1. SALUS why is it important? Tomas Bergvall, MSc Uppsala Monitoring Centre WHO Collaborating Centre for International Drug Monitoring Eudravigilance Expert Working Group London May 28 2015

2. Pharmacovigilance  How do we enable decision makers to make wise therapeutic decisions?

3. WHO Programme for International Drug Monitoring 1968 2014

4. EHR sources

5. UMC EHR research timeline

6. Denominators Longitudinal Data not collected for causality assessment Lack of power* ’Objective’ No clinical suspicion Longitudinal health records

7. Case reports Health records !

8. Embedded reporting Reporter can focus on documenting their clinical suspicion Basic data already there Stronger case reports Health records

9. Health records add to case reports Health records Denominators Temporal patterns Risk group identification

10. Case reports add to health records Health records Causality assessment - Supportive evidence - Alternative explanations

11. Challenges  Local expertise is needed  MedDRA, ICD, SNOMED, WHO-ART…  Common data models  Privacy and social acceptance

12. Case reports Health records !

13. Case reports Health records Literature Registries Web searches Social media Patient commu- nities !

14. Pharmacovigilance  How do we enable decision makers to make wise therapeutic decisions?  Present information that makes sense!  Focus on the strengths!

15. What did we achieve?  Over to the coordinator…