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Pharmacovigilance

Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.

Information received from patients and healthcare providers via pharmacovigilance agreements, as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. In order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority. (See Adverse event reporting below.)

Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance.

Terms commonly used in drug safety
Pharmacovigilance has its own unique terminology that is important to understand. Most of the following terms are used within this article and are peculiar to drug safety, although some are used by other disciplines within the pharmaceutical sciences as well.

The European Medicines Agency defines terms in its Guideline on good pharmacovigilance practices (GVP):
 * Adverse drug reaction  is effects arising  when drug given even in therapeutic dose either immunologically mediated reaction or pharmacologically mediated adverse response or idiosyncratic reaction due to the peculiarities of individual.
 * Adverse event (AE) is a side effect occurring with a drug. By definition, the causal relationship between the AE and the drug is unknown.
 * Benefits are commonly expressed as the proven therapeutic good of a product but should also include the patient's subjective assessment of its effects.
 * Causal relationship is said to exist when a drug is thought to have caused or contributed to the occurrence of an adverse drug reaction.
 * Clinical trial (or study) refers to an organised program to determine the safety and/or efficacy of a drug (or drugs) in patients. The design of a clinical trial will depend on the drug and the phase of its development.
 * Control group is a group (or cohort) of individual patients that is used as a standard of comparison within a clinical trial. The control group may be taking a placebo (where no active drug is given) or where a different active drug is given as a comparator.
 * Dechallenge and rechallenge refer to a drug being stopped and restarted in a patient, respectively. A positive dechallenge has occurred, for example, when an adverse event abates or resolves completely following the drug's discontinuation.  A positive rechallenge has occurred when the adverse event re-occurs after the drug is restarted.  Dechallenge and rechallenge play an important role in determining whether a causal relationship between an event and a drug exists.
 * Effectiveness is the extent to which a drug works under real world circumstances, i.e., clinical practice.
 * Efficacy is the extent to which a drug works under ideal circumstances, i.e., in clinical trials.
 * Event refers to an adverse event.
 * Harm is the nature and extent of the actual damage that could be or has been caused.
 * Implied causality refers to spontaneously reported AE cases where the causality is always presumed to be positive unless the reporter states otherwise.
 * Individual Case Safety Report is an adverse event report for an individual patient.
 * Life-threatening refers to an adverse event that places a patient at the immediate risk of death.
 * Phase refers to the four phases of clinical research and development: I – small safety trials early on in a drug's development; II – medium-sized trials for both safety and efficacy; III – large trials, which includes key (or so-called "pivotal") trials; IV – large, post-marketing trials, typically for safety reasons. There are also intermediate phases designated by an "a" or "b", e.g. Phase IIb.
 * Risk is the probability of harm being caused, usually expressed as a percent or ratio of the treated population.
 * Risk factor is an attribute of a patient that may predispose, or increase the risk, of that patient developing an event that may or may not be drug-related. For instance, obesity is considered a risk factor for a number of different diseases and, potentially, adverse drug reactions. Others would be high blood pressure, diabetes, possessing a specific mutated gene, for example, mutations in the BRCA1 and BRCA2 genes increase propensity to develop breast cancer.
 * Signal is a new safety finding within safety data that requires further investigation. There are three categories of signals: confirmed signals where the data indicate that there is a causal relationship between the drug and the AE; refuted (or false) signals where after investigation the data indicate that no causal relationship exists; and unconfirmed signals which require further investigation (more data) such as the conducting of a post-marketing trial to study the issue.
 * Temporal relationship is said to exist when an adverse event occurs when a patient is taking a given drug. Although a temporal relationship is absolutely necessary in order to establish a causal relationship between the drug and the AE, a temporal relationship does not necessarily in and of itself prove that the event was caused by the drug.
 * Triage refers to the process of placing a potential adverse event report into one of three categories: 1) non-serious case; 2) serious case; or 3) no case (minimum criteria for an AE case are not fulfilled).

Adverse event reporting
The activity that is most commonly associated with pharmacovigilance (PV), and which consumes a significant number of resources for drug regulatory authorities (or similar government agencies) and drug safety departments in pharmaceutical companies, is that of adverse event reporting. Adverse event (AE) reporting involves the receipt, triage, data entry, assessment, distribution, reporting (if appropriate), and archiving of AE data and documentation. The source of AE reports may include: spontaneous reports from healthcare professionals or patients (or other intermediaries); solicited reports from patient support programs; reports from clinical or post-marketing studies; reports from literature sources; reports from the media (including social media and websites); and reports reported to drug regulatory authorities themselves. For pharmaceutical companies, AE reporting is a regulatory requirement in most countries. AE reporting also provides data to these companies and drug regulatory authorities that play a key role in assessing the risk-benefit profile of a given drug. The following are several facets of AE reporting:

Individual Case Safety Report
One of the fundamental principles of adverse event reporting is the determination of what constitutes an individual case safety report. During the triage phase of a potential adverse event report, it is important to determine if the "four elements" of a valid individual case safety report are present: (1) an identifiable patient, (2) an identifiable reporter, (3) a suspect drug, and (4) an adverse event.

If one or more of these four elements is missing, the case is not a valid individual case safety report. Although there are no exceptions to this rule there may be circumstances that may require a judgment call. For example, the term "identifiable" may not always be clear-cut. If a physician reports that he/she has a patient X taking drug Y who experienced Z (an AE), but refuses to provide any specifics about patient X, the report is still a valid case even though the patient is not specifically identified. This is because the reporter has first-hand information about the patient and is identifiable (i.e. a real person) to the physician. Identifiability is important so as not only to prevent duplicate reporting of the same case, but also to permit follow-up for additional information.

The concept of identifiability also applies to the other three elements. Although uncommon, it is not unheard of for fictitious adverse event "cases" to be reported to a company by an anonymous individual (or on behalf of an anonymous patient, disgruntled employee, or former employee) trying to damage the company's reputation or a company's product. In these and all other situations, the source of the report should be ascertained (if possible). But anonymous reporting is also important, as whistle blower protection is not granted in all countries. In general, the drug must also be specifically named. Note that in different countries and regions of the world, drugs are sold under various tradenames. In addition, there are a large number of generics which may be mistaken for the trade product. Finally, there is the problem of counterfeit drugs producing adverse events. If at all possible, it is best to try to obtain the sample which induced the adverse event, and send it to either the European Medicines Agency, FDA or other government agency responsible for investigating AE reports.

If a reporter can't recall the name of the drug they were taking when they experienced an adverse event, this would not be a valid case. This concept also applies to adverse events. If a patient states that they experienced "symptoms", but cannot be more specific, such a report might technically be considered valid, but will be of very limited value to the pharmacovigilance department of the company or to drug regulatory authorities.

Activities involved in pharmacovigilance
1- Case-control study (Retrospective study) 2- Prospective study (Cohort study). 3- Population statistics. and 4- Intensive event report. 5- The spontaneous report in the case is the population of the single case report.

Coding of adverse events
Adverse event coding is the process by which information from an AE reporter, called the "verbatim", is coded using standardized terminology from a medical coding dictionary, such as MedDRA (the most commonly used medical coding dictionary). The purpose of medical coding is to convert adverse event information into terminology that can be readily identified and analyzed. For instance, Patient 1 may report that they had experienced "a very bad headache that felt like their head was being hit by a hammer" [Verbatim 1] when taking Drug X. Or, Patient 2 may report that they had experienced a "slight, throbbing headache that occurred daily at about two in the afternoon" [Verbatim 2] while taking Drug Y.  Neither Verbatim 1 nor Verbatim 2 will exactly match a code in the MedDRA coding dictionary. However, both quotes describe different manifestations of a headache. As a result, in this example both quotes would be coded as PT Headache (PT = Preferred Term in MedDRA).

Seriousness determination
Although somewhat intuitive, there are a set of criteria within pharmacovigilance that are used to distinguish a serious adverse event from a non-serious one. An adverse event is considered serious if it meets one or more of the following criteria:
 * 1) results in death, or is life-threatening;
 * 2) requires inpatient hospitalization or prolongation of existing hospitalization;
 * 3) results in persistent or significant disability or incapacity;
 * 4) results in a congenital anomaly (birth defect); or
 * 5) is otherwise "medically significant" (i.e., that it does not meet preceding criteria, but is considered serious because treatment/intervention would be required to prevent one of the preceding criteria.)

Aside from death, each of these categories is subject to some interpretation. Life-threatening, as it used in the drug safety world, specifically refers to an adverse event that places the patient at an immediate risk of death, such as cardiac or respiratory arrest. By this definition, events such as myocardial infarction, which would be hypothetically life-threatening, would not be considered life-threatening unless the patient went into cardiac arrest following the MI. Defining what constitutes hospitalization can be problematic as well. Although typically straightforward, it's possible for a hospitalization to occur even if the events being treated are not serious. By the same token, serious events may be treated without hospitalization, such as the treatment of anaphylaxis may be successfully performed with epinephrine. Significant disability and incapacity, as a concept, is also subject to debate. While permanent disability following a stroke would no doubt be serious, would "complete blindness for 30 seconds" be considered "significant disability"? For birth defects, the seriousness of the event is usually not in dispute so much as the attribution of the event to the drug. Finally, "medically significant events" is a category that includes events that may be always serious, or sometimes serious, but will not fulfill any of the other criteria. Events such as cancer might always be considered serious, whereas liver disease, depending on its Common Terminology Criteria for Adverse Events (CTCAE) grade—Grades 1 or 2 are generally considered non-serious and Grades 3-5 may be considered serious.

