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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 ...
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...
Provides regulatory oversight over the activities of the United States Postal Service. The Securities and Exchange Commission (SEC) was established to protect investors who buy stocks and bonds. Federal laws require companies that plan to raise money by selling their own securities to file reports about their operations with the SEC, so that ...
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
The Regulatory Review is an online, daily publication devoted to coverage of regulatory news, analysis, and commentary. It is produced under the auspices of the Penn Program on Regulation and operated by students at the University of Pennsylvania Law School .
Owing to the importance of the IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP), the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a ...
The International Organization for Standardization (ISO) and its ISO 37301:2021 (which deprecates ISO 19600:2014) standard is one of the primary international standards for how businesses handle regulatory compliance, providing a reminder of how compliance and risk should operate together, as "colleagues" sharing a common framework with some nuances to account for their differences.
The department, as the Department of Commerce, was formed in 1965 by Section 225 of the Executive Organization Act of 1965, 1965 PA 380, MCL 16.325.The Michigan Department of Licensing and Regulation was abolished with most responsibilities transferred to the newly formed Department. [1]