Pharma / BiotechMedical Device
This course provides a comprehensive description of the various regulatory and legal standards and their specific application to the advertising and promotion of drug and medical device products including detailed analysis of advertisements and promotion. These include regulations and policies of the FDA, FTC, DEA, PHS, Office of the Inspector General (OIG), state attorneys general and prosecutors, and professional guidelines of relevant organizations including ACCME, ACP, PhRMA and the AMA.
The course will cover marketing and promotional issues specific to brand-name (prescription and OTC), generic, and compounding pharmacy contexts, including such areas which are "in flux" as Continuing Medical Education, Advertising of Compounding Products, Off-Label Promotion, Gifts to Physicians, and Direct-to-Consumer Advertising. Advertisements and case studies, including notable enforcement actions by the FDA and FTC will be discussed. Additionally, case law will be examined in detail, including strategies for staying under the "regulatory radar" and developing an effective in-house promotional review system.
Participants will receive resource materials including:
Attendees will have the opportunity to consult with the instructor during breaks and after hours on specific issues. The Course Director has over twenty-five years experience as a food and drug attorney with extensive involvement in drug marketing and advertising issues both in private practice, in-house for a multi-national pharmaceutical company, with direct interaction with the FDA and FTC.
This two-day 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:
The 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 which can affect common marketing and promotional activities.
Advertising and Promotion Regulation Overview
The Laws Governing Advertising and Promotion: FDA
The Role of the Federal Trade Commission
In-Depth Analysis of Requirements for Advertising and Promotion
Anatomy of a Drug Ad
Specific Issues in Drug Promotion and Advertising
Other Communications and Promotion
FDA and FTC Enforcement
New FDA Initiatives and Special Situations
In-depth analysis of FDA Warning Letters
Current Hot Topics in Advertising and Promotion
Questions and Answers
Upon completion of this 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 which regulatory agencies continually review.
Regulatory affairs professionals and attorneys will receive training in the 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.
""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
Yes. This course provides both the underlying legal and regulatory framework as well as practical examples taken from FDA warning letters and other enforcement action so that the participant can understand the conceptual underpinnings of the regulations, and know their practical application in FDA's enforcement actions.
The format of the course combines instruction by the instructor as well as class discussion of case studies. Class participation is encouraged, to take advantage of the different experiences and practices of the different companies represented in the class.
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.
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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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