Expedited reporting
This refers to individual case safety reports that involve a serious and unlisted event (an event not described in the drug's labeling) that is considered related to the use of the drug (US FDA). (Spontaneous reports are typically considered to have a positive causality, whereas a clinical trial case will typically be assessed for causality by the clinical trial investigator and/or the license holder.) In most countries, the time frame for reporting expedited cases is 7/15 calendar days from the time a drug company receives notification (referred to as "Day 0") of such a case. Within clinical trials such a case is referred to as a SUSAR (a Suspected Unexpected Serious Adverse Reaction). If the SUSAR involves an event that is life-threatening or fatal, it may be subject to a 7-day "clock". Cases that do not involve a serious, unlisted event may be subject to non-expedited or periodic reporting.

Clinical trial reporting
Also known as AE (adverse event) or SAE (serious AE) reporting from clinical trials, safety information from clinical studies is used to establish a drug's safety profile in humans and is a key component that drug regulatory authorities consider in the decision-making as to whether to grant or deny market authorization (market approval) for a drug. AE reporting occurs when study patients (subjects, participants) experience any kind of "untoward" event during the conducting of clinical trials. Non-serious adverse events are typically captured separately at a level lower than pharmacovigilance. AE and SAE information, which may also include relevant information from the patient's medical background, are reviewed and assessed for both causality and degree of seriousness by the study investigator. This information is forwarded to a sponsoring entity (typically a pharmaceutical company or academic medical center) that is responsible for the reporting of this information, as appropriate, to drug regulatory authorities.

Spontaneous reporting
Spontaneous reports are termed spontaneous as they take place during the clinician's normal diagnostic appraisal of a patient, when the clinician is drawing the conclusion that the drug may be implicated in the causality of the event.

Spontaneous reporting system (SRS) relies on vigilant physicians and other healthcare professionals who not only generate a suspicion of an adverse drug reaction, but also report it. It is an important source of regulatory actions such as taking a drug off the market or a label change due to safety problems. Spontaneous reporting is the core data-generating system of international pharmacovigilance, relying on healthcare professionals (and in some countries consumers) to identify and report any adverse events to their national pharmacovigilance center, health authority (such as the European Medicines Agency or FDA), or to the drug manufacturer itself. Spontaneous reports are, by definition, submitted voluntarily although under certain circumstances these reports may be encouraged, or "stimulated", by media reports or articles published in medical or scientific publications, or by product lawsuits. In many parts of the world adverse event reports are submitted electronically using a defined message standard.

One of the major weaknesses of spontaneous reporting is that of under-reporting, where, unlike in clinical trials, less than 100% of those adverse events occurring are reported. Further complicating the assessment of adverse events, AE reporting behavior varies greatly between countries and in relation to the seriousness of the events, but in general probably less than 10% (some studies suggest less than 5%) of all adverse events that occur are actually reported. The rule-of-thumb is that on a scale of 0 to 10, with 0 being least likely to be reported and 10 being the most likely to be reported, an uncomplicated non-serious event such as a mild headache will be closer to a "0" on this scale, whereas a life-threatening or fatal event will be closer to a "10" in terms of its likelihood of being reported. In view of this, medical personnel may not always see AE reporting as a priority, especially if the symptoms are not serious. And even if the symptoms are serious, the symptoms may not be recognized as a possible side effect of a particular drug or combination thereof. In addition, medical personnel may not feel compelled to report events that are viewed as expected. This is why reports from patients themselves are of high value. The confirmation of these events by a healthcare professional is typically considered to increase the value of these reports. Hence it is important not only for the patient to report the AE to his health care provider (who may neglect to report the AE), but also report the AE to both the biopharmaceutical company and the FDA, European Medicines Agency, ... This is especially important when one has obtained one's pharmaceutical from a compounding pharmacy.

As such, spontaneous reports are a crucial element in the worldwide enterprise of pharmacovigilance and form the core of the World Health Organization Database, which includes around 4.6 million reports (January 2009), growing annually by about 250,000.

Aggregate reporting
Aggregate reporting, also known as periodic reporting, plays a key role in the safety assessment of drugs. Aggregate reporting involves the compilation of safety data for a drug over a prolonged period of time (months or years), as opposed to single-case reporting which, by definition, involves only individual AE reports. The advantage of aggregate reporting is that it provides a broader view of the safety profile of a drug. Worldwide, the most important aggregate report is the Periodic Safety Update Report (PSUR) and Development Safety Update Report (DSUR). This is a document that is submitted to drug regulatory agencies in Europe, the US and Japan (ICH countries), as well as other countries around the world. The PSUR was updated in 2012 and is now referred to in many countries as the Periodic Benefit Risk Evaluation report (PBRER). As the title suggests, the PBRER's focus is on the benefit-risk profile of the drug, which includes a review of relevant safety data compiled for a drug product since its development.

Other reporting methods
Some countries legally oblige spontaneous reporting by physicians. In most countries, manufacturers are required to submit, through its Qualified Person for Pharmacovigilance (QPPV), all of the reports they receive from healthcare providers to the national authority. Others have intensive, focused programmes concentrating on new drugs, or on controversial drugs, or on the prescribing habits of groups of doctors, or involving pharmacists in reporting. All of these generate potentially useful information. Such intensive schemes, however, tend to be the exception. A number of countries have reporting requirements or reporting systems specific to vaccine-related events.

Risk management
Risk management is the discipline within pharmacovigilance that is responsible for signal detection and the monitoring of the risk-benefit profile of drugs. Other key activities within the area of risk management are that of the compilation of risk management plans (RMPs) and aggregate reports such as the Periodic Safety Update Report (PSUR), Periodic Benefit-Risk Evaluation Report (PBRER), and the Development Safety Update Report (DSUR).

Causality assessment
One of the most important, and challenging, problems in pharmacovigilance is that of the determination of causality. Causality refers to the relationship of a given adverse event to a specific drug. Causality determination (or assessment) is often difficult because of the lack of clear-cut or reliable data. While one may assume that a positive temporal relationship might "prove" a positive causal relationship, this is not always the case. Indeed, a "bee sting" Adverse Event — where the AE can clearly be attributed to a specific cause — is by far the exception rather than the rule. This is due to the complexity of human physiology as well as that of disease and illnesses. By this reckoning, in order to determine causality between an adverse event and a drug, one must first exclude the possibility that there were other possible causes or contributing factors. If the patient is on a number of medications, it may be the combination of these drugs which causes the AE, and not any one individually. There have been a number of recent high-profile cases where the AE led to the death of an individual. The individuals were not overdosed with any one of the many medications they were taking, but the combination there appeared to cause the AE. Hence it is important to include in your/one's AE report, not only the drug being reported, but also all other drugs the patient was also taking.

For instance, if a patient were to start Drug X and then three days later were to develop an AE, one might be tempted to attribute blame Drug X. However, before that can be done, the patient's medical history would need to be reviewed to look for possible risk factors for the AE. In other words, did the AE occur with the drug or because of the drug? This is because a patient on any drug may develop or be diagnosed with a condition that could not have possibly been caused by the drug. This is especially true for diseases, such as cancer, which develop over an extended period of time, being diagnosed in a patient who has been taken a drug for a relatively short period of time. On the other hand, certain adverse events, such as blood clots (thrombosis), can occur with certain drugs with only short-term exposure. Nevertheless, the determination of risk factors is an important step of confirming or ruling-out a causal relationship between an event and a drug.

Often the only way to confirm the existence of a causal relationship of an event to a drug is to conduct an observational study where the incidence of the event in a patient population taking the drug is compared to a control group. This may be necessary to determine if the background incidence of an event is less than that found in a group taking a drug. If the incidence of an event is statistically significantly higher in the "active" group versus the placebo group (or other control group), it is possible that a causal relationship may exist to a drug, unless other confounding factors may exist.

Signal detection
Signal detection involves a range of techniques (CIOMS VIII ). The WHO defines a safety signal as: "Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously". Usually more than a single report is required to generate a signal, depending upon the event and quality of the information available.

Data mining pharmacovigilance databases is one approach that has become increasingly popular with the availability of extensive data sources and inexpensive computing resources. The data sources (databases) may be owned by a pharmaceutical company, a drug regulatory authority, or a large healthcare provider. Individual case safety reports in these databases are retrieved and converted into structured format, and statistical methods (usually a smathematical algorithm) are applied to calculate statistical measures of association. If the statistical measure crosses an arbitrarily set threshold, a signal is declared for a given drug associated with a given adverse event. All signals deemed worthy of investigation, require further analysis using all available data in an attempt to confirm or refute the signal. If the analysis is inconclusive, additional data may be needed such as a post-marketing observational trial.

Signal detection is an essential part of drug use and safety surveillance. Ideally, the goal of signal detection is to identify adverse drug reactions that were previously considered unexpected and to be able to provide guidance in the product's labeling as to how to minimize the risk of using the drug in a given patient population.

