Pharmacovigilance

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This report uncovers drug safety and pharmacovigilance best practices and benchmarks. Use its findings to understand the impact of upcoming regulatory guidances, manage adverse event reporting, and reinforce drug safety structures. Survey data and interview input address budgets, the value of drug safety, REMS program challenges, engaging with the FDA and MHRA, and more.

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Report Details

This report uncovers best practices and benchmarks associated with drug safety.  Drug safety and pharmacovigilance teams fill a critical role, including processing adverse event cases, completing regulatory submissions and refining signal detection thresholds.  As the safety landscape evolves, life science companies prepare for upcoming regulatory changes while rethinking existing structures and practices.

  • Number of chapters: 5
  • Number of graphics: 252
  • Number of company responses featured: 39

Data have been split by team region:

  • Global Teams
  • Country-Level Teams

Data have also been split by company size:

  • Top 20
  • Top 20 Affiliate
  • Top 50
  • Small/Biotech
  • CRO/Vendor

Top Reasons to Buy this Pharmacovigilance Report

Understand the new regulatory environment: Thanks to evolving drug safety regulations worldwide, life science firms are becoming more familiar with REMS and RMPs as a whole.  The study provides trend analysis and best practices to guide drug companies on developing REMs and RMPs, crafting risk mitigation strategies and tracking regulatory changes and their impact on pharmacovigilance.

Reconcile case management processes with industry requirements: Recent ICH updates have encouraged increased harmonization which — ideally — will make global drug safety reporting easier.  Moving forward, this new regulatory guidance may impact how life science teams design their AE reporting and case management structures.  The report explores companies’ adverse event processing and case management activities. This discussion includes the types of channels and healthcare audiences through which companies receive adverse events and the extent of cases that dedicated teams may handle annually.  The study also addresses recently finalized ICH guidelines, which are set to take effect in Europe later in 2016.

Define drug safety team structures:  This study emphasizes the importance of a dedicated pharmacovigilance team — a function that many organizations already leverage.  Companies without a well-defined pharmacovigilance department structure and/or sufficient staffing may struggle to achieve all desired drug safety outcomes.  The study includes detailed outlines of global and country-level drug safety team structures, as well as staffing ratios for 26 companies.  Structure outlines include information about the number of drug safety groups and groups’ structural organization at both global and country-level levels.

Benchmark drug safety budget data.  Budget-building and outsourcing management are key to devising a pharmacovigilance strategy.  Spending and outsourcing practices vary by individual drug safety activity, so teams can strategize these decisions based on activity priorities.   The data identify drug safety budgets, activity costs and the sources of drug safety funding.  A comparison between budget allocations and activity timelines also provides how much money teams dedicate during the clinical and post-marketed drug development stages.  These data are separated between global and country-level drug safety teams.

The following excerpt is from Chapter 3: Harnessing Internal Databases and Subject Matter Expertise to Support Pharmacovigilance Activities.

Vary Global and Country-Level Pharmacovigilance Responsibilities to Drive Drug Safety Excellence

Pharmacovigilance groups are responsible for a wide range of activities.  However, these responsibilities vary across organizations.  Team level — global versus country-specific — certainly impacts activities.  While global teams have the perspective and resources to prepare drug safety information for worldwide initiatives, global groups are able to focus on market-specific needs.  Company size, which may dictate internal drug safety resources, also impacts group responsibilities.

 

This chart (not shown) shows the percentage of surveyed teams taking on specific drug safety activities.  All surveyed teams take on a wide variety of activities.  Key findings for these data include:

  • The largest percentage of all surveyed groups are responsible for regulatory submissions and case management — each at 88%. Another 85% of surveyed teams are responsible for periodic, PSUR and ASR development as well as signal detection and management activities.
  • More than three-quarters of surveyed teams are responsible for aggregate report development (82%), literature services (79%) and drug safety training (76%).
  • More than half of surveyed teams take on responsibilities related to REMS and RMP development (62%), medical services (59%), project management (56%), safety and technology services (53%) and risk mitigation strategy (50%).
  • Just under half of all surveyed teams take on due diligence projects and regulatory consulting — at 47% and 41% of groups, respectively. Another 3% of all surveyed teams — only global teams — are responsible for regulatory inspections and audits.

