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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
- The basics of intended use, adulteration and misbranding
- Understanding what constitutes a "claim"
- Knowing the contours and nuances of on and off-label
- 510(k) general intended use statement in making specific use claims
- FDA enforcement
Lecture 2: Anti-Kickback Statute
- The purpose and scope of the statute
- The kinds of promotional activities/remuneration it covers, e.g., consulting payments including stock/options/royalties, referral marketing, co-marketing, grants, discount, rebates, physician-owned distributorships, etc.
Lecture 3: False Claims Act/Reimbursement
- What is a False Claim?
- The interplay between a false claim and off-label promotion or dissemination
- How to make a false claim-advice, services, promotion
- Risk mitigation
Day 2 - 27th September 2013
Lecture 4: Physician Sunshine Payment Act
- What is reportable?
- Information required for reporting
Lecture 5: Establishing and Maintaining an Effective Compliance Program
- Expectations of the Office of Inspector General
- Code of Conduct/Compliance program and expectations for Compliance Officers/Committees
- A Code on Interactions with Health Care Professionals
Lecture 6: Promotion, Dissemination and Communication
- Issues in promoting a specific claim with a general intended use in a 510(k) device
- Off-label dissemination and working with sales force/reps
- A Code on Interactions with Health Care Professionals
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 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
Toll free: 1800 447 9407
Fax: 302 288 6884
Event Link: http://bit.ly/15BoCQI
LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php
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Suite 216, Fremont, CA 94539, USA
Not sure if you want to exhibit at or attend the 2-day In-person Seminar On Medical Devices Marketing: From Initial Conventional Ads To Referral Marketing At Minneapolis? See the panels below to get the information you need to make an informed decision.
|Conference/Event Dates:||09/26/2013 - 09/27/2013|
|Conference/Event Hours:||09 Hours|
|Other Industries:||Business, Manufacturing, Marketing, Medical|
|Audience:||This seminar will be beneficial for the following medical device personnel:
Senior management of medical device companies
Medical device marketing and sales management
Clinical affairs management
|Venue Type:||Indoor - Hotel|
|Booth Size||Booth Cost||Available Amenities|
|Call for Information.||Electricity:||n/a|
|Marketing Vehicles Allowed:||Call|
|Other Booth Sizes Available: n/a|
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