FDA Scrutiny of Promotion and Advertising Practices 2017

FDA Scrutiny of Promotion and Advertising Practices 2017
Event on 2017-08-24 09:00:00
Course "FDA Scrutiny of Promotion and Advertising Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.
FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. In contrast, FDA's Center for Drug Evaluation and Research (CDER) uses long-standing regulations and a growing number of guidance documents in its regulatory approach. Policing social media has become a new regulatory responsibility and FDA is still trying to figure out how to deal with it. Bottom line, do you know when you fail to meet FDA's requirements or are you guessing? Can you afford to guess? The cost to your business and the confusion left in your customers' mind becomes an unwelcomed nightmare.
In this seminar, you will learn how to navigate FDA's numerous legal options and how to interpret them based on basic legal principles. Applying new guidance documents becomes a new test of the FDA's legal boundaries and enforcement options. The agency is now conducting clinical studies and applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This academic discipline may or may not get to the root of what consumers take away as the message.
Congress and the new FDA Commissioner seem more sympathetic to expanding access to medical treatment before all the conclusive evidence for safety and effectiveness is evaluated by the FDA. Valid off-label information may take the lead in that direction.
This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. Operating in a stovepipe environment will not work. You need to understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion practices.

Learning Objective:

• Learn how FDA faces constitutional constraints on enforcement decisions
• Learn about intersecting federal requirements by the Department of Justice, the Federal Trade Commission, the Securities and Exchange Commission and the Consumer Product Safety Commission
• Learn how the FDA interprets advertising and promotion in principle and in fact
• Understand ways that a firm violates FDA requirements
• Evaluate advertising and promotional material based on interactive group hypotheticals
• See how sales and marketing departments play a central role, for better or worse
• Learn how the federal government holds executive management responsible for missteps in promotion and advertising practices.

Who Will Benefit:

• Sales and Marketing executives and managers
• Regulatory Managers
• In-house Legal Counsel and Contract Specialists
• 3rd party consultants
• Venture Capitalists
• Investors
• Business Acquisition Executives
• Owners of New or Developing Firms
• Own label distributors
• International Trade Managers
• Product specification developers


FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person's behavior and decision outcomes. The vehicle for communication has evolved dramatically over the past 100 years and continues to evolve at a rate faster than one can anticipate at times. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the legal field playing field involves other federal agencies and departments, and they work in concert with FDA. It has become very complicated and very costly if you knowingly or unknowing walk into a legal snare. This seminar is designed to bring you up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.


Day 1 Schedule
8:30 AM – 9:00 AM: Registration
9:00 AM – 10:30 AM
Lecture 1: FDA legal authority
• FDA application of the FD&C Act and implementing regulations
• FTC / mass media
• SEC/False statements
• DOJ / False Claims
• Enforcement authority and options
Cognitive psychology vs. psychoanalytic motivation
10:30 AM – 12:00 PM
Lecture 2: Promotion and Advertising: scope of labeling
• Definitions for "label" and "labeling"
• Hard copy and electronic
• Testimonials
• Blogs
• Sales force
• What is "off-label?"
• Practice of Medicine exemption
• Drugs authority
• Devices
• Dietary supplements
12:00 PM – 1:00 PM Lunch
1:00 PM – 2:30 PM
Lecture 3: Supreme Court / commercial free speech
• Constitutional protection and case law
• Amarin Case: off-label, but true
• Safe harbor
• FDA organizational responsibility
• FDA Guidance
2:30 PM – 2:45 PM Break
2:45 PM – 4:30 PM
• Fair and balanced disclosure
• Social media
• Direct to Consumer Advertising
Hypothetical Workshop
Day 2 Schedule
9:00 AM – 10:30 AM
Lecture 1:
Direct to consumer advertising vectors
Federal Trade Commission interest (economic vs. safety)
Context and format of messaging
Script versus message
• Target population
• Aspirations
• Emotional factors
10:30 AM – 12:00 PM
Lecture 2: False and misleading information
• Statutory basis (21 U.S.C. 352(a))
• New use
• Comparative claims
• Claims for safety and effectiveness
• Sales for solicitation
12:00 PM – 1:00 PM Lunch
1:00 PM – 2:30 PM
Lecture 3:
Off label use – practices and policy
FDA Warning Letters
2:30 PM – 2:45 PM Break
2:45 PM – 4:30 PM
Lecture 4:
Practice of medicine exemption
Custom Device promotion
(Group Hypothetical)
Corporate management responsibili

Casper Uldriks
ex-FDA Expert and former Associate Center Director of CDRH

Casper (Cap) Uldriks through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA's domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.

Location: Minneapolis, MN Date: August 24th & 25th, 2017 and Time: 9:00 AM to 4:30 PM
Venue: Embassy Suites by Hilton Minneapolis Airport 7901 34th Ave South, Bloomington, MN 55425 USA


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Price: ,295.00 (Seminar Fee for One Delegate)
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Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

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at Embassy Suites by Hilton Minneapolis Airport
7901 34th Ave South, Bloomington, MN 55425
Bloomington, United States

