2-Day Virtual Seminar

Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices

BY: Darshan Kulkarni, Principal Attorney, Kulkarni Law Firm

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

December 3-4, 2020
(10:00 AM to 4:00 PM EST)
Virtual Seminar
  • Course Description
  • Agenda
  • Speaker
  • Price/Register

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 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(10:00 AM to 4:00 PM EST)
  • 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?
      • 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(10:00 AM to 4:00 PM EST)
  • 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
Darshan Kulkarni
Darshan Kulkarni Principal Attorney, Kulkarni Law Firm

Dr. Kulkarni is the Principal Attorney at the Kulkarni Law Firm. As an FDA attorney and product development consultant, he focuses on strategic regulatory and pharmaceutical counseling and has extensive experience handling the needs of international pharmaceutical, biopharmaceutical, and medical device companies and their service providers.

As corporate counsel for an international pharmaceutical holding company, Dr. Kulkarni provided corporate and regulatory legal advice. He has experience in corporate quality control and regularly performs varying legal and regulatory functions, including crafting responses to FDA titled and untited letters, reviewing potential ads, and negotiating with and for advertising agencies and scientific writing agencies.

Register Now

Online using Credit card

$1,699.00

Seminar One Registration

December 3-4, 2020, Virtual Seminar
(For Registrations till October 12, 2020 - $1699)
(For Registrations after October 12, 2020 - $1999)

$8,665.00

Group-Max. 10 Attendees

December 3-4, 2020, Virtual Seminar
(For Registrations till October 12, 2020 - $8665)
(For Registrations after October 12, 2020 - $10195)


For discounts on multiple registrations, contact customer care at +1-888-771-6965.

Other Registration Options

By order form / PO#

Payment Modes

By Check -

To pay by check please contact customercare@grcseminars.com

By Wire -

Register / Pay by Wire TransferPlease contact us at +1-888-771-6965 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event »

Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ customercare@grcseminars.com

Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

You Recently Viewed