The Affect on Emotional Intelligence on Effective...

FIT - BUS 5450 Assignment 1: Research Analysis and Proposal The Affect of Emotional Intelligence on Effective Leadership â€Å"Emotional intelligence is the ability to manage one’s own and others’ in order to guide one’s behavior and achieve goals† (Salovey, Mayer, 2005). In simple words, EI is the ability to perceive, control, and evaluate emotions, that is, to regulate your own emotions, and the ability to cheer up or calm down another person. Building on the work of Mayor and Salovey (1997) and others, Goleman (1998) further suggested that there are five critical pillars or competencies of EI, namely self-awareness; self-regulation; self-motivation; social awareness (empathy); and social skills. According to Merriam-Webster website†¦show more content†¦According to the Salovey, Mayer and Caruso four-branch model of emotional intelligence, it is through the establishment of these strong interpersonal relationships that allow for leaders to generate motivation and instill optimism and enthusiasm within his/her followers. Being able to accurately appraise and expre ss emotions ensures the effective communication between individuals and thus provides them with a deeper understanding of the people they work with (Carmeli, 2013, p791). By creating an atmosphere of cooperation and having an improved perception of emotion, followers will be more supportive of a leader’s decisions and thus be more obliged to appreciate and promote the organization’s objectives (Zeidner et al, 2004, p387). The ability to communicate effectively with followers allows a leader to connect on an individual basis and to inspire and share collective visions with the team. Goleman cited in Lam and O’Higgins (2010, p151), â€Å"Empathy†¦ is the fundamental people skill.† showing the concept of ‘social intelligence’ overlapping with that of emotional awareness and the importance of understanding and sympathizing with the concerns, requirements and unspoken feelings of others. As high quality interpersonal relationships significant ly enhance group cohesiveness and collaborationShow MoreRelatedEmotional Intelligence ( Eq )950 Words   |  4 PagesEmotional Intelligence (EQ) can best be described as the ability to identify and manage your own emotions as well as others (Psychology Today). Generically speaking, this definition will suffice, but the more detailed levels of understanding help provide a clearer picture as to what emotional intelligence is. A high level of EQ has a direct correlation with effective leadership because both subjects involve groups of people. Emotional Intelligence can be broken up into five categories, all of whichRead MorePersonal Statement On Emotional Intelligence1593 Words   |  7 Pages Emotional Intelligence Tanveer Vora 1610793 University Canada West Professor: Dr. Michele Vincenti MGMT601 Leadership in the Global Context 16th January 2017 Abstract The paper discusses about the emotional intelligence, which has various factors. The factors are self awareness, motivation, self regulation, social skills and empathy. In case of effective leadership, these factors plays major role. However, emotional intelligence is teachable to improve the personal skills and personality.Read MoreEmotional Intelligence Of Leaders By Daniel Goleman1322 Words   |  6 Pages In Daniel Goleman’s article, â€Å"The emotional intelligence of leaders,† he asserts that emotional intelligence not rational intelligence is what distinguishes exceptional leaders from average leaders. Biologically speaking, feelings and emotions developed in the limbic system before the development of rational thought in the cerebral cortex. Emotional intelligence involves the balance and synergy between the emotional and rational centers of the human brain. Goleman, a psychologist who has writtenRead MoreThe Integration Of Emotional Intelligence Into Healthcare1583 Words   |  7 PagesIntegration of Emotional Intelligence into Healthcare Throughout today’s healthcare industry, many organizations have been constantly striving to stay ahead of the competition. One area of focus has been improvement of the organization’s leaders. In order to create a strong organizational culture and successful healthcare system, effective leadership is needed. It is thought that one major characteristic that aids in the effectiveness of many leaders is the ability