Email Attachments
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Hello @gmc. Apologies for missing this question.
The PAAB resource Clarification regarding digitization of APS provides direction on how to generate general email templates. These emails are subject to the PAAB Code and should go through review. Theoretically, it would be acceptable to include PAAB approved branded pieces and pivotal trial reprints and the PM. There are conditions which may occur that render the email non-compliant which would be addressed during the review process. As an example, if one of the document titles included the therapeutic area and the PM title was included with the brand name, the email would require balance.
The forum thread for the above mentioned link has additional user questions which you may find useful as well. As well, the Document names and descriptions for external use resource contains some additional examples.
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Jennifer, you mention "Fair Balance". If the brand name and therapeutic class is mentioned, but no claims, would the requirement only be for low Fair Balance?
Tina
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Hi @gmc
If limited to brand and therapeutic class, yes, lowest level would be sufficient.
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Ok, I've scoured all communications, PAAB responses and guidance documents. From what I can tell, I can mention brand and TA/disease state in the body copy of the RTE. It's the mixing of brand and TA/disease state in the naming convention that's the issue. Right? For example, could I mention the brand name and multiple sclerosis in the body copy and then attach PDFs with naming conventions that mention brand name but not TA/disease state?
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Sorry for the delay in response.
Yes, you can have brand name and TA/disease state in the body copy providing indication and appropriate fair balance is included in the email body. The attached PDFs within this email can have naming conventions with brand name only or brand name and TA that is consistent with the Product monograph, as the indication and fair balance are already in the APS.
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If there is a general email template created for a company with basic information (e.g. greeting, date and time of phone meeting, sign-off), can there be APS attached from multiple brands given those APS are individually approved and balanced? i.e. if we are looking to respond after a call discussing multiple products in one disease area are we able to attach APS from multiple brands if they are solicited in response to the previous discussion?
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Hey @afpjjim
We moved this post here as this is the thread it's in reference to and should appear with the understanding from the above response.
We are going to attempt to break this response down to try and negate misunderstandings.
First, we suggest familiarizing yourself with the Clarification regarding digitization of APS which speaks to what a templated email can look like as well as the attachment of PAAB approved pieces.
The standardized (templated) email should receive review. During the review, the sponsor should clearly convey their intention to link attachments from multiple brands. The reviewer will assess the acceptability. Per the above document, the sponsor should provide the naming convention for attachments. If there are concerns, they will be raised by the reviewer at that time. After approval of the template (with naming conventions for attachments, confirmation that branded and unbranded will not be disseminated together, and only PAAB approved content will be attached), there is no requirement to submit all possible combinations.
It is important to note that the email should not contain disease state mention. Any content outside of transaction elements, would require assessment for the acceptability of the linkages between unbranded content to all the potential linked branded attachments and their content.
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Administrator repositioned question due to relevance to this thread:
I am curious if when attaching different APS to a generic email template (no branding just generic greeting, date and time of meeting and sign-off) does each combination of APS need to be approved or will the email template and each individual APS approval be sufficient.
For example, if we have APS attachments 1,2,3,4,5 does each combination within these APS need to be independently approved (i.e combo 1,3,5 and 2,4,3 need separate approval) or because all APS are independently approved and balanced does that approval suffice?
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Hello @afpjjim
We’ve moved your question here as it’s a more appropriate location as your questions is covered in the linked communication titled “Clarification regarding digitization of APS”, https://www.paab.ca/resources/clarification-regarding-digitization-of-aps please see the “dissemination” section.
Please give this doc a read and let us know if you have further questions.
For additional training on the acceptability of templated emails, what qualifies as “transactional elements” and distribution, we offer an online training course that includes lessons on these types of communications.
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Thank you for the helpful response. One additional question regarding the naming convention that I did not see covered was the possibility of not including indication information but potentially having the study name instead.
For example, if a brand is indicated across different therapeutic areas is it possible to include the study name as part of the naming convention e.g. (FOREST_Study_Leave_Behind). I ask as this does not include any claims information but I was unsure if this would be generic enough to be included in a generic email template if potentially used across brands.
I'm thinking if there were say two or three different brands and the email was structured to be a genericized template and the attachment appear as below (assuming FOREST, BEACH, MOUNTAIN are trials belonging to 3 different brands);
FOREST_Study_Efficacy
BEACH_Study_Safety
MOUNTAIN_Study_EfficacyIs this brand agnostic enough that a generic template could still be used?
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Hey @afpjjim
The principle to consider is in the “Dissemination” section of the document referenced. The copy reads “If the intent is for the email template to be used across many brands (and therefore not contain fair balance), the document naming convention should not trigger the addition of fair balance. This means that it should not contain claims or copy that links the brand to therapeutic use.” If the brand name appears in the piece and there is a study name, this would create that link (see Attachment of clinical reprints in an RTE). During the submission process, you would define the naming convention as “Study acronym_study_safety_data” and convey that studies across multiple brands could be attached in the same email. The reviewer would assess if indication and fair balance are required.
