The International Conference on Harmonization (ICH) was revolutionized in the 1980's to provide a forum for the pharmaceutical industry to discuss regulatory requirements for registration of new chemical entity. These guidelines have been significantly influenced the content of FDA draft guidelines to develop the scientific information and manufacturing controls. Thus, proper understanding of these guidelines is essential in the drug development process. This course will be designed to focus exclusively on guidelines associated with the registration of small molecules. Completing this course, students will understand the expectations set forth in various FDA and ICH quality topics in order to implement these guidelines and/or engage the regulatory agencies in dialogue in order to provide justification of data or present clear scientific rationale.