RWE Committee Update
Jennifer Carroll last edited by Jennifer Carroll
June 12 UPDATE:Industry feedback has been integrated into the draft RWE guidance document. The depth of progress and the parallel consultation process with other guidance changes required us to give industry more time than initially expected for feedback. These are big changes so we extended timelines to make sure we got ample feedback. PAAB has now launched HCP consultation on the draft guidance. We optimistically anticipate completion of the HCP consultation by end of June/early July. At this time, feedback will be integrated and a final review of the draft will be completed by the expert RWE Committee. Once confirmed, the draft will be sent to Health Canada for review.
Please note that upon completion of the guidance, we will be providing a 3-month training period prior to implementation. This will allow sponsors and agencies to train on the applications of the proposed changes. A full launch timeline will be communicated pending approval of the proposed changes.
April 26 UPDATE:The consultation period for the RWE draft document has closed. PAAB would like to thank all of the organizations and associations who provided feedback, totaling over 25 responses, for your valuable thoughts and suggestions.
We have started to consolidate the feedback and will be developing proposed revisions, clarifications, and elaborations based on the feedback.
Please stay tuned for updates and next steps which will be communicated through the PAAB Forum and our eBlasts.
March 13 UPDATE:The RWE Committee has completed the draft guidance and it is now available upon request for external feedback. If your organization would like to provide feedback, please coordinate a point person to reach out to Pauline Dong (email@example.com) and myself (firstname.lastname@example.org) to acquire the draft document to collect feedback from your organization. We ask that all feedback be collated into a single response provided prior to the consultation deadline.
The consultation period will be from March 13th through to April 3rd. This consultation period was selected with the understanding that this guidance
In November of 2022, PAAB struck a committee to generate a framework for acceptance of Real-World Evidence (RWE) in healthcare professional advertising. While the framework will focus on evidentiary standards and disclosure criteria pertaining to RWE, it will set the stage for guidance pertaining to other forms of evidence which don’t meet evidentiary gold standards but have value to clinical practice. The committee is dedicated to ensuring the framework promotes the use of RWE in advertising in a manner that is truthful, transparent, trustworthy, and in the best interest of all Canadians who rely on informed healthcare professionals.
The committee consists of industry experts from manufacturers and agencies.
Amyn Sayani Ph.D.
Director, Medical Evidence
Medical Advisor and Strategist
Vice-President, Medical & Scientific Affairs
Sr Planner, Strategic Planning
Manushvi Gupta Regulatory Manager Reckitt Nina Hemery
Director of HEOR
Patrick Massad - Commissioner
Pauline Dong - Director of Policy
Jennifer Carroll - Director of Communications
As the committee finalizes the draft document, we will head to industry consultation and consultation with healthcare professionals.
Please stay tuned for further development and updates along the development timeline. If you have any questions or comments, please post them in the chat below.
Jennifer Carroll last edited by