Off-the-Shelf eLearning

PharmaCertify’s off-the-shelf foundational and reinforcement training solutions help you reduce risk with customizable content presented in a modern and fresh design.

Compliance Foundations

Compliance Foundations customizable off-the-shelf eLearning modules cover your most pressing areas of risk, including kickbacks, HCP interactions, transparency, and speaker programs. The modules feature up-to-date content targeted to the life sciences industry and can be launched on your existing LMS or the PharmaCertify Access LMS. Click the industry buttons below to see a list of our titles.

Pharmaceutical Modules

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. Compliant 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.

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 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.

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.

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 Employees 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.

Speaker programs are a growing area of focus for prosecutors and government regulators. Recent corporate integrity agreements in the life sciences industry have included increasing references to the proper management of the programs. Effective and up-to-date training on the proper planning and execution of the programs is necessary to reduce the risk associated with these important educational events. Managing Speaker Program Risk introduces learners to the basic requirements of speaker programs and explains the rules regarding program attendance as well as speaker selection, compensation, and training. The module also covers the proper response required if speakers provide off-label information, and how to report compliance violations that occur during a program.

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.

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 healthcare professionals and healthcare organizations. 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 covers the key definitions related to transparency and the information that must be reported for transparency purposes, as it helps raise the learner’s sense of responsibility toward global transparency.

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.

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.

The tracking and reporting of adverse events and product complaints is required by the FDA. Understanding and Reporting Adverse Events and Product Complaints 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.

Medical Device Modules

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. Compliant Product Promotion introduces learners to the laws and rules related to the promotion of medical device products and also covers the best practices for the use of promotional aids and electronic media for communication.

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 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.

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.

The Health Insurance Portability and Accountability Act, or HIPAA, governs how individually identifiable health information can be transmitted and shared. HIPAA for Medical Device Employees 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.

Speaker programs are a growing area of focus for prosecutors and government regulators. Recent corporate integrity agreements in the life sciences industry have included increasing references to the proper management of the programs. Effective and up-to-date training on the proper planning and execution of the programs is necessary to reduce the risk associated with these important educational events. Managing Speaker Program Risk introduces learners to the basic requirements of speaker programs and explains the rules regarding program attendance as well as speaker selection, compensation, and training. The module also covers the proper response required if speakers provide off-label information, and how to report compliance violations that occur during a program.

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.

Life sciences companies need to ensure the accurate, complete, and on-time collection of data related to payments and other transfers of value to healthcare professionals and healthcare organizations. 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 covers the key definitions related to transparency and the information that must be reported for transparency purposes, as it helps raise the learner’s sense of responsibility toward global transparency.

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.

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 QuickTakes

QuickTakes are reinforcement mini modules that present key compliance concepts and best practices originally introduced in foundational training. Like the Compliance Foundations modules, QuickTakes are easily customized with your policies and contact information.

LMS Hosting and Third-Party Portals

The Access LMS and PharmaCertify’s third-party portal are cost-effective solutions for hosting and tracking training, PDFs and your compliance policies. The systems can be set up in a matter of days, and rosters uploaded, with little time and effort on your part. They offer a secure self-registration feature to simplify your administration and ensure no unwanted visitors can access the site. To address the needs of a global audience, interfaces are available in multiple languages.