Foundational Training

Ready to launch and quick to customize — train on your most pressing areas of risk, including off-label promotion, HCP interactions, Open Payments, and kickbacks.

Compliance Foundations

Off-the-shelf eLearning modules to help integrate effective compliance practices into your staff’s daily activities.

Pharmaceutical Modules

The tracking and reporting of adverse events and product complaints is required by the FDA. The Adverse Events and Product Complaints module helps learners understand how to first recognize, then report adverse events, as well as product complaints, in a timely manner and in accordance with regulatory requirements.

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 include 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 the various pathogens, the methods for protecting against bloodborne pathogens and what to do in the 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.

Massive amounts of data in various forms are collected, stored, and shared daily around the world. When this data is accessed for illicit purposes, harm can come to the individuals or entities whose data was accessed. Companies must take steps to protect the data they collect and exchange. Data Privacy and Protection covers the types of data companies collect and what employees should do to protect that data.

Governments around the world are increasingly concerned with the bribery of foreign public officials, and have introduced new laws, or strengthened existing ones, to combat bribery and corruption. Global Anticorruption Laws introduces learners to the laws, and the affect they have on their daily work lives and the pharmaceutical and medical device industries in general.

In response to the demand for transparency in the relationship between the life sciences industry and the healthcare community, several trade organisations and countries have implemented requirements for tracking and reporting interactions with HCPs. Global Transparency: Reporting HCP and HCO Transfers of Value describes the global transparency requirements learners need to understand to build open relationships with customers and a sense of trust among the patient community.

The life sciences workplace offers myriad methods for communicating with colleagues, customers, other stakeholders, and the public. Timeliness of communication is critical in a fast-paced world, but clarity and accuracy are equally important. This module covers the risks associated with the use of various communication modalities; steps for creating good and safe communications; and the special concerns that arise when communicating through social media.

Sharing information about prescription drugs is key to ensuring that healthcare professionals have access to accurate and up-to-date product information, but increased scrutiny by government regulators, and the penalties associated with legal settlements, requires diligence by those responsible for developing and distributing promotional material. Good Product Promotion introduces learners to the laws and rules related to the promotion of pharmaceutical products and also covers the best practices for the use of promotional aids and electronic media for communication.

Healthcare Compliance Overview covers the key laws, regulations, enforcement organizations, and compliance guidelines regulating the sale of pharmaceuticals to physicians. It also explains how claims are reported to Medicare, Medicaid, and other federal government health programs. Clear examples of improper sales and marketing practices help representatives remain in compliance with the letter and spirit of the law.

The Health Insurance Portability and Accountability Act, or HIPAA, governs how individually identifiable health information can be transmitted and shared. HIPAA for Pharmaceutical Sales Representatives introduces learners to the tenets of the Act, explains who are covered entities, and teaches representatives how to deal with privacy situations they encounter on sales calls.

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 pharmaceutical 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.

Sales representatives and medical science liaisons (MSLs) work together to ensure healthcare professionals (HCPs) receive accurate and timely answers to their questions. However, the nature of topics that may be discussed by each function varies. MSLs and Sales Reps: Understanding the Divide explains the many factors that divide the two roles, including company policies and regulatory requirements.

On-label Promotion covers the rules around discussing off-label uses, including the multimillion dollar fines and penalties levied against drug companies for off-label violations. The module includes practical selling tips and case studies to help reps understand and react to the compliance challenges they face when selling to physicians.

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 eLearning module offers a review of the current PhRMA Code, including recent updates, and helps those responsible for interacting with healthcare professionals understand how to remain in compliance with the Code. Topics include the evaluation of compliant consulting agreements; the distribution of non-educational and practice-related items; understanding the rules around the provision of meals to HCPs; and support for Continuing Medical Education.

A number of state legislatures have passed regulations requiring pharmaceutical and medical device manufacturers to report all gifts and remuneration paid to healthcare providers. State and Federal Spend and Disclosure Requirements covers all of the states with current disclosure regulations and includes updated content based on changes to the laws in Vermont. After an introduction to the Sunshine Act and transparency in general, learners have the opportunity to select which states are relevant to their needs, and review the content for only those sections.

The release of the final rule for the Physician Payment Sunshine Act underscores the need for sales representatives and personnel across a life sciences company to understand the ramifications and reporting requirements of this landmark federal legislation. The Sunshine Act and Open Payments provides up-to-date training on the Act, and the final rule, and includes a comprehensive list of the disclosure requirements included in the law. The topics covered include reportable and excluded payments; the information required by CMS in annual reports; and the difference between the Sunshine Act and state laws.

