Code of Conduct 
Question & Answers
Please be aware of the new 2007 Edition
of the Code of Conduct when browsing through the 2006-2005
questions & answers, as some of the guidelines may have been
amendment in the new version and the response may not be compliant
with the new 2007 Code.
1. Who can submit questions?
Due to the volume of questions received and in order to prioritize
appropriately, responses will only be provided to member companies,
health care professionals (HCPs), recognized health care associations
(such as the CMA) and PAAB. In particular, we have received
a large volume of “pre-clearance” requests from
agencies, which will not be addressed going forward. If the
agency is retained by a member company, they will be requested
to forward their questions to the company’s compliance
representative for review. In the event that the member company
needs additional guidance, the member company may then submit
the question to Rx&D through their compliance representative.
2. How Should Questions be submitted?
To ensure a complete record of all questions and answers is
available for the benefit of each member company, questions
must be submitted in writing (by letter, fax or email). Questioners
contacting Rx&D by phone will be requested to submit their
inquiries in writing to maintain fairness and transparency.
To help the IPC’s analysis and to improve response times,
written submissions should refer to the Code section requiring
clarification or guidance, using the Code question form to
be located shortly in the “Code of Conduct” section
of the Rx&D website. Please do not submit samples, exhibits
or supporting documentation with questions. Given the open
nature of the process, member companies are advised not to
include confidential or proprietary information with questions,
or to pose questions requesting a confidential response.
3. What is the Process for Responses?
Once a question is submitted in accordance with these guidelines,
Rx&D staff will draft a response. All draft responses
will be consolidated and sent to an IPC core group for review
at the end of each business week. At the IPC core group’s
discretion, certain questions may be circulated to the entire
IPC for feedback. If approved by the IPC, Rx&D staff will
then send the response to the questioner. If amendments are
required, the response will not be sent until reviewed and
approved by the IPC. The IPC’s objective is to provide
responses to all written enquiries from authorized questioners
within two weeks of their receipt by Rx&D. Please note
all questions (including follow up or supplementary questions)
will be processed in order of their date of receipt. Rx&D
staff will attempt to post all questions and responses on
a monthly basis for the benefit of all member companies. Rx&D
staff will remove names or terminology from questions and
answers identifying the questioner. A more detailed description
of the revised Q&A process is attached for your reference.
4. What is the Purpose of the Q&A Process?
The Q&A
process is intended to provide supplementary advice and
guidance to member companies, HCPs, recognized health care
associations and PAAB regarding Code issues. It does not
obviate the requirement for all member companies to
familiarize themselves with the Code, and is not intended to
fulfill a pre-clearance or review mechanism for questioners.
Member companies must ultimately be solely and exclusively
responsible for whether their activities, materials and
conduct comply with the Code’s requirements.
Send questions via e-mail to code@canadapharma.org
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