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

The Logistics Strategy For Brewery Industry Commerce Essay

The Logistics Strategy For Brewery Industry Commerce Essay There was a survey on distribution costs by institute of Logistics and Distribution Management in 1992. In this survey, it was recorded that 50% of the distribution costs are occurred in food and tobacco industry and therefore a careful planning is required to control these costs (Institute of Logistics and Distribution Management, 1991/92). These costs can be controlled by effective logistics management and logistics strategy. As far as brewery industry is concerned, a lot of distribution costs are incurred in transportation and logistics and to be a viable concern the brewery industry needs to implement a strong logistics strategy to overcome this problem. In our discussion, we will try to discuss the basic routing problems and vehicle scheduling and then we will try to design a strong logistics strategy to overcome this problem. Brewery Industry in UK is no more a piece of cake now. The market is now saturated and to be a successful market leader a brewery company needs to bring down its costs. The basic routing problem which a brewery industry faces is Selecting the best way or route available to deliver goods to the final consumers. The basic scheduling problem is Selecting the best time available to reach target customers. These problems are incurred whenever there are there is a complexity in the marketing channel system of an organization. The more complex the system, the more complicated the routing and scheduling problems in the logistics management. In our discussion below, we will try to review the strategies followed by a brewery industry and will make an attempt to recommend a valid logistics strategy in the context of UK Market. Analysis of a UK based brewerys current strategic position from a logistics perspective and Critical assessment of available opportunities to develop existing logistics capabilities. An Example of Scottish and New Castle plc: Scottish and New Castle plc is one of the largest UK based brewery groups. This group enjoys a strong financial back plus a pie of giant sales in the UK. The company has well defined market logistics systems and can easily have a competitive edge due to its systematic and professional operations. The Companys main operational parameters are: First the orders from the customers are collected on a telesales system which is also computerized. Then orders are manually punched to the companys main database and further screening is done over there such as credit limits and stocks available. Emergency orders are only accepted after estimating the order lead time for better customer service. They use heavy goods vehicles to transfer the bulk of goods at a time. This approach leads to lower costs and also opportunity cost of time. In case of customer claims a proper back hauling strategy is there to overcome the problem of customer churns and lower costs. The drivers and other crew members are paid properly which are involved in the distribution process. Despite of such a well managed system, there are some problems which need to be reviewed and addressed strategically. More Order to payment cycle Customer Privacy The streets in UK are mostly one way. There are certain government regulations in terms of weight limits. Inappropriate size of order shipments is there The need for a better computerized and technology management system. Drivers are strict to work for 9 hours despite the fact that it is a tough job. (Peter G. Eibl, Roddy Mackenzie, David B. Kidner, 1994) We can review these problems are opportunities which needs to address for a strong and loyal customer base. It is important to note here that business needs to focus on the customer and should have a broad definition of market for a strong and loyal customer base. The main threats to business problem and a source of missed market opportunities is the weak focus on the customer and competition. It is a habit of the market leaders to be strong and have a strong focus on market. These market leaders do not only focus on satisfying current consumer needs but also to see the needs of customers which no one is addressing. As a reason, they enjoy a sound profit and strong and loyal customer base (Roger J Best, 2008). Keeping the above views in mind, we can analyze as a beer manufacturing company, we need to analyze the untapped portion of the market and should need to implement such a logistics strategy to overcome over problem. It is important to note that this company has an experience of computerized vehicle routing and scheduling system. At first the company planned to use the computerized system in 1970, but due to less development in technology and some other constraints it was difficult to achieve this objective. An initial system was developed but it was difficult for the company to meet the demands of the customer appropriately and the cost of technology dropped in the British Market. This also led to the opportunity Technological Advancement. The Scottish and New Castle successfully gained advantage from this opportunity, adopted a computerized logistics management system and it is the secret of its success today in the UK Market (Peter G. Eibl, Roddy Mackenzie, David B. Kidner, 1994). Despite all the above conditions, the company enjoys a sound competitive and strategic position in the market and now we will see that how can we maximize these opportunities to overcome the problem. Since now