FDA Scrutiny of Promotion and Advertising Practices

Description:

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.

Who Will Benefit:

· 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

Agenda:

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

Policy

· 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 responsibility

Speaker:

ex-FDA Expert and former Associate Center Director of CDRH

Casper (Cap) Uldriks owns Encore Insight LLC, which provides consulting services on FDA Law. He 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 as 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.

Location: Baltimore, MD Date: June 27th & 28th, 2019 and Time: 9:00 AM to 4:30 PM

Venue: WILL BE ANNOUNCED SOON

Price:

Until May 20, Early Bird Price: $2,000.00 Price: $2,000.00 (Seminar Fee for One Delegate)

From May 21 to June 25, Regular Price: $2,200.00

Register for 1 attendee Price: $2,000.00

Register for 5 attendees Price: $10,000.00

Register for 10 attendees Price: $20,000.00

Register now and save $200. (Early Bird) use this promo code GCP50 to get 50% off.

Sponsorship Program benefits for seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

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john.robinson@globalcompliancepanel.com

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Registration Link - https://www.globalcompliancepanel.com/seminar/FDA-scrutiny-of-promotion-and-advertising-practices-901960SEMINAR?seo

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