Transcript 1 WHO Programme for International Drug Monitoring & the Uppsala

WHO Programme for International Drug
Monitoring
&
the Uppsala Monitoring Centre
Shanthi Pal and Mary Couper
Quality Assurance and Safety of Medicines
World Health Organization
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Birth of modern pharmacovigilance
Thalidomide – Phocomelia 1961
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16th World Health Assembly 1963
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Assembly Resolution 16.36 - Clinical and
Pharmacological Evaluation of Drugs
INVITES Member States to arrange for a
systematic collection of information on serious
adverse drug reactions observed during the
development of a drug and, in particular, after its
release for general use.
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WHO Programme for International Drug
Monitoring
HQ-WHO
+ 6 Regional
offices
Others
HIV/AIDS
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WHO
Collaborating
Centre, Uppsala
National
Centres
Advisory Committee on Safety of
Medicinal Products (ACSoMP)
The Advisory Committee on Safety of Medicinal
Products shall provide advice on pharmacovigilance
policy and issues related to the safety and
effectiveness of medicinal products
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to the relevant Assistant Director-General in WHO and through
him / her
– to the Collaborating Centre for International Drug Monitoring
(the Uppsala Monitoring Centre), and
– to the Member States of WHO.
Pharmacovigilance in WHO HQ
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Exchange of Information
Policies, guidelines, normative activities
Country support
Collaborations
Resource mobilisation
1. Exchange of Information
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National Information Officers
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Publications (WHO Pharm Newsletter, Restricted
Pharm List, Drug Alerts, WHO Drug Information)
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International Conference of Drug Regulatory
Authorities (ICDRA)
2. Policies, Guidelines and
Normative Activities
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Guidelines
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The Importance of
Pharmacovigilance (2002)
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Safety Reporting - A guide to
detecting and reporting adverse
drug reactions (2002)
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Policy perspectives on medicines
(Pharmacovigilance) 2004
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Safety monitoring of herbal
medicines (2004)
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Pharmacovigilance in Public
Health
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Advisory Committee for the Safe
Use of Medicinal Products
(ACSoMP)
3. Country support
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10 courses
offered in 2008
Training courses on pharmacovigilance
(Regional Training Courses, biennial course by
UMC and HQ)
Address specific / stated needs: kava, ARVs,
antimlalarials….
Annual Meeting of Pharmacovigilance Centres
Over a 100 million people targeted for either
4. Collaborations
& Partnerships
within
diethylcarbamazine citrate
(DEC) plus
WHO albendazole or ivermectin plus albendazole.
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Malaria
HIV/AIDS
Leprosy
Lymphatic Filariasis
Leishmaniasis
Chagas
Patient Safety
Poisons and Chemicals Safety
Traditional Medicines
Vaccines
5. Resource Mobilisation
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Gates foundation
European commission
Global Fund
Others
Human resources: PvSF