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  2. Responsibility assignment matrix - Wikipedia

    en.wikipedia.org/wiki/Responsibility_assignment...

    In business and project management, a responsibility assignment matrix [1] (RAM), also known as RACI matrix [2] (/ ˈ r eɪ s i /; responsible, accountable, consulted, and informed) [3] [4] or linear responsibility chart [5] (LRC), is a model that describes the participation by various roles in completing tasks or deliverables [4] for a project or business process.

  3. Regulatory affairs - Wikipedia

    en.wikipedia.org/wiki/Regulatory_affairs

    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 ...

  4. Internal control - Wikipedia

    en.wikipedia.org/wiki/Internal_control

    The role and the responsibilities of the audit committee, in general terms, are to: (a) Discuss with management, internal and external auditors and major stakeholders the quality and adequacy of the organization's internal controls system and risk management process, and their effectiveness and outcomes, and meet regularly and privately with ...

  5. 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.

  6. Chief risk officer - Wikipedia

    en.wikipedia.org/wiki/Chief_risk_officer

    The chief risk officer (CRO), chief risk management officer (CRMO), or chief risk and compliance officer [1] (CRCO) of a firm or corporation is the executive accountable for enabling the efficient and effective governance of significant risks, and related opportunities, to a business and its various segments. [2]

  7. Qualified Person Responsible For Pharmacovigilance - Wikipedia

    en.wikipedia.org/wiki/Qualified_Person...

    The QPPV must reside in the EU, and should be permanently and continuously at the disposal of the MAH. Each company (i.e. Applicant/Marketing Authorisation Holder or group of Marketing Authorisation Holders using a common pharmacovigilance system) should appoint one QPPV responsible for overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations ...

  8. Organizational structure - Wikipedia

    en.wikipedia.org/wiki/Organizational_structure

    Strong/project matrix: A project manager is primarily responsible for the project. Functional managers provide technical expertise and assign resources as needed. There are advantages and disadvantages of the matrix structure. Some of the disadvantages include tendencies towards anarchy, power struggles and 'sinking' to group and division ...

  9. Legal governance, risk management, and compliance - Wikipedia

    en.wikipedia.org/wiki/Legal_governance,_risk...

    Legal compliance is the process or procedure to ensure that an organization follows relevant laws, regulations and business rules. [5] The definition of legal compliance, especially in the context of corporate legal departments, has recently been expanded to include understanding and adhering to ethical codes within entire professions, as well.

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