Hazel Aranha, Ph.D., RAC, Manager, Viral Clearance & Safety, Catalent Pharma Solutions, will present “Virological Safety of Biopharmaceuticals: Regulatory Considerations and Pragmatic Approaches” at WCBP 2012, the 16th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products in San Francisco, CA on January 24, 2012.
Dr. Aranha’s presentation will cover the following topics:
• Importance of a holistic approach to virus safety;
• Current regulatory guidance as applied to marketing authorization applications (MAAs), and Investigational Medical Products (IMPs); and
• Application of risk assessment and management strategies in designing an overall virus contamination control strategy
Catalent Pharma Solutions is the world’s #1 partner for drug development and formulation services. Catalent provides a broad range of expert services for large molecule development and analytical testings, from cell line development to biophysical characterization, bioassay, stability testing, viral clearance to global clinical trial supply.
The goal of the WCBP Symposium series, which is sponsored by CASSS and the U.S. Food & Drug Administration, is to provide a forum for discussing the latest bioanalytical methods and their practical application to biotechnology pharmaceuticals and other health related products.
Dr. Aranha has over 30 years experience in academia, industry and consulting. She has a Masters in Virology, Ph.D. in Environmental Microbiology and holds Regulatory Affairs Certification (RAC) for the United States and European Union. She is a well-acknowledged expert in the area of virus and prion clearance from biopharmaceuticals and serves on several advisory boards of government/semi-government bodies and the editorial board of BioProcess International Journal. She has authored two books, four book chapters and more than 45 publications.
For more information on this event, please visit here. To schedule an interview with the above mentioned presenter, during WCBP 2012 or after, please contact Patricia McGee.
To receive a copy of this presentation after the event, please visit us here.
