The Advanced Medical Technology Association (AdvaMed) represents companies that develop, produce, manufacture, and market medical products, technologies and related services and therapies used to diagnose, treat, monitor, manage and alleviate health conditions and disabilities (“Medical Technologies”) in order to enable patients to live longer and healthier lives(collectively “Companies,” and individually “Company”).

On December 18, 2008 AdvaMed approved a major update of its Code of Ethics on Interactions with Health Care Professionals (the “Code”). It is crucial for all Medical Technology Companies to understand the guidelines and how they impact interactions with Health Care Professionals.

The term “Health Care Professional” (“HCP”) is defined broadly in the Code and includes persons and entities involved in the provision of patient care and involved in the decision to purchase, lease, or recommend a Medical Technology. These individuals may include purchasing agents, physician practice managers and management within group purchasing organizations.

It is also important to remember that some HCPs are also government employees. More restrictive legal restrictions may apply to such individuals.

After completing this course, you will understand how the AdvaMed Code guides your interactions with HCPs. This updated Code contains important revisions and new provisions including: Further clarifies and distinguishes between appropriate and inappropriate interactions between HCPs and representatives of Medical Technology Companies; A new Code compliance section that will list Companies that certify their adoption of the Code. This list will be available on the AdvaMed website; A prohibition on providing entertainment or recreation to HCPs, as well as a prohibition on gifts; Guidelines for entering into royalty arrangements with HCPs; Parameters for the provision of evaluation and demonstration products; An expanded section addressing the provision of objective reimbursement, coverage and health economics information to HCPs.

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The Massachusetts Department of Public Health promulgated the Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulation 105 CMR 970.000 to implement the provisions of an Act enacted by the legislature to promote cost containment, transparency and efficiency in the delivery of quality health care. The MA Code imposes a number of additional restrictions on pharmaceutical and medical device manufacturing companies’ (including distributors’) interactions with health care practitioners. The regulation also requires these companies to disclose annually certain payments to health care practitioners. These changes will directly affect how you and your company conduct business with Massachusetts-licensed health care practitioners.

The Massachusetts Regulation has the full force of law, including significant fines for non-compliance. You may be required to certify to the Massachusetts Department of Public Health that it has a Code of Conduct in compliance with the regulation, has adopted training programs, and has procedures for conducting investigations of non-compliance.

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This course reflects the updated PhRMA Code on Interactions with Healthcare Professionals (HCPs), released by the Pharmaceutical Research and Manufacturers on America (PhRMA), which is effective as of January, 2009.  This course is designed for pharmaceutical and biotech companies to reaffirm their commitment to following the highest ethical standards as well as all legal requirements while promoting products to the medical community.

The course provides guidance on a range of issues impacting the interactions with healthcare professionals, including meals, prohibition on entertainment and recreation, guidance on Company support for Continuing Medical Education, Third-party education or professional meetings, use of consultants and speakers, scholarships and educational programs, distribution of educational items, prescriber data, and training.  After completing this course you will understand how the PhRMA code impacts your interactions with healthcare professionals as it relates to the marketing of pharmaceutical products.

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FD&C Act regulations (21 CFR 310.305, 314.80, and 314.18) frame the requirements for postmarketing adverse drug experiences (ADE). In addition to these laws, you should always follow your company’s standards and processes for filing adverse drug experience reports.  Congress has required that adverse drug experience information relating to all prescription drugs be made available to FDA so that the Agency can take the appropriate action to protect the public health when necessary.

This course explores the process that prescription drug manufacturers must follow for reporting postmarket adverse drug experiences to FDA. After completing this course, you will be able identify this process.

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This brief course provides a short summary of the HIPAA Privacy Rule and describes how the regulations affect the detailing and customer support activities of medical device sales representatives. Salespeople in direct contact with physicians and other health care providers should take this course to prepare for changes in customer relationships and business practices that are directly related to the health care industry’s HIPAA compliance efforts.
After completing this course, learners will be familiar with the basic provisions of the HIPAA Privacy Rule and recognize how HIPAA affects normal sales and customer support activities. Learners will also be able to correct some common customer misunderstandings about HIPAA while helping customers ensure that patient privacy is not compromised.

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This brief course provides a short summary of the HIPAA Privacy Rule and describes how the regulations affect the detailing and customer support activities of pharmaceutical sales representatives. Salespeople in direct contact with physicians and other health care providers should take this course to prepare for changes in customer relationships and business practices directly related to the health care industry’s HIPAA compliance efforts.

After completing this course, learners will be familiar with the basic provisions of the HIPAA Privacy Rule and recognize how HIPAA affects normal sales and customer support activities. Learners will also be able to correct some common customer misunderstandings about HIPAA while helping customers ensure that patient privacy is not compromised.

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FDA has the authority to oversee the manufacture of medical devices. FDA requires manufacturers, importers, and user facilities to file medical device reports (MDRs) so that device events can be detected and corrected quickly.
Congress enacted legislation requiring manufacturers to report to the U.S. Food and Drug Administration (FDA) all device-related deaths, serious injuries, and certain malfunctions because numerous reports over the years have shown there is widespread underreporting. This underreporting resulted in injuries affecting the public health, which could not be traced by FDA.
After completing this course, you will be able to identify what a medical device report is and the types of reports that exist. You will also recognize a company’s requirements for reporting adverse events for medical devices

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