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Program Code:
215
Date:
Tuesday, June 25, 2013
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Marta Haley Fields,
MBA (SCHNON), Senior Director, Compliance and Quality Systems,
Seattle Genetics, Inc., United States
Marta joined Seattle Genetics in 2008 as Sr Director of Compliance and Quality Systems after 21 years at Amgen where she served as Director of Clinical Compliance. Ms Fields has a BS in Speech from Northwestern University and an MBA in Healthcare Management from California Lutheran University
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SPEAKER
(S):
Cynthia Kleppinger,
MD (SPKAGY), Senior Medical Officer, Office of Scientific Investigations, CDER,
FDA, United States
Member of International Policy/DSI/OC/FDA. Worked prior at SAIC for the Division of Intramural Research/NIAID/NIH as Director, Clinical Safety Office, worked at the Center for the Clinical Trials Network at NIDA/NIH and at the Division of Vaccines and Related Products Applications, CBER.
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Marta Haley Fields, MBA (SPKNON), Senior Director, Compliance and Quality Systems, Seattle Genetics, Inc., United States
Donna has over 20 years of experience in clinical research. Donna is President of DWD & Associates. She works with organizations in implementing clinical quality systems. She is an experience auditor and has expertise in SOP development for both investigator and sponsor organizations.
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Description
While strict compliance with good clinical practice is the best preparation for a regulatory inspection, even the most compliant sponsors and clinical sites view the possibility of an inspection with fear and trepidation. Having a toolkit for managing inspections can go a long way to reducing those concerns. The FDA and EMA have different inspectional approaches and require different means of preparation.
This session will explore those differences and propose alternative methods to approach each experience.