September 26 - 27, 2013
This seminar will help medical device marketing professionals to better understand the myriad statutes and regulations that confront and directly impact their business and operations. It will provide a comprehensive overview and look at expectations and the do and don'ts with regard to the following regulations: The Federal Food, Drug & Cosmetic Act as it relates to advertising and promotion; the Anti-kickback as it relates to remunerative relationships with those who purchase or prescribe your medical devices; the False Claims Act as it relates to seeking reimbursement for your device products; and HIPPA (Health Insurance Portability and Accountability Act of 1996).

Why you should attend:
This course will help you to use statistics correctly and minimize compliance risk.

Day 1 – Agenda
Lecture 1: Advertising and Promotion
Lecture 2: Anti-Kickback Statute
Lecture 3: False Claims Act/Reimbursement

Day 2 – Agenda
Lecture 4: Physician Sunshine Payment Act
Lecture 5: Establishing and Maintaining an Effective Compliance Program
Lecture 6: Promotion, Dissemination and Communication

Who Will Benefit:
This seminar will be beneficial for the following medical device personnel:
• Senior management of medical device companies
• Medical device marketing and sales management
• Regulatory affairs
• Legal counsel
• Compliance management
• Clinical affairs management

About Speaker:
David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having

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