BioSoteria Senior Vice President to present at the 2011 RAPS: Regulatory Convergence in Indianapolis

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BioSoteria Senior Vice President, Pharmacovigilance and Risk Management, James Buchanan will chair a session “Safety In Clinical Trials” at the 2011 RAPS: Regulatory Convergence, October 25, 2011 in Indianapolis

BioSoteria, Inc., Drug Safety and Risk Management Specialists, announced today that its
Senior Vice President, Pharmacovigilance and Risk Management, James Buchanan, PharmD will chair a 90 minute session called “Safety In Clinical Trials.”

The session will cover the FDA final regulations addressing the safety reporting requirements for investigational new drug applications and its impact on a clinical development programs, regulatory and clinical expectations of expectedness and safety surveillance and risk management for medical device clinical studies. The presentation will take place at the 2011 RAPS: Regulatory Convergence on October 25, 2011 from 8:30-10:00 AM at the Indianapolis, Indiana Convention Center.

To register for the session and to find out more about the 2011 Raps: Regulatory Convergence, go to

About BioSoteria
Founded in 2007 with a strong vision of a progressive drug safety and pharmacovigilance consulting services and education, BioSoteria serves the outsourcing needs of the pharmaceutical industry. From strategic risk management consulting services and full-service drug safety operational capabilities to world-class award winning pharmacovigilance training and education programs, BioSoteria provides unmatched experience, expertise, and leadership to support your company’s efforts to maximize your product’s benefit-risk profile. For more information and to learn more about BioSoteria’s drug safety services and training programs, go to


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Les Williams
BioSoteria, Inc.
(866) 660-5553 x 22
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