BioSoteria CEO to Chair Session on Safety Signal Detection at 46th DIA Annual Meeting

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BioSoteria President and CEO Sally Van Doren will chair a session on drug safety signal detection at the 46th DIA Annual Meeting next week in Washington, DC. "Balancing Computational Power and Clinical Prowess in Safety Signal Detection" will review the recommendations of the CIOMS VIII Working Group on Signal Detection, highlight data mining and visualization tools and methodologies, and discuss the role of good clinical judgment in safety signal detection programs.

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The experience shared during this session will emphasize practical application of the CIOMS VIII principles...

BioSoteria, Inc., a drug safety services and training firm, announced today that its President and Chief Executive Officer Sally Van Doren, PharmD, will chair a session on drug safety signal detection at the 46th Drug Information Association (DIA) Annual Meeting, taking place next week in Washington, DC.

The 90-minute session entitled "Balancing Computational Power and Clinical Prowess in Safety Signal Detection" will review the recommendations of the Council for International Organizations of Medical Sciences (CIOMS) VIII Working Group on Signal Detection, use case studies to highlight various data mining and visualization tools and methodologies, and discuss the role of good clinical judgment in safety signal detection programs. Dr. Van Doren selected three thought leaders from academic research and pharmaceutical industry, including a European Union Qualified Person for Pharmacovigilance (EU-QPPV), to thoroughly explore the topic.

“Often when signal detection is discussed, the focus is on the features and functions of hardware and software technology.” said Dr. Van Doren. “The experience shared during this session will emphasize practical application of the CIOMS VIII principle using FDA AERS data as well as internal safety data in periodic safety signal detection, analysis and reporting.”

"Balancing Computational Power and Clinical Prowess in Safety Signal Detection" is an intermediate-level session in the Clinical Safety and Pharmacovigilance track and offers continuing education credit. It will be held on Monday, June 14, from 3:30-5:00 pm, in Room 140B of the Walter E. Washington Convention Center. Presentations comprising the session include:

"Quantitative Safety Signal Detection and CIOMS VIII Working Group Recommendations"
Andrew Bate, PhD, MA

Senior Director, Analytics Team Lead, Epidemiologist, Worldwide Safety Strategy
Pfizer Inc, United States

"A New Approach to Aggregate Data Analysis and Signal Detection"
Irene Fermont, MD
Vice President, Pharmacovigilance and Risk Management
Advanced Drug Development Services, France

"Safety of Biologics in Cancer Care: Applied Data Mining"
Sheila Weiss Smith, PhD, MS, FISPE
Professor; Director, Center for Drug Safety
University of Maryland School of Pharmacy, United States

About the DIA Annual Meeting
The DIA Annual Meeting is the premier event for professionals involved in the discovery, development, and lifecycle management of pharmaceuticals, medical devices, and related products. With 25 content-area tracks, 330 sessions and 20 tutorials, the meeting is appropriate for attendees in all disciplines, works settings, and experience levels. The 46th DIA Annual Meeting takes place June 12-17, 2010, in Washington, DC. For more information on the meeting and program, visit http://www.diahome.org.

About BioSoteria
From strategic risk management consulting services and world-class pharmacovigilance training and education to full-service drug safety department capabilities, BioSoteria provides unmatched experience, expertise and leadership to support pharmaceutical and biotechnology companies’ efforts to maximize the benefit/risk balance of their products. To learn more about BioSoteria, please visit the company’s website at http://www.biosoteria.com, or call 1-866-660-5553.

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JILL NOTTE
BioSoteria
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