DIA 2017 Annual Meeting

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

EMA and FDA collaborative inspections of clinical investigators, sponsors and CROs of clinical trials submitted in support of marketing applications of new drug products have the same objectives of data verification and human subject protection. The goals of the EMA-FDA collaborative initiative are to conduct periodic information exchanges on GCP-related information streamline sharing of GCP inspection planning information, communicate on inspection outcomes effectively and in a timely manner, conduct collaborative GCP inspections by sharing information, experience and inspection procedures, co-operating in the conduct of inspections and sharing knowledge of best practice; share information on the interpretation of GCP, by keeping each other informed of GCP-related legislation, regulatory guidance and related documents and to identify and act together to benefit the clinical research process. Since the EMA-FDA collaborative initiative began in 2009, approximately 48 entities have been inspected by both EMA and FDA for shared applications. This session will characterize and compare the EMA and FDA GCP findings from the 48 entities inspected by both agencies; and provide insight about the extent of the similarities and differences of these common inspections.

Learning Objectives

Identify the shared pre-market applications with common inspections by both EMA and FDA; Compare the inspectional findings of the common inspections; Summarize the similarities and differences of the common inspections by EMA and FDA.

Chair

Sandra L. Kweder

Speaker

An Overview of EMA-FDA Good Clinical Practice (GCP) Collaboration: Focus on Comparison of Inspection Findings Project
Kassa Ayalew, MD, MPH

EMA Perspectives
Anabela Marcal, PharmD

Preliminary GCP Inspection Findings from Common Marketing Applications: Differences and Similarities
Jenn W. Sellers, MD

Comments from Industry Perspectives
Ann Meeker-O'Connell, MS