TransCelerate BioPharma Clinical Quality Management System Conceptual Framework

A podcast featuring the activities of a TransCelerate BioPharma working group addressing Quality Management Systems (QMS) and their initial outline of a proposed conceptual framework for a clinical QMS. TIRS Editor-in-Chief Dr. Stephen Spielberg leads the conversation with Deb Driscoll from Merck, who leads the TransCelerate Quality Management Systems Initiative and Ann Meeker-O’Connell from Johnson &Johnson, who is the lead author on a paper “Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework: Concept Paper Vision and Outline” in the September, 2015 issue of TIRS.