Marketing and Advertising of Pharmaceutical and Medical Devices

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    "This is my 4th CfPIE course and I continue to be impressed by the knowledgeable speakers and the quality of the materials provided. Also the speaker is always open to follow up questions."


    Gillian W., Compliance Specialist, Allergan

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    "This was a fabulous program! The instructor was incredibly knowledgeable. This course will help me so much in my job."


    Robin H., Manager, Quality Assurance, Baxter Healthcare

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    "Outstanding course! Outstanding instructor! It is refreshing to attend professional training and receive it from a superior subject matter expert. I would definitely recommend this course and would enjoy taking another course from this Course Director."  


    David H., QA/QC Director, Hill-Rom

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    "Speaker was engaging and very knowledgeable about discussion topics. He was able to go off script, tie back into course fabric without disruption. Very impressive."


    Ryan D., Product Manager - Marketing, Covidien

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Course Director

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Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

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Course Description

This pharmaceutical and medical device marketing course, led by Irving L. Wiesen, offers comprehensive training on the latest drug marketing, advertising and regulatory compliance and legal standards. Participants will examine issues specific to brand-name — prescription and OTC — generic, and compounding pharmacy contexts, with a focus on continuing medical education, advertising of compounding products, off-label promotion, gifts to physicians, and direct-to-consumer advertising. 


As part of this pharmaceutical promotion compliance workshop, participants will analyze recent case studies and enforcement actions by the U.S. Food and Drug Administration (FDA), Federal Trade Commission (FTC), Federal Food, Drug, and Cosmetic Act (FD&C Act) and other leading agencies. Discussions will include compliance strategies for medical device marketing regulations and insights from the latest drug marketing strategy and advertising trends. 


Course content also covers the role of the Drug Enforcement Administration (DEA), Public Health Service (PHS), Office of the Inspector General (OIG) and state-level regulators. 


Participants will also gain an understanding of the best practices from professional standards such as the ACCME, ACP, PhRMA and the AMA.

Pharmaceuticals and medical device marketing regulations course participants will receive resource materials, including:


  • Copies of laws and regulations 
  • Agency policies and court opinions 
  • Guidance on the FDA's, FTC and OIG websites
  • Guidelines of professional and industry organization


Who Should Attend

This drug marketing strategy and advertising course will provide attendees with a better understanding of responsibilities in the areas mentioned above. Additionally, participants will gain a greater knowledge of the issues faced that can affect common marketing and promotional activities.


This 15-hour pharmaceutical marketing training course was developed to assist personnel who have varying levels of experience in drug and device advertising, marketing and promotion. It is intended for those involved with:



  • Regulatory affairs
  • Marketing and promotional legal issues
  • Marketing, sales and support functions
  • Direct-to-consumer pharmaceutical advertising professionals


Attendees will have the opportunity to consult with the instructor during breaks and after hours on specific issues. The pharmaceutical marketing training course director has over twenty-five years of experience as a food and drug attorney with extensive involvement in drug marketing and advertising issues. They have worked both in private practice and in-house for a multinational pharmaceutical company, with direct interaction with the FDA and FTC.

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  • Learning Objectives

    Upon completion of this direct-to-consumer pharmaceutical advertising training course, participants will have an excellent understanding of the laws and policies affecting advertising, marketing and promotion, and the manner of their application in practice. Attendees will be better able to develop marketing and advertising programs and avoid issues regulatory agencies continually review.


    Regulatory affairs professionals and attorneys will receive training in applicable laws, regulations and agency policies and gain practical knowledge of how to detect and analyze pitfalls in dealing with the review process. Participants will also gain an understanding of how third parties, such as the FDA, the FTC and even the courts, currently view advertising and marketing issues. 


    An increased awareness of the disparate roles of various corporate departments in the development of advertising and promotion and strategies for their interaction/cooperation is also an important goal of the course.

  • Testimonials

    "This was one of the better courses I have attended due to the instructor's breath of knowledge."

    Shaun H., Director, Regulatory Affairs CMC and Operations, Corium


    "Overall, excellent course! Instructor was very experienced and knowledgeable."

    Jonn W., Director, US Medical Affairs


    "This is my 4th CfPIE course and I continue to be impressed by the knowledgeable speakers and the quality of the materials provided. Also the speaker is always open to follow up questions."

    Gillian W., Compliance Specialist, Allergan


    "Speaker was engaging and very knowledgeable about discussion topics. He was able to go off script, tie back into course fabric without disruption. Very impressive."