Risk management plans
A risk management plan is a documented plan that describes the risks (adverse drug reactions and potential adverse reactions) associated with the use of a drug and how they are being handled (warning on drug label or on packet inserts of possible side effects which if observed should cause the patient to inform/see his physician and/or pharmacist and/or the manufacturer of the drug and/or the FDA, European Medicines Agency. The overall goal of a risk management plan is to assure a positive risk-benefit profile once the drug is (has been) marketed.  The document is required to be submitted, in a specified format, with all new market authorization requests within the European Union (EU).  Although not necessarily required, risk management plans may also be submitted in countries outside the EU.  The risks described in a risk management plan  fall into one of three categories: identified risks, potential risks, and unknown risks. Also described within a risk management plan are the measures that the Market Authorization Holder, usually a pharmaceutical company, will undertake to minimize the risks associated with the use of the drug. These measures are usually focused on the product's labeling and healthcare professionals. Indeed, the risks that are documented in a pre-authorization risk management plan will inevitably become part of the product's post-marketing labeling. Since a drug, once authorized, may be used in ways not originally studied in clinical trials, this potential "off-label use", and its associated risks, is also described within the risk management plan. Risk management plans can be very lengthy documents, running in some cases hundreds of pages and, in rare instances, up to a thousand pages long.

In the US, under certain circumstances, the FDA may require a company to submit a document called a Risk Evaluation and Mitigation Strategy (REMS) for a drug that has a specific risk that FDA believes requires mitigation. While not as comprehensive as a risk management plan, a Risk Evaluation and Mitigation Strategy can require a sponsor to perform certain activities or to follow a protocol, referred to as Elements to Assure Safe Use, to assure that a positive risk-benefit profile for the drug is maintained for the circumstances under which the product is marketed.

Risk/benefit profile of drugs
Pharmaceutical companies are required by law in most countries to perform clinical trials, testing new drugs on people before they are made generally available. This occurs after a drug has been pre-screened for toxicity, sometimes using animals for testing. The manufacturers or their agents usually select a representative sample of patients for whom the drug is designed – at most a few thousand – along with a comparable control group. The control group may receive a placebo and/or another drug, often a so-called "gold standard" that is "best" drug marketed for the disease.

The purpose of clinical trials is to determine:
 * if a drug works and how well it works
 * if it has any harmful effects, and
 * if it does more good than harm, and how much more? If it has a potential for harm, how probable and how serious is the harm?

Clinical trials do, in general, tell a good deal about how well a drug works. They provide information that should be reliable for larger populations with the same characteristics as the trial group – age, gender, state of health, ethnic origin, and so on though target clinical populations are typically very different from trial populations with respect to such characteristics.

The variables in a clinical trial are specified and controlled, but a clinical trial can never tell you the whole story of the effects of a drug in all situations. In fact, nothing could tell you the whole story, but a clinical trial must tell you enough; "enough" being determined by legislation and by contemporary judgements about the acceptable balance of benefit and harm. Ultimately, when a drug is marketed it may be used in patient populations that were not studied during clinical trials (children, the elderly, pregnant women, patients with co-morbidities not found in the clinical trial population, etc.) and a different set of warnings, precautions or contraindications (where the drug should not be used at all) for the product's labeling may be necessary in order to maintain a positive risk/benefit profile in all known populations using the drug.

Pharmacoepidemiology
Pharmacoepidemiology is the study of the incidence of adverse drug reactions in patient populations using drug agents.

Pharmacogenetics and pharmacogenomics
Although often used interchangeably, there are subtle differences between the two disciplines. Pharmacogenetics is generally regarded as the study or clinical testing of genetic variation that gives rise to differing responses to drugs, including adverse drug reactions. It is hoped that pharmacogenetics will eventually provide information as to which genetic profiles in patients will place those patients at greatest risk, or provide the greatest benefit, for using a particular drug or drugs. Pharmacogenomics, on the other hand, is the broader application of genomic technologies to new drug discovery and further characterization of older drugs.

International collaboration
The following organizations play a key collaborative role in the global oversight of pharmacovigilance.

The World Health Organization (WHO)
The principle of international collaboration in the field of pharmacovigilance is the basis for the WHO Programme for International Drug Monitoring, through which over 150 member nations have systems in place that encourage healthcare personnel to record and report adverse effects of drugs in their patients. These reports are assessed locally and may lead to action within the country. Since 1978, the programme has been managed by the Uppsala Monitoring Centre to which member countries send their reports to be processed, evaluated and entered into an international database called VigiBase. Membership in the WHO Programme enables a country to know if similar reports are being made elsewhere. When there are several reports of adverse reactions to a particular drug, this process may lead to the detection of a signal, and an alert about a possible hazard communicated to members countries after detailed evaluation and expert review on the biological stasis and homeostasis of the body. Clb12/2020001

The International Council for Harmonisation (ICH)
The International Council for Harmonisation is a global organization with members from the European Union, the United States and Japan; its goal is to recommend global standards for drug companies and drug regulatory authorities around the world, with its activities overseen by the Steering Committee overseeing harmonization activities. Established in 1990, each of its six co-sponsors—the EU, the European Federation of Pharmaceutical Industries and Associations, Japan's Ministry of Health, Labor and Welfare, the Japanese Pharmaceutical Manufacturers Association, the U.S. Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA)—have two seats on the SC. Other parties have a significant interest in the International Council for Harmonisation and have been invited to nominate Observers to the SC; three current observers are the WHO, Health Canada, and the European Free Trade Association, with the International Federation of Pharmaceutical Manufacturers Association participating as a non-voting member of the SC.

The Council for International Organizations of Medical Science (CIOMS)
The CIOMS, a part of the WHO, is globally oriented think tank that provides guidance on drug safety related topics through its Working Groups. The CIOMS prepares reports that are used as a reference for developing future drug regulatory policy and procedures, and over the years, many of CIOMS' proposed policies have been adopted. Examples of topics these reports have covered include: Current Challenges in Pharmacovigilance: Pragmatic Approaches (CIOMS V); Management of Safety Information from Clinical Trials (CIOMS VI); the Development Safety Update Report (DSUR): Harmonizing the Format and Content for Periodic Safety Reporting During Clinical Trials (CIOMS VII); and Practical Aspects of Signal Detection in Pharmacovigilance: Report of CIOMS Working Group (CIOMS VIII).

The International Society of Pharmacovigilance
The International Society of Pharmacovigilance is an international non-profit scientific organization, which aims to foster pharmacovigilance both scientifically and educationally, and enhance all aspects of the safe and proper use of medicines, in all countries. It was established in 1992 as the European Society of Pharmacovigilance.

Society of Pharmacovigilance, India, also established in 1992, is partner member of the International Society of Pharmacovigilance. Other local societies include the Boston Society of Pharmacovigilance Physicians.

Regulatory authorities
Drug regulatory authorities play a key role in national or regional oversight of pharmacovigilance. Some of the agencies involved are listed below (in order of 2011 spending on pharmaceuticals, from the IMS Institute for Healthcare Informatics).

United States
In the U.S., with about a third of all global 2011 pharmaceutical expenditures, the drug industry is regulated by the FDA, the largest national drug regulatory authority in the world. FDA authority is exercised through enforcement of regulations derived from legislation, as published in the U.S. Code of Federal Regulations (CFR); the principal drug safety regulations are found in 21 CFR Part 312 (IND regulations) and 21 CFR Part 314 (NDA regulations). While those regulatory efforts address pre-marketing concerns, pharmaceutical manufacturers and academic/non-profit organizations such as RADAR and Public Citizen do play a role in pharmacovigilance in the US. The post-legislative rule-making process of the U.S. federal government provides for significant input from both the legislative and executive branches, which also play specific, distinct roles in determining FDA policy.

Emerging economies (including Latin America)
The "pharmerging", or emerging pharmaceutical market economies, which include Brazil, India, Russia, Argentina, Egypt, Indonesia, Mexico, Pakistan, Poland, Romania, South Africa, Thailand, Turkey, Ukraine and Vietnam, accrued one fifth of global 2011 pharmaceutical expenditures; in future, aggregated data for this set will include China as well.

China's economy is anticipated to pass Japan to become second in the ranking of individual countries' in pharmaceutical purchases by 2015, and so its PV regulation will become increasing important; China's regulation of PV is through its National Center for Adverse Drug Reaction Monitoring, under China's Ministry of Health.

As JE Sackman notes, as of April 2013 "there is no Latin American equivalent of the European Medicines Agency—no common body with the power to facilitate greater consistency across countries". For simplicity, and per sources, 17 smaller economies are discussed alongside the 4 pharmemerging large economies of Argentina, Brazil, Mexico and Venezuela—Bolivia, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Haiti, Honduras, Nicaragua, Panama, Paraguay, Peru, Suriname, and Uruguay. As of June 2012, 16 of this total of 21 countries have systems for immediate reporting and 9 have systems for periodic reporting of adverse events for on-market agents, while 10 and 8, respectively, have systems for immediate and periodic reporting of adverse events during clinical trials; most of these have PV requirements that rank as "high or medium...in line with international standards" (ibid.). The WHO's Pan American Network for Drug Regulatory Harmonization seeks to assist Latin American countries in develop harmonized PV regulations.

Some further PV regulatory examples from the pharmerging nations are as follows. In India, the PV regulatory authority is the Indian Pharmacopoeia Commission, with a National Coordination Centre under the Pharmacovigilance Program of India, in the Ministry of Health and Family Welfare. Scientists working on pharmacovigilance share their experiences, findings, innovative ideas and researches during the annual meeting of Society of Pharmacovigilance, India. In Egypt, PV is regulated by the Egyptian Pharmacovigilance Center of the Egyptian Ministry of Health.

