Complete Parts A (75% of total marks) and B (25% of total marks)
A – Discuss the short-comings of the TGN1412 clinical trial?
B – Summarise 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.
Support your discussions with relevant peer-reviewed publications where appropriate and include a list of references.
Guidelines
Word limit is 2000 words (+/- 200 words) in total for Parts A & B combined.
Please include the total word count (excluding references) on the title page.
Example of referencing format below and please note policy on plagiarism.
Referencing:
For this assignment the Vancouver or Harvard style of referencing may be used.
As an example of the Vancouver Style of referencing, the references should be listed in a reference section at the end of the essay (not as footnotes), and should cited by number at the end of the sentence or paragraph to which they relate. Every statement of fact should be supported by a reference. If a whole section is derived from one reference, cite it at the end of the first and last sentence of the relevant section.
Authors, journal details, dates and article titles should all be given. Web sources should be cited giving the URL, the title, the authors, and the date last modified (where possible). The reference list at the end of the assignment should contain all the sources cited, listed numerically according to citation order, and be formatted according to the style shown overleaf.
