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Australian Drug Evaluation Committee
{{Use Australian English, date=October 2016 The Australian Drug Evaluation Committee or ADEC, was a committee that provided independent scientific advice to the Australian Government regarding therapeutic drugs. The committee was originally formed in 1963 and more recently authorised under the ''Therapeutic Goods Act 1989 (Cth)'' as part of the Therapeutic Goods Administration (TGA). In 2010, ADEC was replaced by thAdvisory Committee on Prescription Medicines (ACPM) ADEC provided advice to the Minister for Health and Ageing and the Secretary of the Department of Health on: *quality, risk-benefit, effectiveness and accessibility of drugs referred to ADEC for evaluation *medical and scientific evaluations of applications for registration of new drugs An important role of ADEC was the classification of drugs in Australia into pregnancy categories. The two main subcommittees of ADEC which were responsible for specific aspects of drug regulation in Australia: *the Adverse Drug Reaction ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Committee
A committee or commission is a body of one or more persons subordinate to a deliberative assembly. A committee is not itself considered to be a form of assembly. Usually, the assembly sends matters into a committee as a way to explore them more fully than would be possible if the assembly itself were considering them. Committees may have different functions and their types of work differ depending on the type of the organization and its needs. A member of a legislature may be delegated a committee assignment, which gives them the right to serve on a certain committee. Purpose A deliberative assembly may form a committee (or "commission") consisting of one or more persons to assist with the work of the assembly. For larger organizations, much work is done in committees. Committees can be a way to formally draw together people of relevant expertise from different parts of an organization who otherwise would not have a good way to share information and coordinate actions. They may ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration. Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health. Junod notes in her 2005 treatise on Clinical Drug Trials that "Above all, the ICH has succeeded in aligning clinical trial requirements." History In the 1980s the European Union began harmonising regulatory requirem ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical And Health Organisations Based In Australia
Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness. Contemporary medicine applies biomedical sciences, biomedical research, genetics, and medical technology to diagnose, treat, and prevent injury and disease, typically through pharmaceuticals or surgery, but also through therapies as diverse as psychotherapy, external splints and traction, medical devices, biologics, and ionizing radiation, amongst others. Medicine has been practiced since prehistoric times, and for most of this time it was an art (an area of skill and knowledge), frequently having connections to the religious and philosophical beliefs of local culture. For example, a medicine man would apply herbs and say prayers for healing, or ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Defunct Commonwealth Government Agencies Of Australia
{{Disambiguation ...
Defunct (no longer in use or active) may refer to: * ''Defunct'' (video game), 2014 * Zombie process or defunct process, in Unix-like operating systems See also * * :Former entities * End-of-life product * Obsolescence Obsolescence is the state of being which occurs when an object, service, or practice is no longer maintained or required even though it may still be in good working order. It usually happens when something that is more efficient or less risky r ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Evaluation
Evaluation is a systematic determination and assessment of a subject's merit, worth and significance, using criteria governed by a set of standards. It can assist an organization, program, design, project or any other intervention or initiative to assess any aim, realisable concept/proposal, or any alternative, to help in decision-making; or to ascertain the degree of achievement or value in regard to the aim and objectives and results of any such action that has been completed. The primary purpose of evaluation, in addition to gaining insight into prior or existing initiatives, is to enable reflection and assist in the identification of future change. Evaluation is often used to characterize and appraise subjects of interest in a wide range of human enterprises, including the arts, criminal justice, foundations, non-profit organizations, government, health care, and other human services. It is long term and done at the end of a period of time. Definition Evaluation is the st ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Health Products And Food Branch
The Health Products and Food Branch (HPFB) of Health Canada manages the health-related risks and benefits of health products and food by minimizing risk factors while maximizing the safety provided by the regulatory system and providing information to Canadians so they can make healthy, informed decisions about their health. HPFB has ten operational Directorates with direct regulatory responsibilities: * Biologics and Genetic Therapies Directorate * Food Directorate * Marketed Health Products Directorate (with responsibility for post-market surveillance) * Medical Devices Directorate * Natural Health Products Directorate * Office of Nutrition Policy and Promotion * Pharmaceutical Drugs Directorate * Policy, Planning and International Affairs Directorate * Resource Management and Operations Directorate * Veterinary Drugs Directorate Extraordinary Use New Drugs Extraordinary Use New Drugs (EUNDs) is a regulatory programme under which, in times of emergency, drugs can be granted reg ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would not o ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts v ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmacokinetics
Pharmacokinetics (from Ancient Greek ''pharmakon'' "drug" and ''kinetikos'' "moving, putting in motion"; see chemical kinetics), sometimes abbreviated as PK, is a branch of pharmacology dedicated to determining the fate of substances administered to a living organism. The substances of interest include any chemical xenobiotic such as: pharmaceutical drugs, pesticides, food additives, cosmetics, etc. It attempts to analyze chemical metabolism and to discover the fate of a chemical from the moment that it is administered up to the point at which it is completely eliminated from the body. Pharmacokinetics is the study of how an organism affects a drug, whereas pharmacodynamics (PD) is the study of how the drug affects the organism. Both together influence dosing, benefit, and adverse effects, as seen in PK/PD models. Overview Pharmacokinetics describes how the body affects a specific xenobiotic/chemical after administration through the mechanisms of absorption and distribut ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Government Of Australia
The Australian Government, also known as the Commonwealth Government, is the national government of Australia, a federal parliamentary constitutional monarchy. Like other Westminster-style systems of government, the Australian Government is made up of three branches: the executive (the prime minister, the ministers, and government departments), the legislative (the Parliament of Australia), and the judicial. The legislative branch, the federal Parliament, is made up of two chambers: the House of Representatives (lower house) and Senate (upper house). The House of Representatives has 151 members, each representing an individual electoral district of about 165,000 people. The Senate has 76 members: twelve from each of the six states and two each from Australia's internal territories, the Australian Capital Territory and Northern Territory. The Australian monarch, currently King Charles III, is represented by the governor-general. The Australian Government in its exe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Control
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): # Elements such as controls, job management, defined and well managed processes, performance and integrity criteria, and identification of records # Competence, such as knowledge, skills, experience, and qualifications # Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships. Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example. History and introduction ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Chemistry
Chemistry is the scientific study of the properties and behavior of matter. It is a natural science that covers the elements that make up matter to the compounds made of atoms, molecules and ions: their composition, structure, properties, behavior and the changes they undergo during a reaction with other substances. Chemistry also addresses the nature of chemical bonds in chemical compounds. In the scope of its subject, chemistry occupies an intermediate position between physics and biology. It is sometimes called the central science because it provides a foundation for understanding both basic and applied scientific disciplines at a fundamental level. For example, chemistry explains aspects of plant growth ( botany), the formation of igneous rocks ( geology), how atmospheric ozone is formed and how environmental pollutants are degraded ( ecology), the properties of the soil on the moon ( cosmochemistry), how medications work (pharmacology), and how to collect DNA ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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