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Detailed review of the components of ICH, OECD and other key regulatory guidances as they relate to drug safety, quality and efficacy for global submissions. The specific data sets and timing of studies needed at each stage of drug development process will be presented and discussed.

Areas Covered in the seminar:

* Overview of ICH and other key regulatory guidances.
* The "What", "When" and Hows" of proper implementation of ICH and other key regulatory guidance’s as they relate to overall drug safety assessment.
* Details on nonclinical, preclinical, quality and CMC data necessary to achieve approval at each stage of drug development.