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Prequalification Update - 22 March 2012
REGISTRATION IS NOW CLOSED!
Preannouncement: The WHO Prequalification
of Medicines 3rd Meeting with Manufacturers
24
- 25
- 26 September 2012 - Copenhagen, Denmark
The WHO Prequalification of Medicines
(PQP) 3rd Meeting with Manufacturers will be held
on 24, 25 and 26 September 2012, in Copenhagen, Denmark.
Technical workshops will be held on dossier assessment and
good manufacturing practice (GMP) inspections. The
workshops will include updates on WHO guidelines, and an
overview of challenges in implementing stringent GMP and of
deficiencies most commonly observed during WHO site
inspections.
A session will also be held on accelerated
registration of WHO-prequalified products.
On the second day of the meeting, members
of the assessment and inspection teams will be available to
meet with representatives of individual manufacturers, in
particular to address technical issues relating to current
or proposed dossier submissions, and to answer questions
relating to PQP guideline requirements for pharmaceutical
quality, and to efficacy and safety.
Manufacturers interested in participating
in the meeting are kindly requested to notify PQP of their
interest (via email:
prequal@who.int). PQP would welcome any
suggestions for topics to be covered by the meeting.
Further information will be posted on this
site.
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