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Press Release

Two Day Workshop: Latest Compliance Strategies for Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices (San Diego, United States - September 14-15, 2017) - Research and Markets

Research and Markets
Posted on: 28 Aug 17

The "Latest Compliance Strategies for Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices" conference has been added to Research and Markets' offering.

Attendees will have the opportunity to consult with the instructor during breaks and after hours on specific issues relative to seminar content and for two days we will review and discuss the most recent enforcement trends and common red-flags and triggers. The seminar will provide attendees with a better understanding of responsibilities and gain a greater knowledge of the issues faced which can affect common marketing and promotional activities on behalf of their companies.

Participants will have an excellent understanding of the laws and policies and certainly FDA expectations affecting advertising, marketing and promotion, and the manner of their application in real practice. You will be better able to develop marketing and advertising programs and avoid issues which regulatory agencies, like FDA, continually review and certainly by establishing proactive strategies to mitigate compliance exposure. Attendees are encouraged to bring real-life examples to the seminar for interactive group discussion and benchmarking and address compliance solutions that work.

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
  • Lawful Pre-FDA Approval & Pre-FDA Clearance Communication
  • Promotion, Labeling and Advertising
  • 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
  • Untitled Letter and the Warning Letters
  • Seizures
  • Injunctions/Consent Decrees
  • OIG/DOJ/False Claims Act and Other Acts and OIG Settlements/CIA's
  • Physician Payments Sunshine Act
  • The federal Anti-Kickback statute presents many potential pitfalls for medical device manufacturers looking to promote their products

Learning Objectives

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 seminar will uncover and address with the audience.

For more information about this conference visit

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Last updated on: 28/08/2017

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