[IEEE-bhpjobs] NCRAF mtg Sept 15 - Risk Considerations for Drug-Device Combination Products

[esther-l at mailsnare.net]

information at www.ncraf.org


Thursday, September 15, 2005
Elion Hitchings Building, GlaxoSmithKline
5:30 PM – 6:15 PM
Networking and Refreshments
6:30 PM – 8:00 PM
PROGRAM
Risk Considerations for Combination Drug-Device Products
Michael J. Klepper, MD
President and CEO, Integrated Safety Systems®, Inc.
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Dr. Klepper is President and CEO of Integrated Safety Systems, Inc., a company he founded in 1996. He earned his MD degree from Loyola-Stritch School of Medicine and received board certification in Internal Medicine and Emergency Medicine. His pharmaceutical industry experience has included responsibilities in global drug development, NDA preparation, medical documentation and drug safety. Dr. Klepper’s interests are in all aspects of biopharmaceutical and device product safety including training. Areas of training have included: safety reporting and pharmacovigilance; risk assessment; the roles and responsibilities of the medical monitor/drug safety physician; determination of causality and clinical significance; the clinical significance of laboratory and electrocardiographic abnormalities; and the interpretation and presentation of safety data for clinical study reports and the integrated summary of safety. Of particular importance to him are data quality issues and the impact of such issues on the ability of the medical reviewer to provide relevant product benefit-risk assessments. He also has a keen interest in the evaluation and application of new technological tools as they relate to enhancing activities related to ongoing risk assessment.

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LOCATION: GlaxoSmithKline
(directions below) 
Elion Hitchings Building
3030 Cornwallis Road
Research Triangle Park, NC
COST: Free to 2005 NCRAF members ($35 annual membership fee). If you wish to become a member of NCRAF, please complete the attached membership form and bring it with you to the meeting or download the form from the NCRAF website: http://www.ncraf.org/membershipinfo.htm
$20 for non-members