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Michael J. Klepper, MD, has more than 20 years of global pharmaceutical experience. As vice president of safety and pharmacovigilance at RTI-HS, he provides expertise in medical consulting, benefit-risk assessments, risk management, and training. In addition, he oversees all medical writing, coding, and pharmacovigilance services. In 1996, he founded Integrated Safety Systems, Inc. (ISS, Inc.), which was acquired by RTI-HS in 2006. Before founding ISS, Inc., Dr. Klepper was senior director of corporate safety and medical services for the Knoll Pharmaceutical Company (formerly Boots Pharmaceutical). He has also held global clinical development responsibilities with Abbott Laboratories. Of particular importance to him are data quality issues and the impact those issues have 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 pertaining to enhancing activities related to ongoing risk assessment. | 