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 Médecins Sans Frontières (Doctors Without Borders), as well as seven years of industry experience with both pharmaceutical and clinical research organizations. Dr. Misra has also served as a medical monitor and conducted safety surveillance of marketed drugs as well as drugs in development.
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 is transforming clinical trials through our people, innovation and transparency. PRA provides personalized service customized to the unique requirements of each study. We support our global reach and innovative approach through flexible and reliable service, delivered by skilled employees dedicated to ensuring that sponsors achieve their long-term goals.
We serve our clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge. Offering services in 80+ countries and serving sponsors for 30+ years, we have amassed a level of expertise that has enabled us to work on a variety of compounds, ranging from niche treatments and therapies to blockbuster drugs. But at PRA, we are looking to the future, not the past. Our increasingly forward-thinking approach to transforming the clinical trial landscape will continue to make a difference to healthcare patients around the world.
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