to utilize their emotional intelligenceRead MoreEmotional Intelligence : An Effective Leader Needs Essay741 Words   |  3 PagesAccording to Dictionary.com, emotional intelligence is defined as â€Å"skill in perceiving, understanding, and managing emotions and feelings† (dictionary.com). The definition developed by Peter Salovey and John Mayer indicate â€Å"Emotional intelligence is the ability to perceive emotions, to access and generate emotions so as to assist thought, to understand emotions and emotional knowledge, and to reflectively regulate emotions so as to promote emotional and intellectual growth† (Mayer Salovey, 1997)Read MoreLeadership Definitions Of Leadership As A Leader1224 Words   |  5 Pagessituations. The important question is; â€Å"what is leadership?†. Many people question what this term means as it is a fundamental skill which is required in the workforce (Avery, 2004). Leadership definitions have been approached in various ways with many authors relating to the nature of leadership rather than distinctively defining the term itself (Antonakis, Cianciolo, Sternberg, 2004 cited in Northouse, 2014). Many factors contribute to the meaning of leadership; behaviours, influences and theories allRead MoreEmotional Intelligence And Organizational Leadership1445 Words   |  6 PagesEmotional Intelligence and Organizational Leadership Various authors have been debating the issue of emotional intelligence and organizational leadership. However, the existing discourse on the matter has been hampered in terms of limited theoretical applications. Moreover, many analysts have failed to propose effective relationships among constructs, thus failing to offer any meaningful relationship between emotional intelligence and organizational leadership. Nevertheless, many authors offerRead MoreEmotional Intelligence And Psychological Intelligence1493 Words   |  6 Pagescalled â€Å"emotional intelligence† which puts you in tune with not only your emotions but the emotions of others as well. This paper will fully explain â€Å"emotional intelligence† along with examples of the concept, examine the theories of â€Å"emotional intelligence† compared to traditional â€Å"intelligence quotient†, suggest reasons why leaders’ need emotional intelligence in today’s workforce, speculate o n the consequences when leaders do not possess emotional intelligence, explore elements of emotional intelligenceRead MoreThe Impact Of Emotional Intelligence On Leadership999 Words   |  4 PagesThe Impact of Emotional Intelligence on Leadership and Leadership development in the non-profit sector. Gone are the days of intelligence relating only to academia and the testing of the intelligence quotient (IQ). The 21st century brought about the introduction of â€Å"emotional intelligence† as an added skill set in a leader’s tool kit. Essentially, the ability be aware and manage one’s own emotions, the others emotions, and effectively applying that information to guide ones thinking and actionsRead MoreLeadership Styles And Emotional Intelligence1160 Words   |  5 PagesExtremera, 2014; Sadri, 2012). Part of developing effective social skills or intelligence is increasing organizational awareness (Boyatzis, 2011). Organizational awareness is the ability to recognize and comprehend the overt and covert emotional currents as well as power relationship within groups. Leaders with organizational awareness understand the culture and corresponding dynamics (Boyatzis, 2011). Leadership Styles and Emotional Intelligence Leadership can be broken down into two major categories

India- a Growing Country Free Essays

India- A growing country India is growing forward day by day. New methods of science and technology have been introduced since years†¦. Many of the new techniques have been introduced in the field of agriculture†¦ so India has been growing economically forward†¦ great majority of people use science in their day to day life for many purposes†¦ Overall in my point of view the science and technology is improving†¦ Science is the human endeavor to discover truths about the world around us. We will write a custom essay sample on India- a Growing Country or any similar topic only for you Order Now Scientists seek out answers through observation and experimentation. As we discover more and more, we are able to apply what we’ve learned to develop new technologies and to improve everyday life. But