Training Course Syllabus:

Objectives of the Presentation

Gain a better understanding of how the regulatory and legal environment has evolved and affects the marketing and promotion of pharmaceuticals and medical devices
Identify the trends reflected in the latest enforcement actions and policies issued by the FDA
Summarize regulations, enforcement actions, guidelines and trends affecting the advertising and promotion of medical devices and drugs
Identify key regulatory issues surrounding complex and rapidly shifting hot topics in advertising and promotion
Conduct risk assessments for products and promotional strategies
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 and recent concerns

Why Should you Attend

Advertising and promotion of drugs and medical devices is a significant post-market activity of the FDA regulated industry. While maintaining a competitive marketing strategy is increasingly important in today´s marketplace, it is also critical to remain in compliance with FDA statutes and regulations regarding advertising and promotion of drugs and medical products. Disregarding these principles and requirements can result in FDA enforcement actions, including receiving a Warning Letter, which is publicly available, or possibly more severe consequences including monetary and occasionally criminal penalties as this webinar will uncover and address with the audience.

Areas Covered

Introductions and background
Advertising and promotion regulation overview
Required elements of all advertising and promotional materials for drugs and medical devices
Laws governing advertising and promotion: FDA
Misbranding/Off-label information and issues
In-depth analysis of requirements for advertising and promotion
FDA enforcement surveillance
Social Media, latest FDA trends and advertising and promotion issues related to social media
Who should I tell if I think that a prescription drug ad violates the law?
What are Off-label and the consequences with HCP´s?
Off-label Promotion tactics and off-label promotion of medical devices: maximizing your performance claims within FDA´s framework of acceptable practices

Who will Benefit

Management responsible for regulatory and GMP/GLP/GCP compliance and other regulatory requirements seeking a better understanding of FDA, advertising and promotional requirements, regulatory actions and how they can improve their own firm's operations and monitoring of their state of compliance and meeting requirements. Individuals who come in contact with regulatory inspectors, Auditors, Compliance/Regulatory affairs professionals, QA/QC professionals, Senior management executives, Manufacturing managers, supervisors & personnel, Project Managers, Regulatory Affairs Management, Regulatory Affairs Specialist, Compliance Officer, Compliance Specialist, Clinical Affairs, Quality Assurance Management, Marketing & Sales Management, Distributors/Authorized Representatives, Legal Counsel, Consultants, Marketing Communications ,Medical Information and Affairs

Seminar Summary:

The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ( (see full course description)

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