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 www.raps.org.