Speakers

Laurie Graham, PhD

Division Director, Division of Internal Policies & Programs (DIPAP), OPPQ, OPQ, CDER
FDA

Laurie Graham is currently the Director of the Division of Internal Policies and Programs (DIPAP) in the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) at the Center for Drugs Evaluation and Research (CDER).  DIPAP is responsible for the development and evaluation of CDER’s internal policies and programs related to pharmaceutical quality, including application assessment and inspection. Prior to joining OPPQ, Laurie had more than 20 years of experience at the FDA, including inspections and application assessments for monoclonal antibodies, novel antibody products, Fc-fusion proteins, and combination products.