A practical, one-day workshop to build knowledge and confidence in clinical trial safety monitoring, covering safety assessment and documentation, causality evaluation, event classification, reporting responsibilities, regulatory timelines, and ongoing safety surveillance.

 

Pharmacovigilance is fundamental to protecting clinical trial participants and ensuring that safety information is assessed, documented and reported appropriately. This interactive workshop provides a practical introduction to the principles of pharmacovigilance, the regulatory framework governing clinical trial safety, and the processes used to manage and report safety events.

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Who Should Attend

Professionals involved in clinical research, clinical trial operations, safety reporting, clinical data management or related regulatory activities. For example sponsor representatives,, investigators, research nurses, trial coordinators, trial managers, project managers, QA staff or R&D staff who wish to strengthen their understanding of pharmacovigilance.

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Key topics

• Fundamentals and principles of pharmacovigilance, including sources of safety information

• Clinical trial safety regulations and relevant guidance

• Safety event definitions, assessment, documentation, causality and expectedness

• Reference Safety Information (RSI), including the Investigator’s Brochure (IB), Summary of Product Characteristics (SmPC)

• Safety reporting requirements, expedited reporting, roles and responsibilities

 

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As it is only 1 day pre-reading is required prior to attendance.