Navigation

    Forum

    • Register
    • Login
    • Search
    • Categories
    • Recent
    • Popular
    • Users
    • Groups

    177 - We have a new product under review by Health Canada. A part of the approval is the preparation of the Risk Management Plan, which includes a slide deck for HCPs outlining the safety issues with the medication. Should this slide deck be PAAB approved? if yes, how do we go about this, given that PM is not yet approved?

    FYI post-approval change/preclearance exemption/what requires review/PAAB scope
    1
    1
    94
    Loading More Posts
    • Oldest to Newest
    • Newest to Oldest
    • Most Votes
    Reply
    • Reply as topic
    Log in to reply
    This topic has been deleted. Only users with topic management privileges can see it.
    • Jennifer Carroll
      Jennifer Carroll last edited by

      Updated October 19, 2015. Risk management tools should be submitted for PAAB review even when they have been approved by Health Canada. Health Canada has requested that risk management tools (whether targeted to HCPs or provided to patients through HCPs) be reviewed by PAAB. In those instances in which Health Canada has reviewed and approved the pieces, their review focuses on scientific accuracy of the content. Health Canada has therefore asked PAAB to review the pieces to ensure that they are not promotional. At the end of our review, PAAB sends the final piece to Health Canada for their records.

      1 Reply Last reply Reply Quote 0
      • First post
        Last post