Examples of companies that have participated in this study:

ph225-company-list

Table of Contents

13           Executive Summary

17           Drug Safety: Key Recommendations for Success

28           About This Report

37           Identify Best-Fit Drug Safety Budgets, Activity Costs and Outsourcing Practices

39           Standalone Drug Safety Teams Contribute to the Majority Of Drug Safety Budgets

54           Drug Safety Budget Allocated to Specific Activities

98           Drug Safety Outsourcing: Influencing Factors and Activity Costs Outsourced

127        Align Structure Designs and Staffing Allocations with Product-Driven Drug Safety Activity Levels

129        Coordinate Strategy and Encourage Communication with Drug Safety Structures

148        Balance Multiple Functions’ Expertise within Global and Country-Level Drug Safety Teams

165         Determine Responsibilities Before Allocating Pharmacovigilance Staffing

193        Implement and Improve Electronic Databases to Expand Pharmacovigilance Capabilities

199        Additional Drug Safety Tables

203        Harnessing Internal Databases and Subject Matter Expertise to Support Pharmacovigilance Activities

205        Calling on Cross-Functional Groups to Support General Pharmacovigilance Activities

261        Harnessing Internal Expertise to Advance Signal Detection

272        Crafting Risk Evaluation and Mitigation Strategies and Risk Management Plans

283        Reconciling Adverse Event Reporting, Case Management and Literature Searches with Industry Requirements

286        Quantifying Adverse Event Reporting Sources

306        Adverse Event Reporting Outlook: There’s Still Room for Improvement

317        Prevent Late Cases With Robust Clinical and Post-Marketed Case Management Strategies

324         Anticipate Case Management Loads to Reflect the Number of Supported Products

330        Quantifying Data Sources and Assessing Regulations’ Impact on Existing Case Management and Literature Searching Processes

335        Case Management Profiles

13           Executive Summary

17           Drug Safety: Key Recommendations for Success

CHARTS AND GRAPHICS

19           Figure E.1: 2015 Case Management Metrics

20           Figure E.2: Average Ratings of Outsourcing Factor Importance

23           Figure E.3: Frequency of Online Channel Monitoring Activities, by Team Type

25           Figure E.4: Percentage of Functions Involved in Specific Drug Safety Activities: Drug Safety Training

27           Figure E.5: Percentage of Functions Involved in Specific Drug Safety Activities: Risk Mitigation        Strategy

