True/False Questions

Question 1 of 6

 

Which of the following are true?

  • Promotional claims can only relate to licensed indications
  • Imagery in artwork may constitute a promotional claim
  • Claims based on comparisons with competitor products are unfair
  • When claims refer to published studies clear references must be given
  • Extremes of format should be avoided
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Which of the following are true?

  • Imagery but not be inconsistent with the SmPC
  • Balance refers to safety as well as efficacy
  • Providing relative figures without absolute values may be misleading
  • Exploratory endpoints cannot be used to support promotional claims
  • Real world data are not robust enough to substantiate promotional claims
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The following pieces of information are obligatory on promotional assets

  • Unique identifying number
  • Company address
  • Adverse event reporting information
  • Declaration of company involvement
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With respect to websites which of the following are true:

  • They must be protected so that the public cannot access them however the public should not be directed towards promotional content
  • A link to the Legal Notice is mandatory
  • Cookie notices are mandatory this is the case for EU sites but does not need to be applied globally
  • Links to external sites that AZ cannot control are not approvable they are allowed – but judgment needs to be exercised
  • They must show the privacy policy
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With respect to social media:

  • They should be considered as completely accessible to the general public
  • Use of the ‘like’ button on Facebook can be seen as endorsement of the content by a company the FDA at least has expressed this view so it would be wise to apply it generally
  • Company employees can never use them for personal purposes but they must take care to separate personal use from anything that could be seen as on behalf of the company
  • Tweets about therapy areas should be approved by a nominated signatory
  • Filters can be used to restrict access so some forms of promotional activity are acceptable this has been tested and the filters on social media to date have been found to be inadequate to prevent general public access, and so in most countries this is not acceptable
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With respect to meetings and hospitality

  • AZ does not allow champagne as part of hospitality
  • AZ would allow a meeting at a museum if a private room was hired and delegates did not visit the museum
  • A renowned venue could only be used if a discount brought the costs down to acceptable levels
  • If AZ sponsors a third party event it cannot be held responsible for the social aspects
  • Off label information could be shared at an AZ standalone meetings if it was non promotional
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