Note from the Commissioner

2016 marks 40 years of PAAB service in Canada and we are still going strong. Submissions reviews have almost kept pace with last year’s record setting volume and we are meeting our performance outcome standards. We have a great staff and I expect the PAAB to continue its excellent performance within the preclearance review mechanism. Patrick Marshall has replaced Glenn Golaz as Manager, Finance and Administration and is getting his feet on the ground and is well immersed in projects and day-to-day activities. We have replaced Reviewer Chris Seto with Robert Marsala, an accomplished industry regulatory affairs veteran and we have added John Greiss with his pharmacist/lawyer background to help us with the workload. That is the most people changes in one year that we have had in the past 17 years. We have implemented, or are working on, a number of digital advances. The code committee continues its revision work towards an electronic code; and to help people assess their knowledge of the PAAB Code and to assist them in identifying learning needs, we will be launching the gamification of the PAAB code after the national workshops in November, with the support of 40Comets. We are into phase 3 of upgrades to the e-file system and we thank you for your helpful suggestions. We have just launched the Ticket and Tagging System to help us improve our service to clients. Earlier in the year, we implemented a new dashboard for manufacturers to allow them to see their own files. The Health Canada bilat meeting took place in April. The PAAB 40 years celebration golf tournament at the beautiful Coppinwood golf course was a great success and we had many compliments of a great day from our attendees. We thank you for your support. Sign up now to join 300+ registrants at the national workshops in Montreal November 15 and Toronto November 17. Review compliance is high and complaints about advertising are low and I think there is a correlation there. We will conduct a strategic planning meeting in November to provide some direction for the commissioner to take PAAB into the near future. You can get more details on all of the above at www.paab.ca.

Sincerely,

Ray Chepesiuk

PAAB Commissioner

PAAB Stats

January 1 through September 30, 2016

Number of submissions: 5748

Time to first response: average of 6.4 days. 25 files beyond day 10.

Time to revision response: average 2.5 days

Complaints
During the period January 1 to September 30 2016 there were 5 Stage 2 complaints.  All were ruled in favour of the plaintiff. There was no PAAB logo on any of these advertising pieces.

eFiles Ticket and Tagging System

The PAAB is excited to announce that the Ticket and Tagging Innovation on the eFile system is live and ready to go!  You’ve likely noticed new buttons related to the functionality if you’ve logged onto the eFile system recently. 

We want you to help the PAAB to continually improve the customer experience through this digital advance.  There are two sorts of instances in which you’ll want to create a ticket: 

1. Create a ticket in order to tag issues you’ve encountered during the preclearance process.  Tags are simply intended to create a record of issues for periodic review by the PAAB management team.  Tags are NOT a communication tool for resolving issues during the live review of the file.  In fact, the eFiles platform does not show client tags to the reviewers.  Continue to utilize written and verbal correspondences to move files forward and to obtain clarification respectively.  

 

2. Create a ticket in order to submit requests for calls with reviewers (whether file specific or general questions).  Moving forward, we ask that our clients submit requests for calls with reviewers through the ticketing system on the eFile system or the "General Questions For Reviewers" link accessible throughout our website (www.paab.ca).  For general questions please briefly describe the question in the details box.  For calls relating to a particular file, please identify the comment numbers for discussion during the call in the details box.  Please note that calls will be recorded for quality assurance, training and auditing purposes.  Also note that the ticket may be accessed by the client after the call in order to tag issues encountered during that call.  This would help ensure that this particular call is reviewed by a PAAB manager when considering opportunities for training and improvement.  Although tickets relating to call requests are visible to reviewers, the tags placed on these tickets to inform management of issues encountered during the call are not visible to the reviewer. 

For more information, please visit our website, PAAB.ca or Efiles Home page, to view our client training video and Ticket and Tagging Guidance document.  If you have questions regarding this new innovation, please email the PAAB office at info@paab.ca. 