28           About this Report

34           Table E.1: General Team Information (1)

34           Table E.2: General Team Information (2)

35           Table E.3: General Team Information (3)

35           Table E.4: General Team Information (4)

36           Table E.5: Country-Level Team Information

37           Identify Best-Fit Drug Safety Budgets, Activity Costs and Outsourcing Practices

39           Standalone Drug Safety Teams Contribute to the Majority of Drug Safety Budgets

40           Figure 1.1: Total Drug Safety Budget, by Year: Global Teams (Top 20 and Top 50 Companies)

40           Figure 1.2: Total Drug Safety Budget, by Year: Global Teams (Small Pharmaceutical, Biotech and Vendors)

41           Figure 1.3: Average Percentage of Drug Safety Budget Contributed by Function: Global Teams

42           Figure 1.4: Percentage of Drug Safety Funding Provided by Function: Global Teams

43           Figure 1.5: Monetary Value of Funding Provided by Function: Global Teams (2014), Upper-Level Budgets

44           Figure 1.6: Monetary Value of Funding Provided by Function: Global Teams (2015), Upper-Level Budgets

44           Figure 1.7: Monetary Value of Funding Provided by Function: Global Teams (2016), Upper-Level Budgets

45           Figure 1.8: Monetary Value of Funding Provided by Function: Global Teams (2014), Mid-Level Budgets

46           Figure 1.9: Monetary Value of Funding Provided by Function: Global Teams (2015), Mid-Level Budgets

46           Figure 1.10: Monetary Value of Funding Provided by Function: Global Teams (2016), Mid-Level Budgets

47           Figure 1.11: Monetary Value of Funding Provided by Function: Global Teams (2014), Lower-Level Budgets

48           Figure 1.12: Monetary Value of Funding Provided by Function: Global Teams (2015), Lower-Level Budgets

48           Figure 1.13: Monetary Value of Funding Provided by Function: Global Teams (2016), Lower-Level Budgets

49           Figure 1.14: Total Drug Safety Budget, by Year: Country-Level Teams

50           Figure 1.15: Average Percentage of Drug Safety Budget Contributed by Function: Country-Level Teams

51           Figure 1.16: Percentage of Drug Safety Funding Provided by Function: Country-Level Teams

52           Figure 1.17: Monetary Value of Funding Provided by Function: Country-Level Teams (2014)

53           Figure 1.18: Monetary Value of Funding Provided by Function: Country-Level Teams (2015)

53           Figure 1.19: Monetary Value of Funding Provided by Function: Country-Level Teams (2016)

54           Drug Safety Budget Allocated to specific Activities

55           Figure 1.20: Average Percentage of 2015 Drug Safety Budget Dedicated to Specific Activities: Global Teams

55           Figure 1.21: Average Percentage of 2015 Drug Safety Budget Dedicated to Specific Activities: Country-Level Teams

56           Figure 1.22: Percentage of Drug Safety Budget Dedicated to Safety and Technology, by Year: Global Teams

57           Figure 1.23: Percentage of Drug Safety Budget Dedicated to Safety and Technology, by Year: Country-Level Teams

58           Figure 1.24: Safety and Technology Budgets, by Year

59           Figure 1.25: Percentage of Drug Safety Budget Dedicated to Case Management, by Year: Global Teams

60           Figure 1.26: Percentage of Drug Safety Budget Dedicated to Case Management, by Year: Country-Level Teams

61           Figure 1.27: Case Management Budgets, by Year

62           Figure 1.28: Percentage of Drug Safety Budget Dedicated to Aggregate Report Development, by Year: Global Teams

63           Figure 1.29: Percentage of Drug Safety Budget Dedicated to Aggregate Report Development, by Year: Country-Level Teams

64           Figure 1.30: Aggregate Report Development Budgets, by Year

65           Figure 1.31: Percentage of Drug Safety Budget Dedicated to Regulatory Submissions, by Year: Global Teams

66           Figure 1.32: Percentage of Drug Safety Budget Dedicated to Regulatory Submissions, by Year: Country-Level Teams

67           Figure 1.33: Regulatory Submissions Budgets, by Year

68           Figure 1.34: Percentage of Drug Safety Budget Dedicated to Medical Services, by Year: Global Teams

69           Figure 1.35: Percentage of Drug Safety Budget Dedicated to Medical Services, by Year: Country-Level Teams

69           Figure 1.36: Medical Services Budgets, by Year

70           Figure 1.37: Percentage of Drug Safety Budget Dedicated to Literature Services, by Year: Global Teams

71           Figure 1.38: Percentage of Drug Safety Budget Dedicated to Literature Services, by Year: Country-Level Teams

