Reading a Pathology Report, Peer Review, or PWG Report from a Regulator’s Perspective (CE2-5)

One of the most important consumers of the information in a GLP toxicologic pathology report is the regulatory agency to which the report is submitted. This presentation will cover 1) an overview of the drug review process, 2) how a regulatory reviewer approaches the pathology report, 3) what information they find most helpful, 3) what information, when missing from the report, can lead to delays and 4) when peer reviews are considered helpful and the criteria by which the regulatory agency might request a PWG be conducted.