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  • Workshops

    Interactive Workshop: Navigating the OTC Monograph System Online

    Wednesday, October 10th, 1:00-4:00 p.m.
    Hotel du Pont, Wilmington, DE
    (In conjunction with OTC 101 Seminar)

    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

    Registration, Hotel and Travel Information:

    This workshop is being offered in conjunction with the OTC 101 Seminar. Please refer to the OTC 101 Seminar webpage for information and to register.

    Questions

    Content:
    Farleigh Lichstein
    Senior Manager, Education
    202.429.3545
    flichstein@chpa.org

    Registration and Logistics Information:
    Shanae McFadden
    Manager, Meetings
    202.429.3541
    smcfadden@chpa.org

     

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