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Forum

J

jen_kent

@jen_kent

Forum Update: Supporting Community-Led Discussion

The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.

Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:

  • Correct any misunderstandings
  • Provide guidance when questions remain unanswered after a few days
  • Support discussions where official clarification is needed

Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.

Thank you for being part of the conversation.

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Recent Best Controversial

  • Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context.
    J jen_kent

    Hi @Jennifer-Carroll,

    If we've already received full approval of our email template, but are now submitting a new APS (e.g., one-page PDF) that a client would like to be able to email out using that template, do we have to resubmit the template as a new file (even though nothing else has changed) or can we just include the what would be the "attachment name" in the new APS' submission cover letter?

    Similarly, if one of the files that we had specified in the email template is expiring, but is renewed/updated slightly, do we have to resubmit the email template, or just include mention that it "replaces efile 9XXXX in the email template (efile 10XXXX)" in the renewal's submission cover letter? (given that we always confirm that APS will only be disseminated within their approval periods anyways)

    Thanks very much in advance!

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