Introduction to the Prescription Drug Marketing Act (PDMA), a primer to the PDMA and regulations. The course focuses on the FDA regulations that resulted from the PDMA/PDA including 21 CFR Part 203 and 21 CFR Part 205.

Compliance with the Prescription Drug Marketing Act (PDMA). This course is a comprehensive overview explaining how the requirement of the PDMA impacts Field Sales Representatives and Regional/District Managers.

Manufacturer-Healthcare Professional interactions can include a variety of legitimate business purposes. This lesson focuses on the guidance and restrictions on promotional practices for pharmaceutical manufacturers from the FDA regulations, guidance documents and the applicable code of ethics and will help employees understand, recognize and respond to situations of potential concern.

Ethical relationships with healthcare professionals are critical to a manufacturer's goals in helping patients by developing and marketing new and existing medicines. This course is focused on the Code of Conduct issued by the Pharmaceutical Research and Manufacturer's of America (PhRMA) on interactions with healthcare professionals.

Promotional activities have been more closely scrutinized due to recent high profile cases of unethical dealings. As a result, manufacturers are focusing more on their Good Promotional Practices (GPP). This course will provide the foundation to understand the industry standards and best practices to help ensure life science companies comply with applicable laws and ethics codes.

Spend Transparency reporting is explained in this lesson with overviews of the Federal (aka The "Sunshine Act") and State reporting on Healthcare Professional spend and includes timelines, reporting requirements and potential penalties.

Training employees to safeguard Protected Health Information (PHI) is a requirement of the Health Insurance Portability and Accountability Act (HIPAA), as amended by the HITECH (The Health Information Technology for Economic and Clinical Health) Act. This privacy course is specifically tailored to help employees understand what information is private, why it is private and what they can do to protect it. 

Federal fraud and abuse law is a compilation of several laws, including the Federal Anti-Kickback Statute (AKS), the Stark Law, and the False Claims Act. This course focuses on the AKS, with a particular emphasis on its application to pharmaceutical companies.

This course explains the purpose of the False Claims Act (FCA), the scope, how it is enforced and the associated penalties of non-compliance. Potential risks in sales activities are identified and examples are provided as a means to help manufacturers mitigate their risks.

This course explains the rules and regulations governing the correct use of promotional materials, appropriate communications with Healthcare Professionals and how to avoid potential off label promotions.  

This course provides common medical terminology and abbreviations which will provide a baseline for employees to better understand products, improve communications with healthcare professionals and have a better understanding of reportable events.

This Adverse Event course is comprised of two lessons and provides valuable information to enable the trainee to understand and identify an Adverse Event, define the types of Adverse Events, the importance of reporting requirements and tools for compliance.

This course offers a foundation to working with DEA Controlled Substances in the life science industry. The course explains the functions of the Office of Diversion Control, laws and codes related to Controlled Substances, Registrant Responsibilities and more.

Cultural Competency in Life Sciences. This course consists of four modules with knowledge checks throughout and an assessment at the conclusion of the course. Module I takes the learner through the meaning of cultural competency and its philosophies and principles in the healthcare industry. Discussions include culture, race, ethnicity, identity and key terms. Module II to IV introduces the Bennett Model, cross cultural communication, measuring your cultural competence, communication and cultural influences working with health care professionals and practices to improve your cultural competence.