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Good Manufacturing Practice
GOOD MANUFACTURING PRACTICES (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products . These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public. Good manufacturing practices, along with good agricultural practices , good laboratory practices and good clinical practices , are overseen by regulatory agencies in the United States, Canada, Europe, China, and other countries
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Hospital
A HOSPITAL is a health care institution providing patient treatment with specialized medical and nursing staff and medical equipment. The best-known type of hospital is the general hospital, which typically has an emergency department to treat urgent health problems ranging from fire and accident victims to a heart attack . A district hospital typically is the major health care facility in its region, with large numbers of beds for intensive care and additional beds for patients who need long-term care. Specialised hospitals include trauma centres , rehabilitation hospitals , children\'s hospitals , seniors' (geriatric ) hospitals, and hospitals for dealing with specific medical needs such as psychiatric treatment (see psychiatric hospital ) and certain disease categories. Specialised hospitals can help reduce health care costs compared to general hospitals. A teaching hospital combines assistance to people with teaching to medical students and nurses
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Pharmacology
PHARMACOLOGY is the branch of biology concerned with the study of drug action, where a drug can be broadly defined as any man-made, natural, or endogenous (from within body) molecule which exerts a biochemical or physiological effect on the cell, tissue, organ, or organism (sometimes the word pharmacon is used as a term to encompass these endogenous and exogenous bioactive species). More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function. If substances have medicinal properties, they are considered pharmaceuticals . The field encompasses drug composition and properties, synthesis and drug design, molecular and cellular mechanisms , organ/systems mechanisms, signal transduction/cellular communication, molecular diagnostics, interactions , toxicology , chemical biology , therapy, and medical applications and antipathogenic capabilities
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Clinician
A CLINICIAN is a health care professional that works as a primary care giver of a patient in a hospital, skilled nursing facility, clinic, or patient's home. A clinician diagnoses and treats patients. For example, physicians, nurses, nurse practitioners, and physician assistants are clinicians; a speech-language pathologist (SLP) is a clinician, a speech-language pathology assistant (SLPA) is not. Clinicians take comprehensive exams to be licensed and some complete graduate degrees (master's or doctorates) in their field of expertise. Although a clinician must follow evidence-based best-practices and other professional codes of conduct set by laws and professional governing bodies, a clinician can choose to practice without another's supervision
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Good Distribution Practice
GOOD DISTRIBUTION PRACTICE (GDP) deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption. GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments
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GxP
GXP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries , for example good agricultural practice , or GAP. A "c" or "C" is sometimes added to the front of the initialism. The preceding "c" stands for "current." For example, cGMP is an acronym for "current good manufacturing practice". The term GxP
GxP
is frequently used to refer in a general way to a collection of quality guidelines. CONTENTS * 1 Purpose * 2 Examples of GxPs * 3 See also * 4 References PURPOSEThe purpose of the GxP
GxP
quality guidelines is to ensure a product is safe and meets its intended use. GxP
GxP
guides quality manufacture in regulated industries including food, drugs, medical devices and cosmetics
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Toxicology
TOXICOLOGY is a discipline , overlapping with biology , chemistry , pharmacology , medicine , and nursing , that involves the study of the adverse effects of chemical substances on living organisms and the practice of diagnosing and treating exposures to toxins and toxicants . The relationship between dose and its effects on the exposed organism is of high significance in toxicology. Factors that influence chemical toxicity include the dosage (and whether it is acute or chronic), route of exposure, species, age, sex, and environment. TOXICOLOGISTS are experts on poisons and poisoning
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Clinical Trial
CLINICAL TRIALS are experiments or observations done in clinical research . Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines , drugs , dietary choices , dietary supplements , and medical devices ) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy . They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted
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National Health Surveillance Agency
NATIONAL SANITARY SURVEILLANCE AGENCY (in Portuguese, AGêNCIA NACIONAL DE VIGILâNCIA SANITáRIA) is a regulatory body of the Brazilian government, created in 1999 during President Fernando Henrique Cardoso 's term of office. It has a role similar to that of the FDA in the United States
United States
