Regulation of Biological/Drug Development: An Introduction
Examine preclinical and clinical testing, sources of Good Clinical Practice (GCP) requirements and phases of the clinical trial process. Assess the obligations of sponsors and investigators. Discuss how to interact with FDA. Review compliance and enforcement considerations.
Natasha V. Leskovsek, Of Counsel, Cooley LLP
This session was recorded as part of FDLI’s Virtual Introduction to Biologics and Biosimilars Laws and Regulations Course in October 2021.