Medical Device Modules

In the heavily-regulated medical device industry, sales representatives need be aware of voluntary guidance, such as the Advanced Medical Technology Association’s Code of Ethics on Interactions with Healthcare Professionals. The AdvaMed Code online eLearning will provide your learners with a thorough review of the Code and how to stay in compliance with its principles as they interact with healthcare professionals.

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 include 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 the various pathogens, the methods for protecting against bloodborne pathogens and what to do in the 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.

Massive amounts of data in various forms are collected, stored, and shared daily around the world. When this data is accessed for illicit purposes, harm can come to the individuals or entities whose data was accessed. Companies must take steps to protect the data they collect and exchange. Data Privacy and Protection covers the types of data companies collect and what employees should do to protect that data.

Governments around the world are increasingly concerned with the bribery of foreign public officials, and have introduced new laws, or strengthened existing ones, to combat bribery and corruption. Global Anticorruption Laws introduces learners to the laws, and the affect they have on their daily work lives and the pharmaceutical and medical device industries in general.

In response to the demand for transparency in the relationship between the life sciences industry and the healthcare community, several trade organisations and countries have implemented requirements for tracking and reporting interactions with HCPs. Global Transparency: Reporting HCP and HCO Transfers of Value describes the global transparency requirements learners need to understand to build open relationships with customers and a sense of trust among the patient community.

The life sciences workplace offers myriad methods for communicating with colleagues, customers, other stakeholders, and the public. Timeliness of communication is critical in a fast-paced world, but clarity and accuracy are equally important. This module covers the risks associated with the use of various communication modalities; steps for creating good and safe communications; and the special concerns that arise when communicating through social media.

Sharing information about prescription drugs is key to ensuring that healthcare professionals have access to accurate and up-to-date product information, but increased scrutiny by government regulators, and the penalties associated with legal settlements, requires diligence by those responsible for developing and distributing promotional material. Good Product Promotion introduces learners to the laws and rules related to the promotion of pharmaceutical products and also covers the best practices for the use of promotional aids and electronic media for communication.

The Health Insurance Portability and Accountability Act, or HIPAA, governs how individually identifiable health information can be transmitted and shared. HIPAA for Medical Device Representatives introduces learners to the tenants of the Act, explains who are covered entities, and teaches representatives how to deal with privacy situations they encounter on sales calls.

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.

Medical Device Compliance Overview reviews the laws and guidelines that govern what medical device company representatives can and cannot say to HCPs and the rules related to financial transactions with those customers. Topics include medical device reporting requirements; off-label use and marketing; major risk areas; and tips for demonstrating product use in a hospital.

Sales representatives and medical science liaisons (MSLs) work together to ensure healthcare professionals (HCPs) receive accurate and timely answers to their questions. However, the nature of topics that may be discussed by each function varies. MSLs and Sales Reps: Understanding the Divide explains the many factors that divide the two roles, including company policies and regulatory requirements.

On-label Promotion covers the rules around discussing off-label uses, including the multimillion dollar fines and penalties levied against drug companies for off-label violations. The module includes practical selling tips and case studies to help reps understand and react to the compliance challenges they face when selling to physicians.

A number of state legislatures have passed regulations requiring pharmaceutical and medical device manufacturers to report all gifts and remuneration paid to healthcare providers. State and Federal Spend and Disclosure Requirements covers all of the states with current disclosure regulations and includes updated content based on changes to the laws in Vermont. After an introduction to the Sunshine Act and transparency in general, learners have the opportunity to select which states are relevant to their needs, and review the content for only those sections.

The release of the final rule for the Physician Payment Sunshine Act underscores the need for sales representatives and personnel across a life sciences company to understand the ramifications and reporting requirements of this landmark federal legislation. The Sunshine Act and Open Payments provides up-to-date training on the Act, and the final rule, and includes a comprehensive list of the disclosure requirements included in the law. The topics covered include reportable and excluded payments; the information required by CMS in annual reports; and the difference between the Sunshine Act and state laws.

Compliance Foundations Mobile

Make Mobile Matter with training content automatically exported to create an invaluable resource app for your learners’ phones or tablets. Our seamless process extends the value of your training content to where your learners need it most – on demand and at their fingertips.

Implementation and Support

The PharmaCertify technical team brings more than 25 years of experience launching thousands of hours of online training and supporting the technical needs of our clients’ learners.