Once a product is approved by the Food and Drug Administration, pharmaceutical companies must monitor negative reactions, or adverse events, that patients experience with the product. All employees share the responsibility for identifying and reporting adverse events and product complaints associated with our products. Adverse Events and Product Complaints familiarizes learners with the information needed to comply with the rules regarding adverse events and product complaints. The estimated time to complete this module is 20 minutes.

Aseptic Technique and OR Protocol explains the chain of infection as a pathway by which infectious disease is spread and emphasizes the importance of maintaining the patient environment while providing strategies to control the spread of infections. The course covers common sources of infection and offers detailed instruction on hand hygiene and decontamination techniques. Course topics also cover the need to maintain the sterile field while in the operating room and CDC guidelines for isolation precautions.

Bloodborne Pathogens introduces reps to the risks involved with various pathogens, the methods for protecting against bloodborne pathogens and what to do in case of exposure. The course also provides reps with detailed information concerning the appropriate response to requests by hospitals or clinics for proof of training in the dangers of bloodborne pathogens.

Compliant Product Promotion reviews the guidelines that must be followed when pharmaceutical employees promote products to healthcare professionals to ensure they are compliant with all applicable regulations and Company policies. The estimated time to complete this module is 30 minutes.

Life science companies collect personal data from healthcare professionals, business partners and even their own employees. Protecting that data is of utmost importance to maintain the public’s trust and stay compliant with the law. The Data Privacy Compliance Foundations eLearning module introduces learners to the key terms related to privacy and covers the laws, principles, and concerns they need to understand to protect personal data. The estimated time to complete this module is 35 minutes.

Since life sciences companies conduct business in multiple countries and regularly work with foreign companies and individuals, employees need to understand and comply with all applicable anti-corruption laws. Doing so can be a challenge since anti-corruption laws have a wide reach and broadly define who is considered a public official. Global Anti-Corruption Laws provides a basic understanding of the major anti-corruption laws that apply to the life sciences industry and details the business activities that can pose an increased risk of violating those laws. The estimated time to complete this module is 40 minutes.

Good Communication Practices help facilitate the efficient and accurate exchange of information between employees, partners, and customers. Any communication can potentially be viewed and scrutinized by people outside its intended audience. This module reviews the importance of good communication practices and how to create appropriate and effective written communications. The estimated time to complete this module is 30 minutes.

The Health Insurance Portability and Accountability Act (HIPAA) governs how protected health information (PHI) may be transmitted and shared. This module teaches life sciences employees how the HIPAA Privacy Rule affects the healthcare professionals and organizations that they interact with and steps they can take to ensure they remain compliant with the HIPAA Privacy Rule. The estimated time to complete this module is 20 minutes.

Interactions with Healthcare Professionals covers the basic guidelines pharmaceutical company representatives need to follow when interacting with healthcare professionals to ensure those interactions are compliant with all applicable laws, regulations, and policies. It addresses the rules for providing anything of value, such as educational items and meals, as well as consulting agreements and research grants. The estimated time to complete this module is 35 minutes.

Speaker programs offer healthcare professionals access to critical product and disease state information from other HCPs who utilize the products, but they are high-risk from a compliance perspective. Managing Speaker Program Risk covers the guidelines and policies that must be followed when conducting a speaker program to ensure compliance with applicable regulations and policies. The estimated time to complete this module is 30 minutes.

Medical science liaisons (MSLs) and commercial field personnel play a key role in helping life sciences companies improve patients’ lives. But while each group may sometimes interact with the same healthcare professionals, their missions are different. The MSL/Commercial Divide will help your field team better understand the role played by MSLs and the guardrails designed to maintain the distinction between MSLs and commercial field personnel. The estimated time to complete this module is 20 minutes.

Patient support programs are under increased scrutiny for violations of the Anti-Kickback Statute, HIPAA, and the False Claims Act. Patient Programs and Their Risks provides learners with a basic understanding of patient support programs, the key risk areas associated with the programs, and important regulations that apply. The estimated time to complete this eLearning module is 20 minutes.

Life sciences companies need to ensure the accurate, complete, and on-time collection of data related to payments and other transfers of value to HCPs and HCOs. Reporting and disclosing that data must be in compliance with all applicable laws, regulations, industry codes, and voluntary disclosure guidelines. Raising Awareness of Global Transparency reviews key definitions related to transparency and what must be reported for transparency purposes and describes your responsibilities in achieving and maintaining transparency. The estimated time to complete this module is 20 minutes.

Social Media Matters helps employees understand how they can use their personal social media accounts to share their enthusiasm for your company online while avoiding improperly disclosing confidential information, unintentionally engaging in improper product promotion, or appearing to act as company spokespersons. The estimated time to complete this module is 15 minutes.

The PDMA and Drug Sample Management helps learners understand the requirements of the PDMA, as well as the best practices for safely managing the samples distributed to Healthcare Professionals. It includes a comprehensive overview of the law as well as an update on the Affordable Care Act as it relates to sample reporting.

The PhRMA Code Compliance Foundations eLearning module provides an overview of the Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Health Care Professionals (the PhRMA Code), which offers biopharmaceutical industry professionals guidelines for conducting appropriate interactions with healthcare professionals. The estimated time to complete this module is 25 minutes.

The Sunshine Act and Open Payments provides an overview of the Sunshine Act and Open Payments program and introduces learners to the disclosure and reporting requirements of the program. Topics include disclosure law origins; annual reports and public disclosure; reportable and excluded payments; and the difference between the Sunshine Act and state laws. The estimated time to complete this module is 30 minutes.

