OPDP/APLB Data Expectations: A Deep Dive for Medical Professionals (1/2 Day)

UPCOMING DATES:

6/14/23 (10AM-1PM EST)
9/20/23 (10AM-1PM EST)

**If new as a medical reviewer, we strongly encourage this course be taken in tandem with the Introduction to OPDP/APLB Review for Medical Professionals on 6/13/23 and 9/19/23**

Course Description

This innovative intermediate course, focusing on data quality and claim support, is a must for all Pharma and Biotech MEDICAL PROFESSIONALS responsible for reviewing promotional pieces, programs, or campaigns in the copy review system. If you want to increase your confidence AND increase the effectiveness and efficiency of your work in the copy approval team, this program is for you. This program is a true deep dive into understanding data requirements for promotional claims AND understanding the role of the medical professional in this context.

Lucy’s vast experience in industry medical, regulatory, and marketing disciplines, as well as her training and previous work as a physician assistant, makes her uniquely qualified to lead this course and to provide colorful, illustrative stories regarding the “why” and “how” behind the regulatory requirements as related to your medical review.

Utilizing the relevant laws, regulations, guidance, and numerous actual FDA enforcement letters, Lucy will provide an understanding of, and the reasoning behind, the regulations regarding data requirements, providing a firm foundation for your contribution. OPDP for Medical Professionals is a must for all medical professionals who want to improve their knowledge of the regulatory, legal, and medical requirements regarding data support and how they apply to the medical review.

Topics covered include, but are not limited to:

FDA regulatory data requirements for claims, including, but not limited to: comparative claims, patient testimonials, secondary claims, patient preference claims, adherence claims, cost effectiveness claims, patient reported outcomes claims, quotations, press releases, peer-to-peer communications, patient to patient communications, celebrity spokespersons, new FDA draft guidance documents and their potential impact, importance of context, data representation, study interpretation, study design requirements, etc.
Proven ways to most effectively work with your copy approval teams to maximize effectiveness and your medical knowledge contribution.

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 2023 by Lucy Rose and Associates, LLC. All rights reserved.

I have read and agree to the terms above.