European Union
Good Pharmacovigilance Practices (GVP) is a set of set of guidelines ithat apply to the EU member states.
 * 1) Module I: Pharmacovigilance system and Quality system
 * 2) Module II: Pharmacovigilance system master file
 * 3) Module III: Pharmacovigilance inspection
 * 4) Module IV: Pharmacovigilance audit
 * 5) Module V: Risk management system
 * 6) Module VI: Management and reporting of adverse reactions to medical products
 * 7) Module VII: Periodic safety update report
 * 8) Module VIII: Post authorization safety
 * 9) Module IX : Signal management
 * 10) Module X: Additional monetoring
 * 11) Module XI: Public participation in pharmacovigilance
 * 12) Module XII: Post-marketing authorisation: regulatory and procedural guidance for human medicinal products
 * 13) Module XIII: Incident management
 * 14) Module XIV: Referral procedure for safety reasons
 * 15) Module XV: Safety communication
 * 16) Module XVI: Risk minimization measure: Selection of tools and effectiveness indicators

The EU5 (France, Germany, Italy, Spain, United Kingdom) accrued ~17% of global 2011 pharmaceutical expenditures. PV efforts in the EU are coordinated by the European Medicines Agency and are conducted by the national competent authorities (NCAs). The main responsibility of the European Medicines Agency is to maintain and develop the pharmacovigilance database consisting of all suspected serious adverse reactions to medicines observed in the European Community; the data processing network and management system is called EudraVigilance and contains separate but similar databases of human and veterinary reactions. The European Medicines Agency requires the individual marketing authorization holders to submit all received adverse reactions in electronic form, except in exceptional circumstances; the reporting obligations of the various stakeholders are defined by EEC legislation, namely Regulation (EC) No 726/2004, and for human medicines, European Union Directive 2001/83/EC as amended and Directive 2001/20/EC. In 2002, Heads of Medicines Agencies agreed on a mandate for an ad hoc Working Group on establishing a European risk management strategy; the Working Group considered the conduct of a high level survey of EU pharmacovigilance resources to promote the utilization of expertise and encourage collaborative working.

In conjunction with this oversight, individual countries maintain their distinct regulatory agencies with PV responsibility. For instance, in Spain, PV is regulated by the Agencia Española de Medicamentos y Productos Sanitarios, which can suspend or withdraw the authorization of pharmaceuticals already on-market if the evidence shows that safety (or quality or efficacy) of an agent are unsatisfactory.

Rest of Europe, including non-EU
The remaining EU and non-EU countries outside the EU5 accrued ~7% of global 2011 pharmaceutical expenditures. Regulation of those outside the EU being managed by specific governmental agencies. For instance, in Switzerland, PV "inspections" for clinical trials of medicinal products are conducted by the Swiss Agency for Therapeutic Products.

Japan
In Japan, with ~12% of all global 2011 pharmaceutical expenditures, PV matters are regulated by the Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour, and Welfare.

Canada
In Canada, with ~2% of all global 2006 and 2011 pharmaceutical expenditures, PV is regulated by the Marketed Health Products Directorate of the Health Products and Food Branch. Canada was second, following the United States, in holding the highest total prescription drug expenditures per capita in 2011 at around 750 US dollars per person. Canada also pays such a large amount for pharmaceuticals that it was second, next to Switzerland, for the amount of money spent for a certain amount of prescription drugs (around 130 US dollars). It was also accessed that Canada was one of the top countries that increased its yearly average per capita growth on pharmaceutical expenditures the most from 2000 to 2010 with 4 percent a year (with taking inflation into account) The Marketed Health Products Directorate mainly collects adverse drug reaction reports through a network of reporting centers to analyze and issue possible warnings to the public, and currently utilizes newsletters, advisories, adverse reaction centers, as well as electronic mailing lists. However, it does not currently maintain a database or list of drugs removed from Canada as a result of safety concerns.

In August 2017, there was a government controversy in which a bill, known as “Vanessa’s Law”, to protect patients from potentially dangerous prescription drugs was not being fully realized by hospitals; Health Canada only required hospitals to report “unexpected” negative reactions to prescription drugs, rather than any and all adverse reactions, with the justification of managing “administrative overload”.[25]

South Korea
The Republic of Korea, with ~1% of all global 2011 pharmaceutical expenditures, PV matters are regulated in South Korea by the Ministry Of Food And Drug Safety

Azerbaijan
The law on pharmacovigilance in Azerbaijan was revised and implemented as part of the "Regulation of Pharmacovigilance for Medicinal Products" in 2019. This regulation was developed to establish state control over the effectiveness and safety of medicinal products. It outlines measures to detect, evaluate, and prevent adverse reactions and other undesirable effects of medicinal products, applying to marketing authorization holders and all health institutions in Azerbaijan

In Azerbaijan, the Ministry of Health and other relevant state authorities play a crucial role in the functioning of the pharmacovigilance system. These organizations implement various regulatory and oversight mechanisms to ensure drug safety.

Worldwide company Pharmcontrol (https://www.pharmcontrol.com/en ) offers a full range of pharmacovigilance services in Azerbaijan to ensure the safety and effectiveness of medicines on the market. With a team of highly qualified, certified pharmacists, Pharmcontrol ensures the effective monitoring and management of drug safety. The company aligns with international practices and standards, helping to elevate the country's drug safety levels.

The development of pharmacovigilance in Azerbaijan aims to increase public awareness about the safe use of medicines and improve the overall quality of the healthcare system. The integration of international standards and best practices in pharmacovigilance, spearheaded by companies like Pharmcontrol (https://www.pharmcontrol.com/en ), contributes significantly to this goal, ensuring that the safety of patients is always a top priority.

Kenya
In Kenya, PV is regulated by the Pharmacy and Poisons Board.The Pharmacy and Poisons Board provides a Pharmacovigilance Electronic Reporting System which allows for the online reporting of suspected adverse drug reactions as well as suspected poor quality of medicinal products. The Pharmacovigilance activities in Kenya are supported by the School of Pharmacy, University of Nairobi through its Master of Pharmacy in Pharmacoepidemiology & Pharmacovigilance program offered by the Department of Pharmacology and Pharmacognosy.

In Uganda, PV is regulated by the National Drug Authority.

Rest of world
The rest of the world accrued ~7% of global 2011 pharmaceutical expenditures. Some examples of PV regulatory agencies in the rest of the world are as follows. In Iraq, PV is regulated by the Iraqi Pharmacovigilance Center of the Iraqi Ministry of Health.

In India: Pv is regulated by the PVPI (Pharmacovigilance programme of India)

Pharmacoenvironmentology (Ecopharmacovigilance)
Despite attention from the FDA and regulatory agencies of the European Union, procedures for monitoring drug concentrations and adverse effects in the environment are lacking. Pharmaceuticals, their metabolites, and related substances may enter the environment after patient excretion, after direct release to waste streams during manufacturing or administration, or via terrestrial deposits (e.g., from waste sludges or leachates). A concept combining pharmacovigilance and environmental pharmacology, intended to focus attention on this area, was introduced first as pharmacoenvironmentology in 2006 by Syed Ziaur Rahman and later as ecopharmacology with further concurrent and later terms for the same concept (ecopharmacovigilance, environmental pharmacology, ecopharmacostewardship).

The first of these routes to the environment, elimination through living organisms subsequent to pharmacotherapy, is suggested as the principal source of environmental contamination (apart from cases where norms for treatment of manufacturing and other wastes are violated), and ecopharmacovigilance is intended to deal specifically with this impact of pharmacological agents on the environment.

Activities of ecopharmacovigilance have been suggested to include:
 * Increasing, generally, the availability of environmental data on medicinal products;
 * Tracking emerging data on environmental exposure, effects and risks after product launch;
 * Using environmental risk management plans to manage risk throughout a drug's life cycle;
 * Following risk identification, promoting further research and environmental monitoring, and
 * In general, promoting a global perspective on ecopharmacovigilance issues.

Related to medical devices
A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug). Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by physical, mechanical, or thermal means. Medical devices vary greatly in complexity and application. Examples range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as medical robots, cardiac pacemakers, and neuroprosthetics. This modern concept of monitoring and safety of medical devices which is known materiovigilance was quite documented in Unani System of medicine.

Given the inherent difference between medicinal products and medical products, the vigilance of medical devices is also different from that of medicinal products. To reflect this difference, a classification system has been adopted in some countries to stratify the risk of failure with the different classes of devices. The classes of devices typically run on a 1-3 or 1-4 scale, with Class 1 being the least likely to cause significant harm with device failure versus Classes 3 or 4 being the most likely to cause significant harm with device failure. An example of a device in the "low risk" category would be contact lenses. An example of a device in the "high risk" category would be cardiac pacemakers.

Medical device reporting (MDR), which is the reporting of adverse events with medical devices, is similar to that with medicinal products, although there are differences. In contrast to reporting of medical products reports of side-effects play only a minor role with most medical devices. The vast majority of the medical device reports are related to medical device defects or failures. Other notable differences are in the obligations to report by other actors that aren't manufacturers, in the US user-facilities such as hospitals and nursing homes are legally required to report suspected medical device-related deaths to both FDA and the manufacturer, if known, and serious injuries to the manufacturer or to FDA, if the manufacturer is unknown. This is in contrast to the voluntary reporting of AEs with medicinal products. Similar obligations exist in multiple European countries. The European regulation on medical devices and the European regulation on in vitro diagnostic medical devices (IVDR) obliges other economic operators most notably importers and distributors to inform manufacturers, and in certain instances the authorities, of incidents and safety issues with medical devices that they have distributed or imported in the European market.

