ICH Guideline E2C R2 Periodic Benefit Risk Evaluation Report Pbrer
TGA (CWLTH) resource. Rules Mate indexes this as part of the Australian compliance corpus. Click through for the regulator's primary source.
https://www.tga.gov.au/resources/resources/international-scientific-guidelines-adopted-australia/ich-guideline-e2c-r2-periodic-benefit-risk-evaluation-report-pbrer
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