Upcoming Presentation: "CMC in your IND: Getting it Right"

Early stage drug developers generally have their sights firmly set on the initiation of clinical trials, focusing on toxicological and pharmacological studies. Often, the importance of Chemistry, Manufacturing and Control (CMC) data is underestimated. But the CMC package is critical to IND approval, and meeting all FDA requirements demands careful planning and sound execution. This discussion will cover the risk/reward criteria for determining the level and degree of method validation, reference standard characterization and formulation; as well as potential pitfalls and ways to streamline the entire development process.

Don’t miss this important technical presentation at AAPS!

The Critical Role of CMC in your IND Submission
Presenter: Glenn Petrie, Ph.D.
Tuesday, October 27, 11:00-12:00
Exhibitor Seminar Room #4