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Lance Smallshaw

Lance Smallshaw

UCB Biopharma sprl., Belgium

Title: A journey through the new and updated landscape of the European GMP guide and associated European GMP legislation

Biography

Biography: Lance Smallshaw

Abstract

In past few years there has been plethora of revisions and inclusions to the European GMP Guidance general chapters, annexes and GxPs. In addition there have been a number of significant updates related to the European legislation including a new directive for safety relating to the rise of falsified medicines reaching the market place. This presentation will provide a current picture in time of what these changes are and responsibilities, challenges and expectations faced by both individuals and individual companies.