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Complete Parts A (75% of total marks) and B (25% of total marks)
A – Discuss the short-comings of the TGN1412 clinical trial?
B – Summaries the regulatory changes (in particular the EMEA CHMP SWP 2007 guidelines) that were introduced following the TGN1412 incident and explain how then aim to reduce the risks of ‘first-in-man” trials.
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