THE UK Medicines and Healthcare
products Regulatory Agency has
launched a new ‘Good Clinical
Practice Guide’ which covers the
legislation, guidance and good
practice relating to the conduct of
clinical trials of medicinal products
for human use in the UK.
The guide references European
legislation and guidance as well as
international standards, and covers
a range of areas including sponsor
oversight, applying for
authorisations, and Ethics
Committee opinons.
There are also extensive practical
details of the conduct and
management of clinical trials
including documentation,
management of data, safety
reporting and quality systems.
It’s available in paperback form
from The Stationery Office for £45 -
see www.tsoshop.co.uk.The above article was sent to subscribers in Pharmacy Daily's issue from 25 Sep 12 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 25 Sep 12
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