perhaps more importantly, as we gain knowledge through science, we are able to begin satisfying our deep-felt need to know more about ourselves. The word â€Å"science† comes through the Old French, and is derived in turn from the Latin scientia, â€Å"knowledge†, the nominal form of the verb scire, â€Å"to know†. The Proto-Indo-European (PIE) root that yields scire is *skei-, meaning to â€Å"cut, separate, or discern†. Similarly, the Greek word for science is ‘ ‘, deriving from the verb ‘ , ‘to know’. From the Middle Ages to the Enlightenment, science or scientia meant any systematic recorded knowledge. Science therefore had the same sort of very broad meaning that philosophy had at that time. In other languages, including French, Spanish, Portuguese, and Italian, the word corresponding to science also carries this meaning. Technolgy make life more convinient It is used in every house for work . because any house work depend upon this It is used in hospitals in many operation to save people life Organisation,office to communicate ,make wrk up to date with speed and reliability. hrough they can interact ,make presentation. Does modern technolgy make life more convenient,or was life bette when technolgy was simpler? Life was simpler and better before technology . however before technology ,any single work need a lot of time to do and there is no security and reliability in this and it is difficult to lead without technology. after advent of technology ,it ease the work and create more reliability and everything done very easily . before technology we have to communicate one person to another person who live another city ,it take days to†¦ How to cite India- a Growing Country, Essay examples

Rizal free essay sample

When Racial was a sophomore at the University of Santos Atoms and was boarding in the house of Dona Conchs Leave in Intramural he met Eleanor Orange Valuable, his next-door neighbor and daughter of Capitan Juan and Capitan Sandy Valuable. She was a tall girl who carried herself with grace and elegance. Exchanging Love Notes Racial was always welcome at the Valuable home. He eventually courted Eleanor by sending her love notes, which he wrote in invisible ink made from a mixture of water and table salt.He taught Eleanor how to read his letters by heating them over a lamp or a candle to allow the words to surface. Unfortunately, as with his first love, Jose failed to ask for the ladys hand in marriage. Dry. Jose P. Racial is one of the most outstanding student in University of Sandstorms some says that Dry. Jose P. Racial is discriminated against by the university, unfairly treated, recipient of poor grades, dissatisfied with the teaching methods, suffocated by Atomistic philosophy but none of these current opinions, carelessly repeated in textbooks and biographies and easily digested by the students, has foundation in real history. Just like the common people, our national hero also been in loved. Many women were linked to his name. He loved Leonor Rivera, who was his cousin. But he was forced to go to Europe to study medicine, ordered by his brother Paciano, in order to fight against the Spaniards. He became a traveler, and each country he visited, there were always important events that occurred. It was just sad that Rizal did not marry any one of those women and did not have a single child that will continue his blood and will inherit his intelligence. Rizal wrote two novels, the â€Å"Noli Me Tangere† and the second part of it, the â€Å"El Filibusterismo†. The novels reveal how the Spaniards rule the Philippines, how the rights of the Filipinos were abolished and how they abuse their power over the Filipinos. The genius, Dr. Rizal, portrayed himself in his two novels. These two novels awaken the Filipinos and started the revolutionary heart out of them. This was the start of the real fights against the cruel Spaniards. Rizal was never afraid whatever the consequences he may suffer because of his writings that are against the Spaniards. He wanted to free the Philippines from the unjust and cruel government of Spanish colony. Dr. Rizal was a patriot, hero, and a martyr. He sacrificed his own life, for the freedom n and welfare of the Filipino people. He really deserved the respect and salute of all Filipino people not only in these generations but also the next and the next. Rizal indeed deserved to the Philippines National Hero.

