| Description |
This dynamic, interactive workshop will incorporate a hands-on, small team, discussion-based approach with targeted presentations that discuss real-world strategies that can be immediately applied to your development programs.
Professionals from industry and FDA will facilitate all sessions, including team breakout and report back sessions.
Learning Objectives:
At the conclusion of this meeting, participants should be able to:
• Identify issues that commonly arise during the early stage of drug development;
• Integrate the regulatory context (e.g. guidance documents, FDA interaction opportunities) into strategies for addressing emerging issues;
• Contribute to the development of strategies to address issues arising during this dynamic development stage; and
• Apply hands-on experience with selected IND sections and components of FDA meeting requirements and requests.
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