文档介绍:强生制药公司_病人管理_规范营销
2019 Sales of $ Billion
Over 200 operating companies in 57 countries around the world
Leadershipase and, if so, on what terms
Whether to pursue exclusion or debarment of a company
HHS OIG Guidelines (cont’d)
Each OIG Guidance is organized around “seven elements that have been widely recognized as fundamental to an effective compliance program.”
These “seven elements” are:
Implementing written policies and procedures
Designating a compliance officer and committee
Conducting effective training and education
Developing effective lines of communication
Conducting internal monitoring and auditing
Enforcing disciplinary standards for wrongdoing
Responding promptly to detect programs and undertaking corrective action
HHS OIG Guidelines Policies and Procedures
Written policies and procedures should be developed under direction of Compliance Officer and distributed to all relevant employees
Policies and procedures should include:
Code of Conduct: A high-level document that details the fundamental principles, values, and framework for action within a company. It should be brief, understandable, and cover principles applicable to all employees.
Detailed policies in specific risk areas: These policies should address risk areas specific to a company’s business activities, organizational structure, and regulatory requirements.
While policies – alone – do not constitute an effective program, much of an effective program flows from written standards of conduct
HHS OIG Guidelines Compliance Officer and Committee
Every company should designate a high-level official to serve as the Compliance Officer. May be full- or part-time.
Should have access and regularly report to the Board of Directors and Senior Management.
Should have authority to effectuate change within the organization, to exercise independent judgment, and to have access to all documents and information relevant to compliance activities.
HHS OIG Guidelines Compliance Office