taking away a human persons life. It is so unfair for a child who does not have a chance to enter this world. It is no different between abortion and infanticide. The parent should think about the rights of the child and not just make such selfish decide by their own opinion. We should appreciate the life that the god gives. It is the fate that the parent who get an unplanned pregnancy. God give them a chance to have a baby and guide them to another stage of life. All people, regardless of the circumstances of their conception, or whether they are healthy or handicapped, have been personally knit together by Gods fingers. He has planned out all the days of the unborn childs life before one of them has happened (Leadership U 1992).Some of the people might think that the embryo is just a bunch of cells but it actually a soul is inside the embryo. We have human rights because we are human beings. Therefore, direct abortion is never a morally tolerable option. Moreover, abortion should not be encouraged because a womans health would be affected badly by abortion. Abortion brings both physically and mentally harms to women. A woman who done the process of abortion has to face some physical health problem. Abortion is linked to the breast cancer due to the hormone changed after the abortion and resulting in an increase in a number of new breast cells. Infertility also one of the health problems that have to face by whom had done the process of abortion. As everyone knows that infertility which means being unable to have a child is a high risk of the abortion procedure. This health problem occurs is because, during the process of abortion, it damaged our uterus. Abortion brings mentally disturb to a woman too. At the early emotional effects, many women will experience the feelings of relief and numbness. In the later emotional effects, they have to face the complex feelings. They will have some complex feelings such as depression, tearfulness, guilt, anger, shame and so on. The mother who done the process of abortion may find difficult to face t he others who are pregnant or have babies. Flashbacks to the abortion experience also one of the mentally disturb to those who done abortion procedure. In a study report, 92 percent of women who have had an abortion will also feel guilt on that. As stated in Leadership U(1992), the mother would hear this little voice in her head says she is a terrible, awful person because she had done abortion. Due to the guilty feelings on taking away the childs life, they will feel very regret on it and causing they have an illusion that there is a ghost child following them. Lastly, abortion should not be encouraged because the parents have to take their responsibilities seriously towards the child. The parents behave badly so they have to pay the price. As a parent, they should know the values of a childs life and not just take abortion as an easy way to solve problems. Once they get pregnant, they have to do what a parent should do which they have to put afford on the baby and being a good example for the child. To prevent the same mistake again, they should give birth to the child and take care of the child. Whether or not a baby is unwanted is irrelevant. Just because a human being is not wanted does not mean that the human being has no value or should be killed. In addition, there are huge numbers of families who are willing to adopt those unwanted babies. So, those babies are wanted, not unwanted (CARM 2001). Conclusion Based on the evidence above, I strongly disagree abortion should be encouraged. It can not be a smart choice for the parent to do abortion. Abortion brings many disadvantages to the mother such as health problem as stated above. It brings both physically and mentally side effect. Abortion also is an immoral activity which is killing an innocent baby. Besides, if abortion is encouraged, it might cause the citizen to get involve in sexual activities easily because once they get pregnant and abortion could help them to solve the problem. There are many ways to solve the problems of unplanned pregnancy such as adoption, not just abortion. In the 50 sets of the personal survey, 44% of the public thinks that if one of their friends gets an unplanned pregnancy; continue the pregnancy and give the baby up for adoption is the best way for the mother. If the parent does not prepare to have a child yet then they should take action to prevent it before they get pregnant such as a condom. Besides, the government can help to prevent the unplanned pregnancy through education too. For an example, the Minister of Education has to implement sex education in schools to give students a better idea of sexual intercourse. When they get to know more about the sex knowledge, they would know the importance of preventing unplanned pregnancy. Therefore, it helps to prevent it. At the end of the essay, the 50 sets of the personal survey show that 84% of the public do not agree that abortion should be encouraged. The personal survey will be shown in the pie chart below:

