Recent developments in the introduction of
rapid microbiology were discussed at ECA’s Masterclass "PAT in
Microbial QC".
Most participants were convinced that these new technologies bring
great advantages to the pharmaceutical industry.
Those speakers who successfully implemented alternative tests pointed
to their different experiences in the U.S. and Europe. It was dramatically
shown how much more time and costs were involved in the introduction of
rapid methods in Europe in comparison to the U.S. The delegates agreed
that this issue of time and cost is a general disadvantage for the
European pharmaceutical industry. It was also recognised that the new
EP chapter on alternative methods could be a move forward in the right
direction.
In the course of a workshop which was lead by Paul Newby, GSK, and
Peter Ball, Pall, the participants tried to collect individual opinions to
get a better idea on what pharmaceutical companies in Europe plan to do
concerning rapid microbiology.
Due to the animated discussions during this workshop the ECA decided to
take this survey a step forward and to invite all ECA members and everyone
in the pharmaceutical industry who shares an interest in rapid
microbiology to take part in an internet survey.
The internet questions in electronic form are the same as those that
were discussed during the masterclass.
By filling in the questionnaire you will help ECA to decide on further
actions to support our members from industry as well as regulatory
agencies.
The internet survey will be open until April
30, 2006. The results of this survey
and the resultant ECA activities will be published in an ECA newsletter.
Filling in the questionnaire will greatly assist in defining a European
Voice for the successful implementation of rapid microbiology and I would
ask you please to take the time and trouble to do so.
Click here
to read the questionnaire.
Thank you very much for taking the time!
Best Wishes,
Mike Edgington
Director of Regulatory Affairs – European Compliance Academy
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