Join us for an engaging and informative podcast featuring two esteemed experts in the field of drug development and regulatory strategy. In this episode, Marcus Delatte, PhD, Vice President of Regulatory Strategy at Allucent, and Harshini Neelakantan, Executive Director, Research and Development at Ridgeline Therapeutics, delve into the intricate world of Pre-IND (Investigational New Drug) meetings and IND applications. Hosted by Citeline, this discussion covers a range of critical topics including the current landscape of INDs, the benefits and purpose of pre-IND meetings, common misconceptions, and essential strategies for preparing a successful IND application. Our experts share their valuable insights on navigating regulatory challenges, avoiding pitfalls, and anticipating future trends in IND submissions. This podcast offers practical advice and expert perspectives to help you stay ahead in the ever-evolving field of drug regulation.
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If you’re interested in hearing about the incorporation of AI in the clinical trial process and how this influences GCP compliance and inspection readiness, please listen to another exciting Allucent podcast: Artificial Intelligence, GCP Compliance, & Inspection Readiness in Clinical Trials with Ernesto Vera-Sanchez, Vice President, Division Head of GxP Strategy
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