we are talking about the scenario of 1991, the challenges which a brewery company faces in UK environment are nearly the same today for example they need to improve their logistics for better customer service and in this sense there is an opportunity for a brewing company to address this customer need to through proper routing and scheduling for customer convenience. According to the latest trends in brewery industry: There is more growth than before Competitive Turbulence Growth of Local companies competing the giants Extra Capacity and proper logistics and inventory management are the drivers of success and market leadership Economic Conditions have hit the beer market There is a new trend of mergers and acquisitions. (Society of Independent Brewers, Local Brewing Industry Report, 2009) If we analyze the Scottish and New Castle plc with respect to above trends in brewery industry then it is easy to find that we need an effective logistics management system to control over costs. We need to fully implement the Systems Concept and Total Costs Concept for designing a successful logistics strategy. All the above problems are actually opportunities available in the market. Evaluation of the key strategic approaches to logistics management that could be used by a UK based brewery: Strategic and Rational Logistics Planning for Scottish and New Castle plc: In the case of Scottish and New Castle plc, a lot of strategic planning and tactical approaches could be used for designing and strong logistics strategy. A proper an appropriate route planning must be done. In terms of longer routes some special incentives must be given to the drivers and the staff involved in logistics and operations. Unnecessary routes must be avoided to overcome this problem because the reason for that is they will cause costs higher. Using different vehicles to transfer goods to customers also incurs unnecessary costs. Using proper vehicles to deliver goods at the receiving facilities of consumers is a good approach to control the costs. It is also important to note here that all of our methodologies circle around costs. Only those logistics strategy will be successful which will Reduce Costs Provide Customer Convenience Inventory Management Integrated Order Processing. We will try to shape a logistics management strategy in the following scenarios: Fulfillment Management: First of all we need to plan about how to effectively deliver goods to the final consumers. Then we can decide about the best available options such as trucks or small vans to deliver goods to final consumers. As far as UK is less short of two way roads and most of the roads are one way. Therefore we could use larger trucks to deliver goods and services to final consumers. Secondly, It is important to analyze that would these transportation mediums will save us money or not. Extra shipments and lower order sizes of Scottish and New Castle plc will automatically cause extra burden to consumers. There should be a proper documentation and record keeping of transportation and distribution for future referencing and monitoring logistics costs. A proper warehousing system must be developed to ensure proper logistics management. For example, the warehouses must be located at a place near the marketing channels for quick transportation and costs. Small order sizes and uneven orders can ruin the distribution costs. A proper packaging technique must be used to store beer bottles for proper utilization of space and proper distribution of goods. Supply Chain Management: Proper customer service and inventory planning must be done in beer industry because the market is now at its maturity with more competitors and sophisticated customers. Some Master Production plans must be done for logistics management. Beer Industry in UK contains both price conscious and quality conscious customers therefore proper market segmentation and positioning is required by this brewery company. Most of the products fail in market because of their supply. An opportunity for Scottish and New Castle is to make their products widely available for strong consumer response. Effective reverse logistics system can be developed for better customer service. Demand Management: In order to effectively distribute goods to final consumers a proper demand forecasting must be done for cost effective delivery measures and options. Some time larger and excessive production leads to extra costs and are an additional burden over the company. On the other side an underproduction also leads to lose of customers. The consumers find value only in that product which is available easily. We can take help for demand management from our channel intermediaries as well. Channel Intermediaries for Scottish and New Castle plc can provide useful insights about the demand and tastes of consumers. In short we need a consumer point view while deciding about the routes and schedule for distribution of goods and services. In beer industry at UK, we can perform some research and development to reach the end consumers for a loyal customer base. We can redefine our routes by doing some research on what consumers want? (The Above Model was derived from E is for Excellence Leadership in Logistics By Heather Cartwright, PMP, P.Log. as published in LQ Magazine Spring 2004) Technology as a source of Advantage for Scottish and New Castle plc: As we discussed above that the company has already an experience in technology and technology by the company. It is an era of technology. The company had an experience of collecting orders