72           Figure 1.39: Literature Services Budgets, by Year

73           Figure 1.40: Percentage of Drug Safety Budget Dedicated to Signal Detection, by Year: Global Teams

74           Figure 1.41: Percentage of Drug Safety Budget Dedicated to Signal Detection, by Year: Country-Level Teams

75           Figure 1.42: Signal Detection Budgets, by Year

76           Figure 1.43: Percentage of Drug Safety Budget Dedicated to Due Diligence, by Year: Global Teams

77           Figure 1.44: Percentage of Drug Safety Budget Dedicated to Due Diligence, by Year: Country-Level Teams

78           Figure 1.45: Due Diligence Budgets, by Year

79           Figure 1.46: Percentage of Drug Safety Budget Dedicated to Project Management, by Year: Global Teams

80           Figure 1.47: Percentage of Drug Safety Budget Dedicated to Project Management, by Year: Country-Level Teams

81           Figure 1.48: Project Management Budgets, by Year

82           Figure 1.49: Percentage of Drug Safety Budget Dedicated to Risk Mitigation, by Year: Global Teams

83           Figure 1.50: Percentage of Drug Safety Budget Dedicated to Risk Mitigation, by Year: Country-Level Teams

84           Figure 1.51: Risk Mitigation Budgets, by Year

85           Figure 1.52: Percentage of Drug Safety Budget Dedicated to REMS/RMP Development, by Year: Global Teams

86           Figure 1.53: Percentage of Drug Safety Budget Dedicated to REMS/RMP Development, by Year: Country-Level Teams

87           Figure 1.54: REMS/RMP Development Budgets, by Year

88           Figure 1.55: Percentage of Drug Safety Budget Dedicated to Periodic, PSUR and ASR Development, by Year: Global Teams

89           Figure 1.56: Percentage of Drug Safety Budget Dedicated to Periodic, PSUR and ASR Development, by Year: Country-Level Teams

90           Figure 1.57: Periodic, PSUR and ASR Development Budgets, by Year

91           Figure 1.58: Percentage of Drug Safety Budget Dedicated to Regulatory Consulting, by Year: Global Teams

92           Figure 1.59: Percentage of Drug Safety Budget Dedicated to Regulatory Consulting, by Year: Country-Level Teams

92           Figure 1.60: Regulatory Consulting Budgets, by Year

93           Figure 1.61: Percentage of Drug Safety Budget Dedicated to Drug Safety Training, by Year: Global Teams

94           Figure 1.62: Percentage of Drug Safety Budget Dedicated to Drug Safety Training, by Year: Country-Level Teams

