11 January 2023

Cognitive Safety: Satisfying Regulatory Requirements in a Competitive Landscape

Common disease states, environmental toxins, certain medications and the aging process itself can all compromise the integrity of the BBB. Accordingly, both central nervous system (CNS) and non-CNS therapeutics (e.g. for cardiovascular disease, diabetes, cancer, pain) can present significant challenges for cognitive safety in their target patient populations.

Consequently, recent regulatory guidance recognises the critical importance of monitoring cognitive function throughout the drug development process in order to adequately assess the safety and risk profile of new compounds, and make appropriate label claims.

This webinar will provide participants with a firm understanding of how the computerized delivery of objective and sensitive cognitive assessments can enhance the clinical development process. These assessments facilitate early decision-making, profile safety and tolerability and satisfy current regulatory requirements in an increasingly challenging and competitive pharmaceutical landscape.

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