Pharmacovigilance and Pregnancy Registries: Introduction to Concepts

and Tools

ART in Pregnancy, Breastfeeding and Beyond Workshop

June 18, 2012

PEPFAR Expectations for PV/APRs

• Focus in countries moving more rapidly towards B+ with potential appropriate sites, capitalizing on existing infrastructure, political will• HQ/WHO TA visit and approval of plan will be required• Standardized data collection/tools required• Funded in COP budgets with possible potential for supplemental funding on a case by case basis• Will herald PEPFAR’s support of expanded PV

Acknowledgements

• S/GAC PEPFAR Clinical Team• PEPFAR Technical Working Groups (Adult Treatment,

PMTCT)• WHO Department of HIV