For herbal medicines
The safety of herbal medicines has become a major concern to both national health authorities and the general public. The use of herbs as traditional medicines continues to expand rapidly across the world; many people now take herbal medicines or herbal products for their health care in different national health-care settings. However, mass media reports of adverse events with herbal medicines can be incomplete and therefore misleading. Moreover, it can be difficult to identify the causes of herbal medicine-associated adverse events since the amount of data on each event is generally less than for pharmaceuticals formally regulated as drugs (since the requirements for adverse event reporting are either non-existent or are less stringent for herbal supplements and medications).

Novel sources
With the emergence of advanced artificial intelligence methods and social media big data, researchers are now using publicly posted social media data to discover unknown side effects of prescription medications. Natural language processing and machine learning methods are developed and used for identifying non-standard expressions of side effects.

Industry associations
Boston Society of Pharmacovigilance Physicians.

title: Pharmacovigilance


text:
Exact sciences

The exact sciences or quantitative sciences, sometimes called the exact mathematical sciences, are those sciences "which admit of absolute precision in their results"; especially the mathematical sciences. Examples of the exact sciences are mathematics, optics, astronomy, and physics, which many philosophers from Descartes, Leibniz, and Kant to the logical positivists took as paradigms of rational and objective knowledge. These sciences have been practiced in many cultures from antiquity to modern times. Given their ties to mathematics, the exact sciences are characterized by accurate quantitative expression, precise predictions and/or rigorous methods of testing hypotheses involving quantifiable predictions and measurements.

The distinction between the quantitative exact sciences and those sciences that deal with the causes of things is due to Aristotle, who distinguished mathematics from natural philosophy and considered the exact sciences to be the "more natural of the branches of mathematics." Thomas Aquinas employed this distinction when he said that astronomy explains the spherical shape of the Earth by mathematical reasoning while physics explains it by material causes. This distinction was widely, but not universally, accepted until the scientific revolution of the 17th century. Edward Grant has proposed that a fundamental change leading to the new sciences was the unification of the exact sciences and physics by Kepler, Newton, and others, which resulted in a quantitative investigation of the physical causes of natural phenomena.

Linguistics and comparative philology have also been considered exact sciences, most notably by Benjamin Whorf.

license: Creative Commons - Attribution Share-Alike - https://creativecommons.org/licenses/by-sa/4.0/

title: Exact sciences


text:
Talk:Lotus Elise

New Engine
The Lotus website says that the Elise now comes with a 1.6L Toyota engine, the 1ZR-FAE. The 1ZR-FAE section of the ZR family page lists the Elise as being one of the cars that uses it, but it's missing from the Elise page. I've never made an edit that included a link and a citation, so I thought I'd just mention it here and let some one else do it.

Picture
The current picture has a lot of glare, and is also pretty grany when blown up. Anyone got an Elise they can take pictures of?

I added mine. I think it's a nice pic. Got others if you're interested.--Rod 06:46, 3 May 2005 (UTC)

Introduction Date
The first Elise was -introduced- in 1995, but it's the 1996 model.

Predecessor
The proper predecessor to the Elise is not the Lotus 7, but the Lotus Elan (the non-Isuzu motored one). The Elan was more similar in shape, was a convertible (the 7 has no real top), and the Elan (even the non-Isuzu one) was produced by Lotus far more recently than the 7. Just looking at the 3 cars, it's obvious the proper relationship. Bollinger 18:15, 25 April 2007 (UTC)

Price?
stupid price

I added the 42990 figure that was at the lotus cars site.

Where is the price? — Preceding unsigned comment added by 80.220.84.24 (talk) 15:02, 14 July 2012 (UTC)
 * WP:PRICES -- >Typ932 T·C 15:30, 14 July 2012 (UTC)

Austin Rover Group ECV3/Lotus Elise link
What amazes me about this article is that it fails to acknowledge the work that Rover produced, specifically Spen King, which led up to the concepion of the Lotus Elise chassis. One must realise that Rover were creating a lightweight chassis to work in unison with it's K-series power plant in order to come up with a high economy concept vehicle. The chassis itself could be adapted to suit any light vehicle role as was necessary.

Secondly, one must note that at Lotus there was a lot of kitchen sink engineering involved with their version of the K-series block. Problems were being engineered into the unit. As noted by one employee at Powertrain, Lotus never contacted them at all. The problems that Rover suffered with earlier K-series units were fixed throughout the engine's life. One example is the front engine hydro-mount, which cause slight imbalance of the engine whilst cornering.. This was fixed in the earlier Rover 200/400 cars in the early 90's!!! - Yet right up to the last K-series Elises, they were still using them!!

Check out this link for the the truths and myths about the K-series block, and in particular to the Lotus VHPD engine.

K-Series Engine - King K

There are overtones to your posting that whiff slightly, so please don't let the main article which maintains the Wikipedia neutral point of view become yet another sewer arguing the toss about King K.

The King K article and many of the theories presented in it, particularly their "originality", their engineering integrity and the sources quoted there or since original publication have been debunked by all and sundry.

So whoever you are "193.60.133.205" stop trying to stir things up here because you have been banned from elsewhere, it's not big and it's not clever.

Please show credible evidence. Secondly, if the re-engineered version of the K series engine becomes a serious failure in the SAIC/NAC/MG cars, then you can dismiss my comments.. until then, I would like to see your proof. I am not stirring things up, but simply making note of the fact that the Lotus Elise is not ALL Lotus' work. —Preceding unsigned comment added by 77.100.12.167 (talk) 23:55, 26 May 2008 (UTC)

UK price?
It seems a bit silly only to have a US price for a British car. Anyone know the MRSP for the base Elise in the UK? Loganberry (Talk) 03:31, 30 October 2006 (UTC)

Price redux
The price is missing from the article entirely, at present. Without a discussion of the price range of these vehicles, much of the context is lost. As pointed out above by Loganberry, please give in multiple currencies/markets. What's the best source to use? MrZaius talk  20:42, 19 August 2007 (UTC)

 * [ This is a good source of information for all the pricing on european models, you have to give your details and sign up to their junkmail to get to this page, so I don't know if they will want it pasted onto wikipedia, but i have used the british prices from it. There didn't really seem to be much point in taking 6 different prices in euros for each model based on the different taxes of each country, but I think someone should add the prices of the US models since they are slightly different (their engine requirements mean basically they don't have an elise S, they have the elise R simply named "elise" (i think) and the elise SC as in europe) this information should also be added to the main article, but i'm not an expert at american models. I have removed the outdated prices from 2002, the prices of the opel/vauxhall that is no longer sold, the comparison prices of boxters and the prices in swiss francs from 2008 (which are probably accurate, but not too useful especially as the other currencies listed were just the result of pumping the swiss prices into a currency converter). I hope this is more useful--[[User:KX36|KX36]] (talk) 23:34, 3 February 2009 (UTC)

Too informal
I don't want to spread doom and gloom over the article, but it sounds a little too informal, and a bit approving. Take a look at:

As a result, the Elise's acceleration, braking, cornering, and fuel consumption (all of which are    improved by reductions in a car's weight) was nothing short of astonishing in spite of the fact that the engine put out a relatively modest 120 bhp (89 kW).

Also:

It also had more padding in the seats to the horror of purists and the relief of those with nerve endings in their bottoms.

I can't help feeling adjectives like "astonishing" are a bit much.

ManicParroT 20:25, 18 September 2007 (UTC)
 * I agree. This should be rewritten in a more encyclopedic tone.  Needs more/better citations too.  swa  q  17:45, 6 March 2008 (UTC)

also several occasions of the word "hardcore"; what does that even mean in an informal context, let alone an encyclopaedia?

duncanrmi (talk) 23:01, 20 July 2020 (UTC)

Infobox
I have expanded the Infobox slightly. However, I'm thinking it might be best to have two separate Infoboxes. One for the Series 1 and a second for the Series 2. This would make expanding them in more detail easier. swa q  22:33, 6 March 2008 (UTC)

Predecessor
I'm curious why the Lotus 7 is considered the predecessor to the Elise. Especially considering the Lotus 7 article lists the Caterham 7 as its successor. It would seem to me that the 1990's Elan was the Elise's predecessor. Does anyone have sources that address this topic? swa q  15:37, 10 March 2008 (UTC)
 * Also, the Lotus Elan infobox lists the Elise as its successor. swa  q  16:19, 10 March 2008 (UTC)
 * I went ahead and changed this, since one of the sources says "At the Frankfurt Motor Show in September 1995, Lotus unveiled a lightweight two-seat roadster to replace the ageing M100 Elan." swa  q  16:31, 10 March 2008 (UTC)
 * Then your source quite frankly stinks :) The Elise was NEVER EVER, not in a million years ever a replacement for the M100 Elan. It might conceivably been a replacement for the Type 26/36/45 Elan, or, as most, including those who worked on design and development of the car at Lotus view it as, a spiritual successor to the Seven.  BTW the source saying the M100 Elan was ageing in 1996 is a bit of a joke, because prior to the Elise introduction it was the most modern vehicle that Lotus produced, seven years old at this point and two years since production ceased - compared to 20 years old for the Esprit and 22 years (and four years ceased production) for the Excel (based on the introduction date of the Elite/Eclat) M100 (talk) 16:51, 11 March 2008 (UTC)
 * It's not "my" source, it was one that the page already referenced. I welcome more/better sources.  The M100 Elan would seem to me to be the most immediate predecessor, though I recognize that there are significant differences, most notably that the Elan is front-engine/front wheel drive and the Elise is mid-engine/rear wheel drive.  For the record I have nothing against the Elan. :)   swa  q  19:52, 11 March 2008 (UTC)

External links?
- swaq

Why Is the Lotus Techwiki not allowed to be added as an external link?