through telesales and then manually entering the orders in a database. This is an era of technology. For proper order to payment cycle, one recommendation we would like to discuss here is that Scottish and New Castle has not yet developed an online system through internet on which the customers can place their orders. This strategy will help us to attract more and more customers and may definitely decrease order to payment cycle which is one of the costly areas of logistics management. Most of the beer customers today are youngsters and these youngsters use internet more than the people of other ages. Useful insights about the industry from consumer point of view can also be gained by collecting feedbacks from customers. Consumers today love to buy online because they are now more sophisticated and require more information. An online website works as a sales man. We do not need to hire separate professionals. Coming online will automatically a source of competitive advantage for the Scottish and New Castle plc because no one is addressing consumers through this medium of distribution in UK. Identifying the management issues caused by implementing a new logistics strategy with consideration for available capital, technical and human resources: Available Capital: The first problem that will arise from adopting this strategy is that we need to spend a lot in measuring consumer preferences and perceptions about logistics. This thing can cause problems of costing in the short run. For example, redesigning vehicle routes and scheduling is a very daunting task and we need to change our structure fully if we want to implement this strategy. More over we will need to purchase some new technological solutions if we want to do effective and computerized scheduling and routing of goods. Paying drivers more incentives will lead to higher costs and is an extra burden on the firm costs. The management will need to change the allocated overhead costs and new planning with a new allocation of capital overheads will create obstacles for the management to adopt this policy. But if we see the other side of the road then this addition is capital required will lead us profitability in the beer market. For example, by analyzing consumer tastes and preferences will lead to proper scheduling and routing of goods. Customer will be satisfied and it will help the Scottish and New Castle to capture more and more market share. Technical: We require more and more technical professionals in beer industry to operate the latest technological equipment for our professionals. While selecting technology it is important to note that technology must be compatible with the organizational structure and culture otherwise it would become a threat. Moreover while selecting technology, it is important to note that we need it should be sustainable for example it is difficult for the competitors to copy it. Technology is always costly. Apparently from management perspective, it seems that by adopting the new technology will lead us to higher costs rather the control of costs and quality in beer industry. But if we see the other side of picture then we can analyze that using technology will easily help to gain higher profits and better logistics management. For example, by hiring technological professionals will increase the management skills and expertise for Scottish and New Castle plc. We already had an experience in technology since 1970, as we have seen above; we can experience and use technology in different dimensions. Moreover, there is no compatibility issue of adopting the computerized technology for logistics management as we are already using a telesales system to record customer orders. Some new techniques like RFID or Electronic Data interchange must be used in technology which can easily enable us to track where a product is at this time in the marketing channel. Going online has tremendous advantages. We can be successful because there is a dramatic increase in online shoppers. No one is serving customers online. Going online will reduce the order to payment cycle with better customer service. It will also save us money for hiring extra professionals for customer dealing and service. Human Resources: Management concerns about the change in strategy would be they need to hire more and more professionals to manage their operations. For example for redesigning logistics strategy we need to hire a professional leader for research and development. Moreover, paying the logistics staff more benefits will lead to again more costs. Therefore, what is the benefit for adopting a new logistics strategy? But on the other side of river, we will earn revenues in a long run. For example, a logistics strategy will produce more and more customers and simply our revenues will increase. Therefore by hiring more and more professionals such as drivers, computer professionals will lead to more profitability and these costs were cover up in a very small time. Human Resources are the most important assets of any organization. By paying them more incentives will lead to more employee motivation and loyalty. Motivated employees are more valuable than golden nuggets for any organization. This motivated staff can be further trained to use the best available route and proper scheduling for reaching our logistics goals. Employees interact with our customers. Therefore by facilitating logistics employees will lead to very fruitful results in the future. Outlining the strategic significance of new technology developments and business trends