Balance Signal Detection and Case Management Responsibilities with Emerging Drug Safety Regulations



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.


  • Description
  • Additional information

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
Report Features

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.

Reasons to Buy

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.

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.

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.

Chapter Example

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.