Covers federal and state requirements for protecting personal and health data, with a focus on HIPAA, GDPR, and electronic records regulations.

Included Courses:

• HIPAA Privacy Rule
• HIPAA Security Rule
• State Expansions of HIPAA
• HITECH Act
• State Consumer Privacy Laws
• General Data Protection Regulation (GDPR)
• Electronic Records and Electronic Signatures (21 CFR Part 11)

Benefiting Roles:

• Compliance Officers
• IT & Data Security Teams
• Sales and Marketing Teams
• Medical Science Liaisons (MSLs)
• HR & Medical Affairs
• Clinical Research Teams

Addresses post-market safety obligations including product distribution, risk mitigation strategies, and adverse event monitoring.

Included Courses:

• Prescription Drug Marketing Act (PDMA)
• Risk Evaluation and Mitigation Strategy (REMS)
• Pharmacovigilance

Benefiting Roles:

• Compliance Officers
• Field Sales Representatives
• Drug Safety & Pharmacovigilance Teams
• Regulatory Affairs
• Product Managers
• Clinical & Medical Affairs

This bundle provides essential training for hospital credentialing, covering safety protocols, regulatory compliance, infection control, and clinical best practices to ensure staff readiness and facility accreditation.

Included Courses:

• National Patient Safety Goals Training
• Bloodborne Pathogen Training
• Aseptic Techniques Training
• Fire Safety Training
• Electrical Safety Training
• Medical Device Reporting
• Operating Room Protocol Training
• Radiation Safety Training

Benefiting Roles:

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

Covers federal laws aimed at preventing fraud and abuse in healthcare, including kickbacks, false claims, improper referrals, and government-mandated Corporate Integrity Agreements.

Courses:

• History of Pharmaceutical Regulations
• Life Cycle of a Drug
• Federal Agencies
• The FDA’s Office of Prescription Drug Promotion (OPDP)

Benefiting Roles:

• Compliance Officers
• Regulatory Affairs Specialists
• Pharmaceutical Sales Representatives
• Medical Affairs Professionals
• Clinical Research Associates
• Marketing & Promotional Review Committees

Focuses on FDA regulations, ethical codes, and standards governing product labeling, advertising, and promotional practices in the pharmaceutical and medical device industries.

Included Courses:

• Federal Food Drug and Cosmetic Act
• Package Inserts and Boxed Warnings
• FDA’s Marketing and Labeling Laws
• Dissemination of Materials
• PhRMA Code
• AdvaMed

Benefiting Roles:

• Compliance Officers
• Marketing & Promotional Review Committees
• Regulatory Affairs
• Sales and Marketing Teams
• Medical Affairs

This group introduces the structure of pharmaceutical regulation in the U.S., covering the lifecycle of a drug and the roles of federal agencies and the FDA’s promotional oversight.

Included Courses:

• History of Pharmaceutical Regulations
• Life Cycle of a Drug
• Federal Agencies
• The FDA’s Office of Prescription Drug Promotion (OPDP)

Benefiting Roles:

• Compliance Officers
• Regulatory Affairs
• Pharmaceutical Sales Representatives
• Medical Affairs Professionals
• Marketing & Promotional Review Committees

Covers regulations requiring disclosure of transfers of value and communications with healthcare providers, including federal and state-level reporting laws.

Included Courses:

• The CAN-SPAM Act
• FCC Laws and the Junk Fax Rules
• Speaker Programs
• Patient Protection and Affordable Care Act Sections 6002 & 6004
• Aggregate Spend for States

Benefiting Roles:

• Compliance Officers & Teams
• Transparency Reporting Teams
• Marketing Teams
• Speaker Bureau Coordinators
• Field Sales Representatives
• Legal Teams