Insights into evolving pharmacovigilance trends and their impact on biosimilars and generic products

Experts from PAREXEL International Corporation (Nasdaq: PRXL), a leading global biopharmaceutical services provider, will provide insights into evolving pharmacovigilance trends and their impact on biosimilars and generic products at the World Generic Medicines Congress Americas, being held November 17 - 20, 2009 in Washington, DC. PAREXEL is a sponsor of the second annual congress, which will address the health economics, pricing, and competition pressures facing the generics sector in the U.S. as well as issues around building scale and value through globalization.

The congress program features the following sessions on Thursday, November 19, which will be led by Ravi Harapanhalli, Ph.D., Principal Consultant and Practice Lead, Late Stage Development, PAREXEL Consulting:

• Economic Implications of Outsourcing Pharmacovigilance (8:00 a.m. - 8:50 a.m.)

This special breakfast briefing session will identify the key opportunities for biopharmaceutical outsourcing in the area of pharmacovigilance, including a presentation of case study analyses of key processes that can be outsourced with high value to biopharmaceutical companies.

• Pharmacovigilance and Biosimilars: Ensuring Patient Safety (2:30 p.m. - 3:00 p.m.)

Experts from PAREXEL will be available during the congress to discuss a broad range of capabilities including:

Pharmacovigilance: PAREXEL offers a comprehensive portfolio of services for the active management of safety, risk, and patient health during the entire lifecycle of a product from early phase development through the conclusion of the marketing period of a product. For more information about PAREXEL's pharmacovigilance capabilities visit: https://www.parexel.com/

Biosimilars/Follow-on Biologics: PAREXEL has the expertise and experience needed to help formulate a successful Follow-on Biologics (FOB) program and can bring together regulatory, product development, pharmacology, medical, clinical research, statistical and medical marketing experts to create a tailored, comprehensive, effective and efficient development program for any FOB. For more information about this offering visit: https://www.parexel.com/.

Bioequivalence Studies: PAREXEL's early phase clinical units worldwide with experience in conducting bioequivalence studies provide specialized bioequivalence development services involving patient populations as well as healthy volunteers. PAREXEL's early phase clinical unit in Bloemfontein, South Africa, a center of excellence in this area with an on-site bioanalytical laboratory, has more than 27 years of experience in the conduct of clinical trials for the generics industry and is strategically located in a fast study-start up environment. For more information about PAREXEL's early phase bioequivalence services visit: https://www.parexel.com/.

Information about the World Generic Medicines Congress Americas can be found at: http://www.healthnetworkcommunications.com/2009/genericsusa/index.stm.