TWO DAY Intensive Introductory Course - Introduction to OPDP (2 Days)

UPCOMING DATES: 

• March 6th and 7th, 2024
• June 5th and 6th, 2024
• September 11th and 12th, 2024
• December11th and 12th, 2024

Course Description

This innovative LRA flagship OPDP introduction course, is a must for all new Pharma and Biotech professionals responsible for creating or reviewing promotional pieces, programs, and campaigns. If you want to increase your confidence AND increase the effectiveness and efficiency of your work in the creation of materials or in the copy approval team, this program is for you. This program is a true deep dive into understanding the FDA requirements for promotional claims AND understanding the role of each discipline in this process. Discipline examples: Marketing, Regulatory, Legal, Medical, Compliance, Communications, Training, Development, Agencies, etc.

Lucy’s vast experience in medical, regulatory, marketing, sales, and communication disciplines, as well as her training and previous work as a physician assistant, make 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  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 advertising and promotion, providing a firm foundation for your contribution. INTRO TO OPDP is a must for all professionals who want to improve their knowledge of the regulatory, legal, and medical requirements how they apply to an effective and efficient 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 basics: fair balance, false and misleading, comparative claims, claim support data requirements, patient testimonials celebrity spokespersons, disease state considerations, “unbranded” promotion, public relations considerations, medical conventions, launch campaigns, internet considerations, social media, influences, concept of independence, DTC promotion, patient preference claims, adherence claims, Payer promotion, speaker programs, secondary endpoint promotions, etc.

1. Proven ways to most effectively work within your copy approval teams to maximize effectiveness and your contribution.

4. Overview of copy review best practices.
5. Hands-on review practice.

The course will be held ONLINE.

The course begins promptly at 10:00 AM EST and will end at 5:00 PM EST with a lunch break from 1PM-2PM EST.

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: $2,600.00

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

Course / Date:*

TWO DAY OPDP 3/6-3/7 TWO DAY OPDP 6/5-6/6 TWO DAY OPDP 9/11-9/12 TWO DAY OPDP 12/11-12/12

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Regulatory Legal Medical Marketing

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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 2024 by Lucy Rose and Associates, LLC.  All rights reserved.

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