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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.
The U.S. policy framework contrasts with that of some of its major trading partners: the European Union, Japan, South Korea, China, Australia and New Zealand either have or are establishing separate mandatory labeling requirements for products containing genetically modified organisms. This framework governed specific agency policies.
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 ...
The National Research Act of 1974 also set up the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which produced the Belmont Report (Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research) in 1979. This report established a moral framework for the regulation ...
"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.
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