PHRMSCI X495

Application of ICH Guidelines - Regulatory Strategy Development and Dossier Preparation

A well-planned regulatory strategy formulated in the early stages of product development is critical for a product’s success. This course will examine the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines. Discover how ICH guidelines guide the development of regulatory strategies for product development. Learn how to apply ICH Guidelines for preparation of market authorization application dossiers. Exploration of ICH guidelines during this course will include those establishing the chemistry, manufacturing, and controls data needed to support investigational and marketing applications. The ICH guidelines establishing the required structure and content of the Common Technical Document (CTD) are also covered. This class emphasizes the practical application of ICH guidelines to help build a successful dossier for submission to regulatory authorities.

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Course
Approximate Cost TBD
Format Online
Duration TBD
Total Credits 2