Introduction to OPDP/APLB for Agency & Marketing Professionals: Maximizing Material Development and Review (1/2 Day)

UPCOMING DATES:

Course Description

This innovative course is for all new Pharma and Biotech marketing professionals, AND public relations and advertising agency professionals responsible for creating promotional pieces, programs, or campaigns (Advertising or PR). If you want to create impactful, compliant programs and materials AND increase the effectiveness and efficiency of your interactions with marketers 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 communication, regulatory, marketing and medical disciplines, as well as her FDA communication leadership experience, 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 and programs. This course is a must for all agency and marketing professionals who want to improve their knowledge of the regulatory, legal, and medical requirements for increasing pitch effectiveness and creating successful, sustainable promotional materials and programs, both marketing and public relations.

Topics covered include, but are not limited to:

Current regulatory/legal/compliance environment (including FDA and other government agencies, payers, Congress, etc.) and enforcement action examples.
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, patient to patient interaction, paid media, influencers, patient testimonials, celebrity spokespersons, Direct-to-Consumer promotion, new FDA draft guidance documents and their potential impact.
Innovative marketing tactics and programs, such as virtual reality, micro-targeted marketing (such as geofencing), considerations when developing a compliant overall marketing strategy, and legal and regulatory concerns and considerations when developing internal marketing strategy documents and presentations.
Proven ways to most effectively work with your clients and their copy approval teams to maximize efficiencies and convert “no” to “yes.”

Participants may NOT receive a refund for any reason (unless LRA cancels course). If the participant cannot attend the course they may send a substitute. Course registration may be transferred to another participant at any time by notifying lucyrose01@aol.com prior to the start of the course.

Price: $750.00

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To register, please fully complete the registration form below, including checking the box agreeing to the terms, then click submit.

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Terms & 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 2022 by Lucy Rose and Associates, LLC. All rights reserved.

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