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PRA Experts to Speak at Drug Safety Conference Breakout Session on Risk Management Strategies
Date:9/9/2011

RALEIGH, N.C., Sept. 9, 2011 /PRNewswire/ -- PRA, a leading Clinical Research Organization, announces that two experts from our Safety and Risk Management (SRM) group will present at the European World Drug Safety Congress being held in London from 13-16 September 2011.  PRA will also host an exhibit at booth #2, where additional SRM representatives will be available to discuss PRA's approach to pharmacovigilance.

Dr. Sabine Richter, PRA's Vice President of SRM, will chair the "Risk Management" breakout stream on day one of the event.  At 1:00PM BST, Dr. Richter will deliver opening remarks for the session, which will cover risk management plans, safety reporting, and risk-benefit balance during research and development.

Dr. Hemendra Misra, Director of Risk Management at PRA, will give a presentation titled, "Development Safety Update Reports (DSURs): The Time is Now" at 2:25PM BST.  Dr. Misra's speech will summarize new legal requirements and explain how a DSUR can be used as an effective tool for risk identification and assessment.

Dr. Richter has over 20 years of research experience in the pharmaceutical and clinical research industries as well as in academia. Since joining PRA's SRM team in 2004, she has delivered numerous projects for a variety of clients and led large, long-term safety programs involving as many as 50 countries on five continents. As the head of PRA's SRM group, Dr. Richter has developed robust procedures and quality control measures to ensure consistent high performance and regulatory compliance.

A pharmacovigilance physician with 15 years of international work experience, Dr. Misra's background includes positions at hospitals in India and with Medecins Sans Frontieres (Doctors Without Borders), as well a
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