Safety & Risk Management Services

PRA's Safety & Risk Management team has an impeccable record of providing comprehensive range of pharmacovigilance services throughout the product life-cycle. PRA provides global coverage with centralized Drug Safety Centers in North America and Europe. Within each Drug Safety Center, our experienced management team leads a group of qualified Drug Safety Associates. From 2007 to September 2008, PRA accomplished the following for our clients:

• Over 30,000 expedited safety reports processed
• 7 Annual Safety Reports written
• Over 30 PSURs generated
• 10 data integration and pooled analysis projects
• 4 client audits of pharmacovigilance organizations conducted
• Over 30 pharmacovigilance client audits and 2 regulatory agency inspections successfully completed

PRA's Safety & Risk Management draws upon expertise from other groups within PRA such as Therapeutic Expertise, Analysis & Reporting, and Late Phase Services. By working in such cross-functional fashion, PRA assists clients in the effective management of their drug safety information in the face of stricter international regulations, downsizing trends and heightened information quality requirements.

For more information on our Safety and Risk Management Services, please contact:

Dr. Sabine Richter
Vice President, Safety and Risk Management
Dynamostr. 13 - 15
68165 Mannheim
Germany
T: +49 (621) 8782-107
E: RichterSabine@praintl.com