Pharmaceutical Compliance Training
Stay Compliant. Stay Informed.
Explore our modules covering regulatory standards, ethical practices, and industry compliance
Package Inserts and Boxed Warnings
Package Inserts and Boxed Warnings
This course provides a detailed understanding of prescription drug labeling requirements, focusing on package inserts (Prescribing Information) and FDA-mandated boxed warnings. Participants will learn regulatory standards, content requirements, and best practices for communicating critical drug information to healthcare providers and patients
Patient Protection and Affordable Care Act Sections 6002 & 6004
Patient Protection and Affordable Care Act Sections 6002 & 6004
This course provides a clear understanding of the Physician Payments Sunshine Act provisions (Sections 6002 & 6004 of PPACA), which mandate transparency in financial relationships between healthcare manufacturers and covered recipients. Participants will learn exact reporting requirements, compliance timelines, and enforcement implications.
Pharmacovigilance
Pharmacovigilance
This training course provides pharmaceutical professionals with a working knowledge of the U.S. pharmacovigilance system, focusing on adverse event monitoring and regulatory reporting requirements. Participants will learn to identify, document, and report safety data in compliance with FDA regulations.
PhRMA Code
PhRMA Code
This course provides a foundational overview of the PhRMA Code on Interactions with Healthcare Professionals, exploring its historical development, core principles, and practical applications in the pharmaceutical industry. Participants will gain essential knowledge to navigate compliant engagements with HCPs while maintaining ethical standards.
Prescription Drug Marketing Act (PDMA)
Prescription Drug Marketing Act (PDMA)
This targeted training provides pharmaceutical professionals with a clear understanding of the Prescription Drug Marketing Act (PDMA) requirements governing drug sample distribution. Participants will learn to navigate sampling regulations, maintain compliant records, and prepare for PDMA investigations.
Radiation Safety Training
Radiation Safety Training
This course teaches safe handling of ionizing radiation in diagnostic and therapeutic settings. Topics include ALARA principles (As Low As Reasonably Achievable), radiation exposure limits, protective shielding, dosimetry monitoring, and regulatory compliance (NRC, state regulations). Required for radiologic technologists, oncologists, and other personnel working with radiation-emitting equipment.
Risk Evaluation and Mitigation Strategy (REMS)
Risk Evaluation and Mitigation Strategy (REMS)
This course provides a comprehensive understanding of Risk Evaluation and Mitigation Strategies (REMS), the FDA’s safety program for high-risk medications. Participants will learn to navigate REMS requirements, implement compliant processes, and utilize available resources effectively.
Speaker Programs
Speaker Programs
This course provides pharmaceutical and medical device professionals with a clear framework for establishing and conducting compliant speaker programs. Participants will learn regulatory requirements, best practices for program management, and strategies to maintain compliance while effectively educating healthcare professionals (HCPs).
State Consumer Privacy Laws
State Consumer Privacy Laws
This course provides a clear roadmap to evolving state privacy laws, with special focus on emerging consumer health data acts. Learn how these regulations impact data handling practices across industries and how to implement compliant privacy programs.
State Expansions of the Health Insurance Portability and Accountability Act (HIPAA)
State Expansions of the Health Insurance Portability and Accountability Act (HIPAA)
This specialized training explores how state privacy laws extend patient protections beyond HIPAA for pharmaceutical companies. Participants will learn key requirements under California’s CMIA and Texas’ TMRPA, and how to implement compliant communication practices and data safeguards.
The CAN-SPAM Act
The CAN-SPAM Act
This course provides a clear understanding of the CAN-SPAM Act, the U.S. law governing commercial email communications. Participants will learn key requirements for lawful email marketing, enforcement risks, and best practices to maintain compliance while executing effective campaigns.