Module 10: Pharmacovigilance

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Presentation transcript:

Toolkit for research and development of paediatric antiretroviral drugs and formulations

Module 10: Pharmacovigilance

Background – definitions

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

Burden of adverse drug reactions in children

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

Importance of pharmacovigilance in context of expanded antiretroviral therapy

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

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

Solutions (1/3)

Solutions (2/3)

Solutions (3/3)

Case studies

Summary

Key considerations

Acknowledgements