Hobbes vs Rousseau Essay

In the 17th and 18th centuries, the Age of Enlightenment was an important cultural movement of intellectuals in Europe. Philosophers of the time interpreted many theories and concepts about man and inequality in civilization and also ideas about government and the ways in which society could be controlled. Many believed that humans were naturally good, while others believed that humans were inherently bad. The argument of nature has lasted throughout time without a definitive answer, but with centuries of philosophical arguments to aid in the understanding of our own human nature. Two important philosophers of this time period were Thomas Hobbes and Jean Jacques Rousseau. Both philosophers wrote about their ideas of human nature and the state of nature, also addressing equality within the state and the role government and civilization plays in man’s actions. While Hobbes had a very cynical view of man, believing man to be brutal and violent working only towards self-interest, Rousseau had a more positive view; depicting man as essentially good and compassionate, believing that only through society and civilization does man become corrupt. Although both philosophers’ arguments are well developed and supported, Rousseau’s understanding of the natural man and the state of nature is stronger than Hobbes’ opposing views. Rousseau’s positive view of human nature illustrates man as living in harmony with nature while Hobbes’ pessimistic view portrays man acting only for self-interest. Rousseau views the mankind as inherently good, capable of feeling compassion and pity for others around him as well as self-love. The condition of this natural man is a man without any forms of civilization, including clothes and language. Man is able to live individually, peacefully and in harmony when he is in this state of inh erent goodness. However, through civilization man becomes â€Å"wicked.† Oppression and dominance develop through the evolution of civilization, also creating inequality among men, destroying the harmony in which they lived. When man is able to satisfy his own needs, he is able to live peacefully (Rousseau 161). Through evolution of society, man is weakened and begins to depend on others to sustain his life, creating oppression and causing man to lose his natural goodness. Hobbes disagrees with Rousseau’s positive view of the nature of man, believing that men are instinctively violent and evil, acting only out of self-interest or for self-gain. He believes men are constantly in competition to become superior in worth or honor, creating continual jealousy and violence among each other. Hobbes believes that men are so brutal and wicked they are unable to survive as individuals but need a strong, central authority to force peace and cooperation among men. Hobbes states, â€Å"Without the terror of some power to cause them to be observed, are contrary to our natural passions, that carry us to partiality, pride, revenge and the like,† (Hobbes 106). Hobbes believes that in order to control man’s instinctive evil, they need to fear the law. Hobbes admits that inequality is a product of creating this commonwealth, but, unlike Rousseau’s idea of inequality in society, Hobbes says men are ignorant to the inequality, believing that the covenants create equal terms of law among men. This false sense of equality is able to control the violence and competition among men, allowing them to coexist more peacefully. So while Rousseau credits civilization to the destruction of peace and goodness, Hobbes does not believe man has any inherent goodness and thinks civilization is the only way to avoid war. Although Hobbes and Rousseau agree that in a state of nature men are equal, they have opposing views of what man is like in this state. A state of nature is a term used to describe a state lacking a form of government or laws. Rousseau believes in the state of nature, man lives individually in harmony with nature. Rousseau addresses this natural man as a â€Å"savage man,† stating that their actions are determined by their needs and these needs are met without the help of others. In this nature, men are peaceful and good. Men also have a natural sense of pity and compassion in this state (Rousseau 163). Because man lives solitarily, there is no one to dominate or control and thus no competition for power. Rousseau believes that this peace is sustained by the ability of the savage man to feel compassion, which allows them to govern the peace of their nature. However, this peace is diminished as inequality becomes prevalent through the progression of society. As property and family units evolved, man began to change his lifestyle and skills and talents developed (Rousseau 164). Families weakened man and woman in mind and body, causing them to rely on others to successfully fulfill their needs. This was the crucial part in development of oppression and domination, because inequality occurs when man becomes dependent on others to survive. Rousseau states, â€Å"But the moment one man needed the help of another; as soon as it was found to be useful for one to have provisions for two, equality disappeared, property appeared,† (Rousseau 167). The relationship between slave-master or worker-owner develop when men requires the help of another. Inequality creates oppression and domination, which, according to Rousseau, destroy man’s inherent goodness. Hobbes’ view of human nature contrasts Rousseau’s dramatically, seeing as Hobbes believed man to be naturally wicked and only through government systems are men able to live peacefully. Hobbes compares man to a machine, constantly in motion and always seeking something (3). He believes human nature is to act for their own self-interest, which causes men to be in constant competition for honor or worth, creating a state of war. Because Hobbes believes that men are constantly in a state of war, he believes that men are always trying to increase their power to be superior to others. He believes that in the state of nature where man is not governed by central authority, men are constantly in competition. Jealousy and competition among men make it impossible for men to live peacefully in a state of nature, creating the need for a strong, central authority to govern over the peace of man. Contrary to Rousseau, Hobbes believes that government is a way for people to â€Å"get themselves out of that miserable condition of war,† by governing peace that men are incapable of alone (Hobbes 106). Hobbes believes that through strong government, men are forced to coexist peacefully, because covenant creates a false sense of equality among men. Hobbes believes that men are incapable of surviving individually, unlike Rousseau who believes that men are better made to live individually. Their differing views of inherent behavior create contrasting conceptions of the state of nature. Based on their arguments of the nature of mankind, Rousseau’s explanation of man is more complete and logical than Hobbes’. In Rousseau’s view of nature, man is essentially good, able to survive on his own and able to peacefully coexist. This view of man could be considered naà ¯ve by some, but it must be considered that this man is also the â€Å"savage man,† a man before any form of civilization. Rousseau explains that a man is inherently good in a state of nature because he has no desire for power, but does feel pity. Rousseau goes into an in depth description of the development of inequality among men, describing oppression and domination developing and the ways in which these factors destroyed man’s intrinsic goodness. Man was unable to live individually in the new state of society, which destroyed their natural goodness. Being unable to live individually, they were forced to rely on others, which created domination and inequality, which leads to competition for power and corruption. The inequality also led to the diminishment of pity and compassion, which was crucial to man’s ability to peacefully coexist. Rousseau’s thorough time-line of man’s condition created a stronger and more agreeable argument than Hobbes’ pessimistic view of man.

