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From Trial to Market: Navigating Pharmacovigilance Case Management Differences
What changes when a therapy moves from clinical trials to the real world?
In this episode of the Cognitio podcast, ARCS Australia CEO Tim Boyle speaks with Carl Bufe about the critical differences between clinical development safety management and post-market pharmacovigilance.
From SUSAR reporting and ICH E6 to ICH E2D, signal detection, spontaneous adverse event reporting and scaling safety systems, this discussion explores how compliance, data volumes, accountability and risk management evolve across the product lifecycle.
Essential listening for professionals in regulatory affairs, clinical research, medical affairs and drug safety.
Join the conversation. Join ARCS.
View all episodes
By ARCS AustraliaWhat changes when a therapy moves from clinical trials to the real world?
In this episode of the Cognitio podcast, ARCS Australia CEO Tim Boyle speaks with Carl Bufe about the critical differences between clinical development safety management and post-market pharmacovigilance.
From SUSAR reporting and ICH E6 to ICH E2D, signal detection, spontaneous adverse event reporting and scaling safety systems, this discussion explores how compliance, data volumes, accountability and risk management evolve across the product lifecycle.
Essential listening for professionals in regulatory affairs, clinical research, medical affairs and drug safety.
Join the conversation. Join ARCS.