Emeryville, California (EastBayDaily) — 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 http://www.raps.org.
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 http://www.biosoteria.com.