Jean Piaget s Theory Of Cognitive Development - 2404 Words

Introduction When we are born we have a different mindset then when we are at adult age. We view our surroundings and experiences differently and even our learning styles differ. Researchers such as Jean Piaget, Erick Erikson, and Lawrence Kohlberg have taken their interest in the areas of developmental growth and through research have brought us fascinating theories and observations. We also have certain developmental milestones in which we have certain abilities that we must learn at certain stages of life. Jean Piaget developed his Stage Theory of Cognitive Development which stated that we progress through our youth into adulthood passing through 4 key stages. Each stage marks a change in the way we understand the world. Erick†¦show more content†¦His theory showed us that we grow through 4 key stages in life, and each stage mark’s a change in how we understand the world. The first stage is the sensorimotor stage which we experience from birth to age 2. In the sensorimotor stage we as infants acquire our knowledge through basically observations and grabbing and touching objects. From here we progress to the preoperational stage from age 2 to age 7. In this stage we as children learn through pretend lay. However, we still struggle with logic and understanding other’s points of view. Then from ages 7 through 11, we experience the concrete operational stage. In the concrete operational stage kids think more logically, but we still have some trouble with logic hypothetical concepts and abstract thoughts. Once we have reached our adolescence, we enter the final stage known as the formal operational stage. In this stage we experience an increase in logic and increase in reasoning. We also begin to understand abstract ideas. Piaget once stated that children don’t possess less knowledge then adults, rather they just view the world differently. Once we examine the formal operational stage and how our thinking changes are in this stage, I began to ponder when I entered this stage. It is hard for me to pinpoint this time for me since I always reminisce on my childhood and admit I was always immature until now. I

