White Guide and Orange Guide Formatting Project - Pfizer

More documents

Recommendations

Info

How to Handle Uninvited Guests Orange Guide – Chapter 9: Speaker Programs for HCPs Q. What should I do if an HCP brings a spouse or guest who is not otherwise an appropriate attendee to a speaker program? Is it OK for the guest to stay if the HCP agrees to pay for his or her meal? A. No. You should remind the HCP that Pfizer guidelines and the PhRMA Code prohibits guests, spouses or domestic partners from attending Pfizer speaker programs. This is clearly stated on the approved speaker program invitation. If the guest does not independently qualify as an HCP or other appropriate office staff attendee, you must respectfully ask that the guest leave the program. Q. What should I do if I believe that an uninvited HCP belongs to a specialty that is excluded for the product being discussed at the speaker program I’m sponsoring? A. If an uninvited HCP arrives whom you know (or are able to reasonably ascertain) is subject to an applicable specialty exclusion, you must respectfully ask that the HCP leave the program. Your Role During a Speaker Program Monitor for Consistency with Labeling The information presented during a speaker program must be consistent with the FDA-approved labeling for Pfizer’s products and present a fair balance of the benefits and risks. During the program, you must be prepared to project the RC-approved slide deck from your Pfizer laptop and you must monitor the presentation to ensure that the speaker’s discussion is consistent with the slides and the product's labeling. You must ensure that the speaker presents appropriate safety information, consistent with product labeling. If a speaker discusses any product that contains a “Black Box” warning, you must ensure that the speaker appropriately presents the warning and the Other Safety Information in order to provide a fair and balanced presentation. Further, if any attendee arrives after fair balance content (safety, risks and contraindications) has been presented to the audience, the speaker must review that content with the late attendee(s). HCPs may not use speaker opportunities to generate business and may not distribute business cards during programs. 168 Rev. 09/12 Page 17 of 25
Orange Guide – Chapter 9: Speaker Programs for HCPs A speaker may only discuss off-label information in response to a specific unsolicited question from the audience. Any answer by the speaker to an off-label question must be brief and limited to the specific question asked. If the HCP asking the question requires additional information or the question cannot be answered adequately in the time available, the speaker (or Pfizer Representative) must refer the HCP to the Medical Information department. The mandatory Pfizer Speaker Program Policy slide at the beginning of each speaker program notifies attendees that you must make a clarifying statement if the Speaker presents information that is inconsistent with an FDA-approved label or Pfizer policy. Different rules apply to consumer audiences. For Pfizer’s policies regarding presentations to consumers, see Chapter 16: Consumer and Employee Interactions. Off-Label Information Q. What should I do if a speaker presents off-label information during his or her presentation that was not in response to a question? A. You should: Handouts and Give-aways • Promptly and courteously clarify to the audience that the off-label information provided is not within product labeling (this should be done as soon as possible after the speaker has presented and prior to the Q&A). • Remind the speaker after the presentation that Pfizer’s guidelines require that off-label information be provided only in response to a specific, unsolicited question. • When you close out the program in EZSpeak, indicate, as prompted in the system, that a violation was committed by the speaker. Once submitted, your Regional Manager, District Manager, and Regional Attorney will receive an e-mail that summarizes your report. Speakers who proactively speak off-label may be subject to further action, up to and including deactivation. Note: If the speaker answers an unsolicited off-label question briefly and as permitted by policy, no “corrective” statement is required and no policy violation should be indicated when you close out the program. Copies of the approved package insert for each Pfizer product being discussed must be available at each presentation. Only RC-approved educational materials may be provided to attendees. Unless prohibited by the Review Committee, you may disseminate paper copies of EZSpeak slides at a 169 Rev. 09/12 Page 18 of 25
Page 1 and 2:
Dear Colleagues: Pfizer Inc 235 Eas
Page 3 and 4:
To expand the bookmarks for a chapt
Page 5 and 6:
Orange Guide - Chapter 1: Overview
Page 7 and 8:
Page 9 and 10:
Page 11 and 12:
Page 13 and 14:
Page 15 and 16:
Foreign Corrupt Practices Act Orang
Page 17 and 18:
Pfizer’s Corporate Integrity Agre
Page 19 and 20:
Page 21 and 22:
Orange Guide - Chapter 2: Detailing
Page 23 and 24:
Key Points to Ensure Compliance Ora
Page 25 and 26:
Page 27 and 28:
Communicating Formulary Status Mail
Page 29 and 30:
Page 31 and 32:
Page 33 and 34:
Hospital Protocols Comparative Clai
Page 35 and 36:
Page 37 and 38:
Page 39 and 40:
Interacting with RMRS Colleagues Or
Page 41 and 42:
Page 43 and 44:
Page 45 and 46:
Page 47 and 48:
Detailing at Journal Club Meetings
Page 49 and 50:
Orange Guide - Chapter 3: Support o
Page 51 and 52:
Page 53 and 54:
Page 55 and 56:
Medical Education Grants Overview O
Page 57 and 58:
International Grant Activity Orange
Page 59 and 60:
Page 61 and 62:
“Not-for-Profit” Defined Orange
Page 63 and 64:
Page 65 and 66:
Page 67 and 68:
Information on Pfizer’s External
Page 69 and 70:
Overview Orange Guide - Chapter 3:
Page 71 and 72:
Awards, Scholarships and Fellowship
Page 73 and 74:
Page 75 and 76:
Orange Guide - Chapter 4: Federal E
Page 77 and 78:
Page 79 and 80:
Page 81 and 82:
Promotional Activities Orange Guide
Page 83 and 84:
Page 85 and 86:
Speaker Program Meals Part-Time VA
Page 87 and 88:
Page 89 and 90:
Page 91 and 92:
Page 93 and 94:
Page 95 and 96:
Page 97 and 98:
Page 99 and 100:
Page 101 and 102:
Orange Guide - Chapter 5: Interacti
Page 103 and 104:
Page 105 and 106:
Page 107 and 108:
Page 109 and 110:
Page 111 and 112:
Page 113 and 114:
Page 115 and 116:
Discussing Payer Rebates Medical Ac
Page 117 and 118:
Page 119 and 120:
Orange Guide - Chapter 6: Clinical
Page 121 and 122: Orange Guide - Chapter 6: Clinical
Page 127 and 128: Orange Guide - Chapter 7: P&T Commi
Page 131 and 132: Questions From a P&T Committee Memb
Page 139 and 140: Orange Guide - Chapter 8: Privacy:
Page 145 and 146: Seek Only De-Identified Data Orange
Page 147 and 148: Consent Forms and Mentorships Orang
Page 149 and 150: REMEMBER Orange Guide - Chapter 8:
Page 151 and 152: Proper Use of HCP Prescriber Data O
Page 157 and 158: Orange Guide - Chapter 9: Speaker P
Page 161 and 162: Speaker Selection Scheduling Issues
Page 163 and 164: Use of Pfizer Approved Speaker Slid
Page 169 and 170: Providing In-Office Meals to Office
Page 171: U.S. HCP Payment Disclosure Policy
Page 175 and 176: Closeouts Orange Guide - Chapter 9:
Page 179 and 180: Physical Separation of Speaker Prog
Page 181 and 182: Chapter 10: STARTERS CONTENTS Start
Page 183 and 184: Key Points to Ensure Compliance Ora
Page 185 and 186: Orange Guide - Chapter 10: Starters
Page 187 and 188: Inclusion of Materials with Starter
Page 191 and 192: Distribution of Starters to Colleag
Page 199 and 200: Orange Guide - Chapter 11: Patient
Page 205 and 206: A special note about Medicare Part
Page 207 and 208: Refer any questions to your team at
Page 209 and 210: Chapter 12: CONTRACTING Introductio
Page 211 and 212: Orange Guide - Chapter 12: Contract
Page 213 and 214: Orange Guide - Chapter 12: Contract
Page 215 and 216: Key Points to Ensure Compliance Ora
Page 217 and 218: Chapter 13: HEALTH SCREENINGS Intro
Page 219 and 220: Orange Guide - Chapter 13: Health S
Page 221 and 222: If organized by Pfizer: Orange Guid
Page 223 and 224:
Orange Guide - Chapter 13: Health S
Page 225 and 226:
Orange Guide - Chapter 14: CGC Tool
Page 227 and 228:
Orange Guide - Chapter 14: CGC Tool
Page 229 and 230:
Discussing Pfizer Products While Me
Page 231 and 232:
Orange Guide - Chapter 15: Non-Reba
Page 233 and 234:
Page 235 and 236:
Page 237 and 238:
Orange Guide - Chapter 16: Consumer
Page 239 and 240:
Page 241 and 242:
Page 243 and 244:
Providing Food to Consumers at a Di
Page 245 and 246:
Page 247 and 248:
Content of Consumer Slide Decks Att
Page 249 and 250:
Adverse Events Orange Guide - Chapt
Page 251 and 252:
Orange Guide - Chapter 17: State La
Page 253 and 254:
Page 255 and 256:
Page 257 and 258:
Page 259 and 260:
Page 261 and 262:
Page 263 and 264:
California Orange Guide - Chapter 1
Page 265 and 266:
Page 267 and 268:
Page 269 and 270:
Page 271 and 272:
Page 273 and 274:
Page 275 and 276:
Page 277 and 278:
Educational Items Orange Guide - Ch
Page 279 and 280:
Page 281 and 282:
Page 283 and 284:
Page 285 and 286:
Page 287 and 288:
Page 289 and 290:
Orange Guide - Chapter 18: Meals, E
Page 291 and 292:
Page 293 and 294:
Meals to HCPs Orange Guide - Chapte
Page 295 and 296:
Page 297 and 298:
Page 299 and 300:
Page 301 and 302:
Page 303 and 304:
Page 305 and 306:
Page 307 and 308:
Page 309 and 310:
Page 311 and 312:
Orange Guide - Chapter 19: Sales Ac
Page 313 and 314:
Pricing Considerations Orange Guide
Page 315 and 316:
Page 317 and 318:
Page 319 and 320:
Page 321:
show all

White Guide and Orange Guide Formatting Project - Pfizer

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?