Seminar | FDA Advertising and Promotion of Pharma and Medical Devices

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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

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

The real-time and live presentation as in in-person events
Private chat for company-specific conversation – the same as you would get in an in-person seminar
Opportunities to connect with your peers to share knowledge at a different time and have group discussions
Live workshop activities
Live Q&A during the event and offline Q&A assistance after the event
As usual more content, activities and case studies and now adding homework for a comprehensive understanding
Certification

Download Brochure

Day 01(10:00 AM to 5:00 PM EDT)

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 5:00 PM EDT)

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

Michael A Swit
Principal, Law Offices of Michael A. Swit

Michael A. Swit focuses on solving the legal challenges confronted by the pharmaceutical, medical device, and other life sciences industries in tackling the myriad of legal mandates enforced by the U.S. Food & Drug Administration. Mr. Swit has extensive experience counseling life sciences firms on the demands of compliance with FDA's statutory and regulatory requirements to develop and market safe and effective drugs, biologics, medical devices, IVDs and other products. He also has advised regulated firms on a wide range of FDA regulatory matters, including drug and device approvals and marketing/promotional claims, dietary supplement health claims and regulatory issues in corporate acquisitions. His experience includes FDA development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts. Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. Before joining Duane Morris LLP, Mr. Swit served for seven years as vice president at a preeminent scientific and FDA regulatory consulting firm, where he developed and ensured execution of a broad array of regulatory and other services to clients, both directly and through outside counsel.

Register Now

1
March 18-19, 2021
Virtual Seminar

Online using Credit card

$1,699.00

Seminar One Registration

March 18-19, 2021, Virtual Seminar
(For Registrations till January 5, 2021 - $1699)
(For Registrations after January 5, 2021 - $1999)

$8,665.00

Special Group Discount Register for Six attendees

March 18-19, 2021, Virtual Seminar
(For Registrations till January 5, 2021 - $8665)
(For Registrations after January 5, 2021 - $10195)

Other Registration Option

By order form / PO#

Download the Order Form
Fill this form with attendee details & payment details
Fax it to +1-650-362-2367, or
Email it to customercare@complianceonline.com

Payment Mode

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Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

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USA

By Wire -

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Note: In view of Coronavirus situation and travel advisory issued, ComplianceOnline will waive off all cancellation charges for the registrations till December 30, 2020.

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 @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:

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

Cancellations and substitutions for In-person Seminars:

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 before 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 ComplianceOnline 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 ComplianceOnline cancels the seminar, ComplianceOnline 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.

Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% 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 training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.

Offers:

Early bird seats are limited and based on first-come, first-serve.

Multiple offers cannot be combined.