    Ryan D., Product Manager - Marketing, Covidien


    "The course director is extremely knowledgeable to the subject matter. In addition his presentation style is interesting and engaging. I found the course to be very well stimulated and informative. I would highly recommend the course to others in my company."

    Tina C., VP Commercialization, EOS


    "This was a fabulous program! The instructor was incredibly knowledgeable. This course will help me so much in my job."

    Robin H., Manager, Quality Assurance, Baxter Healthcare


    "Great class! I gained so much more knowledge on the details and history of the regulations and guidelines than just reading them."

    Ellen S., Sr. Corporate Compliance Auditor, Abbott


    "Outstanding course! Outstanding instructor! It is refreshing to attend professional training and receive it from a superior subject matter expert. I would definitely recommend this course and would enjoy taking another course from this Course Director."

    David H., QA/QC Director, Hill-Rom

  • Agenda


    Session 1:  Introduction


    Advertising and Promotion Regulation Overview

    • What types of matter constitute advertising and promotion
    • The jurisdiction of the various agencies, principally the FDA and FTC
    • Professional Organizations guidelines: PhRMA, AMA, ACCME

    Session 2: The Laws Governing Advertising and Promotion: FDA

    • Food, Drug and Cosmetic Act
    • Code of Federal Regulations
    • Case law review and discussion

    The Role of the Federal Trade Commission

    • Memorandum of Understanding
    • Jurisdiction of FTC and FDA over drug advertising
    • Case law review and discussion

    Other Agencies

    • Office of the Inspector General
    • Public Health Service

    Session 3: In-Depth Analysis of Requirements for Advertising and Promotion

    • Submission of materials to the Agency
    • The Role ofOPDP (formerly DDMAC) and pre-clearance of advertising
    • Fair Balance
    • Brief Summary and Full Prescribing Information
    • Reminder advertisements
    • Standards in the CFR; Agency policies and guidelines

    Session 4: Anatomy of a Drug Ad

    • What triggers the issue of advertising and promotional review
    • Various types of advertising and promotion
    • Third-Party literature
    • Case studies of ads and promotion
    • When things go wrong: prevention and remedial measures

    Session 5: Specific Issues in Drug Promotion and Advertising


    Off-Label Promotion

    • What is off-label promotion
    • What does FDA consider off-label
    • Comparative advertising and claims of superiority
    • Examples of off-label promotion
    • Examples of FDA enforcement efforts
    • Whistleblower cases involving off-label promotion
    • Quality of life claims

    Medical Education

    • Continuing Medical Education (CME)
    • Responding to requests from physicians and health care professionals
    • Single-sponsor publications
    • Seminars, exhibits, scientific symposia
    • Honoraria, gifts, compensation and remuneration

    Session 6: Other Communications and Promotion

    • Financial disclosure and investor relations
    • Communications with formularies
    • Product sampling
    • Pharmacy compounding

    FDA and FTC Enforcement

    • Standards applied by each Agency
    • Case studies of enforcement Actions
    • Warning Letters
    • Consent decrees
    • Court adjudicated cases and sanctions imposed

    Session 7: New FDA Initiatives and Special Situations

    • Social Media and other recent FDA guidances
    • Internet, web sites, blogging and how to comply
    • Off-label issues— what is allowed and how should it be handled?
    • Videos, emails, and other situations presenting particular compliance issue

    Session 8: In-depth analysis of FDA Warning Letters

    • Applying the lessons learned to company promotion via Warning Letters
    • What are the most frequent FDA objections
    • What are FDA hot button items
    • How to construct advertising and promotion to avoid a Warning Letter

    Current Hot Topics in Advertising and Promotion


    Questions and Answers

FAQs

  • Will this course update me on important FDA developments in marketing and promotion?

    Absolutely. Regulation of marketing and promotion is a highly dynamic area, both on the Federal and State levels. This course will cover the most significant and up-to-date developments in areas such as social media, the internet, electronic communications and the reporting of gifts to physicians.

  • Does the course provide hands-on practical instruction on how to handle and analyze advertising and promotion?

    Yes. This course provides both the underlying legal and regulatory framework and practical examples taken from FDA warning letters and other enforcement actions so that the participant can understand the conceptual underpinnings of the regulations and know their practical application in FDA's enforcement actions.

  • Whis the format of the course?

    The course format combines instructor-led instruction and class discussion of case studies. We encourage class participation to take advantage of the different experiences and practices of the different companies represented in the class.

  • What is the opportunity for follow-up, if I have questions after the conclusion of the course?

    The instructor remains available for questions and follow-up via telephone and email on any topics covered in the course, in case the attendees require further explanation, or if something comes up in their work on which they would like further guidance.

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.