The House on Mango Street Seeking Independence Essay Example For Students

The House on Mango Street: Seeking Independence Essay In the book The House on Mango Street, author Sandra Cisneros presents a series of vignettes that involve a young girl, named Esperanza, growing up in the Latino section of Chicago. Esperanza Cordero is searching for a release from the low expectations and restrictions that Latino society often imposes on its young women. Cisneros draws on her own background to supply the reader with accurate views of Latino society today. In particular, Cisneros provides the chapters Boys and Girls and Beautiful and Cruel to portray Esperanzas stages of growth from a questioning and curious girl to an independent woman. Altogether, Boys and Girls is not like Beautiful and Cruel because Cisneros reveals two different maturity levels in Esperanza; one of a wavering confidence with the potential to declare her independence, and the other a personal awareness of her own actions and the decision to take action and wage her own quiet war (Cisneros 89). We will write a custom essay on The House on Mango Street: Seeking Independence specifically for you for only $16.38 $13.9/page Order now Author Sandra Cisneros was born in 1954 in the Latino section of Chicago (Encarta 1). Cisneros is an American novelist, short-story writer, essayist, and poet (Encarta 1). Her works have brought the perspective of the Mexican American woman into the mainstream of literary feminism (Encarta 1). She earned her Bachelors Degree from Loyola University in 1976 and her Masters Degree from the University of Iowa in 1978 (Encarta 1). The House on Mango Street is Cisneros first novel, and is her most critically acclaimed (Encarta 1). The novel is constructed with a series of short interconnected chapters (Encarta 1). Cisneros writes of the hopes, desires, and disillusionments of a young writer growing up in a large city (Encarta 1). After reading The House on Mango Street, the reader is left with a greater sense of the everyday oppressions the roles created for women in Hispanic society (Encarta 1). Cisneros decides to accept the oppression as part of culture, but also detach from this view by telling women, old and young alike, to find their own independence. Cisneros uses Esperanza as a vehicle to express the power of womanhood and determination to reach certain goals. In Boys and Girls, Cisneros introduces a gender separation that dominates Esperanzas experiences. Esperanza is dissatisfied that she and her younger sister Nenny are paired as playmates; Nenny is too young to be my friend (Cisneros 8). Esperanza is dependent on her childhood and is like a red balloon, a red balloon tied to an anchor (Cisneros 9). This description reveals that Esperanza singles herself out of her differences, of which she seems keenly aware. She also considers her differences as a source of isolation, as she floats in the sky for all to see. She longs to escape, much like a helium balloon. The anchor hinders her flight, similar to the confines that her granted by her society. Cisneros supplies Esperanza with a small voice, but also with a tone of wishful thinking, which gives her the ability to be powerful. Beautiful and Cruel marks the beginning of Esperanzas own quiet war against machismo (Hispanic culture powered by men). She refuses to neither tame herself nor wait for a husband, and this rebellion is reflected in her leaving the table like a man, without putting back the chair or picking up the plate (Cisneros 89). Cisneros gives Esperanza a self-empowered voice and a desire for personal possessions, thing that she can call her own: Esperanzas power is her own (Cisneros 89). Cisneros discusses two important themes: maintaining ones own power and challenging the cultural and social expectations one is supposed to fulfill. Esperanzas mission to create her own identity is manifest by her decision to not lay (her) neck on the threshold waiting for the ball and chain (Cisneros 88). Cisneros rough language and violent images of self-bondage reveal the contempt with which Esperanza views many of her peers whose only goal is to become a wife. .ub840eb269d9a402334bf3bf7cd329489 , .ub840eb269d9a402334bf3bf7cd329489 .postImageUrl , .ub840eb269d9a402334bf3bf7cd329489 .centered-text-area { min-height: 80px; position: relative; } .ub840eb269d9a402334bf3bf7cd329489 , .ub840eb269d9a402334bf3bf7cd329489:hover , .ub840eb269d9a402334bf3bf7cd329489:visited , .ub840eb269d9a402334bf3bf7cd329489:active { border:0!important; } .ub840eb269d9a402334bf3bf7cd329489 .clearfix:after { content: ""; display: table; clear: both; } .ub840eb269d9a402334bf3bf7cd329489 { display: block; transition: background-color 250ms; webkit-transition: background-color 250ms; width: 100%; opacity: 1; transition: opacity 250ms; webkit-transition: opacity 250ms; background-color: #95A5A6; } .ub840eb269d9a402334bf3bf7cd329489:active , .ub840eb269d9a402334bf3bf7cd329489:hover { opacity: 1; transition: opacity 250ms; webkit-transition: opacity 250ms; background-color: #2C3E50; } .ub840eb269d9a402334bf3bf7cd329489 .centered-text-area { width: 100%; position: relative ; } .ub840eb269d9a402334bf3bf7cd329489 .ctaText { border-bottom: 0 solid #fff; color: #2980B9; font-size: 16px; font-weight: bold; margin: 0; padding: 0; text-decoration: underline; } .ub840eb269d9a402334bf3bf7cd329489 .postTitle { color: #FFFFFF; font-size: 16px; font-weight: 600; margin: 0; padding: 0; width: 100%; } .ub840eb269d9a402334bf3bf7cd329489 .ctaButton { background-color: #7F8C8D!important; color: #2980B9; border: none; border-radius: 3px; box-shadow: none; font-size: 14px; font-weight: bold; line-height: 26px; moz-border-radius: 3px; text-align: center; text-decoration: none; text-shadow: none; width: 80px; min-height: 80px; background: url(https://artscolumbia.org/wp-content/plugins/intelly-related-posts/assets/images/simple-arrow.png)no-repeat; position: absolute; right: 0; top: 0; } .ub840eb269d9a402334bf3bf7cd329489:hover .ctaButton { background-color: #34495E!important; } .ub840eb269d9a402334bf3bf7cd329489 .centered-text { display: table; height: 80px; padding-left : 18px; top: 0; } .ub840eb269d9a402334bf3bf7cd329489 .ub840eb269d9a402334bf3bf7cd329489-content { display: table-cell; margin: 0; padding: 0; padding-right: 108px; position: relative; vertical-align: middle; width: 100%; } .ub840eb269d9a402334bf3bf7cd329489:after { content: ""; display: block; clear: both; } READ: Hiv Aids Essay Conclusion To learn how to guard her power from men, Esperanza looks to the example of the movie vixen with (the) red red lips who is beautiful and cruel (Cisneros 89). Esperanza gains strength in herself by accepting the situation she is in as it is, be acquiring a determination to leave it . The House On Mango Street Seeking Independence Essay Example For Students The House On Mango Street: Seeking Independence Essay In the book The House on Mango Street, author Sandra Cisneros presents a series of vignettes that involve a young girl, named Esperanza, growing up in the Latino section of Chicago. Esperanza Cordero is searching for a release from the low expectations and restrictions that Latino society often imposes on its young women. Cisneros draws on her own background to supply the reader with accurate views of Latino society today. In particular, Cisneros provides the chapters Boys and Girls and Beautiful and Cruel to portray Esperanzas stages of growth from a questioning and curious girl to an independent woman. Altogether, Boys and Girls is not like Beautiful and Cruel because Cisneros reveals two different maturity levels in Esperanza; one of a wavering confidence with the potential to declare her independence, and the other a personal awareness of her own actions and the decision to take action and wage her own quiet war (Cisneros 89). We will write a custom essay on The House On Mango Street: Seeking Independence specifically for you for only $16.38 $13.9/page Order now Author Sandra Cisneros was born in 1954 in the Latino section of Chicago (Encarta 1). Cisneros is an American novelist, short-story writer, essayist, and poet (Encarta 1). Her works have brought the perspective of the Mexican American woman into the mainstream of literary feminism (Encarta 1). She earned her Bachelors Degree from Loyola University in 1976 and her Masters Degree from the University of Iowa in 1978 (Encarta 1). The House on Mango Street is Cisneros first novel, and is her most critically acclaimed (Encarta 1). The novel is constructed with a series of short interconnected chapters (Encarta 1). Cisneros writes of the hopes, desires, and disillusionments of a young writer growing up in a large city (Encarta 1). After reading The House on Mango Street, the reader is left with a greater sense of the everyday oppressions the roles created for women in Hispanic society (Encarta 1). Cisneros decides to accept the oppression as part of culture, but also detach from this view by telling women, old and young alike, to find their own