Year 2013 marks the 37th year of the PAAB since its incorporation in 1976. To see the current edition of the PAAB Code, visit the PAAB Web-site www.paab.ca
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MISSION, VISION, VALUES
MISSION: To provide a preclearance review that fosters trustworthy healthcare communications within the regulatory framework.
VISION: Trusted healthcare product communication that promotes optimal health.
VALUES: Integrity, Competency, Credibility, Independence, Excellence, Transparency
PAAB CODE LAUNCH
The revised PAAB Code of Advertising Acceptance took effect on July 1, 2013. Please get an electronic copy from www.paab.ca at no charge. Print copies are available from the PAAB office at $5 each. You can get the new PAAB Code app at the Apple Store for IPad and from the PAAB website for web browser. There is no cost for the electronic app. It includes the code, advisories and guidances in English and French. The commissioner is pleased to report he has received little negative feedback about the implementation of the revised code.
PAAB RESEARCH WITH CLIENTS
The PAAB thanks all clients who participated in the telephone interviews during December and January to help us improve the PAAB. We have used the information to plan the October workshops and other forms of training and communications coming to you in 2013.
COMMITTEE TO LOOK AT REVIEWER CONSISTENCY
The PAAB directors have struck a committee to review and analyze consistency during the PAAB review process. One representative from each of the four trade association members of the PAAB and Chief Review Officer Patrick Massad will be committee members. Commissioner Ray Chepesiuk will chair the committee. The first meeting is scheduled in October and the committee will decide on a schedule of activities at that time. Terms of Reference are:
- Define Consistency for the purpose of this review.
- Devise a study with methodology agreed on by all committee members to measure PAAB reviewer “consistency”.
- Analyze the results.
- Make recommendations to the PAAB commissioner. Members of the committee are:Crawford Wright of Rx&D, Joseph Chan of CHPC and Maryse Lemieux of CPGA. BioteCanada did not name a person.
PAAB SPEAKS
The PAAB is recognized as a world leader in pharma advertising regulation and guidance. Commissioner Chepesiuk has spoken in Canada, United States and Europe on digital marketing activities. The Commissioner and Chief Review Officer Patrick Massad are available for presentation by invitation.
In April, Commissioner Chepesiuk presented at the EyeforPharma Patient Centricity conference and the EXL Pharma Digital Health Conference. CRO Patrick Massad presented at the EXL Pharma Digital Health Conference and the EyeforPharma Sales Excellence Conference in June. In the Fall Commissioner Chepesiuk will speak in Toronto at the EyeforPharma Digital Marketing Conference and act as a judge for the 2013 Digital Marketing Awards. He will also speak at the PAAB workshops in Montreal and Toronto. In late November he will speak in London, England at a PharmaCreates session “Deliver value beyond the pill to Payers, Physicians and Patients to create a customer centric business.” Commissioner Chepesiuk will present a lecture at the Pangaea Marketing course in October and CRO Massad will present a lecture on applied statistics to a graduate class at the University of Toronto.
PAAB staff can conduct learning sessions about the PAAB and the Code of Advertising Acceptance or Direct-to-Consumer advertising of Rx or biological health products on-site at your workplace. Sessions are usually 2 hours long and the content can be tailored to your needs. Q&A about your confidential marketing situations can be discussed. There is a fee and travel expenses charge. See the web-site www.paab.ca for fee info.
Contact Chief Review Officer Patrick Massad for details and fee information 905-509-2275.
PAAB WORKSHOPS
The next training workshop events will be held in Montreal October 22 and in Toronto October 24, 2013. “Create a Compliant Digital Multichannel Marketing Campaign”. We are planning an interactive learning event to help you understand the application of the new PAAB Code of Advertising Acceptance coming into effect July 1, 2013. Go to www.paabtraining.com for registration info.
The agenda is based on research conducted by jon Gwillim with 250 pharma industry and suppliers executives. PAAB is responding to what they have asked for. Come out and learn how to create advertising that is compliant with the PAAB Code of Advertising Acceptance.
REVIEW ACTIVITY
During the period of January 1 to September 30, 2013, the total number of first review submissions was 5,436 files with 37 files going more than 10 days on first review. In the same period of 2012 the PAAB reviewed 5,227 new submissions. For all reviewers, the average of turnaround for first review was 6.9 days. 87% of the reviews went to acceptance in three revisions or less.
The PAAB can generate a report to show how long the client holds a file vs. the PAAB during the review process to acceptance. In 2013, on average the PAAB has held the file 3.8 days vs. the client holding it 11.1 days.
NEW PAAB ELECTRONIC FILES PROJECT UPDATE
The PAAB has engaged the services of Innovasium Inc.(Dan Hageman) to build a new electronic files file submission and review system. The previous system was in place from 2007 and has served the PAAB well. Being a leader in the area of electronic applications, the PAAB is looking to improve on the system. Several focus groups and surveys have been conducted with clients to identify areas of improvement. A staff committee is assisting Innovasium in the design of the program at the early stages, an innovative procedure not used with the previous system. The launch is projected for January 1, 2014. Commissioner Chepesiuk states “Innovasium will bring more effectiveness and efficiencies to the PAAB electronic file system on both the client and PAAB interfaces. We are very excited about this project.”
PAAB STRATEGIC PLANNING
The PAAB directors held a strategic planning session in April 2013. Highlights include:
- rewording of the Mission statement subject to approval of the members.
- rewording of the vision statement subject to approval by the members.
- Strategic Goal 1: agreed to perform an external consultation and review of the PAAB governance structure and function prior to training of the PAAB directors.
- Strategic Goal 2: PAAB should explore closer alignment to Health Canada.
- Strategic Goal 3: The commissioner should form a committee with representation from the 4 member trade associations to explore the allegations of review inconsistency and report back to the board.
- The directors will vote on approval of the plan at the November 15, 2013 General Meeting.
PAAB COMPLAINT REPORT
During the period of July 1 to September 30, 2013, the PAAB Commissioner processed 0 Stage 2 complaints. Total for the year is 1. In addition, PAAB has continued to regularly monitor journals, the Internet, and receive direct-mail/detail aid materials collected by health professionals as part of its monitoring program. When Code violations are discovered, PAAB sends a letter to the advertiser seeking their cooperation to meet the requirements of the Code. When appropriate, PAAB will notify the advertiser’s trade association and/or Health Canada for their assessment of additional penalties. The PAAB sent 1 monitoring notice.
STAGE TWO DECISIONS
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