PLEASE EXPLAIN. —Preceding unsigned comment added by 93.97.74.188 (talk) 21:06, 21 June 2009 (UTC)

Popularity
As I understand it the car sold well, and was a very significant model for Lotus; it helped secure the future of the company during an otherwise dismal time. It was certainly more popular than the Mk 2 Lotus Elan. The article is purely technical and doesn't mention any of this perhaps because it's hard to source, but sales figures at least should be available somewhere. -Ashley Pomeroy (talk) 20:14, 14 August 2009 (UTC)

For short drivers only?
Considering the few Lotis Elises I've encountered, I'm surprised anybody over 5'6" can comfortably drive one. I suspect there's more legroom in a Nissan Versa or Honda Civic. If I'm wrong, how much headroom and legroom does the Elise have? DanTD (talk) 01:40, 11 January 2011 (UTC) It's not very encylopeadic, but I'm a 6'2" male and can drive one comfortably. —Preceding unsigned comment added by 82.110.244.202 (talk) 15:37, 7 February 2011 (UTC)

Face lift
The Elise was face lifted some time during 2010 and theres no mention of it here. — Preceding unsigned comment added by Hennelly14 (talk • contribs) 21:06, 1 June 2011 (UTC)

Lotus Eco Elise with hemp
http://www.lotuscars.com/engineering/eco-elise

I did not see this version of the car mentioned in the article. There is plenty of coverage from reliable sources on the web. --Timeshifter (talk) 15:20, 13 September 2012 (UTC)

Succesor: Hennesey Venom?
I assume that someone was joking when they put this in? Sure, the Venom has a Lotus base, but it's about as similar to an Elise as I am to a Lemur. — Preceding unsigned comment added by 86.8.10.2 (talk) 03:20, 26 July 2014 (UTC)

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title: Talk:Lotus Elise


text:
Targe

The targe (from Old Franconian targa 'shield', Proto-Germanic targo 'border') is a type shield that was used by Scottish Highlanders in the early modern period. From the late 16th century, until the Battle of Culloden in 1746, the Scottish Highlander's main means of defence in battle was his targe. In February 1596, the clan leader John Grant of Freuchie was able to muster 500 men, including 40 armed "according to the Highland custom" with bows, helmets, swords, and targes. After the disastrous defeat of the Jacobites at Culloden, the carrying of the targe had been banned by the Disarming Act, and many were destroyed or put to other uses. Those that remain have intricate patterns and are decorated, indicating that they would have originally belonged to important people.

The targe is a concave shield fitted with enarmes on the inside, one adjustable by a buckle, to be attached to the forearm, and the other fixed as a grip for the left hand.

Etymology
Targe (from Old Franconian targa 'shield', Proto-Germanic targo 'border') was a general word for shield in late Old English. Its diminutive, target, came to mean an object to be aimed at in the 18th century.

The term refers to various types of shields used by infantry troops from the 13th to 16th centuries, or earlier. From the 15th century, the term could also refer to special shields used for jousting. A fair number were created wholly for show.

Structure of the Scottish targe

Targes are generally round shields between 18 in and 21 in (45–55 cm) in diameter. The inside of the targe was formed from two very thin layers of flat wooden boards, with the grain of each layer at right angles to the other. They were fixed together with small wooden pegs, forming plywood. The front was covered with a tough cowhide, which was often decorated with embossed Celtic style patterns. This was fixed to the wood with many brass, or in some cases, silver, nails, and occasionally brass plates were also fixed to the face for strength and decoration. Targes generally had center bosses of brass. A Highlander was usually armed with a broadsword or dagger in one hand and targe on his other arm for close combat. It was also common for a dirk to be held in the targe hand, with the blade extending below the targe.

The back of the targe was commonly covered in deerskin, and a very few had some packing of straw etc. behind this. Although all the old targes show signs of handles and arm straps, of various designs including centre-grips, there is very little evidence to indicate that there was any guige strap for carrying the targe over the shoulder.

title: Targe


text:
Talk:Emmanuel Levinas

Wiki Education Foundation-supported course assignment
This article is or was the subject of a Wiki Education Foundation-supported course assignment. Further details are available on the course page.

Above undated message substituted from Template:Dashboard.wikiedu.org assignment by PrimeBOT (talk) 20:30, 16 January 2022 (UTC)

IPA transcription of Levinas' name
Can someone provide an IPA transcription of Levinas' name? 128.12.32.199 23:12, 29 September 2006 (UTC)

 * More important, is there an accent on the "e" or isn't there? --ND 22:39, 31 August 2007 (UTC)

"Knowledge of Love"
I would caution the use of this phrase, as it seems to simplify the profundity of Levinas's argument. The way I understand, Levinas believes that the fundamental groundwork for an ethics is not the same as the phenomenological accounts of "Eros," "Fecundity", and "Filiality" to be found in Totality and Infinity. "As Levinas was fond of putting it, the entirety of his philosophy can be summarized in the simple words, 'Apres vous, Monsieur," sites Simon Critchley; it is a move towards the obligatory and infinite nature of the ethical bond resting on the invocation and vertical relationship with the Other. "Knowledge" and "love" can conjure images of possession and self-fulfillment, which seem antithetical to this argument.

Removed "Some of his work is rather hard to understand, but one could say that." Seems subjective, as I understand it just fine. Bodhidharma 02:51, Feb 28, 2005 (UTC)

Starting Points?
Thought I'd start a discussion about how and with what work to begin if you want to read Levinas. Personally, I found the gentlest approach was to start with the essay "is Ontology Fundamental" and then read "Totality and Infinity." the Ontology essay is a pretty easy read that gives a good cursory explanation of where he's coming from, so that when you read "Totality & Infinity" its easier to keep up. Any other thoughts or recommendations? —The preceding unsigned comment was added by Themanfromlamancha (talk • contribs) 21:42, 15 February 2007 (UTC).

 * I got into Levinas by first reading his 1946-47 lectures, "Time and the Other". A good dictionary for words like 'hypostasis' and some knowledge of phenomenology will help as well.  The work is short, reads well, has a well written conclusion, and everything is spelled out very clearly.  If someone is looking for a good general introductory essay on the philosophy of Levinas I highly recommend Hilary Putnam's essay "Levinas and Judaism" which is found in the Cambridge Companion to Levinas.

Teetotaler

Reformatting the Article
In its current state the article seems to be some what disjointed. There is a discussion of Levinas' life and philosophy and only then a discussion of his war time experience. However, it would seem more appropriate to have a traditional biography section and then a discussion of Levinas' philosophy, particularly because Levinas' war time experiences play an influential role in his philosophy. However, I thought I would bring this suggestion up on the discussion page before moving ahead with changing the article. Thanks, Golem88991 04:01, 24 April 2007 (UTC)

Accent
I made a comment above but it went unanswered, so I'll try again: how is Levinas' last name spelled: with an accent on the "e" or without? This article uses an accent but judging from the books & catalogue entries I've seen this is probably wrong. --ND 14:31, 2 October 2007 (UTC)

In the « Dialogues avec Philippe Nemo » titled ETHIQUE ET INFINI his name has an accent on the uncapitalized "e": « Ils constituent une présentation succincte de la philosophie d’Emmanuel Lévinas […] » (9); «Emmanuel Lévinas est né en janvier 1906 à Kaunas, en Lithuanie » (11) etc. A cover of Totalité et infini (of uncertain date but post 1987) has the accent even on the capitalized "e" (LÉVINAS; the title page does not). That said, even the French wiki has this problem: « Levinas ou Lévinas, tout est dans l'accent » (in the Discussion). — Preceding unsigned comment added by 2604:2000:14C5:2283:5142:EA16:FF5D:C483 (talk) 17:04, 10 August 2019 (UTC)

Full Descriptions of Major Works and Terminology
I think there should be a seperate section or summary for 1) his critique of husserl 2)his critique of heideggar 3) a overview of T&I 4) derrida's "violence in metaphysics" 5) otherwise than being 6) postmodern ethics 7) major terminology- other, Other, excendance, face to face, subject, 'living from,' le tiers, the Saying, the Said, and sensibility... for beginners interested in his work this information is critical. Any comments to further this? Zeldy345 (talk) 07:48, 24 February 2008 (UTC)

Broken Links
The last external link was broken so I removed it. Ali Altaf Mian, "Islamic Morality vis-à-vis Levinas." Abo 3adel (talk) 08:41, 29 March 2008 (UTC)

This man is not a philosopher, is just a moralist who thoght that a decadent religion like christianity (an all its derivateds) could be the model of our conduct. Altruism, and all the ethics out of the own subject, or that give preference to the other before the ego, are just rubbish, pseudo-philosophy. —Preceding unsigned comment added by 81.203.105.32 (talk) 20:05, 26 December 2009 (UTC)

