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@Manufacturer @Agency

Introducing our Renewals Management Dashboard!

We are pleased to announce the launch of the Renewal Management Platform on February 14, 2024, designed to streamline the renewals of your APSs.

At PAAB, we continually strive to innovate and improve our services to better meet the needs of our valued clients. The Renewal Management Dashboard represents our commitment to efficiency by making your renewal tracking and submission process smoother and less costly.

The key features of this initiative include:

1. The Renewals Management Dashboard in eFiles: Find all of your upcoming renewals in one place and submit them with a few clicks. You only need to upload what’s new, as everything else will be pulled forward from the previous submission.
2. Reminder Emails: Timely communications to alert you to upcoming APS expiries where you are listed as the renewal contact. This will give you time to act on the renewal long before the discount period and previous eFile expire.
3. Early renewal discount: If a qualifying renewal is submitted 6 weeks or more before the expiry of the backfile, you will receive a 50% discount on the associated fee for the file.

Please note that it remains the manufacturer or its agent’s responsibility to resubmit to PAAB if there are changes to the Product Monograph or market changes that impact the piece.

Your feedback is important. As you engage with this new platform, we encourage you to share your thoughts and suggestions to help us further refine and optimize our services.

Please visit our website for detailed information on this new service.

To help ease the transition from the traditional way of submitting renewals to the new dashboard, you will continue to be able to renew via the ‘new submissions’ button until the end of Q1.

Thank you,
The PAAB Team

Hi @dmauri ,

You are correct that revising an existing statement to an updated version of the same statement would be acceptable as a minor update, assuming it is only one presentation that is changing within the piece and the rest of the piece is confirmed to be identical.

Regarding the addition of a new statement, such as ‘now available in tablets’, we can consider that for a minor update assuming a dosing presentation is already present in the piece, and again, the remainder of the piece is confirmed to be identical and it’s only this dosing presentation that is being updated.

As a reminder, when submitting a piece as a minor update, no new approval number is issued. The approval window (12 month period) stays the same as the original submission. If a new 12-month window is desired, the piece should be put through a full review (not as a minor update).

Messenger is an additional service exclusive to ARO submissions that allows you to communicate directly with your reviewer within your eFiles APS documents. It can be used selectively to help move key elements of your APS forward and gain binding review decisions on pivotal segments of your piece prior to full resubmission.

Coming soon, all submission that qualify for ARO will be eligible for our messenger service at an incremental cost. This is a pilot of the messenger service and may be subject to change in fees, policies and procedures in the future, as well as expansion to a larger number of submission types.

Look out for more information in the coming weeks!

The new CEI Dashboard is now available in eFiles. This dashboard allows you to access all active survey invitations that are awaiting completion within your eFiles account.

Once you have logged in to your eFiles account, you will see a new tab in the top navigation bar labelled “My surveys”. Within this tab is a list of your active survey invitations for any eFile where you have been identified as the CEI Contact.

To complete the survey from this list, simply click the “Launch the survey” button associated with the eFile you wish to complete the survey for, and the survey will open within eFiles for completion. After completion, the survey will disappear from your list. If you abandon the survey before completing it, the survey will remain in your list until expiry so that you are able to complete it at a later time.

Please note: Surveys will disappear from your list upon expiry. Survey invitations expire 2 weeks after initial invitation. If you would like to complete a survey for an eFile for which the link has expired, please contact review@paab.ca for assistance.

Q: Can you provide more details around what is considered a time-sensitive announcement?

A: A time-sensitive announcement is a short APS focused on an announcement that requires dissemination in an urgent manner. For example, these announcements may communicate formulary coverage changes, a guideline update, product shortages, availability announcements, etc. We consider an announcement to be 2 pages of new content or less.

Examples:
• A banner ad with the message “Brand X is now on formulary!”
• A short email detailing issues related to a product shortage
• A post card intended to bring awareness to a new indication, with the message “Now indicated for the treatment of…”

What is not a time-sensitive announcement?

Examples:
• An APS with a rush timeline that does not focus on any of the above announcements
• A large APS containing diverse content containing an announcement (e.g. a website with efficacy, safety and MOA information that also contains the flash “Now on formulary”)
• A pre-NOC submission

If you are unsure as to whether your piece qualifies as a time-sensitive announcement, please reach out to our team.

PAAB is excited to invite industry professionals—agencies, manufacturers, and stakeholders—to an open townhall where we’ll discuss the future of our submission platform and explore opportunities to enhance the process through AI-powered tools.

Date: December 19, 2024
Time: 10:30am - 11:30am
Location: MS Teams

Why Attend?
This is your chance to share your initial thoughts on PAAB's approach to integrating AI tools into the client-facing submission platform. Your feedback is invaluable in shaping a system designed to:
Streamline timelines
Simplify processes
Enhance collaboration

What’s on the Agenda?
Learn about PAAB's vision for AI-augmented tools.
Share your wish list of features or improvements that would make
submissions easier for your team.
Discuss challenges you face with the submissions process and how
PAAB can support you better.
Collaborate with peers to shape the future of PAAB submissions.

Whether you’re a seasoned submission expert or new to the process, your voice matters! This is a unique opportunity to influence how technology can improve the way we work together.

Reserve your spot now: Register

Looking forward to hearing your thoughts on how we can build a smarter, faster, and more user-friendly submission experience!

@agency