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White Guide and Orange Guide Formatting Project - Pfizer

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Use of RC-Approved Slides/Content<br />

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

Q. Can a speaker at a <strong>Pfizer</strong> promotional program for HCPs describe a case study<br />

during his or her presentation?<br />

A. During a speaker program, a speaker may verbally describe a case study if their<br />

comments are consistent with the approved slides <strong>and</strong> product labeling <strong>and</strong> if<br />

they make clear that their comments are based on their personal experience.<br />

Q. Can a speaker add case study slides? Can he or she add slides that are approved<br />

for use by <strong>Pfizer</strong> Medical, Public Policy, or other non-commercial colleagues?<br />

A. No. Speakers may only present <strong>and</strong> speak to slides from RC-approved slide<br />

decks. A speaker may not add slides to the presentation that have been<br />

approved by <strong>Pfizer</strong> for other (e.g., Medical or Policy Group) uses. In very limited<br />

instances, a speaker can obtain pre-approval from the Review Committee to<br />

present slides that are not contained in the EZSpeak slide kit through the<br />

Exceptions Process.<br />

Use of Unapproved On-Label Clinical Reprints<br />

Q. Can a speaker present data from an unapproved clinical reprint that is<br />

substantiated, scientifically sound <strong>and</strong> seems to be on-label but is not RCapproved?<br />

A. No. All information presented must be RC-approved. A speaker at a<br />

promotional program represents <strong>Pfizer</strong> <strong>and</strong> must follow the same promotional<br />

policies as a member of the <strong>Pfizer</strong> sales force, with two exceptions:<br />

Roundtables <strong>and</strong> Use of Approved Materials<br />

1. He or she may provide off-label information or refer to an unapproved<br />

clinical study (if appropriate) only in response to a specific, unsolicited<br />

question; <strong>and</strong><br />

2. He or she may create <strong>and</strong> use his or her own slides only if they are<br />

approved by the Review Committee prior to the speaker program in<br />

accordance with the Exceptions Process.<br />

Q. When a speaker is presenting information to a small group of HCPs in a<br />

“roundtable” format, does the speaker have to use <strong>Pfizer</strong> approved slides?<br />

A. Yes, a speaker must always use only RC-approved slides. Where projecting the<br />

approved slides is not feasible, the approved <strong>Pfizer</strong> slides may be h<strong>and</strong>ed out<br />

(in their entirety) to attendees, unless prohibited by the product review<br />

committee. The relevant product package insert must also be made available<br />

to all attendees.<br />

160<br />

Rev. 09/12<br />

Page 9 of 25

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