A6 – Preparing for Australian Pharmacovigilance Inspections

This session will look first hand at the Therapeutics Goods Administration (TGA) Pharmacovigilance (PV) Inspection Programme from the perspective of both the TGA and companies that have participated in the ‘Pilot Inspection Programme’. A representative from the TGA will provide an overview of the progress of the pilot programme to date, their expectations and some learnings from the regulator side and, where possible, observations and common findings. The PV professionals from companies who have already participated in the programme will provide their perspective on what sponsors could expect, what to consider when preparing, who was involved, what happened during the course of the inspection and their learnings from the experience. Attendees at this session should gain insight into the complete inspection process, allowing them to be better prepared for their own future inspections. PV inspections involve all disciplines across companies, therefore this session is open to all functional disciplines who may be asked to participate in an inspection but particularly for: PV personnel, regulatory affairs, medical affairs, quality assurance, clinical and market researchers.

 

Chairperson: Theresa McGarry, Consultant PV Specialist