The Process of an IND Preparation and Submission-Regulatory Strategy (miniseries)
Автор: Regulatory Affairs 101
Загружено: 2026-02-18
Просмотров: 5
Описание:
In this episode of the IND Preparation and Submission miniseries, we break down "Establishing a Robust Regulatory Strategy" — the foundation for every successful IND.
You’ll learn how to:
Clarify your clinical development plan, including Phase 1 objectives and
rationale
Select the appropriate IND pathway (Commercial vs. Investigator)
Assess regulatory precedents and key FDA/ICH guidance
Identify potential expedited programs (Fast Track, Orphan, Breakthrough,
RMAT)
Align cross‑functional teams on timelines, data readiness, and eCTD
expectations
Whether you're new to regulatory affairs or refining your IND process, this video gives you a clear, practical roadmap to start your IND the right way.
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