 * Learn how to argue and sign your posts, simple cracker. Hineini.  Teetotaler

Merger proposal
I propose merging Face-to-face to this article. Face-to-face doesn't really make for a good separate topic. It would be better in this article. Bhny (talk) 14:52, 18 September 2012 (UTC)
 * I don't agree. Face-to-face is certainly an important concept for Levinas, but it's not his only concept. We have many pages dedicated to terms used by philosophers. (The more famous the philosopher, the more pages on their terminology... for better or for worse.) Keeping face-to-face separate allows for more growth of that page, including discussion of future uses of the concept in philosophy. groupuscule (talk) 03:09, 19 September 2012 (UTC)
 * Oppose - Thanks Bhny (talk) for your interest in Emmanuel Levinas (1996-1995) and his face-to-face concept. Unfortunately I agree with groupuscule (talk): keeping the face-to-face article separated allows for more growth on that article page including discussions on future uses of this concept in philosophy. Sorry. Maurice Carbonaro (talk) 09:29, 29 October 2012 (UTC)
 * Oppose Face-to-face is a separate issue from, and is explored by people in addition to, Levinas. Saylors (talk) 02:11, 11 November 2012 (UTC)

The Face-to-face article just rambles on without ever defining a topic. I tried to create one but found nothing. If it's going to be a separate article it needs a definition Bhny (talk) 13:58, 29 October 2012 (UTC)

 * Oppose as per Saylors. Note that a defintion has been provided by Saylors in the meanwhile. --Omnipaedista (talk) 00:14, 12 November 2012 (UTC)

 * What is this supposed to mean, it's unreadable- "the responsibility of face-to-face contact "ordains" a person with a responsibility that is an unlimited responsible, no matter how our responsibility is reciprocated" Bhny (talk) 00:28, 12 November 2012 (UTC)

 * I clarified the definition. It is based on a quote from Ethics and Infinity (p. 97): "The face orders and ordains me" --Omnipaedista (talk) 02:17, 12 November 2012 (UTC)

Levinas NOT Lévinas
This is tiring: the French write Levinas, not Lévinas and this backed up by Larousse the authority on French language. At the Sorbonne where he taught he was "Levinas" and if you check amazon.com in French you will see that he published under the name of Levinas. So, can someone rid the English wiki of this erro?. It is moronic. — Preceding unsigned comment added by 105.226.129.64 (talk) 19:27, 9 April 2013 (UTC)

 * "At the Sorbonne where he taught he was 'Levinas'": may you cite a source stating this? "if you check amazon.com in French you will see that he published under the name of Levinas": I checked, there are works published under "Lévinas" as well. --Ebdòmero (talk) 17:30, 6 May 2013 (UTC)

As noted below as well, the French do (at times at least) write Lévinas: "In the « Dialogues avec Philippe Nemo » titled ETHIQUE ET INFINI his name has an accent on the uncapitalized "e": « Ils constituent une présentation succincte de la philosophie d’Emmanuel Lévinas […] » (9); «Emmanuel Lévinas est né en janvier 1906 à Kaunas, en Lithuanie » (11) etc. A cover of Totalité et infini (of uncertain date but post 1987) has the accent even on the capitalized "e" (LÉVINAS; the title page does not). That said, even the French wiki has this problem: « Levinas ou Lévinas, tout est dans l'accent » (in the Discussion)." — Preceding unsigned comment added by 2604:2000:14C5:2283:5142:EA16:FF5D:C483 (talk) 17:06, 10 August 2019 (UTC)

Requested move
Emmanuel Lévinas → Emmanuel Levinas — Per the comment above. It was an ill-considered move anyway and there was no consensus behind it. (Note that such page moves can only be done by administarors (Requested moves).) --Omnipaedista (talk) 17:39, 4 May 2013 (UTC)

 * It's "Lévinas" according to levinas.fr, among others. Behind the move there was not consensus because there is plenty of reliable, cited sources. Also it is clear that moves like that can be done by every user, otherwise the system would prevent them. The comment "Levinas NOT Lévinas" is written by a charlatan; according to him, on amazon.fr only books published under "Levinas" are listed, but this is false, just see this, this, this or this, for example. --Ebdòmero (talk) 17:23, 6 May 2013 (UTC)
 * No, reverting your move cannot be done by every user. Charlatan or not 105.226.129.64 did provide a tertiary source where the alternate spelling is employed. In fact most reliable sources on Levinas either in French or English (see The Cambridge Companion to Levinas and references therein) do not use the accented form of the name, and unless I am terribly mistaken, Levinas himself did not use it either. So your move was indeed contentious. --Omnipaedista (talk) 00:38, 14 May 2013 (UTC)
 * My point is that primary and secondary references (books published by Levinas and by Levinas scholars) are more authoritative than tertiary references (encyclopedia articles). See also a somewhat relevant discussion on the French wikipedia. --Omnipaedista (talk) 00:31, 28 June 2013 (UTC)
 * The page is not move-protected, so I moved the article, made the relevant fixes, and also added a new footnote/reference. Please discuss before making any changes related to this issue. --Omnipaedista (talk) 00:43, 28 June 2013 (UTC)

--Ebdòmero (talk) 18:13, 7 September 2013 (UTC)
 * I provided tertiary sources too.
 * I gave BOTH versions of the possible pronunciation.
 * You invite me to discuss before editing, but you should do that too.
 * You contradict yourself: "reverting your move cannot be done by every user", "The page is not move-protected".
 * I wasted enough time here

Possessive form of Levinas
According to both the Chicago Manual of Style (16th ed., section 7.16) and the Oxford Manual of Style (ed. 2002, section 5.2.1), the correct possessive form of Levinas is Levinas's, not Levinas'. This has been corrected in several places. Piperh (talk) 14:03, 10 June 2014 (UTC)

Early education
I am modifying the "life and career" section to expand the section on early life and to make it chronological. I've eliminated the vague formulation "traditional Jewish education". Levinas did attend a all-Jewish gymnasium for the final two years before he started university in France, but that was after his family had spent its years in Ukraine. There doesn't seem to be evidence that his education up until that point was steeped in Jewish traditions, although his family and community was Jewish. His parents owned a Russian-language bookstore, and he attended an integrated Russian school as a young child, which likely focused more on mainstream European culture and history. I know that the role of Jewish heritage in Levinas's intellectual itinerary is a site of disagreement, so please assume my good faith in these edits. Jazzcowboy (talk) 13:51, 17 February 2017 (UTC)

External links modified
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Date of naturalisation?
The French page has 1931: Il obtient à sa demande la nationalité française en 1931 2603:7000:3902:B10A:8D1:25DC:5AF:C01C (talk) 03:14, 20 October 2022 (UTC)

title: Talk:Emmanuel Levinas


text:
User talk:Tadint

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Charlottetown Islanders

The Charlottetown Islanders are a Canadian junior ice hockey team in the Quebec Maritimes Junior Hockey League (QMJHL) based in Charlottetown, Prince Edward Island. They are members of the Maritimes Division, and play their home games at the Eastlink Centre.

History

Originally located in Montreal, and called the Montreal Rocket, the team relocated to Charlottetown, Prince Edward Island, in 2003. They were named after Maurice "Rocket" Richard of the Montreal Canadiens, and their team crest depicted his number, 9.

In their first season on PEI, the Rocket won 40 regular season games and made it to the second round of the playoffs, where they lost in six games to the Moncton Wildcats led by future NHL star goaltender Corey Crawford.

Beginning in the 2013–14 season, the Rocket rebranded as the Charlottetown Islanders.

President and governor Serge Savard Jr. confirmed on April 17, 2013, that the QMJHL had contacted the Rocket two days earlier with a proposal to buy the struggling franchise. Savard said he intended to accept the offer, somewhere in the area of $3.5 million, unless he was able to find a local buyer or buyers for the team. Savard said league commissioner Gilles Corteau had given him until April 26 to secure a buyer. One interested group intended to relocate the team to Sorel, Quebec.

However, an ownership group led by Geoff Boyle agreed to purchase the team, ensuring its future in Charlottetown for 2013–14 and beyond. The new Islanders logo and colour scheme was unveiled on May 27.

In the 2014–15 season, for the first time since the franchise's inaugural season as the PEI Rocket, the Charlottetown Islanders advanced to the second round of the QMJHL playoffs, after defeating the Sherbrooke Phoenix 4–2 in the first round. However, in the second round, they were eliminated by the Quebec Remparts 4–0.

On June 29, 2015, the Islanders hired Jim Hulton as head coach after Gordie Dwyer was relieved of his duties as head coach.

On March 29, 2016, the Islanders set a new QMJHL record for most shots on goal in one period of a playoff game with 32. The previous record was 30, shared by four teams.

On June 4, 2016, the Charlottetown Islanders hosted the 2016 QMJHL Draft, a first for the franchise since 2006 when they were known as the P.E.I. Rocket.

On April 13, 2017, the Islanders advanced to the third round of the playoffs for the first time in franchise history, eliminating the Cape Breton Screaming Eagles four games to none in the second round.

On May 30, 2022, the Islanders won their third round series to make their first-ever appearance in the President's Cup Final. This also marked the fourth time in the previous five playoffs that the team reached the third round.

