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Quality Assurance for Signal Detection Programs
Program Code:
257
Date:
Tuesday, June 25, 2013
Time:
1:45 PM to 3:15 PM
EST
CHAIR
:
Elizabeth E. Garrard,
PharmD,RPh (SCHNON), Specialist Leader, Strategy Operations,
Deloitte Consulting LLP, United States
Dr. Garrard is a Specialist Leader in our Life Sciences practice, focused on leveraging over 18 years of experience in providing PVG consulting services. For the past 12 years, she was a senior executive officer and co-founder of Drug Safety Alliance, Inc. a service based Pharmacovigilance company.
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SPEAKER
(S):
Dr. Kerstin Geldmeyer is working in the QM Department of Dr. Ebeling & Assoc. GmbH and is responsible for Quality Assurance, process development and audits. She completed her studies in Medical Biotechnology in Berlin and joined the pharmaceutical industry shortly after her PhD thesis.
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Morell B. David, MSc (SPKNON), NDA Group, United Kingdom
George N. Pajovich, Pajovich, RPh (SPKNON), Head of Safety Risk Research, Pfizer Inc, United States
Description
New EU legislation requires quality assurance of critical safety processes, including signal detection. This forum will offer the chance to discuss how best to measure compliance, effectiveness, and efficiency of a signal detection program.