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  2. Regulatory risk differentiation - Wikipedia

    en.wikipedia.org/wiki/Regulatory_risk...

    The risk differentiation process requires the regulator to directly link a robust risk assessment, such as via a risk scoring model, to different regulatory responses (e.g. financial penalties, criminal imprisonment). Regulatory risk differentiation is also referred to as the Compliance Model in some regulatory agencies. [1]

  3. Trial master file - Wikipedia

    en.wikipedia.org/wiki/Trial_master_file

    The first version of the TMF Reference Model (TMF RM) [5] was released in June 2010 and was updated in February, 2011 (v1.1) based on feedback provided by Regulators, and again in December, 2011 (v1.2), based on feedback provided by users of the model as they used it within their respective organizations to structure their paper and electronic ...

  4. Regulatory takings in the United States - Wikipedia

    en.wikipedia.org/wiki/Regulatory_takings_in_the...

    The "polestar" of regulatory takings jurisprudence is Penn Central Transp. Co. v.New York City (1973). [3] In Penn Central, the Court denied a takings claim brought by the owner of Grand Central Terminal following refusal of the New York City Landmarks Preservation Commission to approve plans for construction of 50-story office building over Grand Central Terminal.

  5. Executive Order 12866 - Wikipedia

    en.wikipedia.org/wiki/Executive_Order_12866

    Executive Order 12866 in the United States, issued by President Clinton in 1993, requires a cost–benefit analysis for any new regulation that is "economically significant", which is defined as having "an annual effect on the economy of $100 million or more or adversely affect[ing] in a material way the economy, a sector of the economy, productivity, competition, [or] jobs," or creating an ...

  6. Regulatory Flexibility Act - Wikipedia

    en.wikipedia.org/wiki/Regulatory_Flexibility_Act

    Publish an initial regulatory flexibility analysis (IRFA) and/or a final regulatory flexibility analysis (FRFA) in the Federal Register, or provide a certification that the regulation will have no "significant impact" The RFA has added important elements of management oversight, predictability and transparency to the federal regulatory process.

  7. Regulatory agency - Wikipedia

    en.wikipedia.org/wiki/Regulatory_agency

    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.

  8. Electronic trial master file - Wikipedia

    en.wikipedia.org/wiki/Electronic_trial_master_file

    An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.

  9. List of financial regulatory authorities by jurisdiction

    en.wikipedia.org/wiki/List_of_financial...

    China Banking Regulatory Commission (2003–2018), China Insurance Regulatory Commission (2003–2018), China Banking and Insurance Regulatory Commission (2018–2023), and Financial Stability and Development Committee (2017–2023) Hungarian Financial Supervisory Authority (2000–2013) Financial Regulator (Ireland) (2003–2010)