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Regulatory Affairs
Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods). Regulatory affairs professionals (aka regulatory professionals) usually have responsibility for the following general areas: * Ensuring that their companies comply with all of the regulations and laws pertaining to their business. * Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, i.e., working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking). * Advising their companies on ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Industry (economics)
In macroeconomics, an industry is a branch of an economy that Production (economics) , produces a closely-related set of raw materials, Good (economics) , goods, or Service (economics) , services. For example, one might refer to the wood industry or to the insurance industry. When evaluating a single group or company, its dominant source of revenue is typically used by industry classifications to classify it within a specific industry. For example the International Standard Industrial Classification (ISIC) – used directly or through derived classifications for the official statistics of most countries worldwide – classifies "statistical units" by the "economic activity in which they mainly engage". Industry is then defined as "set of statistical units that are classified into the same ISIC category". However, a single business need not belong just to one industry, such as when a large business (often referred to as a conglomerate (company), conglomerate) Diversification (m ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Elixir Sulfanilamide
Elixir sulfanilamide was an improperly prepared sulfonamide antibiotic that caused mass poisoning in the United States in 1937. It is believed to have killed more than 100 people. The public outcry caused by this incident and other similar disasters led to the passing of the 1938 Federal Food, Drug, and Cosmetic Act, which significantly increased the Food and Drug Administration's powers to regulate drugs. History Aside from the Pure Food and Drug Act of 1906 and the Harrison Act of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control in the United States of America for drugs until Congress enacted the 1938 Food, Drug, and Cosmetic Act in response to the elixir sulfanilamide poisonings. In 1937, S. E. Massengill Company, a pharmaceutical manufacturer, created an oral preparation of sulfanilamide using diethylene glycol (DEG) as the solvent or excipient, and called the preparation "Elixir Sulfanilamide". DEG is poisonous to humans and other mamma ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Occupations
Occupation commonly refers to: * Occupation (human activity), or job, one's role in society, often a regular activity performed for payment *Occupation (protest), political demonstration by holding public or symbolic spaces *Military occupation, the martial control of a territory *Occupancy, use of a building Occupation or The Occupation may also refer to: Arts and entertainment * ''Occupation'' (2018 film), an Australian film * Occupation (2021 film), a Czech comedy drama film * ''Occupation'' (TV series), a 2009 British drama about the Iraq War * "Occupation" (''Battlestar Galactica''), a 2006 television episode * "The Occupation" (''Star Wars Rebels''), a 2017 television episode *'' The Occupation'', a 2019 video game *''The Occupation'', a 2019 novel by Deborah Swift See also *Career, a course through life * Employment, a relationship wherein a person serves of another by hire * Job (other) * Occupy (other) * Position (other) *Profession, a vocatio ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Professional
A professional is a member of a profession or any person who works in a specified professional activity. The term also describes the standards of education and training that prepare members of the profession with the particular knowledge and skills necessary to perform their specific role within that profession. In addition, most professionals are subject to strict codes of conduct, enshrining rigorous ethical and moral obligations. Professional standards of practice and ethics for a particular field are typically agreed upon and maintained through widely recognized professional associations, such as the IEEE. Some definitions of "professional" limit this term to those professions that serve some important aspect of public interest and the general good of society.Sullivan, William M. (2nd ed. 2005). ''Work and Integrity: The Crisis and Promise of Professionalism in America''. Jossey Bass.Gardner, Howard and Shulman, Lee S., The Professions in America Today: Crucial but Fragile. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Global Harmonization Task Force
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry”GHTF General Information whose goal was the standardization of medical device regulation across the world. The representatives from its five founding members (the , the , , [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Device A medical device is any device intended to be used for medi |
