1. Toolkit for research and development of paediatric antiretroviral drugs and formulations

2. Module 10: Pharmacovigilance

3. Background – definitions

4. Timeline of pharmacovigilance for a drug from development (pre-market) to post-marketing use

5. Burden of adverse drug reactions in children

6. Number of pharmacoepidemiological safety studies in children (Osokogu et al, 2016)

7. Importance of pharmacovigilance in context of expanded antiretroviral therapy

8. Challenges of antiretroviral therapy pharmacovigilance in low- and middle-income countries (1/2)

9. Challenges of antiretroviral therapy pharmacovigilance in low- and middle-income countries (2/2)

10. Solutions (1/3)

11. Solutions (2/3)

12. Solutions (3/3)

13. Case studies

14. Summary

15. Key considerations

16. Acknowledgements