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PRA International to Present Key Challenges for Safety Professionals at the World Drug Safety Congress: PRA Experts discussing REMS at Washington DC Conference
Date:4/17/2009

RALEIGH, N.C., April 17 /PRNewswire/ -- PRA International, a leading Clinical Research Organization, announces it will present at the Third Annual World Drug Safety Congress scheduled for April 21-24, 2009, in Washington, D.C. Dr. Sabine Richter, Vice President of Safety and Risk Management at PRA, will chair the session, while Mark Nelson Tyrrell, Director of Risk Management at PRA, will discuss "Assessment of stakeholders for risk mitigation strategies." The discussion will focus on the design, implementation, and ongoing evaluation of Phase-IV studies, registries and observational studies, and RiskMAP / REMS development.

From pre-clinical proof of concept, to end of phase, to post-approval - PRA specializes in designing all components of risk management planning. Areas of specialty include:

  • Late phase studies (Phase III-B and Phase IV);
  • Professional support centers (IVRS, web-based and live support);
  • Focused registries: Patient, Product, Disease, & Pregnancy

PRA offers its clients a dedicated team of physicians, nurses, pharmacists, biostatisticians, pharmacoepidemiologists and medical writers - each qualified through years of experience in risk management activities. Members of the team have contributed to many of the FDA-REMS programs currently in effect, focusing on dermatology, oncology and immune disorders. PRA has implemented programs in support of novel drugs and biologicals, such as TNFa blockers, as well as mature products such as antiepileptic drugs.

About PRA International

PRA International is a global Clinical Research Organization providing services through all phases of clinical development. We perform studies in all therapeutic areas, with specialization in Oncology, Neurosciences, Respiratory/Allergy, Cardiovascular and Infectious Diseases. PRA has supported over 2,100 c
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SOURCE PRA International
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