Biosafety of Biological Drug Products Training Course :

<strong>Course Schedule - June 4-5, 2009</strong><br/><br/>This course will introduce the unique perspectives and considerations of safety testing of biological drug products in contrast to typical safety testing of chemically-derived pharmaceuticals. Regulatory recommendations and requirements at each level of development will be outlined and accepted methods will be discussed in detail.<br><br> The course will also use the history of the last 25 years of safety assessment of biologically derived therapeutics and a case study approach to identifying current approach strengths, weaknesses and successful pathways.