22 Apr 2021Ended

Risk Assessment of Extractables and Leachables in Different Phases of Development


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Apr 2021


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In order to ensure safety of patients, the toxicological risk assessment needs to thoroughly evaluate all potential risks which may be caused by any .. Read more component present in a pharmaceutical drug product. In consequence, the entry of E&L into the pharmaceutical product needs to be controlled and assessed. Adequate control of E&L requires an understanding of the materials used in production as well as the manufacturing process. As the knowledge on the manufacturing process evolves during the development of a drug product or medical device, it is advised to include learning cycles into the development program to avoid existence of critical E&Ls. These learning cycles offer the opportunity to increase the knowledge on E&L associated with the product over its development time. He started his professional career in 1990 at Schering AG, Berlin-Germany. From 2000-2006 he became Head of Animal Pharmacokinetics where he also successfully supervised the generation of two doctoral theses.

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