94           Figure 1.63: Drug Safety Training Budgets, by Year

96           Figure 1.64: Activity Timing Definitions

96           Figure 1.65: Company Blinding Information

97           Figure 1.66: Timing of Drug Safety Budget Allocations, by Activity (2015)

98           Drug Safety Outsourcing: Influencing Factors and Activity Costs Outsourced

101        Figure 1.67: Average Ratings of Outsourcing Factor Importance: Pre-Launch

101        Figure 1.68: Average Ratings of Outsourcing Factor Importance: Post-Launch

102        Figure 1.69: Preferred Vendor Capabilities, by Team Type

105        Figure 1.70: Percentage of Companies Outsourcing Drug Safety Activities, by Team Type

106        Figure 1.71: Percentage of Safety and Technology Costs Outsourced

107        Figure 1.72: Percentage of Aggregate Report Development Costs Outsourced

108        Figure 1.73: Percentage of Regulatory Submission Costs Outsourced

109        Figure 1.74: Percentage of Medical Services Costs Outsourced

110        Figure 1.75: Percentage of Literature Services Costs Outsourced

111        Figure 1.76: Percentage of Signal Detection Costs Outsourced

112        Figure 1.77: Percentage of Due Diligence Costs Outsourced

113        Figure 1.78: Percentage of Project Management Costs Outsourced

114        Figure 1.79: Percentage of Risk Mitigation Costs Outsourced

115        Figure 1.80: Percentage of Periodic, PSUR and ASR Development Costs Outsourced

116        Figure 1.81: Percentage of Regulatory Consulting Costs Outsourced

117        Figure 1.82: Percentage of Drug Safety Training Costs Outsourced

117        Figure 1.83: Percentage of REMS/RMP Development Costs Outsourced

119        Figure 1.84: Percentage of Case Management Costs Outsourced

120        Figure 1.85: Distribution of Case Management Responsibility: Bookend Triage

121        Figure 1.86: Distribution of Case Management Responsibility: Data Entry

122        Figure 1.87: Distribution of Case Management Responsibility: Medical Coding

123        Figure 1.88: Distribution of Case Management Responsibility: Medical Review

124        Figure 1.89: Distribution of Case Management Responsibility: Narrative Writing

125        Figure 1.90: Distribution of Case Management Responsibility: Other

127        Align Structure Designs and Staffing Allocations with Product-Driven Drug Safety Activity Levels

129        Coordinate Strategy and Encourage Communication with Drug Safety Structures

130        Figure 2.1: Overall Drug Safety Decision-Making Structure, by Team Level

131        Figure 2.2: Drug Safety Decision-Making Structure, by Team Level: Global Teams

131        Figure 2.3: Drug Safety Decision-Making Structure, by Team Level: Country-Level Teams

132        Figure 2.4: Executive in Charge of Drug Safety, by Team Level

133        Figure 2.5: Executive in Charge of Drug Safety, by Team Level: Global Teams

133         Figure 2.6: Executive in Charge of Drug Safety, by Team Level: Country-Level Teams

134         Figure 2.7: Sample Executive Titles, by General Classification

135        Figure 2.8: Status of Standalone Group Dedicated to Drug Safety: All Teams

136        Figure 2.9: Age of Standalone Drug Safety Group: All Global Teams with Existing Group

136        Figure 2.10: Age of Standalone Drug Safety Group: All Country-Level Teams with Existing Group

137        Figure 2.11: Function in Charge of Drug Safety, by Team Level

138        Figure 2.12: Function in Charge of Drug Safety, by Team Level: Global Teams

138        Figure 2.13: Function in Charge of Drug Safety, by Team Level: Country-Level Teams

141        Figure 2.14: Functions Involved in Drug Safety, by Team Level

142        Figure 2.15: Functions Involved in Drug Safety, by Team Level: Global Teams

143        Figure 2.16: Functions Involved in Drug Safety, by Team Level: Country-Level Teams

148        Balance Multiple Functions’ Expertise within Global and Country-Level Drug Safety Teams

149        Figure 2.17: Standalone Drug Safety Group Size: Global Teams

151        Figure 2.18: Number of Clinical FTEs Performing Drug Safety Activities: Global Teams

152        Figure 2.19: Number of Medical Affairs FTEs Performing Drug Safety Activities: Global Teams

153        Figure 2.20: Number of Regulatory FTEs Performing Drug Safety Activities: Global Teams

154        Figure 2.21: Number of Legal FTEs Performing Drug Safety Activities: Global Teams

155        Figure 2.22: Number of Compliance FTEs Performing Drug Safety Activities: Global Teams

156        Figure 2.23: Number of FTEs from Other Functions Performing Drug Safety Activities: Global Teams

158        Figure 2.24: Standalone Drug Safety Group Size: Country-Level Teams

160        Figure 2.25: Number of Clinical FTEs Performing Drug Safety Activities: Country-Level Teams

161        Figure 2.26: Number of Medical Affairs FTEs Performing Drug Safety Activities: Country-Level Teams

162        Figure 2.27: Number of Regulatory FTEs Performing Drug Safety Activities: Country-Level Teams

163        Figure 2.28: Number of Legal FTEs Performing Drug Safety Activities: Country-Level Teams

