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New
Beyond FDALaws and Regulations Affecting Medical Device Promotion,
Marketing and Sale in the US
Medical device manufacturers must walk an increasingly narrow line between the aggressive marketing necessary to successfully launch a new medical device in today’s competitive environment while avoiding violations of federal and state laws governing the marketing, promotion and sales of medical products in the US. Apart from FDA post-marketing regulatory requirements, marketing, promotion and sales of medical products in the...Continue reading
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Issues to be covered
- Brief overview of FDA post-marketing regulation, outlining the fine line where FDA jurisdiction stops, and other jurisdictions begin
- Introduction of the governing agencies and associated jurisdictions
- Overview of the main federal laws affecting medical devices (FCA, AKS, FTCA, Sunshine, HIPAA, HITECH, etc.)
- Challenges in identifying risks and avoiding non-compliance
- Interactive discussions of real-life case studies
Who should attend
- Medical device company personnel who work in regulatory, quality management, clinical research, medical affairs, marketing and other related areas
- Individuals who are responsible for company, medical, promotional and investor communications
- Individuals wishing to expand their knowledge and understanding of laws and regulations governing the advertising, marketing and sale of medical devices in the US
Benefits to the Participants
On completion of this course, participants will be able to:
- Identify the various jurisdictions and governing agencies
- Understand the main US federal laws affecting medical devices
- Recognize the importance of avoiding non-compliance and their associated consequences
- Benefit from interactive discussion and participants/instructor experience
About The Lecturer
