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Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found 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 ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The Illinois Department of Financial and Professional Regulation (IDFPR) is the Illinois state government code department [1] [2] that through its operational components, the Division of Banking, Division of Financial Institutions, Division of Professional Regulation, and Division of Real Estate, oversees the regulation and licensure of banks and financial institutions, real estate businesses ...
The U.S. Government Antimicrobial Resistance (AMR) Challenge, initiated in 2018, is a global effort that calls upon pharmaceutical and health insurance companies, food animal producers and purchasers, medical professionals, government health officials, and industry leaders worldwide to collaborate in combating antibiotic resistance.
Pharmaceutical sales representatives or Medical sales respresentatives [1] are salespeople employed by pharmaceutical companies to persuade doctors to prescribe their drugs to patients. Drug companies in the United States spend ~$5 billion annually sending representatives to doctors, [ 2 ] to provide product information, answer questions on ...
The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as: [8]: 10 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or ...
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