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Why do we need this course

Training course on the Pharmacovigilance of antiretroviral medicines 23 – 28 November 2009 Rationale, Objectives and Expected Outcomes. Why do we need this course. Significant safety issues exist with ARVs Both short and long-term effects Good experience in above issues in industrialised world

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Why do we need this course

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  1. Training course on the Pharmacovigilance of antiretroviral medicines23 – 28 November 2009Rationale, Objectives and Expected Outcomes

  2. Why do we need this course • Significant safety issues exist with ARVs • Both short and long-term effects • Good experience in above issues in industrialised world • Insufficient / little information in RLS • Important to address safety issues as relevant to RLS: with characteristic co-morbidities etc • New tools to share

  3. Who is organizing this • WHO HQ Regions Countries • HIV AIDS Department • Essential Medicines Department • With funds from BMGF, EC • HIV PV project • EC malaria project

  4. How do we approach this • Modelling on WHO structure Norms, Standards, Techniques for Safety of Medicines Essential medicines programme PV Public health programmes HIV AIDS, Malaria, TB Treatment norms policies; patient monitoring and care

  5. In countries Regional Office AFRO WHO CC Ghana Other collaborations National PV Centre NACP, NMCP Others PV Evidence, Information Implement Joint Activities

  6. ObjectivesMajor: to agree upon a common approach to PV • To build capacity for ARV-PV (in NPVCs & NACP) • To introduce the principles of • PV in HIV programmes • Cohort Event Monitoring for ARVs • The clinical management of adverse reactions with ARVs • PV/HIV training modules • To initiate plans for early implementation of pilot projects

  7. Audience and perspectives Expected outcomes

  8. Audience: Who are we? • PV and HIV experts • From WHO HQ, regions and countries, UMC and UMC-A • 8 Countries invited based on specific strengths and criteria: • "Teams" from members countries of the drug monitoring programme • With experience to share, commitment in HIV and PV • Readiness to implement

  9. A tripartite programme WHO Collaborating Centres, Uppsala Ghana WHO HQ + 6 Regional offices National Programmes & Centres

  10. What do we look at? Norms, Standards, Techniques for Safety of Medicines Essential medicines programme PV Public health programmes HIV AIDS, ??? Methods and Tools Strategies Training Plans Treatment norms policies; Patient monitoring and care

  11. Key questions How best could we: • Prevent the HIV "verticalism and exceptionalism": • Integrate • passive and active monitoring • cohorts collaborations • promote cross countries collaborations

  12. What do we expect? • A critical look at needs and means to address these

  13. What to bring back? • A proposed plan for modelling PV for ARVs • A training package to be rolled on in countries

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