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).
In addition to these concerns, a myriad of laws, regulations and industry guidance govern arrangements between medical device manufacturers and providers, which could present significant traps to organizations and individuals that conduct business in this industry. We will begin with a high-level overview and discussion of advertisement and promotion requirements for medical device marketing including the 510(k) premarket notification submission and approval. We will review the Anti-Kickback Statute, False Claims Act/Reimbursement, Physician Sunshine Payment Act and other Advertising and Promotion Laws and Reporting.
What is important for the attendees will be to navigate the regulatory waters and establish and maintain a compliance program in order to avoid FDA and OIG/DOJ enforcement actions, fines and penalties and other sanctions. We will also discuss the promotional side of marketing a 510(k) device, including very important terms such as promotion, dissemination and communication. Attendees will learn the issues in promoting a specific claim and how to conduct lawful Off-Label dissemination and how to engage in different "communication" activities and strategies. Off-label use of medical devices is a common practice and is generally legal under existing FDA regulations, as long as that use does not rise to the level of commercialization or is intended primarily to collect clinical data. However, there are a variety of legal and institutional concerns that impact these activities that should be considered whenever there is ongoing off-label use of medical devices.
Day 1 – 26th September 2013
Lecture 1: Advertising and Promotion
Lecture 2: Anti-Kickback Statute
Lecture 3: False Claims Act/Reimbursement
Day 2 - 27th September 2013
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:
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 a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.
DATE, VENUE & PRICE:
Location: Minneapolis, MN | September 26th & 27th, 2013 | 9 AM to 6 PM
Hotel: WILL BE ANNOUNCED SOON
Register now and save $200. (Early Bird)
Until March 29, Early Bird Price: $1,295.00
from March 30 to April 30, Regular Price: $1,495.00
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