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Pharmacovigilance: First Training workshop to introduce monitoring of
safety and efficacy of antiretrovirals in Africa, 1-10 September 2004.
Pharmacovigilance
Many countries in Africa are introducing combinations of
antiretrovirals as a part of WHO's strategy to provide
antiretroviral treatment to additional 3 million people by 2005.
Most of the needed first-line drugs are also available as
multi-source generics. As with many of the newly registered
products there is still limited experience with the operational
use of antiretroviral drugs in general, especially in the
different developing country settings. It is imperative that
measures should be undertaken not only to guarantee the quality
of the products but also to ensure proper monitoring of their
safety and efficacy
A workshop course is being organized by WHO in Pretoria, South Africa
from 1-10 September for HIV/AIDS programme managers and officials
responsible for pharmacovigilance in eight African countries (Kenya,
Malawi, Nigeria, Mozambique, Tanzania, South Africa, Uganda and
Zambia). The aim is to introduce a common system of
pharmacovigilance of antiretrovirals, to provide access to the WHO
database and international expertise, and to initiate plans for
early implementation of pilot projects in the respective countries.
It is hoped that this initiative will be strengthened by follow-up
activities and expanded, pending sufficient funding being available,
to other countries where extensive treatment programs are starting
The presentations, materials and recommendations
given in this event are as follows:
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Presentations
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Case Report forms
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Country ARV's
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Country Presentations
Related links
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WHO and Quality and Safety
of Medicines: Safety, efficacy, utilization
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The
WHO
Collaborating Centre for International Drug Monitoring
at Uppsala, Sweden, holds the operational responsibility for the
programme, including the maintenance of the database which
currently contains over three million reports of suspected
adverse drug reactions. Over 75 countries now
participate in the Programme.
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The
WHO Collaborating Centre for Drug Statistics Methodology
centered in Oslo is responsible for the maintenance of the
» WHO
classification system: the Anatomical, Therapeutic and Chemical
(ATC) and Defined Daily Dose (DDD). In 1996 an International
Working Group for Drug Statistics Methodology was established in
order to make the classification system more global. This group
consists of 12 appointed experts in clinical pharmacology, drug
utilization, drug regulation, drug evaluation, statistics and
medicine. The members of the Working Group represent different
users of the ATC/DDD system and different nationalities as they
represent the 6 WHO global regions. They provide advice to the
Centre during biannual meetings and stimulate the practical use
of the system by co-operating with researchers in the field of
drug use.
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