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GCP Inspection Findings: A Roundtable Discussion

Track:
Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice

Day & Time:
June 17, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
243

Room Number:
8

Level:
Intermediate

Type:
Forum

Title:
GCP Inspection Findings: A Roundtable Discussion

Chair(s):
Deborah Driscoll
Vice President, Quality Assurance, Medical Division
Pfizer Inc, United States

Description:
During the course of GCP inspections, some important themes are identified by the inspectors as being common to multiple inspections. In a similar way, GCP auditors working for industry identify key issues of concern. This forum provides an opportunity to identify and discuss some of these key findings with a panel of GCP inspection experts from regulatory authorities. Attendees will be asked to submit questions related to GCP inspections and audits in advance and at the forum for the panel to address.

Please come prepared with your questions for the GCP Roundtable panel. You may submit questions and topics of interest in advance to annualmeetingprogram@diahome.org, and include “GCP Roundtable” in the subject line.

Learning Objective(s):
Identify key findings on GCP inspections from experts from regulatory agenices.

Presentation(s) & Speaker(s):
Panelist
Jean Mulinde, MD
Acting Senior Advisor, Division of GCP Compliance, OSI, CDER
FDA, United States

Panelist
Anabela Marcal, PharmD
Head of Compliance and Inspections Department
European Medicines Agency, European Union, United Kingdom

Panelist
Tomonori Tateishi
Senior Scientist for Medical Science, Office of Conformity Audit
Pharmaceuticals and Medical Devices Agency (PMDA), Japan