What's new?
The Faculty of Pharmaceutical Medicine (FPM)
FPM is now enrolling trainees on to its new training programmes in Human Pharmacology.
The Diploma in Human Pharmacology
is a two-year programme of structured training and an examination for medical doctors intending to work as investigators for studies involving the first administrations of potential new medicines to humans. Please click here for further information -
http://www.fpm.org.uk/humanpharm/diphumanpharm
. Initial application for the
DHP
requires submission of the completed CV template to the Faculty office -
fpm@fpm.org.uk
. Your CV will then be reviewed for eligibility and if you are provisionally approved you will be sent an enrolment pack. The CV template is available to download from our website (please follow the link above).
The Certificate in Human Pharmacology
is a part-time programme of courses and an examination for scientists in the pharmaceutical industry, universities and regulatory authorities who have an interest in early clinical drug development. Please click here for further information -
http://www.fpm.org.uk/humanpharm/certhumanpharm
. If you are interested in applying for the
CHP
, please request
an application pack
from the Faculty Office -
fpm@fpm.org.uk.'
ABPI
Final guideline for Phase I Clinical Trials is now available
.
For
more information go to the “ABPI” section and click on "ABPI guidelines for Phase I"
MHRA
CTA Assessment Information is now available, which includes both pharmaceutical guidance and medical guidance. Two guidance documents are also available “Contraception Clarification” and “QT Interval Guidance”. For more information go to the “Regulatory Bodies” section and click on “CTA Assessment Information”.
FAMHP
The
Federal Agency for Medicines and Health products in
Belgium
has published a guidance paper on Exploratory Trials.
For more information go to the "Guidance and Position paper" section and click on "FAMHP".
EMEA
The European Medicines Agency has published a final guideline on requirements for first-in-man clinical trials, including those for potential high-risk medicinal products. For more information go to the "Guidance and Position paper" section and click on "EMEA".