on future logistic strategies for a beer manufacturer: Adapting new technology will open new dimensions for logistics management for a beer manufacturer like Scottish and New Castle plc. Some of them are discussed below: Using a computer or professional software and database of vehicle routing and scheduling will open new dimensions for logistics management. We will have a lot of savings than we are saving manually. For example by using RFID or EDI may it is costly for a beer manufacture to manage operations but we will have better inventory tracking and logistics management According to the recent trends in the market. Almost all the companies are now on web for reaching target customers. Moreover the number of online shoppers is increasing day by day. No one in the beer industry is serving the market online in UK. I think it is an untapped portion of the market and this portion can be tapped by going online. Selling goods to customer online will not only lower the costs of distribution but also but also reduce order to payment cycle. It is easy for customers to gather information from the web. Now the consumption patterns of the consumers have changed. Now the consumer is more sophisticated and more aware of its needs. In the past, there was trend the man earned and woman played the role of house keeper. But now there is blurring gender roles as the number of working women are increasing. Moreover there is poverty of time for consumers. In this case, while defining a logistics strategy, we should keep these things in our mind. (Management Review : Market and Strategy, 2009) Now due to competitive turbulence, we need to have a first mover advantage. People buy only those products which are most readily available and which they do not need to search for. In beer market, it would be really a strong strategy to gain a first movers advantage. This first movers advantage can be achieved by proper logistics strategy and inventory management. Conclusion: In our discussion, we have taken our point of discussion as Scottish and New Castle Inc as our point of discussion and as an example of how to adopt a successful logistics strategy in the beer market of UK. We have seen that there are a lot of opportunities available such as technology for developing and establishing a competitive advantage in the market. All these are simple measures but these simple measures can do a lot for us. For example, it can provide us better cost savings and better customer base. It can also provide us convenience in operations. Beer Industry is a food industry and according to research above that there are a lot of expenses in the logistics of food rather than any other product. Keeping the above strategy in mind, we can easily improve our logistics operations in the beer industry. But we also need to implement the continuous process improvement.

Discuss Wharton’s presentation of the character development of Newland Archer

The character of Newland Archer is presented in this passage through his meditations on a range of issues. The scene is set directly after an Archer family dinner with a friend, Sillerton Jackson. Archer's reflections give us a glimpse into the way he thinks and the sort of person he is. Initially we learn about Archer himself and his background, he is from a wealthy family, with ever â€Å"vigilant † servants, â€Å"bronze† statuettes and his own study. We can also see from the description of the study that he is cultured, intelligent and well read. The passage allows us to see a little of his history, especially of the tale of his romance with May Welland. Her â€Å"large photograph† has displaced all others on his table, signifying that she and no other is first in his affections. Archer's view of their impending marriage is initially that he will be her â€Å"soul's custodian†, showing that it will be a very traditional relationship, that she is naive compared to him, and that he must protect and enlighten her. He was taught that marriage to May would be like â€Å"safe anchorage† in life but he tells us his belief is changing, that he believes it may be like a â€Å"voyage on uncharted seas†. This clear nautical imagery lets us see how Archer is coming to doubt his previously unquestioned conventional beliefs – â€Å"old settled convictions† – and that it may be dangerous for him to go into this marriage so unprepared. He is moving on, intellectually, questioning what he once held firm. Archer's attitude to his relationship with May is inextricably linked to his basic conventional traditional mindset. He sees himself and May as key players in a courtship ritual that they possibly could become stereotypical examples of people â€Å"linked by ignorance on the one side and hypocrisy on the other†. In a way he believes this is inevitable due to the society they both belong to, but it is not what he wants from marriage. He desires â€Å"passionate and tender comradeship† with May in their marriage; he loves her â€Å"sincerely†. However her attitude to her character shows that he does not fully understand her. He sees her as partly as an † artificial product† produced by her family, her up bringing, making her innocent and frank. He feels this is wrong that she has somehow been denied the right to be a full person, as she has been denied the experience of life, social, cultural and sexual, that he has been allowed to explore. He feels what has been created in her personality is false, but somehow we get the impression that this is something that has been hard for him to come across. He sees her as less than