Starting from regulatory authority expectations, participants will follow a guided pathway that, step by step, will enable them to:
– Apply targeted products strategies
– Adopt scientific investigative methods for data evaluation
– Understand statistical methods of disproportionality
– Recognize the relationships between signals and risks
– Monitor the implementation of signals in product labeling
– Identify process indicators (KPIs)
– Be better prepared for audits and inspections.
The discussion includes future amendments to the Commission Implementing Regulation 520/2012 and will be enriched with practical exercises, including the analysis of eRMR, offering the chance to apply the concepts learned.
The following topics will be covered across the 3 modules:
– Operation of EVHUMAN with specific reference to EVDAS outputs
– Regulatory requirements for Signal Management
– Product strategy definition for Signal Detection, with practical exercises/simulations
– Various signal investigation methods
– Evaluation of scientific literature: search criteria, quality assessment and bias, with practical exercises
– Qualitative analysis: single case and case series analysis
– Causality assessment
– Confounders
– MedDRA SMQs: introduction, examples, and usage
– Signal validation with examples of different situations
– Disproportionality measures
– EVDAS operations and interface
– eRMR analysis
– Practical exercise/simulation of eRMR analysis
– Management of confirmed signals: from signal to labeling
– Monitoring of variations implementation
– Process performance indicators
– Regulatory compliance in audits and inspections
Pharmacovigilance personnel involved in signal management, auditors in pharmacovigilance, from:
– Pharmaceutical companies
– Service providers (CRO, CSO, service providers, consultants)
– Biotech companies
Participant experience: it is recommended to have knowledge of the relevant GVP guidelines (Modules I, VI, V, and IX) and at least 2 years of experience in pharmacovigilance.
The course is highly interactive and includes practical parts where participants will actively apply the knowledge they have acquired.
There will be ample room for discussion with the audience about the complexities encountered, possible solutions, and exchange of ideas.