This Work Package sought to improve understanding of signal management within the network of National Competent Authorities (NCAs) and to develop best practice in signal management and provide training. Questionnaires were used to gather information on all aspects of signal management including signal detection, signal validation, signal assessment, and signal management of reports of special interest. It also built on work done to improve signal detection from medication error and misuse/abuse of medicines. Using this intelligence, best practice guide and e-learning module were created and shared with the European Network through training sessions. To read more about WP5 - Signal Management click here.
Learning objectives for Signal Management best practice guide and e-learning module:
What does this document cover?
The target audience is primarily European assessors and signal management staff working at European NCAs involved in any step of signal management process. However this document may also be useful for other NCA staff, such as policy makers from national agencies or regional pharmacovigilance centres. It may also be helpful for other stakeholders involved in signal management, such as the EMA or Marketing Authorisation Holders (MAHs).
The readers of the BPG should be familiar with all relevant legislation and available guidelines, such as the GVPs Module IX – Signal management and Questions and Answers on signal management. A basic understanding of other regulatory procedures, such as Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) assessments and (safety) variations, is also recommended.
68 pages PDF.
Click here to access Signal Management Best Practice Guide.
What does this e-learning module cover?
Click here to access signal management e-learning module.
Other documents delivered by Work Package 5 – Signal Management: