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Critical Components of a Robust CMC Due Diligence Framework (with a Focus on Drug Substance)
Manage episode 444159353 series 3603634
Kandungan disediakan oleh Despina & Ethan at Enkrisi and Ethan at Enkrisi. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Despina & Ethan at Enkrisi and Ethan at Enkrisi atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.player.fm/legal.
Podcast Description:
In this episode, we explore the essential components of a robust Chemistry, Manufacturing, and Controls (CMC) due diligence framework, with a special focus on drug substance evaluation. Join us as we break down the comprehensive steps involved in conducting due diligence during pharmaceutical acquisitions or in-licensing. From regulatory compliance to technical assessments, we discuss how to mitigate risks, enhance regulatory readiness, and ensure the quality of drug substances. This episode highlights the importance of aligning CMC due diligence with international guidelines, like the ICH’s CTD Module 3, and emphasizes the role of multidisciplinary teams in navigating the complexities of drug development. Whether you’re a regulatory professional or working in pharmaceutical development, this discussion provides key insights for a successful CMC due diligence process.
5 episod
Kongsi
