Navigating Regulatory Submissions & Ensuring Safety in Early-Phase Trials
Time: 9:01 am
day: Pre-conference day
Details:
This workshop will equip you with the knowledge and strategies needed to navigate complex regulatory expectations, proactively address safety concerns, and streamline the submission process for IND and CTA applications.
In this workshop, you will:
• Review the essential components of an IND or CTA submission, including the nonclinical safety data required to meet regulatory expectations
• Identify potential safety red flags and discuss how to address them proactively to ensure patient safety in first-in-human studies
• Simplify regulatory guidance and practical tips for small companies to navigate the submission process effectively and avoid common pitfalls
