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  • WorkshopsRoll up your sleeves and participate in OTC Academy workshops, which provide hands-on, intensive training on niche industry topics with an intimate group.


    Interactive Workshop: Navigating the OTC Monograph System Online

    October 20, 2017
    1:00-4:00 p.m.
    The Heldrich Hotel
    New Brunswick, NJ

    Workshop Overview

    Regardless of potential OTC Monograph system reforms, navigating the monograph system online will remain critical to bringing OTC products to shelf. Join this interactive workshop to gain hands-on experience navigating the various online resources on OTC monographs. Learn how to expeditiously explore and understand the regulatory history of the monographs to save your company time and resources. Participants will also have the opportunity to work on several case studies.

    Learning objectives

    • Review the various parts of the OTC monograph.
    • Understand where and how to find the monograph online, including from FDA and other governmental agencies.
    • Identify how to look at all of the online resources and publications related to monographs.
    • Get a deep dive into the various types of monographs: final, tentative final, advance notice of proposed rulemaking, and call for data.
    • Explore and understand the preambles for the rules to extract key information.

    Who should attend?

    • Regulatory affairs professionals
    • Regulatory counsels
    • R&D professionals

    Course Level

    Basic – For the professional who is brand new to the industry and wants to learn general information and best practices, or for those in the industry looking for a refresher on the basics.

    Registration Information

    • CHPA Member price: $199
    • Non-member price: $499

    Register Online
    2017 OTC Monograph Registration Form

    Meeting Location

    The Heldrich Hotel
    10 Livingston Ave
    New Brunswick, NJ 08901
    866.609.4700
    http://www.theheldrich.com/

    CHPA has a limited room block at The Heldrich Hotel. Please contact Shanae McFadden to make a hotel reservation.

    Logistics Information

    Airport*

    • Newark International Airport (EWR)

    Train*

    • Closest Amtrak Service is to New Brunswick 
    • New Jersey Transit ONLY to New Brunswick (limited schedule). Click here for fare and schedule information. 

    Ground Transportation

    Newark International Airport/Newark Penn Station to The Heldrich Hotel

    • Taxis are readily available from Newark Airport and Newark Penn Station*
      • Approx. $81 to/from Newark Airport
      • Approx. $68 to/from Newark Penn Station

    *Travel time from Newark International Airport and Newark Penn Station to The Heldrich Hotel is approximately 35-50 minutes or 45-60 minutes during rush hour. Travel time from New Brunswick Train Station to The Heldrich Hotel is approximately 5 minutes.

    Questions

    Aurora Tice
    Director, Education
    202.429.3515
    atice@chpa.org

    Registration and Logistics Information

    Shanae McFadden
    Coordinator, Meetings and Education
    202.429.3541
    Smcfadden@chpa.org

    Allie Mamone
    Manager, Meetings & Events
    202.429.3544
    amamone@chpa.org

    If you are interested in a private workshop for your company, please contact CHPA’s Aurora Tice.

     

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