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ICH guideline revisions for RBQM, what they mean for you

 

In this three-part video series, Parexel RBQM experts Amy Kissam-Sands and Tim Audin speak with PharmaVoice editor Taren Grom about ICH guidelines E8 (R1), E6 (R3) and Q9 (R1) and how they will impact clinical development.

Part 1ICH E8 (R1) - its impact on the industry and how we can fill the gaps

Part 2: ICH E6 (R3)  - how to implement a proactive risk-management approach and address patient input in study design

Part 3: ICH Q9 (R1) - predictions on what the guidance will cover