RALEIGH, N.C., April 12, 2011 /PRNewswire/ -- PRA International, a leading Clinical Research Organization, announces that two experts from our Safety and Risk Management (SRM) group will speak at the World Drug Safety Congress being held in Boston, MA from 12-15 April 2011. PRA will also host an exhibit at booth #2.
Dr. Sabine Richter, PRA's Vice President of SRM, will chair the first breakout stream, "Operational Safety," on 13 April at 1:50 PM EDT. Dr. Richter will provide opening remarks and moderate the session, which will address global safety regulatory intelligence, adverse event reporting and risks associated with missing data.
At 2:00 PM EDT, Dr. Kathleen Boyden, PRA's Director of Drug Safety Centers Americas, will deliver a presentation titled, "Adverse Event Monitoring and Global Safety Regulatory Intelligence." Dr. Boyden will discuss strategies for maintaining global compliance, focusing specifically on relevant cultural, protocol and technological considerations associated with gathering and reporting adverse events.
Dr. Richter has over 20 years of research experience in the pharmaceutical and CRO 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.
Dr. Boyden has nearly 15 years of clinical research experience in academia and the CRO industry. She joined PRA in 2007 as manager of Clinical Operations responsible for study start-up and legal services. In 2003, Dr. Boyden earned a Ph.D. in nursing from the University of Virginia, where she conducted funded research as a National Institutes of Health Predoctoral Research Fellow.
Additional PRA representatives from SRM, Clinical Operations and Business Development will be available at our booth to discuss our successful approach to drug development programs.
PRA's SRM group provides services throughout the entire product life cycle. The team includes over 100 experts available to clients for consultancy as well as routine and specialty pharmacovigilance services. Most of these staff members are healthcare professionals (nurses, pharmacists, physicians) or life scientists. PRA's drug safety centers are based in our Mannheim, Germany; Swansea, UK; Charlottesville, VA (US); and Sao Paulo, Brazil offices.
PRA conducts clinical trials across all therapeutic areas in more than 80 countries and provides services in all phases of clinical development through its 39 global offices.
PRA's therapeutic expertise, global reach and project experience combined with its extensive local knowledge and differentiating philosophy—THE PERSONAL ELEMENT— enable its project teams to deliver consistent and on-time performance. This unique PRA philosophy recognizes that true client service comes only from trained, empowered and dedicated employees who are encouraged to be innovative and to use their personal commitment to accelerate the development life cycle.
SOURCE PRA International