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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 regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous jurisdiction over some area of human activity in a licensing and regulating capacity.
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.
Writers concerned with regulatory policy in relation to corporate governance practices often use broader structural descriptions. A broad (meta) definition that encompasses many adopted definitions is "Corporate governance describes the processes, structures, and mechanisms that influence the control and direction of corporations."
Obligational awareness refers to the ability of the organization to make itself aware of all of its mandatory and voluntary obligations, namely relevant laws, regulatory requirements, industry codes and organizational standards, as well as standards of good governance, generally accepted best practices, ethics and community expectations.
India's National Voluntary Guidelines on Social, Environmental and Economic Responsibilities of Business (NVGs) [1] were released by the Ministry of Corporate Affairs (MCA) [2] in July 2011 by Mr. Murli Deora, the former Honourable Minister for Corporate Affairs. The national framework on Business Responsibility is essentially a set of nine ...
The MHRA and the US Food and Drug Administration were criticised in the 2012 book Bad Pharma, [43] and in 2004 by David Healy in evidence to the House of Commons Health Committee, [44] for having undergone regulatory capture, i.e. advancing the interests of the drug companies rather than the interests of the public.
"International regulation" is regulation that occurs at the international level, often exercised by international organizations.An advantage of international regulation is that it allows localities and the individuals in them to be held accountable for the impact that their actions (e.g. pollution) have on other localities.