The Knowledge Group Has Scheduled a Live Webcast on FDAs New Off-Label Guidance: Significant Issues Explored

Top Quote The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, announced today that it has scheduled a live webcast entitled: FDAs New Off-Label Guidance: Significant Issues Explored! This one hour event is scheduled on Wednesday, December 19, 2018 at 3:00 PM - 4:00 PM ET. End Quote
  • (1888PressRelease) December 10, 2018 - The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, announced today that it has scheduled a live webcast entitled: FDAs New Off-Label Guidance: Significant Issues Explored! This one hour event is scheduled on Wednesday, December 19, 2018 at 3:00 PM - 4:00 PM ET.

    Event Synopsis:
    Previous Off-label Guidance left unclear boundaries on what exactly is there to abide that only resulted in repeated incidences of violations. Hence, pharmaceutical companies continue to push the U.S. Food and Drug Administration (FDA) as well as the court system to elucidate on the issue.

    Recently, the FDA put into print two additional guidance documents, one addressing how insurance companies and other payors can share economic and other information, and the other addressing how companies can communicate information that is not contained in a product's labeling but is still consistent with the labeling. Thus, the latest published documents casts light for pharmaceutical companies and manufacturers in avoiding possible risks and pitfalls when comparing the safety and efficacy of one drug to another.

    In this LIVE Webcast, a panel of thought leaders and professionals assembled by The Knowledge Group will provide the audience with an in-depth analysis of the FDAs New Off-Label Guidance. Speakers will also present the fundamentals and legal considerations of the guidance, as well as tips and strategies to avoid prevalent drawbacks.

    Key issues that will be covered in this course are:
    - FDAs New Off-Label Guidance: An Overview
    - Scope, Triggers and Limitations
    - Common Risks and Pitfalls
    - Current Issues and Developments
    - What Lies Ahead

    Speakers/Faculty Panel

    Berkeley Research Group, LLC
    Katherine Norris
    Director

    Berkeley Research Group, LLC
    Edward Buthusiem
    Managing Director

    For an updated list of the faculty panel, please visit:
    https://theknowledgegroup.org/event-homepage/?event_id=3831

    About The Knowledge Group/The Knowledge Congress Live Webcast Series
    The Knowledge Group brings together the world's leading authorities and industry participants through informative two-hour webcasts that study the impact of changing regulations and help businesses succeed through proper regulatory compliance.

    Visit http://theknowledgegroup.org/ for further information and inquiry.

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