Regulatory compliance in the context of "Medical writer"

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⭐ Core Definition: Regulatory compliance

In general, compliance means conforming to a rule, such as a specification, policy, standard or law. Compliance has traditionally been explained by reference to deterrence theory, according to which punishing a behavior will decrease the violations both by the wrongdoer (specific deterrence) and by others (general deterrence). This view has been supported by economic theory, which has framed punishment in terms of costs and has explained compliance in terms of a cost-benefit equilibrium (Becker 1968). However, psychological research on motivation provides an alternative view: granting rewards (Deci, Koestner and Ryan, 1999) or imposing fines (Gneezy Rustichini 2000) for a certain behavior is a form of extrinsic motivation that weakens intrinsic motivation and ultimately undermines compliance.

Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations. Due to the increasing number of regulations and need for operational transparency, organizations are increasingly adopting the use of consolidated and harmonized sets of compliance controls. This approach is used to ensure that all necessary governance requirements can be met without the unnecessary duplication of effort and activity from resources.

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Regulatory compliance in the context of Anti-corruption

Anti-corruption (or anticorruption) comprises activities that oppose or inhibit corruption. Just as corruption takes many forms, anti-corruption efforts vary in scope and in strategy. A general distinction between preventive and reactive measures is sometimes drawn. In such framework, investigative authorities and their attempts to unveil corrupt practices would be considered reactive, while education on the negative impact of corruption, or firm-internal compliance programs are classified as the former.

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Regulatory compliance in the context of Whistleblowing

Whistleblowing (also whistle-blowing or whistle blowing) is the activity of a person, often an employee, revealing information about activity within a private or public organization that is deemed wrongful – whether it be illegal, immoral, illicit, unsafe, unethical, or fraudulent. Whistleblowers can communicate in a variety of ways internally, and/or publicly. Over 83% of whistleblowers report internally to a supervisor, human resources, compliance, or a neutral third party within the company, hoping that the company will address and correct the issues. A whistleblower can also bring allegations to light by communicating with external entities, often becoming a source in investigative journalism or other media, or law enforcement or other government agents. Some countries legislate as to what constitutes a protected disclosure, and the permissible methods of presenting a disclosure. Whistleblowing can occur in the private sector or the public sector.

Whistleblowers often face retaliation for their disclosure, including termination of employment. Several other actions may also be considered retaliatory, including an unreasonable increase in workloads, reduction of hours, preventing task completion, mobbing or bullying. Whistleblower protection laws in many countries offer some protection for whistleblowers and regulate whistleblowing activities. These laws tend to adopt different approaches to public and private sector whistleblowing.

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Regulatory compliance in the context of Practice of law

In its most general sense, the practice of law involves giving legal advice to clients, drafting legal documents for clients, and representing clients in legal negotiations and court proceedings such as lawsuits, and is applied to the professional services of a lawyer or attorney at law, barrister, solicitor, or civil law notary. However, there is a substantial amount of overlap between the practice of law and various other professions where clients are represented by agents. These professions include real estate, banking, accounting, and insurance. Moreover, a growing number of legal document assistants (LDAs) are offering services which have traditionally been offered only by lawyers and their employee paralegals. Many documents may now be created by computer-assisted drafting libraries, where the clients are asked a series of questions that are posed by the software in order to construct the legal documents. In addition, regulatory consulting firms also provide advisory services on regulatory compliance that were traditionally provided exclusively by law firms.

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Regulatory compliance in the context of White-collar workers

A white-collar worker is a person who performs knowledge-based, aptitude-based, managerial, or administrative work generally performed in an office or similar setting. White-collar workers include job paths related to banking, finance, compliance, legal, risk management, internal audit, data privacy, cybersecurity, insurance, government, consulting, academia, accountancy, business and executive management, customer support, design, economics, science, technology, engineering, market research, human resources, operations research, marketing, public relations, real estate, information technology, networking, healthcare, architecture, and research and development.

In contrast, blue-collar workers perform manual labor or work in skilled trades; pink-collar workers work in care, health care, social work, or teaching; green-collar workers specifically work in the environmental sector; and grey-collar jobs combine manual labor and skilled trades with non-manual or managerial duties.

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Regulatory compliance in the context of Interoperation

In engineering, interoperation is the setup of ad hoc components and methods to make two or more systems work together as a combined system with some partial functionality during a certain time, possibly requiring human supervision to perform necessary adjustments and corrections.

This contrasts to interoperability, which theoretically permits any number of systems compliant to a given standard to work together a long time smoothly and unattended as a combined system with the full functionality by the standard.

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Regulatory compliance in the context of Regulatory law

Regulatory law refers to secondary legislation, including regulations, promulgated by an executive branch agency under a delegation from a legislature; as well as legal issues related to regulatory compliance. It contrasts with statutory law promulgated by the legislative branch, and common law or case law promulgated by the judicial branch.

Regulatory law also refers to the law that governs conduct of administrative agencies (both promulgation of regulations, and adjudication of applications or disputes), and judicial review of agency decisions, usually called administrative law. Administrative law is promulgated by the legislature (and refined by judicial common law) for governing agencies.

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Regulatory compliance in the context of Style guide

A style guide is a set of standards for the writing, formatting, and design of documents. A book-length style guide is often called a style manual or a manual of style. A short style guide, typically ranging from several to several dozen pages, is often called a style sheet. The standards documented in a style guide are applicable for either general use, or prescribed use in an individual publication, particular organization, or specific field.

A style guide establishes standard style requirements to improve communication by ensuring consistency within and across documents. They may require certain best practices in writing style, usage, language composition, visual composition, orthography, and typography by setting standards of usage in areas such as punctuation, capitalization, citing sources, formatting of numbers and dates, table appearance and other areas. For academic and technical documents, a guide may also enforce best practices in ethics (such as authorship, research ethics, and disclosure) and compliance (technical and regulatory). For translations, a style guide may even be used to enforce consistent grammar, tone, and localization decisions such as units of measure.

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