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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  • Discover the Latest in Inhalation Product Development and Regulatory Standards

    Speaker:
    Location:  113C
    Track: Drug Development
    Pass Type: Connect Delegate, VIP Attendee - Get your pass now!
    Vault Recording: TBD

    I. Overview of inhalation therapies
    • What are the US regulatory pathways for inhaled products
    • Why we like 505(b)(2) and 505(j) inhaled products
    • Latest cGMP requirements for combination products

    II. Development of generic inhaled products:
    • How to select formulations and devices
    • What analytical methods are typically required for development and quality control
    • How to qualify packaging components
    • Challenges with in-vitro and in-vivo bioequivalence studies for US filing

    III. Interactive Exercise:
    Compounds with known toxicity can potentially be leached from packaging components into an MDI, leading to a great concern to regulators. Routine testing for component extractables is typically required on those MDI components which contact either the drug product and/or the patient's mucosa. We'll discuss how to effectively deal with extractables and leachables in MDIs to ensure consistency and safety of the container closure system.

    Bonus Material
    · FDA Bioequivalence Recommendations for Various Inhalation Products