RALEIGH, N.C., June 15 /PRNewswire/ -- PRA International, a leading Clinical Research Organization with expertise in Pharmacovigilance and Late Phase studies will host a webinar on June 16, 2009. The presenters are PRA's Risk Management, Epidemiology, and Late Phase Operational experts who are currently consulting, designing and conducting Risk Evaluation and Mitigation Strategies (REMS) under the new FDAAA Regulations. PRA's experts will present various REMS strategies based on a "Tiered" approach along with recent case studies. In addition, presenters will cover lessons learned and program components to consider based on FDA current thinking and requirements for REMS. To register for the webinar, navigate to www.prainternational.com / Events.
PRA provides its clients with dedicated teams of physicians, nurses and pharmacists along with experienced biostatisticians, pharmacoepidemiologists and medical writers. Each team member is uniquely qualified through longstanding experience in risk management activities. PRA staff have contributed to several of the FDA-REMS programs currently in effect, focusing on dermatology, oncology, and immune disorders. PRA has implemented REMS programs in support of novel drugs and biologicals, such as TNF alpha 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 clinical trials through its 35 global offices. PRA's therapeutic expertise, global reach and project experience, combined with extensive local knowledge and our differentiating PERSONAL ELEMENT enable our project teams to deliver consistent and on time performance for our clients. This unique PRA philosophy - THE PERSONAL ELEMENT - recognizes that true client service comes only from trained, empowered and dedicated employees who are encouraged to use innovation and their personal commitment to accelerate the development lifecycle.
To learn more about PRA International, please visit http://www.prainternational.com, email endpoints@praintl.com or call our Global Headquarters at +1 (919) 786-8200.
CONTACT: Roger Boutin, Director of Marketing of PRA International, Inc.,
+1-434-951-3924
Web site: http://www.prainternational.com/
