Live Seminar: Advertising and Promotional Requirements for Drugs and Medical Devices 2014
conferences > Health conferences > Live Seminar: Advertising and Promotional Requirements for Drugs and Medical Devices
8 August, 2014
San Diego CA , USA
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 ("FDA"). How the FDA will deal with such advanced communication technology that can go "viral" and just as quickly disappear is the question that the industry is eager to have answered.
The FDA regulates the promotion of prescription drugs, biologics, medical devices and biotechnology products to ensure that the information is not false or misleading. The FDA has for decades regulated traditional advertising for decades, published various guidance documents for industry and issued many violation letters. If the FDA determines that drug or medical device promotional material is false or misleading or lacking in fair balance as between benefits and risks, companies could be forced to implement costly corrective actions, such as remedial advertising, suffer damage to their reputations and incur monetary fines. Already, the government has collected billions of dollars in fines, forfeitures and disgorgements from drug companies for the alleged marketing of a product for unapproved, or "off-label," uses.
Who Will Benefit:
This seminar will provide an overview and in-depth snapshot of the key principles and requirements for advertising and promotion expectations and ensuring compliance success. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the advertising and promotional requirements for drugs and medical devices, including:
• Management responsible for regulatory and GMP/GLP/GCP compliance and 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 r
The FDA regulates the promotion of prescription drugs, biologics, medical devices and biotechnology products to ensure that the information is not false or misleading. The FDA has for decades regulated traditional advertising for decades, published various guidance documents for industry and issued many violation letters. If the FDA determines that drug or medical device promotional material is false or misleading or lacking in fair balance as between benefits and risks, companies could be forced to implement costly corrective actions, such as remedial advertising, suffer damage to their reputations and incur monetary fines. Already, the government has collected billions of dollars in fines, forfeitures and disgorgements from drug companies for the alleged marketing of a product for unapproved, or "off-label," uses.
Who Will Benefit:
This seminar will provide an overview and in-depth snapshot of the key principles and requirements for advertising and promotion expectations and ensuring compliance success. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the advertising and promotional requirements for drugs and medical devices, including:
• Management responsible for regulatory and GMP/GLP/GCP compliance and 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 r
800-447-9407