Speakers

Although the risk from TSEs in biopharmaceutical products have significantly decreased since the peak in the late 90s early 2000s era, controlling the TSE risk for such product still forms an important component of the product registration. TSE clearance studies can often provide useful data supporting product safety, but their implementation and execution requires careful adherence to regulatory guidelines. This presentation will focus on how TSE clearance studies fit into the overall TSE safety profile for a range of biopharmaceutical products and medical devices and will present key aspects related to their successful implementation.

Andy Bailey specialised in Virology while serving for nine years at the MRC Virology Unit, Glasgow University in Scotland. In 1995, he moved to the industry sector, initially as Director of Virus Validation services with Q-One Biotech Ltd, and later at the Global Pathogen Safety group of Baxter Healthcare in Vienna, Austria. Over the last 25 years Andy has been actively involved in the virus and prion safety field, presenting at numerous regulatory agencies either in support of products or as an invited speaker at expert workshops. In 2005 he founded ViruSure with the goal of providing a high quality science-based testing service to the biopharmaceutical industry.