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The financial, research, and pharmaceutical regulatory structures in one country, for example, may be similar but with particularly different nuances in another country. These similarities and differences are often a product "of reactions to the changing objectives and requirements in different countries, industries, and policy contexts".
Regulation in the social, political, psychological, and economic domains can take many forms: legal restrictions promulgated by a government authority, contractual obligations (for example, contracts between insurers and their insureds [1]), self-regulation in psychology, social regulation (e.g. norms), co-regulation, third-party regulation, certification, accreditation or market regulation.
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.
Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a ...
A series of powerful international regulatory regimes have arisen especially in fields dealing with risk, such as banking, accountancy and the actuarial profession. [1] In banking, the Basel Accords regulate a wide range of bank behavior, such as capital adequacy , the requirement to have capital reserved against risk.
On February 2, 2020, the European Commission published its White Paper on Artificial Intelligence – A European approach to excellence and trust. [97] [98] The White Paper consists of two main building blocks, an 'ecosystem of excellence' and a 'ecosystem of trust'. The 'ecosystem of trust' outlines the EU's approach for a regulatory framework ...
Regulatory science is the scientific and technical foundations upon which regulations are based in various industries – particularly those involving health or safety. . Regulatory bodies employing such principles in the United States include, for example, the FDA for food and medical products, the EPA for the environment, and the OSHA for work sa
Regulatory risk differentiation is also referred to as the Compliance Model in some regulatory agencies. [1] See for example the Australian Prudential Regulatory Authority risk differentiation approach known as: PAIRS [2] / SOARS. [3] PAIRS is the Probability And Impact Rating System, while SOARS is the Supervisory Oversight And Response System.