2-Day Virtual Seminar Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices


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Topic: 2 -Day Virtual Seminar Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices 
Duration: 8 Hrs (4Hrs/Day)
Dates: 27-28 Sep @11:00 AM ET
Mode of delivery: Online (GoToWebinar)

Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena.

What’s at stake if your advertising and promotional efforts violate the law? Colossal fines – the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing.

Learning Objectives:

Key goals of the conference will include learning:

  • The basics of FDA law and regulations governing advertising and promotion, as well as sister agencies such as the Federal Trade Commission, which shares jurisdiction with FDA on certain regulated products (e.g., OTC drugs).
  • The distinctions between labels, labeling, and advertising and how that impacts the FDA's powers, and
  • How to properly position Direct-to-Consumer (DTC) promotions
  • The Dos and Don'ts of promoting products on the internet, including social media sites such as Facebook and Twitter
  • The perils of off-label promotion, including criminal and civil actions that have led to multi-billion dollar settlements by regulated drug companies
  • Whether the First Amendment provides any insulation for truthful statements regarding regulated products;
  • When disseminating medical educational materials crosses the line into improper promotion; and
  • Key considerations on how to implement appropriate procedures and controls in your company to minimize the potential for regulatory action by the FDA or the FTC relative to promotion and advertising.

Who Will Benefit:

Senior executives, directors, managers, and those who have responsibility for implementing advertising and promotional activities, as well as those that have key collateral roles in reviewing advertising for drug and device firms, including officials from these areas within regulated companies:

  • Sales
  • Marketing
  • Medical Affairs
  • Legal
  • Regulatory
  • Compliance
DAY 01
  • I. Understanding the Basics
    • Who Has Jurisdiction
      • Drugs & Biologics
        • Rx Drug Advertising
        • OTC Drug Advertising
      • Devices
        • Restricted
        • all other
    • Labeling vs. Advertising
    • Basic drug rules
      • Fair balance
    • Device rules
      • Intended use deviations
    • DTC advertising
      • Print
      • TV
    • Comparative Claims
      • standard to support
      • push to pursue CER
    • Detailing and Sampling
      • is there still a future?
      • what can be said?
      • the danger of “custom” pieces
    • How FDA learns of violations
      • Keep your house clean or your competitors will rat you out
  • II. Scientific Exchange
    • Guidances on Dissemination of Scientific Information
    • Risks involved in Off-Label Statements
    • Procedural Requirements and Unsolicited Requests for Information
  • III. First Amendment
    • Understanding “Commercial Speech” Doctrine
    • FDA and the Regulation of Advertising
  • IV. Websites & Social Media
    • FDA Policies on the Internet
    • Recent FDA Enforcement Activities
    • How to Handle at the Company Levels
DAY 02
  • V. Enforcement Trends
    • FDA Hot Buttons
      • Understating risk
      • Overstating effectiveness
    • FTC
      • POM Wonderful and substantiation
    • Private Litigation – Understanding
      • Lanham Act
      • State Unfair Competition
  • VI. False Claims Act and Criminal Liability
    • Review of Key Settlements
    • “Responsible Corporate Official” Liability
  • VII. Handling at the Company Level
    • Compliance Programs
    • Internal processes
Seminar (Price/Register)
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Other Registration Option
  1. Download the Order Form
  2. Fill this form with attendee details & payment details
  3. Fax your PO to 1-888-883-7697 or,
  4. Email it to cs@compliance.world

Payment Mode

By Check -

Pay your check issued from the payee to "Redstone Learning Inc." (Our Parent Company) and mail the check to –
Compliance.world (Redstone Learning Inc.)
1180 Avenue of the Americas,
8th Floor, New York,
NY 10036

  Media Partners

If you wish to partner with us for this event

please contact us: partner or
call us: 1-866-978-0800

Media Partner Benefits

  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner to do

  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

  Sponsors

If you wish to partner with us for this event

please contact us: sponsor@compliance.world or
call us: 1-866-978-0800
Speaker: Michael C Redmond, CEO and Lead Consultant, Redmond Worldwide

Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.

Michael's MBA in Risk Management included courses in Information Security and Risk Management for Medical Devices and Healthcare. Michael is certified as a Senior Lead Manager in Information Security for Healthcare ISO 27999.As a practitioner, she has been implementing ISO 27999 and ISO 14971 for over 10 years for clients. 

Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.

Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.




Get in touch

(315) 632-0735,
(315) 750-4379