PAAB Workshop Update

 PAAB’s only 2016 workshop 

The agenda is ready & the dates are set for PAAB's only full day workshop of 2016

 

Montreal - November 15

Toronto - November  17

 

With over 400 attendees in 2015, the PAAB workshops have become the must attend event for anyone working on healthcare communication materials. Join the over 300 people who are already registered for this year’s event.

 

This year’s learning objectives will help you become a trusted resource to doctors, patients & consumers, by effectively applying the PAAB standards across your multi-channel communication materials.

2016 Highlights include:

 

·         Influence the code change; understand how the 2017 code change will impact you.

·         Digital do’s and don’ts: Reviewer recommendations on how to embrace digital tactics covering: SEO, websites, banner adverts, and apps.

·         Network and collaborate: co-create a multi-channel marketing campaign in this highly interactive session.

·        Health Canada Regulatory Advertising Oversight. 

 

You can see the full brochure which drills down into each session here: http://bit.ly/29QFoVZ

 

PAAB is collaborating with Create Health to create the workshop.

PAAB Code. The game – launching November 21st 2016 

As part of PAAB’s commitment to helping improve your knowledge of PAAB and the PAAB code we have created an interactive virtual game.
Over a two-week period the interactive game will teach and test your knowledge on various aspects of the PAAB code and guidance.
Launching November 21st this interactive game will:

• Benchmark your skills against other individuals
• Improve your PAAB knowledge: The game uses psychological principles designed to create long term knowledge retention
• Be fun! It’s designed to be enjoyable and interactive

For more details contact eventadmin@paaab.ca
PAAB is working with 42 Comets to create the game.

Review Tips & Cases
 

Review Tips, Cases & Guidance Documents

Tips relating to subjective versus objective endpoints

The term “subjective endpoints” refers to variables whose values are…  Read more

[links to]: http://www.paab.ca/Review_Tips.__Subjective_vs_objective_endpoints_(September_2016)_(002).pdf

 

New PAAB Guidance Documents added to the website
 

Guidance on Advertising for Drugs with Notice of Compliance with Conditions (NOCc)

The following copy should be captured on the front cover, or at product first mention in a piece… Read more

[links to]:

http://www.paab.ca/Guidance_on_Advertising_for_Drugs_with_Notice_of_Compliance_with_Conditions_(NOCc)._September_2016._pdf.pdf

 

HCP and Patient Targeted Risk Minimization Tools (RMTs)

The purpose of RMTs is to convey important identified risks, important potential risks, and… Read more

[links to]:

http://www.paab.ca/Guidance_on_Risk_Managment_Tools_(September_2016).pdf

Training & Events

Archie Kwan Leaves PAAB

PAAB reviewer Archie Kwan has left PAAB after 2 years of dedicated service.  We will miss him and we wish him all the best

The PAAB welcomes Robert Marsala to our team

Robert Marsala, B.Sc. Phm, M. Sc. brings over 25 years of combined experience in Regulatory, Medical Information and Product Development with major pharmaceutical and consumer healthcare organizations, to the role of PAAB Reviewer.

Robert is a member of the Ontario College of Pharmacists with retail and hospital pharmacy experience. He earned both his Bachelor of Science & Master of Science degrees in Pharmacy at the University of Toronto.

He is looking forward to helping the PAAB continue to fulfill its mandate ensuring that healthcare product communication for prescription, non-prescription, biological and natural health products is accurate, balanced and evidence-based, and reflects current and best practice.

Robert has gained expertise in review of proposed pharmaceutical advertising to meet PAAB code requirements for a number of organisations in the pharmaceutical industry and has extensive experience in providing regulatory support and guidance to Marketing and R&D colleagues thereby contributing to competitive business development and regulatory agency compliance.
 

The PAAB welcomes John Greiss to our team

John Greiss is a pharmacist who has worked in a variety of community pharmacies over the past 12 years. He recently completed a Masters in Health Law and Policy at the University of Toronto focusing on the regulation of pharmaceuticals and healthcare delivery in Canada.