Early Drug Development: Navigating the Treacherous Rapids
|Event Date/Time: May 05, 2009||End Date/Time: May 06, 2009|
Professionals from industry and FDA will facilitate all sessions, including team breakout and report back sessions.
At the conclusion of this meeting, participants should be able to:
â€¢ Identify issues that commonly arise during the early stage of drug development;
â€¢ Integrate the regulatory context (e.g. guidance documents, FDA interaction opportunities) into strategies for addressing emerging issues;
â€¢ Contribute to the development of strategies to address issues arising during this dynamic development stage; and
â€¢ Apply hands-on experience with selected IND sections and components of FDA meeting requirements and requests.