Strategies in Preclinical and Clinical Research for Regulatory Affairs in Animal Health

Catalog description

In this course, students will review the history of regulations as well as gain an understanding of the integration of science into successful product approval outcomes. Students will learn how to achieve target claims for developing new products while ensuring safety. Students will also be introduced to the planning, design, and conduct of preclinical and clinical studies. The topics covered include protocol design and the evaluation and assessment of regulatory submissions. The course will consider practical issues in regulatory affairs. Students may participate in case study exercises.