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Featuring US and EU Regulatory Updates
WESTBOROUGH, MASS - November 8, 2010 - IBC Life Sciences is pleased to hold its 8th International Viral Safety for Biologicals conference in Orlando, FL, February 24-25, 2011.
After a multi-year hiatus, IBC's Viral Safety for Biologicals conference has returned to provide the latest updates on viral detection and testing methods, emerging technologies and evolving regulatory guidances for viral safety studies for recombinant proteins, vaccines and blood/ plasma products.
"We decided to bring this conference back because it is such a timely topic. I knew we would be able to provide the information that people in the industry are looking for and presentations that will help them create a comprehensive viral safety action plan," says Michael Keenan, the producer of this IBC conference.
This two day conference includes strategies, technologies and regulatory perspectives for viral safety detection, prevention and remediation in upstream, downstream and manufacturing operations. Attendees will gain the
tools they need to detect and prevent viral contaminations in raw materials, cell culture processes and their entire supply chain.
Featured on the program are three FDA talks focusing on the current guidance on the testing of cell substrates used to manufacture viral vaccines for adventitious agents, key components of viral safety assessment of preventive vaccines regulated by OVRR and FDA/CBER approaches for evaluating viral clearance studies with regard to plasma-derived products. Plus, a presentation on the regulatory updates on harmonization of virus safety requirements for Europe.
In addition, presentations from GlaxoSmithKline and Genzyme will discuss their current efforts and lessons learned for post-contamination quality control and prevention.
"Creating safeguards to detect, prevent and remediate viral contamination is a top priority for anyone involved in the development or manufacturing of biologicals. This important conference brings together industry experts and regulators who will provide you with the latest technologies, strategies and regulatory expectations you must consider as you develop your own approach to mitigate the risk of adventitious viruses," says Qi Chen, Ph.D., Associate Director of Process Virology and Senior Scientist, Genentech, Inc.
Complete conference information is available at: www.IBCLifeSciences.com/ViralSafety.
About IBC Life Sciences
IBC Life Sciences is the worldwide leader in scientific, technological and business conferences and courses for the life science industry. For more information, visit: http://www.IBCLifeSciences.com.