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Avoca Blog

A space where we share our musings and encourage dialogue on topics that intrigue, perplex, and create a world of possibilities.

Inspection Preparation With a Risk-Based Approach Consistent with ICH E6 (R2) Requirements

Post in Risk Mitigation

The Avoca Group recently conducted a webinar about strategies for inspections using a risk-based approach as outlined in ICH E6 (R2). Audience members submitted many questions focused on the Trial Master File (TMF). This blog summarizes the most frequent inquiries from the webinar related to TMFs and offers our responses.   TMF Regulatory Requirements Because […]

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