OVERVIEW
The AdvaMed Code of Ethics on Interactions with Health Care Professionals (HCPs) is effective on July 1, 2009. It sets out the principles guiding Medical Device Companies, both AdvaMed members and nonmembers, in structuring ethical collaborations and arrangements with HCPs. We strongly encourage all Medical Device Companies to adopt the Code and implement an effective compliance program.
“Basics of the AdvaMed Code” prepared with Kaplan EduNeering is the only AdvaMed-approved training course on the new Code. We urge Medical Device Companies to undertake training to enable certification of compliance with the new Code.
ABOUT THE COURSE
The course is divided into nine chapters. Each chapter is followed by a brief “open book” quiz that you must pass with 80% proficiency before being allowed to move to the next chapter. At the end of the final chapter is a closed-book final exam that includes 25 questions. After completing the exam and providing your e-signature, you will receive a certificate that recognizes your successful completion of the course.
The full course takes approximately 60 minutes to complete. You can stop at the end of any chapter and resume the course later. Your progress will be bookmarked and easily retrieved for continuation.
Chapters (topics)
- Overview
- What is the AdvaMed Code?
- Company Conducted Product Training and Education
- Third-Party Educational Conferences and Business Meetings
- Consulting Arrangements
- Evaluation and Demonstration Products
- Modest Meals, Prohibition on Entertainment and Gifts
- Coverage and Reimbursement
- Grants and Donations
- Final Challenge (exam)
Key Course Content
After completing this course, you will understand how the AdvaMed Code guides your interactions with HCPs. The newly updated Code contains important revisions and new provisions including:
- 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 about the provision of information to HCPs about reimbursement, coverage and health economics;
- Clarification of 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.
Who Should Take the Course?
All Medical Technologies Companies, both AdvaMed members and non-members, are strongly urged to adopt the Code and implement an effective compliance program. In addition, AdvaMed encourages HCPs to understand and embrace the ethical principles contained in the Code, with respect to their interactions with Medical Technology Companies.
About Kaplan EduNeering
Kaplan EduNeering is part of Kaplan, Inc., a leading international provider of educational and career services and a subsidiary of The Washington Post Company. A pioneer in online learning, the company develops technology-enabled compliance solutions and works with AdvaMed to develop unique compliance and online learning solutions. Kaplan EduNeering maintains a unique relationship with The US FDA Office of Regulatory Affairs (ORA), providing the on-line training and technology-enabled management solution for ORA’s virtual university, used to train its 30,000 investigators.