Introduction to OPDP/APLB Review for Medical Professionals (1/2 Day)

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UPCOMING DATES:

  • 6/13/23 (10AM-1PM EST)
  • 9/19/23 (10AM-1PM EST)

**We strongly encourage this course be taken in tandem with the OPDP/APLB Data Expectations: A Deep Dive for Medical Professionals on 6/14/23 and 9/20/23**

Course Description

This innovative introductory course is a must for all new 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. In addition to covering all of the regulatory basics you need to know, we will address the new, rapidly evolving promotional environment.

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 actual FDA enforcement letters, Lucy will provide the reasoning behind the regulations and guidances, 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 and how they apply to the medical review.

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, claim support data requirements, disease state communications, public relations and press releases, medical conventions/conferences, launch campaign development, internet, social media, publications, supporting documents, patient testimonials, celebrity spokespersons, Direct-to-Consumer promotion, new FDA draft guidance documents and their potential impact.
  3. 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

REGISTER NOW

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






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.