him intellectually, as she is not educated as he has been, in the arts and literature, and therefore senses her comprehension is less, when really it may just be her lack of exposure to his amount of learning. Newland Archer's relationship with the women soon to be his cousin through his impending marriage to May, Ellen Olenska, is that this point in the novel, still slight. He knows her partially through acquaintance but mostly through gossip. The way he thinks of her as â€Å"Countess† shows the distance and formality between them and he does believe that she has done something reprehensible that requires â€Å"championship†. This shows that although he believes † Women should be free†, this will never really apply to New York standards and he resents the â€Å"coil of scandal† her arrival has placed him in. Her arrival and the talk surrounding it seems to have acted as a catalyst to his thought patterns, hinting of a deeper relationship to come. She is this woman with foreign ways who could be â€Å"free† as men are, and she makes Newland aware of the implications and reality of his betrothal. Newland Archer's character development is presented throughout the passage as a struggle between what he did believe in and what he is coming to doubt the validity of through new experiences and thoughts. His attitude to society is important as it stands for his old conventional self, and his reactions to its dictates, especially on the theme of marriage, show how he is maturing and thinking independently. The imagery he uses to describe New York society are important, â€Å"conventions that tied things together and bound people down† – this rope imagery suggests the constricting nature of tradition and how it hods all subject to it captive. The irony betrayed by Edith Wharton's' tone in the presentation of the conscious thoughts of Newland Archer shows the slightly ridiculous nature of New York society. The situation Archer is in regarding his own defence of Countess Olenska is ironic, as he would be forced to condemn May should she ever behave similarly to her cousin. Another irony in the passage is the description of the state of typical New York high society marriages as having an â€Å"enviable ideal† when frankly they are in a pitiable state. Lefferts is described as the â€Å"high priest of form† when really he has no substance or true beliefs and is truly hypocritical, especially in regard to his treatment of Beaufort's affairs. The behaviour of Mrs Welland's simulated reluctance at the announcement of the engagement when really she expected it is sarcastically commented on showing the double standards between what is said and what is expected throughout New York society. Edith Wharton uses conflicting ideas within Newland Archer's mind to effectively present a man who is changing and developing into a deeper way of thinking about his own life and society in general.

Google: Research Google’s Attempt to Buy Into Wireless Via the 700 Mhz Spectrum Auction.

Verdell ChesterTM-583 Case 4 – Google: Research Google’s attempt to buy into wireless via the 700 MHz Spectrum Auction. 1. Why  did Google making this move? Google’s Motivation to bid into the wireless marketplace through the use of the 700MHz Spectrum Auction was the opportunity to develop possibly a 50 state network â€Å"The FCC is auctioning 1,099 wireless licenses in the 700 MHz band, but the most attractive spectrum for many bidders is the â€Å"C-block† of 12 regional licenses that may be combined to create a 50-state network. (Reiter, 2008) This new product development would allow Google to become a cellular network operator. This market includes firms such as AT;amp;T and Verizon, Google would not only compete with these firms but also would have had the opportunity to network with other entities to develop some innovative new products. What do they hope to accomplish? The prospect of entering into the wireless market offers Google many potenti al growth and development practices as well as competencies. There are also many risks associated with this strategy, including the cost of building and maintaining a billion dollar network.One particular goal that may have been in mind with this decision is the growth of Google’s vast wireless software portfolio that includes Gmail, Maps, Docs, Calendar Sync and various other applications that can be downloaded to many phones. There may have been other reasons Google chose to take interest into the wireless market such as the ownership of Youtube and its developments in a new website and java beta application that allows people to view tens of millions of videos via cell phone. . How does Google’s support for Open Access fit into Google’s plans? Google supporting Open Access really makes this a popular decision. Many people are rooting for Google to bid on the 700MHz spectrum for reasons that it will allow for competitive pricing of many cellular internet featu res. Furthermore research shows that Google supports open access initiatives like a concept called network neutrality, this is a principle proposed for user access networks participating in the Internet.It advocates that no restrictions can be imposed by internet service providers and governments on content, sites, platforms, the kinds of equipment that may be attached, and the modes of communication. Google still supports this idea but has made moves in this direction like stated in their public policy blog â€Å"FACT: Google has been the leading corporate voice on the issue of network neutrality over the past five years. No other company is working as tirelessly for an open Internet. But given political realities, this particular issue has been intractable in Washington for several years now.At this time there are no enforceable protections – at the Federal Communications Commission or anywhere else – against even the worst forms of carrier discrimination against In ternet traffic. † (Whitt ;amp; Counsel, 2010) This bid would provide google the ability to offer the most openly accessible network. 