164        Figure 2.29: Number of FTEs from Other Functions Performing Drug Safety Activities: Country-Level Teams

165         Determine Responsibilities Before Allocating Pharmacovigilance Staffing

166        Figure 2.30: Number of FTEs Performing Safety and Technology Services: Global Teams

167        Figure 2.31: Number of FTEs Performing Safety and Technology Services: Country-Level Teams

168        Figure 2.32: Number of FTEs Performing Case Management: Global Teams

169        Figure 2.33: Number of FTEs Performing Case Management: Country-Level Teams

171        Table 2.1: 2013 Case Management Metrics

171        Table 2.2: 2015 Case Management Metrics

172        Figure 2.34: Number of FTEs Performing Aggregate Report Development: Global Teams

173        Figure 2.35: Number of FTEs Performing Aggregate Report Development: Country-Level Teams

174        Figure 2.36: Number of FTEs Performing Periodic, PSUR and ASR Development: Global Teams

175        Figure 2.37: Number of FTEs Performing Periodic, PSUR and ASR Development: Country-Level Teams

176        Figure 2.38: Number of FTEs Performing Regulatory Submissions: Global Teams

177        Figure 2.39: Number of FTEs Performing Regulatory Submissions: Country-Level Teams

178        Figure 2.40: Number of FTEs Performing Medical Services: Global Teams

178        Figure 2.41: Number of FTEs Performing Medical Services: Country-Level Teams

179        Figure 2.42: Number of FTEs Performing Literature Services: Global Teams

180        Figure 2.43: Number of FTEs Performing Literature Services: Country-Level Teams

181        Figure 2.44: Number of FTEs Performing Signal Detection and Management: Global Teams

182        Figure 2.45: Number of FTEs Performing Signal Detection and Management: Country-Level Teams

183        Figure 2.46: Number of FTEs Performing Due Diligence Projects: Global Teams

184        Figure 2.47: Number of FTEs Performing Due Diligence Projects: Country-Level Teams

185        Figure 2.48: Number of FTEs Performing Project Management: Global Teams

186        Figure 2.49: Number of FTEs Performing Project Management: Country-Level Teams

187        Figure 2.50: Number of FTEs Performing Risk Mitigation Strategy Development: Global Teams

188        Figure 2.51: Number of FTEs Performing Risk Mitigation Strategy Development: Country-Level Teams

189        Figure 2.52: Number of FTEs Performing REMS and/or RMP Development: Global Teams

190        Figure 2.53: Number of FTEs Performing US, EU and/or Other Regulatory Consulting: Global Teams

191        Figure 2.54: Number of FTEs Performing Drug Safety Training: Global Teams

192        Figure 2.55: Number of FTEs Performing Drug Safety Training: Country-Level Teams

193        Implement and Improve Electronic Databases to Expand Pharmacovigilance Capabilities

195        Figure 2.56: Life Science Teams’ Global Drug Safety Database Organizational Strategy

196        Figure 2.57: Life Science Teams’ Global Drug Safety Database Positioning

197        Figure 2.58: Percentage of Database Management Responsibility Outsourced: Data Storage and/or Back-Up

198        Figure 2.59: Percentage of Database Management Responsibility Outsourced: Data Migration

198        Figure 2.60: Percentage of Database Management Responsibility Outsourced: Dictionary Management

199        Table 2.3: Global and Country-Level Team Structures, by Company (1)

199         Table 2.4: Global and Country-Level Team Structures, by Company (2)

199        Additional Drug Safety Tables

200        Table 2.5: Global and Country-Level Team Structures, by Company (3)

200        Table 2.6: Global and Country-Level Team Structures, by Company (4)

201         Table 2.7: Total Product to Staffing Ratios, by Company (1)

201         Table 2.8: Total Product to Staffing Ratios, by Company (2)

202         Table 2.9: Total Product to Staffing Ratios, by Company (3)

202         Table 2.10: Total Product to Staffing Ratios, by Company (4)

203        Harnessing Internal Databases and Subject Matter Expertise to Support Pharmacovigilance Activities

205        Calling on Cross-Functional Groups to Support General Pharmacovigilance Activities

207        Figure 3.1: Percentage of Teams Using Selected Resources to Identify Drug Safety Information

208        Figure 3.2: Percentage of Teams Using Additional Tools to Identify Drug Safety Information

211        Figure 3.3: Percentage of Teams Conducting Drug Safety Activities, by Team Level

213        Figure 3.4: Percentage of Teams Conducting Drug Safety Activities, by Team Level: Global Teams

215        Figure 3.5: Percentage of Teams Conducting Drug Safety Activities, by Team Level: Country-Level Teams

217         Figure 3.6: Percentage of Functions Involved in Specific Drug Safety Activities: Regulatory Submissions

219         Figure 3.7: Percentage of Functions Involved in Specific Drug Safety Activities: Case Management

221         Figure 3.8: Percentage of Functions Involved in Specific Drug Safety Activities: Periodic, PSUR and ASR Development

