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White Guide and Orange Guide Formatting Project - Pfizer

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Use of <strong>Pfizer</strong> Approved Speaker Slide Kits<br />

<strong>Orange</strong> <strong>Guide</strong> – Chapter 9: Speaker Programs for HCPs<br />

Q. Is a speaker required to use all slides contained in a <strong>Pfizer</strong> approved slide kit?<br />

A. It depends. A speaker must appropriately emphasize all slides that relate to<br />

safety, risks, <strong>and</strong> contraindications to ensure fair balance (these slides are<br />

typically designated in EZSpeak as “m<strong>and</strong>atory” slides). Speakers are not<br />

required to use slides addressing other issues as long as the information<br />

presented is accurate <strong>and</strong> truthful, consistent with approved product labeling,<br />

supported by substantial evidence, <strong>and</strong> includes a balanced discussion of<br />

benefits <strong>and</strong> risks. (Note that for speaker slide decks intended for use with<br />

consumers, all slides must be used.)<br />

Review Policies with Speakers<br />

Before the program, you are responsible for downloading a copy of the speaker’s slides from EZSpeak<br />

<strong>and</strong> must hold a discussion with the speaker to review <strong>Pfizer</strong>’s promotional speaker policies <strong>and</strong> to<br />

ensure that he or she underst<strong>and</strong>s <strong>Pfizer</strong>’s requirements for the presentation. A copy of <strong>Pfizer</strong>’s<br />

Promotional Speaker Policy is provided to all speakers as part of their contract. Your pre-program<br />

discussion with the speaker must include the items outlined in the Speaker Program Checklist located<br />

at the beginning of this Chapter, including:<br />

A reminder that the speaker is speaking on <strong>Pfizer</strong>’s behalf <strong>and</strong> that discussions must be on-<br />

label;<br />

A reminder that the speaker must present the current RC-approved slide deck, without any<br />

unapproved materials or modifications, <strong>and</strong> that you will be prepared to project the slides<br />

from your <strong>Pfizer</strong> laptop (except at roundtable programs where h<strong>and</strong>outs may be used);<br />

A reminder of the appropriate duration of the program (minimum of 45 minutes for venue<br />

programs, or minimum of 30 minutes for programs with attendees in an in-office setting);<br />

A reminder that the speaker must start the program by clearly stating that <strong>Pfizer</strong> is<br />

sponsoring the presentation <strong>and</strong> that he/she is presenting on <strong>Pfizer</strong>’s behalf; <strong>and</strong><br />

A reminder that if an attendee asks the speaker a specific unsolicited off-label question, the<br />

speaker may answer briefly, <strong>and</strong> limited to the specific question asked, after stating that the<br />

information to be discussed is off-label <strong>and</strong> is based on the speaker’s personal experience or<br />

opinion.<br />

159<br />

Rev. 09/12<br />

Page 8 of 25

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