Connect Conference & Show Floor Educational Sessions

View, browse and sort the list of Connect Conference sessions and show floor programming by pass type, track, and format. Please note, all Connect Conference delegates have access to CPhI Connect and InformEx Connect programming. Seating is first come, first serve, so please arrive early to sessions that you would like to attend. Sessions are subject to change.

To learn more about the Connect Conference program, click here.

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  • Navigating GDUFA - Reduce Cost and Accelerate Delivery

    Speakers:
    • Jonathan S. Helfgott  |  Adjunct Professor, Johns Hopkins University Graduate Program in Regulatory Science & Former Acting Associate Director, Office of Scientific Investigations, CDER, Johns Hopkins
    • John DiLoreto  |  Executive Director, Bulk Pharmaceuticals Task Force
    Location:  113C
    Track: Regulatory / Quality
    Pass Type: Connect Delegate, VIP Attendee - Get your pass now!
    Vault Recording: TBD

    In this session, our expert explores the role of FDA CDER's Office of Generic Drugs (OGD) in its review and approval of Abbreviated New Drug Applications (ANDAs). Topics covered include:

    • Tips for a successful ANDA submission
    • FDA's focus during an ANDA review
    • The role of GDUFA and it's impact on reviews and timelines of ANDAs
    • When a Bioequivalence study is required to support an ANDA
    • Conducting a high-quality Bioequivalence study
    • FDA site inspections of Bioequivalence studies
    • Role of technologies used to support Bioequivalence studies