223         Figure 3.9: Percentage of Functions Involved in Specific Drug Safety Activities: Signal Detection and Management

225         Figure 3.10: Percentage of Functions Involved in Specific Drug Safety Activities: Aggregate Report Development

227         Figure 3.11: Percentage of Functions Involved in Specific Drug Safety Activities: Literature Services

229         Figure 3.12: Percentage of Functions Involved in Specific Drug Safety Activities: Drug Safety Training

231         Figure 3.13: Percentage of Functions Involved in Specific Drug Safety Activities: REMS/ RMP Development

233         Figure 3.14: Percentage of Functions Involved in Specific Drug Safety Activities: Medical Services

235         Figure 3.15: Percentage of Functions Involved in Specific Drug Safety Activities: Risk Mitigation Strategy

237         Figure 3.16: Percentage of Functions Involved in Specific Drug Safety Activities: Project Management

239         Figure 3.17: Percentage of Functions Involved in Specific Drug Safety Activities: Safety and Technology Services

241         Figure 3.18: Percentage of Functions Involved in Specific Drug Safety Activities: Due Diligence

243         Figure 3.19: Percentage of Functions Involved in Specific Drug Safety Activities: US, EU and/or Other Regulatory Consulting

245        Figure 3.20: Regulatory Submissions: Activity Start and Peak, by Company

246        Figure 3.21: Case Management: Activity Start and Peak, by Company

247        Figure 3.22: Periodic, PSUR and ASR Development: Activity Start and Peak, by Company

248        Figure 3.23: Signal Detection and Management: Activity Start and Peak, by Company

249        Figure 3.24: Aggregate Report Development: Activity Start and Peak, by Company

251        Figure 3.25: Literature Services: Activity Start and Peak, by Company

252        Figure 3.26: REMS and/or RMP Development: Activity Start and Peak, by Company

254        Figure 3.27: Medical Services: Activity Start and Peak, by Company

255        Figure 3.28: Drug Safety Training: Activity Start and Peak, by Company

256        Figure 3.29: Risk Mitigation Strategy: Activity Start and Peak, by Company

257        Figure 3.30: Project Management: Activity Start and Peak, by Company

258        Figure 3.31: Safety and Technology: Activity Start and Peak, by Company

259        Figure 3.32: Due Diligence: Activity Start and Peak, by Company

260        Figure 3.33: US, EU and/or Other Regulatory Consulting: Activity Start and Peak, by Company

261        Harnessing Internal Expertise to Advance Signal Detection

263         Figure 3.34: Average Company-Rated Importance of Specific Data When Building a Signal Detection Threshold

264        Figure 3.35: Frequency of Risk-Threshold Parameter Adjustment, by Team Type

270        Figure 3.36: Ownership of Online Channel Adverse Event Monitoring Responsibilities, by Team Type

271        Figure 3.37: Frequency of Online Channel Monitoring Activities, by Team Type

272        Crafting Risk Evaluation and Mitigation Strategies and Risk Management Plans

276        Figure 3.38: Percentage of Teams Using Selected REMS Materials

277        Figure 3.39: Percentage of Teams Using Selected Communication Plans

278        Figure 3.40: Percentage of Teams Using Selected Post-Marketing REMS Strategies

279         Figure 3.41: REMS Timeline Comparison: Time from Receiving FDA REMS Notification Letter to REMS Submission

280        Figure 3.42: REMS Timeline Comparison: Time from REMS Submission to REMS Approval

281        Figure 3.43: Percentage of Teams Using Selected Tools to Evaluate the Success of REMS Programs

283        Reconciling Adverse Event Reporting, Case Management and Literature Searches with Industry Requirements

286        Quantifying Adverse Event Reporting Sources

288        Figure 4.1: Percentage of Total Adverse Event Reports Received, by Channel: General Telephone Number

288        Figure 4.2: Percentage of Total Adverse Event Reports Received, by Channel: Medical Information Team / Physician Hotline