independence. Cisneros uses Esperanza as a vehicle to express the power of womanhood and determination to reach certain goals. In Boys and Girls, Cisneros introduces a gender separation that dominates Esperanzas experiences. Esperanza is dissatisfied that she and her younger sister Nenny are paired as playmates; Nenny is too young to be my friend (Cisneros 8). Esperanza is dependent on her childhood and is like a red balloon, a red balloon tied to an anchor (Cisneros 9). This description reveals that Esperanza singles herself out of her differences, of which she seems keenly aware. She also considers her differences as a source of isolation, as she floats in the sky for all to see. She longs to escape, much like a helium balloon. The anchor hinders her flight, similar to the confines that her granted by her society. Cisneros supplies Esperanza with a small voice, but also with a tone of wishful thinking, which gives her the ability to be powerful. Beautiful and Cruel marks the beginning of Esperanzas own quiet war against machismo (Hispanic culture powered by men). She refuses to neither tame herself nor wait for a husband, and this rebellion is reflected in her leaving the table like a man, without putting back the chair or picking up the plate (Cisneros 89). Cisneros gives Esperanza a self-empowered voice and a desire for personal possessions, thing that she can call her own: Esperanzas power is her own (Cisneros 89). Cisneros discusses two important themes: maintaining ones own power and challenging the cultural and social expectations one is supposed to fulfill. Esperanzas mission to create her own identity is manifest by her decision to not lay (her) neck on the threshold waiting for the ball and chain (Cisneros 88). Cisneros rough language and violent images of self-bondage reveal the contempt with which Esperanza views many of her peers whose only goal is to become a wife. .u4c491b71e75431348a85a9668fdbcbe4 , .u4c491b71e75431348a85a9668fdbcbe4 .postImageUrl , .u4c491b71e75431348a85a9668fdbcbe4 .centered-text-area { min-height: 80px; position: relative; } .u4c491b71e75431348a85a9668fdbcbe4 , .u4c491b71e75431348a85a9668fdbcbe4:hover , .u4c491b71e75431348a85a9668fdbcbe4:visited , .u4c491b71e75431348a85a9668fdbcbe4:active { border:0!important; } .u4c491b71e75431348a85a9668fdbcbe4 .clearfix:after { content: ""; display: table; clear: both; } .u4c491b71e75431348a85a9668fdbcbe4 { display: block; transition: background-color 250ms; webkit-transition: background-color 250ms; width: 100%; opacity: 1; transition: opacity 250ms; webkit-transition: opacity 250ms; background-color: #95A5A6; } .u4c491b71e75431348a85a9668fdbcbe4:active , .u4c491b71e75431348a85a9668fdbcbe4:hover { opacity: 1; transition: opacity 250ms; webkit-transition: opacity 250ms; background-color: #2C3E50; } .u4c491b71e75431348a85a9668fdbcbe4 .centered-text-area { width: 100%; position: relative ; } .u4c491b71e75431348a85a9668fdbcbe4 .ctaText { border-bottom: 0 solid #fff; color: #2980B9; font-size: 16px; font-weight: bold; margin: 0; padding: 0; text-decoration: underline; } .u4c491b71e75431348a85a9668fdbcbe4 .postTitle { color: #FFFFFF; font-size: 16px; font-weight: 600; margin: 0; padding: 0; width: 100%; } .u4c491b71e75431348a85a9668fdbcbe4 .ctaButton { background-color: #7F8C8D!important; color: #2980B9; border: none; border-radius: 3px; box-shadow: none; font-size: 14px; font-weight: bold; line-height: 26px; moz-border-radius: 3px; text-align: center; text-decoration: none; text-shadow: none; width: 80px; min-height: 80px; background: url(https://artscolumbia.org/wp-content/plugins/intelly-related-posts/assets/images/simple-arrow.png)no-repeat; position: absolute; right: 0; top: 0; } .u4c491b71e75431348a85a9668fdbcbe4:hover .ctaButton { background-color: #34495E!important; } .u4c491b71e75431348a85a9668fdbcbe4 .centered-text { display: table; height: 80px; padding-left : 18px; top: 0; } .u4c491b71e75431348a85a9668fdbcbe4 .u4c491b71e75431348a85a9668fdbcbe4-content { display: table-cell; margin: 0; padding: 0; padding-right: 108px; position: relative; vertical-align: middle; width: 100%; } .u4c491b71e75431348a85a9668fdbcbe4:after { content: ""; display: block; clear: both; } READ: A playbook for Strategy, Summary To learn how to guard her power from men, Esperanza looks to the example of the movie vixen with (the) red red lips who is beautiful and cruel (Cisneros 89). Esperanza gains strength in herself by accepting the situation she is in as it is, be acquiring a determination to leave it .