All biopharmaceutical employees perform functions that directly or indirectly involve regulated activities. Whether their work focuses on research, manufacturing, product promotion, or business operations, there are laws and regulations that apply to everyone’s job. Even the perception of wrongdoing can damage a company’s reputation and make it subject to government investigations. US Healthcare Compliance Overview provides an overview of the regulatory environment in which companies operate and the activities companies engage in that are subject to healthcare compliance regulations. The estimated time to complete this module is 30 minutes.

Aseptic Technique and OR Protocol explains the chain of infection as a pathway by which infectious disease is spread and emphasizes the importance of maintaining the patient environment while providing strategies to control the spread of infections. The course covers common sources of infection and offers detailed instruction on hand hygiene and decontamination techniques. Course topics also cover the need to maintain the sterile field while in the operating room and CDC guidelines for isolation precautions.

Bloodborne Pathogens introduces reps to the risks involved with various pathogens, the methods for protecting against bloodborne pathogens and what to do in case of exposure. The course also provides reps with detailed information concerning the appropriate response to requests by hospitals or clinics for proof of training in the dangers of bloodborne pathogens.

The information medical device employees share with healthcare professionals must be truthful and accurate and include a balance of the benefits and risks associated with products. Violating government regulations undermines the goal of helping patients and can have serious consequences for companies and individual violators. Compliant Product Promotion for Medical Device reviews the guidelines that must be followed when promoting medical device products to healthcare professionals to ensure compliance with all applicable regulations and policies. The estimated time to complete this module is 30 minutes.

Life science companies collect personal data from healthcare professionals, business partners and even their own employees. Protecting that data is of utmost importance to maintain the public’s trust and stay compliant with the law. The Data Privacy Compliance Foundations eLearning module introduces learners to the key terms related to privacy and covers the laws, principles, and concerns they need to understand to protect personal data. The estimated time to complete this module is 35 minutes.

Since life sciences companies conduct business in multiple countries and regularly work with foreign companies and individuals, employees need to understand and comply with all applicable anti-corruption laws. Doing so can be a challenge since anti-corruption laws have a wide reach and broadly define who is considered a public official. Global Anti-Corruption Laws provides a basic understanding of the major anti-corruption laws that apply to the life sciences industry and details the business activities that can pose an increased risk of violating those laws. The estimated time to complete this module is 40 minutes.

Good Communication Practices help facilitate the efficient and accurate exchange of information between employees, partners, and customers. Any communication can potentially be viewed and scrutinized by people outside its intended audience. This module reviews the importance of good communication practices and how to create appropriate and effective written communications. The estimated time to complete this module is 30 minutes.

The Health Insurance Portability and Accountability Act (HIPAA) governs how protected health information (PHI) may be transmitted and shared. This module teaches life sciences employees how the HIPAA Privacy Rule affects the healthcare professionals and organizations that they interact with and steps they can take to ensure they remain compliant with the HIPAA Privacy Rule. The estimated time to complete this module is 20 minutes.

Interactions with Healthcare Professionals continue to be highly scrutinized by regulators, the public and the press. Ensuring these interactions are conducted ethically, and within legal boundaries, is critical for all customer-facing medical device personnel. This module covers the best practices and guidelines for interacting with healthcare professionals one-on-one, and in a group dynamic, such as a speaker program. Content covering how to properly contract with healthcare professional consultants is included.

Speaker programs offer healthcare professionals access to critical product and disease state information from other HCPs who utilize the products, but they are high-risk from a compliance perspective. Managing Speaker Program Risk covers the guidelines and policies that must be followed when conducting a speaker program to ensure compliance with applicable regulations and policies. The estimated time to complete this module is 30 minutes.

Medical science liaisons (MSLs) and commercial field personnel play a key role in helping life sciences companies improve patients’ lives. But while each group may sometimes interact with the same healthcare professionals, their missions are different. The MSL/Commercial Divide will help your field team better understand the role played by MSLs and the guardrails designed to maintain the distinction between MSLs and commercial field personnel. The estimated time to complete this module is 20 minutes.

Life sciences companies need to ensure the accurate, complete, and on-time collection of data related to payments and other transfers of value to HCPs and HCOs. Reporting and disclosing that data must be in compliance with all applicable laws, regulations, industry codes, and voluntary disclosure guidelines. Raising Awareness of Global Transparency reviews key definitions related to transparency and what must be reported for transparency purposes and describes your responsibilities in achieving and maintaining transparency. The estimated time to complete this module is 20 minutes.

Social Media Matters helps employees understand how they can use their personal social media accounts to share their enthusiasm for your company online while avoiding improperly disclosing confidential information, unintentionally engaging in improper product promotion, or appearing to act as company spokespersons. The estimated time to complete this module is 15 minutes.

The Advanced Medical Technology Association’s Code of Ethics on Interactions with Healthcare Professionals (the AdvaMed Code) provides guidelines for appropriate interactions between healthcare professionals and companies that produce medical devices, diagnostic products, and health information systems. The AdvaMed Code Compliance Foundations eLearning module helps learners understand and abide by the tenets of the Code. The estimated time to complete this module is 40 minutes.

The Sunshine Act and Open Payments provides an overview of the Sunshine Act and Open Payments program and introduces learners to the disclosure and reporting requirements of the program. Topics include disclosure law origins; annual reports and public disclosure; reportable and excluded payments; and the difference between the Sunshine Act and state laws. The estimated time to complete this module is 30 minutes.

The medical device industry is highly regulated. While companies pursue the goal of manufacturing and marketing devices that improve patients’ lives, they must also comply with all applicable laws and regulations. What employees say about products, and their interactions with health care professionals, are two aspects of the business that receive significant regulatory attention. US Healthcare Compliance Overview for Medical Device Companies will help medical device professionals understand the key compliance issues and concerns that affect their daily business activities and the primary laws and regulations that apply. The estimated time to complete this module is 35 minutes.