Looking back, I can conclude that 2015 was quite a good year for the PAAB.
 
At the board level, we completed the governance review that was started in 2014, resulting in some changes.  The Executive Committee was dissolved, the number of general meetings was increased to four per annum, policies were upgraded and a directors’ handbook for guidance was implemented. The first independent audit of the PAAB preclearance review mechanism was commissioned by the board and it showed that the system is a well-oiled, efficient machine with no evidence of inconsistency.  

At the operations level, we created and implemented a communications strategy involving a six-pronged Social Media activity bundle.  Thanks to Patrick Massad and Jennifer Carroll for generating content that has proven to be useful to PAAB clients.  We had two successful training workshops in Toronto and Montreal that attracted 400 registrants.  We have made further improvements by implementing E-files phase two with the support of Innovasium. The staff performance throughout the year was impressive.  Despite a record volume of submissions reviewed by the staff, we were at 99.5 % on getting first reviews completed within the 10 day deadline.  PAAB was made aware of 12 stage one complaints that resulted in 6 stage two complaint decisions by the commissioner. Only one file reviewed by the PAAB had a complaint that was upheld.

Looking ahead to 2016, which marks 40 years of PAAB service in Canada, I see a lot of activity. I expect the PAAB to continue its excellent performance within the preclearance review mechanism.  We will implement a new e-training program that has been requested by clients through survey responses.  There is an ongoing PAAB Code review committee that has recommended a change in the format, structure and flow of the PAAB Code to modernize it and make it easier to use.  Also, we hope to see you on June 27, 2016 at the PAAB 40 years celebration golf tournament at the exclusive Coppinwood golf course.  Sponsorship opportunities exist if you want to help make this event a great success. It is not a fundraiser and all funds will be put into the tournament to make it a lot of fun for all registrants.

It has been a privilege to be the PAAB Commissioner since 1999 and I look forward to a great year for the PAAB in 2016.

Sincerely,

Ray Chepesiuk
PAAB Commissioner

Taking Stock

2015 was an active year for PAAB on the communication front. Take a moment to ensure you are up to date on all review guidances and review tips which were added to the PAAB website in 2015. Here is a list for your convenience.
 
Guidance Documents:

• Guidance on Branded Patient Information

Tips:

• Study Presentations Involving Dose Titration
• Retention and Market Share Claims
• Marketing Benefit Claims: What are they and what level of support do they require?
• What Constitutes Current Medical Opinion?
• Tips for EACH Step of the PAAB Approval Process
• Tips and Checklists for Creating and Selecting Fair Balance
• Tips on Claims Relating to Patient Assistance Programs

 
Have you missed any of these? If so, they are all a couple of clicks away. Simply visit www.paab.ca and click on the “Resources” tab. If you want to be among the first to hear about future review guidances and tips, follow @ThePAAB on Twitter. We’ll have a lot more to share with you in 2016.
 
    

Reminder regarding the escalation process

The PAAB is committed to providing written correspondences which clearly outline code infractions and, where possible, provide suggestions on how to move forward toward approval. However, additional dialogue is sometimes helpful to clear up areas of contention or confusion. Should the need arise, a phone call can be scheduled with a reviewer in order to obtain clarification on a review comment. Contact our administrative staff to set up a call from a reviewer. 
 
There is also a formal escalation process for important disagreements between the client and the reviewer. Clients may escalate the review decisions to the Deputy Commissioner upon receiving a PAAB letter about the same issue which was discussed on the phone with the reviewer. This process is outlined in the PAAB code (s8.6.ii) and in the “Guidance Document for the Submission Process” on the PAAB website. Representatives from the manufacturer will be required to participate on an escalation call. If you wish to escalate a review comment, please contact PAAB administrators with the eFile # and the issue to be discussed.
 
Please note that the formal process above relates to escalations for disagreements relating to particular comments within a submission under review. The PAAB is always open to discussing concerns and suggestions about broader issues such as customer service, efficiency, and consistency. As a continually improving organization, we welcome your input. Please contact Deputy Commissioner Patrick Massad or Commissioner Ray Chepesiuk.