This Research Topic is associated with the Pre-Conference Course 'Traditional and innovative approaches for signal detection' as part of the International Society of Pharmacovigilance 2022 Annual Meeting.
Signal detection is one of the main activities of Pharmacovigilance (PV). This process is essential to identify new drug safety problems and is involved at different levels, and with different roles of all PV stakeholders.
The approach to signal generation, refinement, and confirmation has evolved over years, opening new frontiers of debate and the need for an implementation of regulatory framework, publication rules, and risk communication strategies. In 2021, the circumstances of the approval of COVID-19 vaccines were exceptional and provided an unprecedented challenge for signal detection that deserves to be studied in depth.
We are interested in narratives reviews, systematic reviews, and leading articles that may address the following themes:
1) Signal detection: current regulatory framework and possible implementations
2) Signal detection using industry databases: processes, strengths, and limitations
3) Audit and inspections for signal detection activities: the pharma industry perspective
4) Signal detection in academia: current research approaches
5) Signal detection during crisis: examples from the COVID-19 pandemic
6) Publishing good quality signal detection articles
7) Communicating signals
8) Vaccine signal detection
This Research Topic is associated with the Pre-Conference Course 'Traditional and innovative approaches for signal detection' as part of the International Society of Pharmacovigilance 2022 Annual Meeting.
Signal detection is one of the main activities of Pharmacovigilance (PV). This process is essential to identify new drug safety problems and is involved at different levels, and with different roles of all PV stakeholders.
The approach to signal generation, refinement, and confirmation has evolved over years, opening new frontiers of debate and the need for an implementation of regulatory framework, publication rules, and risk communication strategies. In 2021, the circumstances of the approval of COVID-19 vaccines were exceptional and provided an unprecedented challenge for signal detection that deserves to be studied in depth.
We are interested in narratives reviews, systematic reviews, and leading articles that may address the following themes:
1) Signal detection: current regulatory framework and possible implementations
2) Signal detection using industry databases: processes, strengths, and limitations
3) Audit and inspections for signal detection activities: the pharma industry perspective
4) Signal detection in academia: current research approaches
5) Signal detection during crisis: examples from the COVID-19 pandemic
6) Publishing good quality signal detection articles
7) Communicating signals
8) Vaccine signal detection