Retired numbers

 * 9 Maurice Richard (Montreal Rocket, DNP)
 * 22 Pierre-André Bureau (P.E.I. Rocket, 2000–2005)

NHL alumni
The following players have played in at least one National Hockey League (NHL) game as of the 2023-24 season:

 * Nikita Alexandrov
 * Antoine Bibeau
 * Samuel Blais
 * Guillaume Brisebois
 * Filip Chlapik
 * Ryane Clowe
 * Lukas Cormier
 * Josh Currie
 * Hunter Drew
 * Marc-André Gragnani
 * Ryan Graves
 * Ross Johnston
 * Pierre-Olivier Joseph
 * Maxime Lagace
 * David Laliberté
 * Maxim Lapierre
 * Pascal Leclaire
 * Nicolas Meloche
 * Andrej Nestrasil
 * Louis Robitaille
 * Daniel Sprong

NHL first round draft picks
List of first round selections in the NHL Entry Draft:

Season-by-season results

 * 1999–2003 Montreal Rocket
 * 2003–2013 P.E.I. Rocket
 * 2013–present Charlottetown Islanders

Regular season
OTL = Overtime loss SL = Shootout loss

title: Charlottetown Islanders


text:
Abner Mikva

Abner Joseph Mikva (January 21, 1926 – July 4, 2016) was an American politician, federal judge, and legal scholar. He was a member of the Democratic Party. After serving in the Illinois House of Representatives, Mikva ran for congress in 1966 but lost the primary to incumbent congressman Barrett O'Hara. In 1968, Mikva defeated O'Hara. Mikva served in the United States House of Representatives representing Illinois's 2nd congressional district (1969–1973) and 10th congressional district (1975–1979). He was appointed as a United States circuit judge of the United States Court of Appeals for the District of Columbia Circuit by President Jimmy Carter, serving from 1979 to 1994. He served as the White House Counsel from 1994 to 1995 during Bill Clinton's presidency. He was one of the few people in modern times to serve in the executive, legislative and judicial branches of the Federal government.

In his later career, Mikva taught at the University of Chicago Law School, the Georgetown University Law Center and the Northwestern University Pritzker School of Law. He mentored future President of the United States Barack Obama and future United States Attorney General Merrick Garland (who also succeeded him on the D.C. Circuit) during their early years in law. In 2014, Obama honored Mikva with the Presidential Medal of Freedom.

Early life and family
Mikva was born in Milwaukee, Wisconsin, the son of Ida (Fishman) and Henry Abraham Mikva, Jewish immigrants escaping from pogroms in Ukraine. Mikva and his parents spoke Yiddish at home. During the Great Depression, his father was often unemployed and the family relied on welfare. Abner attended local public schools. During World War II, he enlisted and was trained in the United States Army Air Corps, but the war ended the day before he was due to be deployed. Afterward, the GI Bill enabled Mikva to attend the University of Wisconsin–Milwaukee before transferring to Washington University in St. Louis, where he met his future wife, Zorita Rose (Zoe) Wise. Both graduated in 1948 and soon married.

The couple moved to Chicago, Illinois, where Zoe had urged Mikva to enroll at the University of Chicago Law School. He graduated in 1951 with a Juris Doctor, having served as editor-in-chief of the University of Chicago Law Review. The couple eventually had three daughters: Mary Lane (b. 1953), an Illinois Appellate Court judge in Chicago; Laurie, who teaches at Northwestern University and is on the board of directors of the Legal Services Corporation; and Rachel, a rabbi and professor who teaches at the Chicago Theological Seminary.

Political career
After graduation, Mikva clerked for Supreme Court Justice Sherman Minton. He also returned to Chicago and began practicing law, at a firm which became Goldberg, Devoe, Shadur & Mikva after he made partner. The firm handles labor, real estate, commercial and civil rights cases, as well as some criminal defense. Nonetheless, his early interest in Chicago clearly was politics: One of the stories that is told about my start in politics is that on the way home from law school one night in 1948, I stopped by the ward headquarters in the ward where I lived. There was a street-front, and the name Timothy O'Sullivan, Ward Committeeman, was painted on the front window. I walked in and I said, "I'd like to volunteer to work for [Adlai] Stevenson and [Paul] Douglas." This quintessential Chicago ward committeeman took the cigar out of his mouth and glared at me and said, "Who sent you?" I said, "Nobody sent me." He put the cigar back in his mouth and he said, "We don't want nobody that nobody sent." This was the beginning of my political career in Chicago.

He spent ten years, 1956 to 1966, in the Illinois House of Representatives. He was defeated for reelection in 1966, but "reinvented himself" as a community activist, winning election to the United States Congress in 1968. In the Illinois House, Mikva was part of the "Kosher Nostra", a group of independent, clean Democrats that included future United States Senator and Presidential candidate Paul Simon, future Illinois Comptroller and candidate for Governor Dawn Clark Netsch, and Representative Anthony Scariano. He served in the U.S. House of Representatives from 1969 to 1973 and 1975 to 1979.

He first represented Illinois's 2nd District, which included the South Side's lakefront wards including Hyde Park, his residence and the University of Chicago. Both parties attempted to redistrict Mikva out of Congress. The redistricting for the 1972 elections put Hyde Park in the 1st District for the first time since 1903. This would have pitted Mikva against Democratic incumbent Ralph Metcalfe in a nearly 90% black district; moving to stay in the 2nd District would have matched him against Democratic incumbent Morgan F. Murphy, who had previously represented the 3rd District. Mikva instead moved to the North Shore's 10th District.

After he was defeated by Republican Samuel H. Young in 1972, he ran in the 1974 Democratic wave election and beat Young with 50.9% of the vote; his status was enhanced in the predominantly Republican, suburban district because he was viewed as critical of the Chicago Democratic establishment. In 1976, he was reelected by 201 votes against Young in a rematch that was one of the most expensive congressional races up to that time. When he defeated Republican State Representative John Porter by 650 votes in 1978, he joked to supporters that he had "won by a landslide." Porter won the seat after Mikva resigned to become a federal judge.

Federal judicial service

Mikva was nominated by President Jimmy Carter on May 29, 1979, to the United States Court of Appeals for the District of Columbia Circuit, to a new seat authorized by 92 Stat. 1629. Despite opposition from anti-gun control interests that spent over $1 million to oppose his nomination, Mikva was confirmed by the United States Senate on September 25, 1979 and received his commission on September 26, 1979. He served as Chief Judge from 1991 to 1994. His service terminated on September 19, 1994, due to retirement, after which he became White House Counsel to President Bill Clinton.

During his 15 years as judge, including four as Chief Judge, Mikva used his experience in the legislative branch as well as with the conservative Justice Minton to craft his opinions. Mikva's most controversial decisions struck down the Pentagon ban against gay people serving in the U.S. military (overturned on appeal by the circuit sitting en banc, but the ban was ultimately overturned by Executive Order), and - in 1982 - upheld regulation of air bags in automobiles.

In 1992, while serving as Chief Judge on the D.C. Circuit, Mikva appeared in the Kevin Kline comedy Dave as "Supreme Court Justice Abner J. Mikva," in a scene in which he administers the presidential oath of office to the Vice President (played by Ben Kingsley).

Post-judicial career
Mikva taught law at Northwestern University and was White House Counsel under President Bill Clinton from 1994 to 1995, finding himself the oldest member of the White House team, and eventually resigning due to exhaustion. He then returned to the University of Chicago Law School, serving as the Schwarz Lecturer and the senior director of the Mandel Legal Aid Clinic. While at the University, Mikva came to better know future president Barack Obama, whom he mentored and supported politically. Obama awarded Mikva the Presidential Medal of Freedom on November 24, 2014. Mikva offered Obama a law clerk position in his judicial office after Obama graduated from Harvard Law School, but Obama declined. Future Obama appointee and United States Supreme Court Justice Elena Kagan did serve as one of Mikva's law clerks and was then a professor at the University of Chicago Law School. Mikva also encouraged Obama to listen to preachers to understand public speaking, "listen[ing] to patterns of speech, how to take people up the ladders. It's almost a Baptist tradition to make someone faint, and, by God, he's doing it now."

Other pursuits
Mikva served as a mediator through JAMS, and was co-chairman of the Constitution Project's bipartisan Constitutional Amendments Committee. In November 2004, Mikva was an international election monitor of Ukraine's contested presidential election. In July 2006, Illinois Governor Rod Blagojevich named Mikva chair of the Illinois Human Rights Commission. In 2009, Illinois Governor Pat Quinn requested that Mikva lead a commission investigating the University of Illinois at Urbana–Champaign for admitting applicants (many of whom were not very well qualified) whose relatives or backers had connections to and had donated money to Illinois state lawmakers.

Mikva Challenge
Mikva and his wife Zoe started the Mikva Challenge in 1997. Mikva Challenge is a non-profit, non-partisan organization whose mission is to develop youth to be informed, empowered, and active citizens and community leaders who will promote a just and equitable society. Mikva Challenge has chapters in Chicago, Illinois, Washington, D.C., and Los Angeles, California, and partner sites spanning the country including Cobb County, Georgia, Wilmington, Delaware, Rochester, New York, New York City, New York, Louisville, Kentucky, Riverside, California, New Hampshire, Detroit, Michigan, and Macomb County, Michigan, Madison, Wisconsin, and Milwaukee, Wisconsin. The organization helps youth to expand their political desire by working as election judges, volunteering on campaigns, advising city officials, and creating local activism projects to improve their schools and communities. Their motto is "Democracy is a Verb!" As of 2020, Mikva Challenge reaches 100,000 youth annually in programs in over 3,000 schools across the country.

Death
Mikva died under hospice care in Chicago, Illinois, from complications of bladder cancer on July 4, 2016, aged 90. He was also suffering from chronic obstructive pulmonary disease at the time of his death.

Legacy and awards
Mikva's congressional and judicial papers are archived at the Abraham Lincoln Presidential Library in Springfield, Illinois. In 1998, Mikva received the Chicago History Museum's "Making History Award" for Distinction in Public Service. In 2016, Congress renamed the United States Post Office in downtown Evanston, Illinois, after Mikva, who had lived in Evanston and represented it as a congressional representative.

title: Abner Mikva