This episode of ToxChats is designed to offer listeners a practical and insightful overview of the waiver process for carcinogenicity studies in pharmaceutical development, with a focus on the ICH S1B and S1B(R1) guidance documents. In this episode, host Zac Iloyd engages with two recognized experts to explore critical considerations for obtaining waivers, discuss the characteristics of strong versus weak waiver requests, and share real-world strategies for leveraging the weight of evidence framework. Through an accessible conversation, we discuss key data requirements, regulatory expectations, and common pitfalls in preparing a successful waiver application.
To learn more about the speakers and connect with them professionally, please visit their LinkedIn: Todd Bourcier and Tim McGovern
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