Regulatory Strategy for Product Development and Life-Cycle Management

Catalog description

Examines the preparation of regulatory strategies to support product development and life-cycle management while providing students the opportunity to examine domestic and international processes relevant to regulatory strategy. In developing target product profiles, strategic regulatory plans, and life-cycle management plans, students appraise key components of regulatory strategies, evaluate core elements of product life cycle in the generation of those strategies, and integrate business needs into regulatory planning. Upon completion of the course, successful students should possess the fundamentals to formulate regulatory strategies supporting product development and life-cycle management and be equipped with a stronger understanding of the high-visibility role regulatory professionals serve in developing sound regulatory strategy.