|
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 o ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Industry (economics)
In macroeconomics, an industry is a branch of an economy that produces a closely-related set of raw materials, goods, or 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) diversifies across separate industries. Industries, though associated with specific products, pr ... [...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 mamm ... [...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 vocation *Stan ... [...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 medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it wasn't until the Federal Food, Drug, and Cosmetic Act (FD&C ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been described as a ''sui generis'' political entity (without precedent or comparison) combining the characteristics of both a federation and a confederation. Containing 5.8per cent of the world population in 2020, the EU generated a nominal gross domestic product (GDP) of around trillion in 2021, constituting approximately 18per cent of global nominal GDP. Additionally, all EU states but Bulgaria have a very high Human Development Index according to the United Nations Development Programme. Its cornerstone, the Customs Union, paved the way to establishing an internal single market based on standardised legal framework and legislation that applies in all member states in those matters, and only those matters, where the states have agreed to ac ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Title 21 Of The Code Of Federal Regulations
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). It is divided into three chapters: * Chapter I — Food and Drug Administration * Chapter II — Drug Enforcement Administration * Chapter III — Office of National Drug Control Policy Chapter I Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act. Notable sections: * 11 — electronic records and electronic signature related * 50 Protection of human subjects in clinical trials * 54 Financial disclosure by clinical investigators * 56 Institutional review boards that oversee clinical trials * 58 Good laboratory practices (GLP) for nonclinical studies The 100 series are regulations pertaining to food: * 101, especially 101.9 — Nutrition facts label related ** (c)(2)(ii) — Requirement to ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Safe Medical Device Amendments Of 1990
Safe Medical Device Amendments of 1990 or Safe Medical Devices Act sanctioned progressive reporting and tracking rules for medical devices classified by the Medical Device Regulation Act. The Act mandates reporting requirements by medical device manufacturers regarding adverse safety events and product effectiveness of devices classified as substantially equivalent to Class III medical devices. The United States Statute established the Health and Human Services Office of International Relations and a U.S. Food and Drug Administration office for regulatory activities concerning healthcare products which are considered a combinational biological, device, or drug product. The Act of Congress transferred the electronic product radiation control provisions established by the Radiation Control for Health and Safety Act. Congressman Henry A. Waxman and Senator Edward M. Kennedy were the chairperson sponsors of the safe medical device amendments. The H.R. 3095 legislation was passed by ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Device Regulation Act
The Medical Device Regulation Act or Medical Device Amendments of 1976 was introduced by the 94th Congress of the United States. Congressman Paul G. Rogers and Senator Edward M. Kennedy were the chairperson sponsors of the medical device amendments. The Title 21 amendments were signed into law on May 28, 1976, by the 38th President of the United States Gerald R. Ford. The U.S. legislation enacted in 1976 amended the Food, Drug, and Cosmetic Act of 1938 signed by the 32nd President of the United States Franklin D. Roosevelt Franklin Delano Roosevelt (; ; January 30, 1882April 12, 1945), often referred to by his initials FDR, was an American politician and attorney who served as the 32nd president of the United States from 1933 until his death in 1945. As the .... History During the 1960s, the Secretary of Health, Education, and Welfare (HEW) commissioned the Cooper Committee to study the adverse effects of medical devices for human use. In 1970, the study committee re ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
