L06.2 – Regulatory Submissions Best Practices for Clinical Trials (A)

This advanced level lecture provides a practical guide to regulatory submission strategies that drive clinical trial success worldwide. Participants will learn how to prepare high-quality regulatory packages, navigate region-specific requirements, and avoid common pitfalls that cause delays or rejections. The session covers best practices in dossier planning, document management, cross-functional coordination, and effective use of electronic submission platforms such as the eCTD.