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Online Marketing Course

How to Turn “NO” into “YES”

Understanding FDA: Unlocking the Mystery for Maximizing Material Development and Review


  • 4/19/18 (10:00AM - 1:00PM EST and from 3:00PM - 6:00PM EST)  

Course Description

This innovative course is a must for all new Pharma & Biotech marketers. If you want to create impactful, compliant programs and materials AND increase the effectiveness and efficiency of your interactions with advertising agencies and copy approval teams, this program is for you. In addition to covering all of the regulatory basics you need to know, we will address the new, rapidly evolving promotion and broader manufacturer communication environment. Lucy’s vast experience in industry regulatory, marketing and medical disciplines makes her uniquely qualified to lead this course and to provide colorful, illustrative stories regarding the “why” and “how” behind the regulatory requirements.

Utilizing the relevant laws, regulations, guidance, and actual FDA enforcement letters, Lucy will provide the reasoning behind the copy review team’s evaluation and interpretation of claims. Understanding FDA is a must for all marketers who want to improve their knowledge of the regulatory, legal, and medical requirements for creating successful, sustainable promotional materials, as well as for those who want to improve their strategic planning capabilities for designing effective and compliant launch and in-line campaigns.

The program is intentionally designed to fit into your busy schedule. The on-line, interactive format requires no travel time or related expenses, creating the best possible value for you. The full program is designed as 2 three-hour modules conducted over two consecutive afternoons. Though provided on-line for logistical ease, Lucy will personally lead this program as a live, interactive video webinar learning experience.

Topics covered include, but are not limited to:

1.      Current regulatory/legal/compliance environment (including FDA and other government agencies, payers, Congress, etc.) and enforcement action examples.

2.     FDA regulatory requirements, including, but not limited to: truthful and non-misleading, consistent with labeling, fair balance, comparative claims, disease state communications, public relations and press releases, medical conventions/conferences, launch campaign development, internet, social media, Direct-to-Consumer promotion, new FDA draft guidance documents and their potential impact.

3.     Innovative marketing tactics and programs, such as virtual reality and patient assistance and support programs, copy review best practices for marketers, considerations when developing a compliant overall marketing strategy, and legal and regulatory concerns and considerations when developing internal marketing strategy documents and presentations.

4.     Proven ways to most effectively work with your agencies and copy approval teams to maximize efficiencies and convert “no” to “yes.”


To register please follow the two step process. First, fill out the registration form below and hit SUBMIT. Then click the PAY NOW button and follow the steps to pay and complete your registration. 

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Terms and Agreement *
This program and all materials supporting the program are intended for educational purposes only. They are not intended to provide legal, regulatory or risk advice or guidance regarding any specific situation or scenario and are not a substitute for the advice of your advisors on specific issues. This material is based on the laws and regulations  and  DDMAC/OPDP/APLB enforcement letters in place at the time of the presentation and reflects the individual opinions of Lucy Rose and Associates, LLC.  Because regulations change and risk evaluation is a subjective matter, the information  and opinions provided and expressed  as part of the program should not be relied upon for decision-making purposes. Further, Lucy Rose and Associates, LLC does not warrant or guarantee that you or your employer or any of its employees or contractors, by relying on the educational materials provided by the program, would not be subject to regulatory or  legal enforcement actions. This material is copyrighted ; it or any part of it may not be photocopied, reproduced, disseminated ,or otherwise used by anyone other than Lucy Rose and Associates, LLC  without the express written prior authorization of  Lucy Rose and Associates, LLC.    Each individual paid registration is for one attendee. The program may not be shared with anyone other than a paid registrant either during its live presentation or in any recorded format. The program or any part of it may not be recorded or reproduced in any format including but not limited to: video, photographs, screen shots, audio recordings or by any other mechanism in existence now or in the future capable of reproducing or transmitting the program in whole or in part. Copyright 2017 by Lucy Rose and Associates, LLC.  All rights reserved.