OPDP/APLB INTERMEDIATE COURSE FOR REVIEWERS (1 Day)

UPCOMING DATES:

6/12/23 (10:00AM - 1:00PM EST and from 2:00PM - 5:00PM EST)
9/18/23 (10:00AM - 1:00PM EST and from 2:00PM - 5:00PM EST)

Topics include, but are not limited to:

Successfully communicating with OPDP
Best Practices for a successful review program and working as a team
Extensive case study review with an emphasis on data interpretation
Comprehensive review of recent OPDP draft and final guidances
Best Practices for effectively working with clinical, marketing, and compliance
Maximizing Drug development for most successful labeling and commercialization – your role and interacting with others

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: $1,500.00

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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.