, is responsible for the regulation and approval of pharmaceutical drugs , sanitary standards and regulation of the food industry. The agency bills itself as "an independently administered, financially autonomous" regulatory body that offers "security of tenure" for its five-member Collegiate Board of Directors during their mandate periods. REFERENCES * ^ "Sanitary Surveillance\'s official website in English". Archived from the original on 2013-02-16
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Central Drugs Standard Control Organization
The CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency of the European Union
European Union
, the PMDA of Japan
Japan
and the Food and Drug Administration of the United States
United States
. Within the CDSCO, the Drug Controller General of India
India
(DCGI) regulates pharmaceutical and medical devices, under the gamut of Ministry of Health and Family Welfare . The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). It is divided into zonal offices which do pre-licensing and post-licensing inspections, post-market surveillance, and recalls when needed
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NAFDAC
The NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC) is a Nigerian federal agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food , drugs , cosmetics , medical devices , chemicals and packaged water . The immediate past director-general of NAFDAC, Paul Orhii, holds a PhD in medicine
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Inspectorate
An INSPECTORATE or INSPECTORATE-GENERAL (or GENERAL INSPECTORATE) is a civil or military body charged with inspecting and reporting on some institution or institutions in its field of competence. Inspectorates cover a broad spectrum of organizations which vary in a number of terms, notably whether and to the degree to which they become involved in criminal investigations; the extent to which they achieve independence from the institutions being inspected; as well as the nature of their inspection regimes and reporting processes. Inspectorates are commonplace in government; for example, in the United States, there are some 73 standard form Office of the Inspector Generals charged with examining the actions of a government agency, military organization, or military contractor as a general auditor of their operations and headed by an Inspector General . Inspectorates in various jurisdictions oversee civil activities such as mining and the nuclear industry
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International Organization For Standardization
The INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO) is an international standard -setting body composed of representatives from various national standards organizations . Founded on 23 February 1947, the organization promotes worldwide proprietary, industrial and commercial standards . It is headquartered in Geneva
Geneva
, Switzerland, and works in 162 countries. It was one of the first organizations granted general consultative status with the United Nations Economic and Social Council
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Best Practice
A BEST PRACTICE is a method or technique that has been generally accepted as superior to any alternatives because it produces results that are superior to those achieved by other means or because it has become a standard way of doing things, e.g., a standard way of complying with legal or ethical requirements. Best practices are used to maintain quality as an alternative to mandatory legislated standards and can be based on self-assessment or benchmarking . Best practice is a feature of accredited management standards such as ISO 9000 and ISO 14001 . Some consulting firms specialize in the area of best practice and offer pre-made 'templates' to standardize business process documentation. Sometimes a "best practice" is not applicable or is inappropriate for a particular organization's needs
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Chief Medical Officer
CHIEF MEDICAL OFFICER (CMO) is the title used in many countries for the senior government official designated head of medical services, sometimes at the national level. The post is held by a physician who serves to advise and lead a team of medical experts on matters of public health importance. The post of Chief Medical Officer dates back to Victorian times
Victorian times
. The equivalent title may go under different names across countries, for example known as the Surgeon General in the United States and the Chief Public Health Officer in Canada. By extension, Chief Medical Officer is also used as a job title , for the physician who is the professional lead of all physicians at an hospital
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Cultural Competence In Health Care
CULTURAL COMPETENCE IN HEALTHCARE refers to the ability for healthcare systems to demonstrate cultural competence toward patients with diverse values , beliefs , and behaviors. This process includes consideration of the individual social, cultural , and linguistic needs of patients for effective cross-cultural communication with their health care providers. The goal of cultural competence in health care is to reduce health disparities and to provide optimal care to patients regardless of their race , ethnic background, native languages spoken, and religious or cultural beliefs. Cultural competency training is important in health care fields where human interaction is common, including medicine, nursing, allied health , mental health, social work, pharmacy, oral health , and public health fields. The term cultural competence was first used by Terry L
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