Simple Strategies To Maximize Your Practice’s Profitability

Simple Strategies To Maximize Your Practice’s Profitability
Event on 2017-07-14 10:30:00
Simple Strategies To Maximize Your Practice's Profitability  "How can healthcare professionals leverage the power of the internet to gain new patients, minimize wasted collections activities, better organize their time and resources, and manage/track patient referrals?" In this LIVE Q&A event, 3 industry experts are combining forces to discuss how healthcare practices can generate new patient leads, grow practice revenue at more rapid rates, and provide quality patient care through patient referral management systems. This event was specifically constructed for entrepreneurial minded healthcare professionals who would like to learn about the best strategies and solutions to maximize both their practice’s profitability, and client base.  Networking and light refreshments will be offered before the event officially begins. Presentations: 4 Site Digital Marketing Agency 4 Site Digital presents "Optimizing Patient Marketing: Proven Methods to Getting More Out of Your Digital Marketing and Your Web Presence."  Nearly 66% of Small Business Owners say that finding new customers is a top concern. Search Engine Optimization is essential for securing these desired new leads – “82% of local online searchers follow up with an offline contact such as a phone call, a visit to the store, or a purchase.” Are you missing out? Google  A Google internet strategy specialist will provide an enlightening guest presentation on need to know industry stats, trends, and impactful tools your business should be using.  Whether you are focused on brand building, patient education, or direct new patient marketing, the experts at Google will uncover a new tool to incorporate in your marketing mix. MEDINEXO® Presenting "How Much Time & Money Is Your Practice Losing By Poorly Handling Referrals?" Patient leakage is a real problem for practices’ bottom-line and it damages the patient experience. This session will enlighten healthcare professionals on simple web based solutions that will simplify these processes, allow professionals to know referrals are picked up, expedite consults with necessary diagnostics & records transfer, and load balancing options to make the most of your available time. PRECYM CEO Abdiel Louis presents, “How Your Practice Can Transform Its Ability To Get Paid As Quickly As Possible.” In this session we will explore internal and external factors facing practices of all sizes, including a methodical cost analysis of your current revenue cycle.  A number of health providers are recognizing that increasing their cash flow is critical for their success, but many struggle to reduce suspended claims, increase reimbursement and collection without increasing headcount. Beyond just tracking a claim, optimizing your revenue cycle management will help your practice become more profitable by identifying and fixing your historical data debt, denial percentage, claims submission, and payment posting.   For CIC Visitor Parking Instructions, Please View The Map Below.  For Additional Instructions on Parking or Directions Call: 314.236.9010  

at Cambridge Innovation Center (CIC) – Venture Cafe
4240 Duncan Ave
Saint Louis, United States

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Axel Kuhn has mentored over a hundred Canadian online startups. In this session, Axel leverages this experience and discusses some of the key tools and techniques entrepreneurs can use not only to drive high-quality prospects to their new online businesses, but also to convert those prospects to customers and partners.   The presentation covers: Mining the Internet for strategic insights on customer demand and competitors Micropositioning to set yourself apart from the online noise
 Using analytics to design and optimize your website to increase conversions and real business results Finding the right online channels (SEO, referral, social, paid) to scale your business   Speakers  Axel Kuhn, Principal and Co-founder, ePath eCommerce Consulting  Since the mid-90s, Axel Kuhn has pioneered e-business solutions for leading companies—both multinational as well as small and medium-sized businesses—across North America and Europe. He is a serial entrepreneur, having founded and led several businesses in the Internet technology and technology services markets, including Canada’s top-ranked technology marketing firm. Axel holds a BASc from the University of Toronto, an MBA from the Queen’s School of Business, and an IMBA from the Samuel Curtis Johnson Graduate School of Management at Cornell University. Axel currently teaches e-business and e-commerce management to entrepreneurs and business professionals at the University of Toronto.

at Room CR-3, MaRS Discovery District
101 College St
Toronto, Canada

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Some horrible website no one has ever heard of has ranked the worst places to live in Wisconsin, and central Wisconsin ranks high on the list. The website Roadsnacks.net, a content farm that apparently specializes in listing the 10 worst places in …
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Educated Patients Restructures Company to Better Serve Audiology Practices

(PRWEB) May 27, 2015

Educated Patients, an audiology marketing and practice building company, has recently restructured the company in anticipation of accelerated growth. As an industry leader in audiology marketing, the company has reorganized itself around the competencies that form the core of its proven practice building system.

To prepare for this growth, Educated Patients has brought on several new hires across the company to provide focused services in key areas. The new divisions include patient-attraction website production, online marketing, and practice building coaching. As a virtual organization, Educated Patients has been able to hire the best minds in the industry without being constrained by geography, allowing for the kind of flexibility the industry demands.

The patient attraction website group ensures the creation of websites with high conversion rates among prospective patients. Each website is built to motivate patients to take action through the combination of patient-focused design, usability, and copywriting. In addition to attractive designs and ease of use, each website includes the emotional triggers that compel patients to pick up the phone and contact the practice.

The online marketing group ensures that each website is optimized for search engines, converts visitors to patients, and is updated regularly with expert content. This group also utilizes best practices in off-site search engine optimization, including social media marketing, article marketing, and press release distribution for maximum patient education and engagement.

The practice building coaching group ensures that each clients business processes are operating at peak efficiency. From front desk training to ongoing professional development, the coaching division ensures that each practice is operating at a level of performance that allows for clients to spend more time on the things that they enjoy, while avoiding having to work excessive hours. Front desk scripts, patient scheduling procedures, and time management techniques are just a few of the services offered by each practice building coach.

Overseeing the new divisions is the executive management team, consisting of Kevin St. Clergy, audiologist and founder, Charlie Cook, CEO and Chief Marketing Officer, and Liz Oswald, Director of Operations. Kevin is widely sought out as a featured speaker on audiology practice management, and Charlie is an acclaimed small business marketing and management expert who has helped thousands of small businesses grow their profits.

With the new structure in place, Educated Patients is prepared to serve its expanding client base across the country. Additional information can be found at http://www.educatedpatients.com.

About Educated Patients

Educated Patients helps private practice audiologists and hearing professionals attract more patients, gain more profits, and secure more free time by using proven systems in marketing, web design, SEO, social media, and business process coaching and consulting.


Jen Irons

Educated Patients