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Two Day Intensive Introduction to OPDP

TWO DAY Intensive Introductory Course - Introduction to OPDP


  • 12/5/18 - 12/6/18

  • 3/13/19 - 3/14/19

  • 6/19/19 - 6/20/19

  • 9/11/19 - 9/12/19

  • 12/11/19 - 12/12/19

A comprehensive introductory course for anyone new to the design or regulation of prescription drugs/biologics promotion. Professionals working in regulatory affairs, legal, medical, clinical research, marketing, sales, sales training, medical writing, communications, public relations, continuing medical education, or any other discipline related to marketing or regulating prescription drug/biologic products will find this course essential.

Topics covered include, but are not limited to:

Current regulatory/legal/compliance environment, DOJ/OIG interest in prescription drug promotion, OIG Compliance Guide and Pharma Code on Interactions with Healthcare professionals, FDA regulatory basics, fair balance, comparative claims, CME, disease state considerations, public relations considerations, medical conventions, launch campaigns, internet, DTC

The course will be held at the Philadelphia Downtown Marriott Courtyard on Juniper Street.

The hotel has reserved a small number of overnight rooms at a special rate. To make reservations please call Marriott Worldwide Reservations at 1-800-321-2211 or the hotel at 215-496-3200 and mention Lucy Rose and Associates, LLC – this course. Hotel accommodations and rates are subject to availability.

The course begins promptly at 8:30 AM and will end at 4:00 PM

Course includes breaks and lunch, as well as appropriate course materials. Transportation, hotel (if needed), and other meals are the participant’s responsibility. 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 prior to the start of the course.

PRICE: $2,600


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.