289        Figure 4.3: Percentage of Total Adverse Event Reports Received, by Channel: MSL Interactions

291        Figure 4.4: Percentage of Total Adverse Event Reports Received, by Channel: Company Website

291        Figure 4.5: Percentage of Total Adverse Event Reports Received, by Channel: Company Database

292        Figure 4.6: Percentage of Total Adverse Event Reports Received, by Channel: Email

292        Figure 4.7: Percentage of Total Adverse Event Reports Received, by Channel: Social Media

293        Figure 4.8: Percentage of Total Adverse Event Reports Received, by Channel: Other

295        Figure 4.9: Percentage of Solicited Adverse Events Received, by Audience

295        Figure 4.10: Percentage of Unsolicited Adverse Events Received, by Audience

296        Figure 4.11: Breakdown of Total Adverse Events, by Audience: Physicians

297        Figure 4.12: Breakdown of Total Adverse Events, by Audience: Patients

297        Figure 4.13: Breakdown of Total Adverse Events, by Audience: Medical Information Teams

298        Figure 4.14: Breakdown of Total Adverse Events, by Audience: Sales Reps

298        Figure 4.15: Breakdown of Total Adverse Events, by Audience: Patient Assistance Programs

299        Figure 4.16: Breakdown of Total Adverse Events, by Audience: Retail Pharmacists

299        Figure 4.17: Breakdown of Total Adverse Events, by Audience: Specialty Pharmacists

301        Figure 4.18: Percentage of Solicited Serious Adverse Events Received, by Audience

301        Figure 4.19: Percentage of Unsolicited Serious Adverse Events Received, by Audience

302        Figure 4.20: Breakdown of Serious Adverse Events, by Audience: Physicians

303        Figure 4.21: Breakdown of Serious Adverse Events, by Audience: Patients

303         Figure 4.22: Breakdown of Serious Adverse Events, by Audience: Medical Information Teams

304         Figure 4.23: Breakdown of Serious Adverse Events, by Audience: Sales Reps

304        Figure 4.24: Breakdown of Serious Adverse Events, by Audience: Patient Assistance Programs

305        Figure 4.25: Breakdown of Serious Adverse Events, by Audience: Retail Pharmacists

305        Figure 4.26: Breakdown of Serious Adverse Events, by Audience: Specialty Pharmacists

306        Adverse Event Reporting Outlook: There’s Still Room for Improvement

309        Figure 4.27: Desired Adverse Event Reporting Process Improvements, by Team Level

317        Prevent Late Cases with Robust Clinical and Post-Marketed Case Management Strategies

324         Anticipate Case Management Loads to Reflect the Number of Supported Products

325        Figure 4.28: Number of Investigational Products Supported in 2015, by Team

325        Figure 4.29: Number of Investigational Product Cases in 2015, by Team

326        Figure 4.30: Number of Marketed Products Supported in 2015, by Team

327        Figure 4.31: Number of Marketed Product Cases in 2015, by Team

329        Figure 4.32: Percentage of Teams Conducting Selected Case Management Activities

330        Quantifying Data Sources and Assessing Regulations’ Impact on Existing Case Management and Literature Searching Processes

335        Case Management Profiles

337         Figure 5.1: Case Management Profile A: Company 1

338         Figure 5.2: Case Management Profile B: Company 39

339         Figure 5.3: Case Management Profile C: Company 30

340         Figure 5.4: Case Management Profile D: Company 27

341         Figure 5.5: Case Management Profile E: Company 6

342         Figure 5.6: Case Management Profile F: Company 12

343         Figure 5.7: Case Management Profile G: Company 9

344         Figure 5.8: Case Management Profile H: Company 10

345         Figure 5.9: Case Management Profile I: Company 11

346         Figure 5.10: Case Management Profile J: Company 32

347         Figure 5.11: Case Management Profile K: Company 33

348         Appendix A: A Comparison of Profiled Companies’ Specific Product Cases with Overall 2015 Caseload