Pharmaceutical Compliance Training

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Stay Compliant. Stay Informed

This training covers FDA regulations for drug/device promotion, including labeling requirements, advertising rules and social media compliance.

Suggested For:

• Compliance Officers
• Field Based Sales Professionals
• Marketing Personnel
• Regulatory Affairs
• Promotional Review Committees
• Medical Device Representatives

Introduces key federal agencies (FDA, DEA, OIG, FTC, CMS) and their roles in drug commercialization, enforcement, and compliance.

Suggested For:

• Compliance Officers
• Compliance Teams
• New to Pharma
• Field Based Sales Professionals
• Promotional Review Committees
• Legal Teams

This course provides a foundational understanding of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the primary law governing the safety and regulation of food, drugs, medical devices, cosmetics, and tobacco products in the United States. Participants will explore the Act’s key provisions, enforcement mechanisms, and its impact on industry compliance.

Teaches fire prevention, evacuation procedures, and compliance with NFPA codes tailored for hospital staff and facilities.

Suggested For:

• Field Based Sales Professionals
• Medical Device Representatives
• Medical Science Liaisons

This module covers the FCPA’s anti-bribery provisions, focusing on interactions with foreign officials and healthcare professionals (HCPs). Participants will learn to identify high-risk activities, understand exceptions and review enforcement case studies.

Suggested For:

• Compliance Officers
• Field Based Sales Professionals
• Marketing Personnel
• Regulatory Affairs
• Medical Device Representatives

This training explains GDPR requirements for handling personal data of EU individuals, including patient health records, clinical trial data, and employee information.

Suggested For:

• Compliance Officers
• Compliance Teams
• IT and Data Security
• Legal Teams

This module details HIPAA Privacy Rule requirements for protecting PHI, patient rights, and permitted disclosures. Safeguards and breach penalties are emphasized.

Suggested For:

• Compliance Officers
• Compliance Teams
• Field Based Sales Professionals
• Medical Affairs Personnel
• Marketing Personnel
• Medical Science Liaisons
• IT and Data Security
• New to Pharma
• Legal Teams

This module outlines the HIPAA Security Rule’s standards for protecting electronic Protected Health Information (PHI). Participants will learn about administrative, physical, and technical safeguards, risk assessments, and breach response protocols. Real-world enforcement cases highlight consequences of non-compliance.

Suggested For:

• Compliance Officers
• Compliance Teams
• IT and Data Security
• Legal Teams

Traces the evolution of U.S. pharmaceutical regulations, from the 1906 Pure Food and Drug Act to modern FDA frameworks.

Suggested For:

• Compliance Officers
• New to Pharma
• Regulatory Affairs
• Promotional Review Committees

This course provides an overview of the HITECH Act, its impact on HIPAA protections, and guidelines for compliance. Topics include Business Associate Agreements, breach notifications, and revised penalties under HITECH.

Suggested For:

• Compliance Officers
• Compliance Teams
• IT and Data Security
• Legal Teams

This module explains the drug development process, from discovery to post-market monitoring, including FDA involvement, industry structure, and key regulations like the FDCA.

Suggested For:

• Compliance Officers
• Compliance Teams
• New to Pharma
• Legal Teams

This module defines compliant scientific exchange vs. promotional activity for MSLs, covering unsolicited off-label requests, KOL engagement, and collaboration with commercial teams.

Suggested For:

• Compliance Officers
• Compliance Teams
• Medical Affairs Personnel
• Medical Science Liaisons