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Compliance

11:13 EDT 24th April 2017 | BioPortfolio

Compliance with regulations, laws and industry codes is paramount in the pharmaceutical industry.  Compliance with these laws builds trust with patients, healthcare professionals (HCPs), institutions, purchasers, and the government.

Understanding of the laws, regulations, guidance, and industry codes that apply to the pharmaceuytical industry including:

Key Healthcare Laws:

  • Anti-Kickback Laws (state and federal)
  • Medicaid Best Price Law & Medicare Part D Regulations
  • FDA Laws & Regulations
  • State Pharmaceutical Compliance and Disclosure Laws

Other Key Laws:

  • False Claims Act
  • Privacy Laws
  • State Consumer Protection Laws
  • Foreign Corrupt Practices Act

Industry Codes, Guidance and State AG Agreements:

  • PhRMA Code on Interactions with Healthcare Professionals
  • PhRMA Guiding Principles on Direct to Consumer Advertising
  • OIG Compliance Program Guidance for Pharmaceutical Manufacturers
  • Corporate Integrity Agreements
  • State Attorneys General Agreements

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