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OPDP/APLB Intermediate Course for Reviewers

OPDP/APLB Intermediate Course for Reviewers    


  • 2/18/18 (10:00AM - 1:00PM EST and from 2:30PM - 5:30PM EST)  

Course Description

  • “Next Step” from our flagship two-day comprehensive Introductory Course (prior attendance at the two-day Introductory Course required for attendance)

  • Recent and not-so-recent graduates will equally benefit as we will focus on numerous case studies, as well as process best practices.

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


To register please follow the two step process. First, fill out the registration form below and hit SUBMIT. Then click the PAY NOW button and follow the steps to pay and complete your registration. 

Name *
Terms and 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 2017 by Lucy Rose and Associates, LLC.  All rights reserved.