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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Top Reasons to Read 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 pharmacovigilance 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 levels.

Benchmark pharmacovigilance 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.

Key Questions That This Study Answers About Pharmacovigilance

  1. Which functions contribute to pharmacovigilance funding, and how much should they provide?
  2. How much of teams’ drug safety budgets should be allocated to key activities, such as case management, signal detection, and risk mitigation strategies?
  3. How much should global or country-level teams expect in percentage of outsourcing costs for specific pharmacovigilance activities?
  4. How should my company handle the distribution of pharmacovigilance  responsibilities between in-house and outsourced staff?
  5. In what ways can we improve drug safety team structure to promote consistent strategy, save on costs and enhance interteam communication?
  6. How can we redistribute pharmacovigilance responsibilities to improve FTE workloads and ensure quality data?
  7. What processes and tactics have other companies used to outline drug safety responsibilities in the event of a co-marketing or co-licensing deal?
  8. When should we initiate specific pharmacovigilance activities, relative to the drug development cycle—and when do these responsibilities typically reach their peak?
  9. What pharmacovigilance tools are teams currently using, and how are they affecting or improving data analysis? In what ways can Big Data preserve data quality?
  10. What standard operating procedures (SOPs) can teams employ to smooth out case management processes and allow for greater flexibility?
  11. How are teams demonstrating the return on their REMS programs?
Price $4,895
Publication Date July 2016
Pages 348
Chapters 5 + Appendix
Metrics 500 +
Charts / Graphics 200 +