3. It looks like Google wants to get into wireless; yet, wireless is not one of Google’s core competencies. What should Google do about this? Google is not known for developing a large wireless network, but they are known for its advertising capabilities.This opportunity can present Google the chance to gain this ability and further strengthen its advertising ability. Google should invest in this opportunity although it may currently not fall into its current competencies; Google has capabilities that can allow them to develop newer competencies through their current ones. By taking their ability to advertise and the ability to deliver new internet products they can develop a superior network that enhances their ability to advertise and present customers with vast channels of information.Another option is looking toward some of Google†™s partnerships and ownerships and collecting resources from their wide variety of talent to develop a team tasked with developing the new competencies needed to make the new business venture successful. Similar to Google spearheading the Open Handset Alliance’s Android mobile platform, this new venture will need to break boundaries and establish Google as a premiere wireless network. â€Å"This situation has crippled consumers' ability to use the Internet on their mobile devices, compared to how they use it on their PCs.Google executives say their aim is to bring the PC-style of Internet openness to the mobile world so that users have more choice in mobile services and applications, as well as price. † (Mills, 2007) Google has the opportunity to develop the competencies for emerging as a successful wireless network yet they have to take the risk of investing into this opportunity. Google has the customer support and the finances to go for it, and it doesn’t l ook like a bad choice.Bibliography:Mills, E. (2007, 11 30). Cnet news. Retrieved 12 5, 2010, from Google versus the Telcoms: http://news. cnet. com/Google-versus-the-telecoms/2100-1039_3-6220909. html Reiter, A. (2008, 2 5).Internet Evolution. Retrieved 12 5, 2010, from Internet Evolution: http://www. internetevolution. com/author. asp? section_id=526;amp;doc_id=144810 Whitt, R. , ;amp; Counsel, W. T. (2010, 8 12).Google Public Policy Blog. Retrieved 12 5, 2010, from Google Public Policy Blog: http://googlepublicpolicy. blogspot. com/search/label/Net%20Neutrality

Profile of Carlos the Jackal

Named Ilich as a paeon to Lenin (whose full name was Vladimir Ilyich Lenin) by his Marxist father, Ramirez was later known as Carlos the Jackal. His nickname came in part from the novel, The Day of the Jackal, a thriller once found by authorities among his belongings. Background Born in 1949 in Caracas, Venezuela, where he was raised. He was also schooled in England and attended university in Moscow. After his expulsion from the university in 1970, he joined the Palestinian Front for the Liberation of Palestine (PFLP), a pan-Arab leftist group then based in Amman, Jordan. Claim to Notoriety Ramirez most famous terrorist move was the takeover of OPEC headquarters in Vienna at a 1975 Conference, where he also took 11 members hostage. The hostages were eventually transported to Algiers and freed. Although later debunked, assumptions that Ramirez had a hand in killing two of the Israeli athletes taken hostage at the 1972 Olympic Games in Munich added to his reputation as a ruthless and effective terrorist. Indeed, many of Ramirez feats had murky origins and unclear goals and sponsors—which also gave the self-proclaimed terrorist a mysterious glamour. A 1994 review of David Yallops Tracking the Jackal: The Search for Carlos, the Worlds Most Wanted Man suggests that the OPEC kidnappings may have been sponsored by Saddam Hussein, rather than by the PFLP, as has been suggested, or by Libyan leader Muammar Al Qaddafi: Although it has long been thought that the armed attack on a Vienna meeting of the oil cartel and the kidnapping of 11 of the oil ministers were conceived and paid for by Col. Muammar el-Qaddafi, the book makes a persuasive case that behind it was actually Saddam Hussein, seeking an increase in the price of oil to finance his impending war with Iran. Mr. Hussein intended Carlos to use the kidnapping as a pretext to assassinate the Saudi opponents of a price rise, Mr. Yallop says, but the unreliable Carlos sold out his employer, as he so often did, and instead took a $20 million ransom from the Saudi Government (the hostages were in fact released). Where He Is Now The Jackal was arrested by the French in 1994, in Sudan where he was living. He was convicted for several murders in 1997 and as of 2017 is still in prison. Cross-Links Ramirez has expressed admiration for Osama bin Laden from prison, and more broadly for Revolutionary Islam, which is the title of a 2003 book he published from prison. In it, the jailed terrorist showed shades of his lifelong affiliation with leftist secular groups whose vision of conflict is shaped by class differences describing Islam as the sole transnational force capable of standing up the enslavement of nations.