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GCP Inspection Findings: A Roundtable Discussion
Session Chair(s)
Deborah Driscoll, MS
Vice President, MRL Quality Assurance
Merck & Co., Inc., United States
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 : Identify key findings on GCP inspections from experts from regulatory agenices.
Speaker(s)
Panelist
Jean M. Mulinde, MD
FDA, United States
Associate Director, Division of Clinical Compliance Evaluation, OSI
Panelist
Anabela Marcal, PharmD
European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
Panelist
Tomonori Tateishi
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Scientist for Medical Science, Office of Conformity Audit
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