How Computers Affected The Privacy Of Citizens - 1655 Words

How have computers affected the privacy of citizens in the U.S - Collection of data by the government from from websites and ISP s. Legal terms-of-use agreements (Kevin Santos) A) Governmental legislations (The Patriot Act of 2001): There have been concerns about privacy of American citizens for many years but, ever since telecommunications advances mainly through computers, there has been a major concern in society. One contributing factor that affects privacy is the governmental legislations. The classic example of this situation was the implementation of the Patriot Act of 2001 after the 9/11 terrorist attacks. Computer technology was already a part of society during the implementation of this law and were available to consumers. Note that this was back in 2001, so computers were not sophisticated as they are today. 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Reviewing A Qualitative And Quantitative Research Article

Reviewing a Qualitative and Quantitative Research Article Do not select a meta-analysis or systematic review Qualitative Research Assignment Directions: Type your article references in APA format and answer the following questions in complete sentences about the article. You do not have to provide in text citations in the answers. (2 points for grammatical issues) APA Reference (9.5 points) Questions (0.5 points each) Critiquing Criteria derived from LoBiondo-Wood Haber, 2010, p. 135-136 Article in APA format here: Vejzovic, V., Wennick, A., Idvall, E., Bramhagen, A. (2014). A private affair: children’s experiences prior to colonoscopy. Journal of Clinical Nursing, 24, 1038—1047. doi:10.1111/jocn.12661 1. What is the phenomenon of interest and is it clearly stated for the reader? The phenomenon of interest is the emotional experiences of children undergoing stressful testing such as colonoscopies and it’s clearly stated. 2. What is the justification for using a qualitative method? 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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. 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Rinspeed Splash Amphibious Hydrofoil Sportscar Essay Example For Students

Rinspeed Splash Amphibious Hydrofoil Sportscar Essay The Rinspeed Splash Amphibious Hydrofoil Sportscar the Splash is capable of 80 kmh (approx. 45 knots) on the water and 200 kmh on land. The design is yet another concept from Swiss creative studio Rinspeed, whose concept designs have graced the pages of Gizmo several times in our short history. Under the ultra-light carbon-composite skin lies much more than just an agile and lively sports car. At the push of a button an hydraulic mechanism transforms the sports car into an amphibious vehicle and an integrated hydrofoil system enables the Splash to fly at an altitude of about 60 cm above the water. The almost magical transformation from a street vehicle into a floating and flying all-rounder is made possible by an electronically controlled high-pressure hydraulic system with an array of sophisticated sensors. The transformation starts at the rear panel, which flips up to reveal a watercraft Z-drive in horizontal rest position. The Z-drive is fitted with a conventional 3-bladed propeller and can be lowered to its fully standing position from the cockpit. The position of the drive is infinitely variable, which guarantees immediate propulsion upon entering the water. A transfer case sends power to the rear wheels, the propeller or both, depending on the input from the pilot. Starting at a water depth of about 1.1 meters the Z-drive can be lowered all the way to its fully standing position. Steering commands are entered via the steering wheel and transferred to the Z-drive. The body of the Splash is designed to be watertight and additional buoyancy chambers are fitted to provide extra lift. Also borrowed from shipbuilding are a bulkhead design with independent chambers and bilge pumps in case some water does find its way into the cockpit or the engine bay. Fourteen rubber bellows guarantee freedom of movement of drive train, suspension and steering. The Splash is powered by an environmentally friendly bivalent turbocharged natural-gas engine. Natural gas is an extremely clean-burning fuel that consists almost entirely of methane with near-zero sulphur content. A turbocharged two-cylinder four-valve 750cc engine powers the Splash, delivering maximum power of 140 bhp/103 kW at 7000rpm and peak torque of 150Nm at 3500 rpm. Though the Splash has only a small motor, its street performance is nothing to be ashamed of: the 825 kg quick-change artist accelerates in to 100kmh in 5.9 seconds and reaches a top speed of 200 kmh.