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)

Family Strengths Article Example | Topics and Well Written Essays - 750 words

Family Strengths - Article Example It begins by defining what family strengths are, and goes on to discuss the insights from available research relating to what makes for strong families. The findings from the two surveys that were considered reveal an American population where family strength levels are fairly high. The article notes that such a focus on family strengths is necessary to counteract the dearth of knowledge in this area, owing from the traditional focus on family ills in the literature, to the detriment of serious inquiry on how healthy and strong families work. The findings that family strength levels are healthy for the majority of the American population has implications for the kinds of future related research that may yield fruit regarding how family strengths impact the well-being of children and parents (Moore, Chalk, Scarpa and Vandivere, 2002). B. Response The surveys paint a healthy picture with regard to measures of family strengths in majority of American families. Measures of stability and routine, for instance, and the way they relate to the stability of the children and their developmental progress, are instructive, and believable. The article posits that predictability is good for children, in that they are able to function and grow in an environment where predictability and routine contributes to feelings of safety. Where routines are in place for meals and for doing errands are set, for instance, there is an environment where children develop the ability to control themselves, and to produce life outcomes that are positive. The large majority of homes sharing dinner together on a regular basis, and doing routinary tasks at home likewise regularly, contribute to this environment of predictability and stability. The insight here is that the establishment of such an environment coincides with relatively stable economic and social conditions in the general society, something that I can accept as plausible in the time frames considered for the survey. Those were relat ively prosperous and stable years for the US in general (Moore, Chalk, Scarpa and Vandivere, 2002, pp. 2-3). Part 2- Assessment of Family Strengths, Results B. Family Introduction, Description, Reason for Choice The chosen family is African American, with a household salary estimated at about $200,000 a year, with both parents being professionals, and with two children, one a boy aged 15, and another a girl aged 10. The family owns the home they live in, and the children attend private school near their place of residence. The parents work during the day and come home in time for dinner. The parents are also well-educated and are well-traveled. The reason for the choice is that given the healthy outward arrangements of the family, the family and their strength measures can easily validate or invalidate the assertion of the article relating to family strengths and child behavioral and life outcomes vis a vis the relative stability of the family (Moore, Chalk, Scarpa and Vandivere, 20 02, pp. 2-3). C. Survey Identification The chosen survey is the strengths assessment survey, administered to the chosen family member for this exercise, the 15-year old eldest son. This survey was chosen because an assessment of the strengths of the boy would give an indication of the relative family strengths, from the life outcomes of the eldest son at that

Managerial Accounting Assignment Example | Topics and Well Written Essays - 750 words

Managerial Accounting - Assignment Example In an article by Shanker, she recognizes the importance of accounting information in providing managers with solid information that they could base their decision making (Par 1). The author further points out that accounting information eliminate the need for business executives to use personal perception and gut to make decisions (Shanker par 1). In addition, the article recognizes that accounting is used in understanding the appropriateness of strategies used to attain short term goals. Shanker points out that short term financial goals such as an increase in sales, amount of debt, number of creditors and level of loss can be accurately determined by providing accounting information (par 1). The article is of the assumption that to acquire accurate and effective accounting information; a business entity should be formulated in three steps. Firstly, the cash numbers should be acquired. Shanker points out that cash is the most significant asset in an organization (par 2). For this reason, executives should analyze how cash-wise an organization is, and use the information to plan for short and long-term financial expenditure. For instance, if a business has cash balance of $50,000 and requires purchasing assets worth $120,000, the manager should come up with alternatives that would raise the money without using the cash balance of the business. To understand the current financial data in organizations, most executives use ratios to analyze the financial position of their businesses (Shanker par 2). For instance, the current ratio is used to determine the ability of a company to pay its short-term debt. It is determined by comparing its current assets and liabilities. The second step is to mind the budget. This can be determined by analyzing the value of income and expenditure at a specific time. This ensures that the business runs of a specific budget. Shanker is of the assumption that; if a