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Promotion and Advertising Practices – FDA Scrutiny 2019

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Start Date: 2019-01-17
End Date: 2019-01-18
Time: 9:00 am to 6:00 pm

Phone: 18004479407

Location: Hilton San Francisco Airport Bayfront 600 Airport Blvd, Burlingame, CA 94010

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Description

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
  • 3rdparty 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:

Casper Uldriks

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:  SFO, CA Date: January 17th &18th, 2019 and Time: 9:00 AM to 6:00 PM

Venue:  Hilton San Francisco Airport Bayfront 600 Airport Blvd, Burlingame, CA 94010

 

Price:

Register for 1 attendees Price: $2,000.00

Register for 5 attendees Price: $10,000.00

Register for 10 attendees Price: $20,000.00

 

Sponsorship Program benefits for seminar

For More Informationhttps://www.globalcompliancepanel.com/control/sponsorship

 

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

[email protected]

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Website: http://www.globalcompliancepanel.com

 

Registration Link –  https://www.globalcompliancepanel.com/seminar/FDA-scrutiny-of-promotion-and-advertising-practices-901930SEMINAR?seo

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Organizers

Organized by :  Netzealous LLC DBA - Globalcompliancepanel Organizer's Address : 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Tel : 18004479407 Email : [email protected] Website : www.globalcompliancepanel.com

Contact the Organizer

About the Organizers :

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

www.globalcompliancepanel.com/seminar/FDA-scrutiny-of-promotion-and-advertising-practices-901930SEMINAR?eventogo-JAN-SEO-2019

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