1. Challenges for the WHO Programme for International Drug Monitoring Mary Couper, Shanthi Pal, Mitsuko Imai, Maria Cuadrillero, Ana Garcia

2. WHO International Pharmacovigilance Programme Full and Associate members

3. Strengths Strengths  Global PV network  National Centres Meetings  Only available global database of ADRs  Over 40 years track record in medicine safety  Public health approach  No hidden agendas Weaknesses Weaknesses  Inadequate representation in Africa  Only Spontaneous reporting no denominator data no denominator data Poor quality reports Poor quality reports  Little or no budget  PHPs: Vertical approach

4. Opportunities  Donor interest in PV  New partners  Malaria, HIV AIDS, neglected diseases urgent PV needs urgent PV needs investing in new methods investing in new methods Threats Threats  Lucrative business  Lack of harmonization  Duplication of efforts efforts

5. An analysis of pharmacovigilance activities in 55 low- and middle- income countries An analysis of pharmacovigilance activities in 55 low- and middle- income countries –Sten Olsson a, Shanthi Pal b, Andy Stergachis c, Mary Couper a –Drug Safety 2009/2010 (a: WHO CC, Uppsala; b: WHO QSM; c: UWa)

8. 3 tiers-approach for WHO 1. As before (Spontaneous reporting) Regional trainings Regional trainings 2. More than before (Active surveillance) Tools Tools Handbooks Handbooks Nigeria, Tanzania, Ghana Nigeria, Tanzania, Ghana 3. As never before Indicators Indicators Fundraising (EuropeAid; BMGF; FP7) Fundraising (EuropeAid; BMGF; FP7) Centres of excellence (Ghana, Morocco) Centres of excellence (Ghana, Morocco) PVSF PVSF Maintain as the cheapest, easiest, most sustainable method Cohort event monitoring; ECDD; EML; DTC Measure, support, optmise