Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices: 2-Day In-person Seminar (Cambridge, United States - November 9-10, 2017) - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices: 2-day In-person Seminar" conference to their offering.

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:

- 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 Should Attend:

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

Agenda:

Day 01 (8:30 AM - 4:30 PM)

08.30 AM - 09.00 AM: Registration

09.00 AM: Session Start

I. Understanding the Basics

II. Scientific Exchange

III. First Amendment

IV. Websites & Social Media

Day 02(8:30 AM - 4:30 PM)

V. Enforcement Trends

VI. False Claims Act and Criminal Liability

VII. Handling at the Company Level

For more information about this conference visit http://www.researchandmarkets.com/research/tpwzpm/ensuring

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Business, Healthcare Services, Medical Devices

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Business, Healthcare Services, Medical Devices