Pharmacovigilance Updates

Today’s tech alert provides members with an update on the following:

Update on PV Guidelines version 3.0: Additional FAQs published; Webinars

– The TGA has compiled a document of frequently asked questions (FAQs) for the new version 3.0 PV Guidelines in response to webinar questions.

– The recording and slides of the first TGA webinar are now available.

– The final TGA webinar is planned for mid-December and will provide a further opportunity for Q&A. Registration information for this webinar will be distributed by the TGA in the coming weeks.

New adverse event search function and related guidance

– The TGA are seeking feedback on the new Adverse Event Management System (AEMS) search function and guidance prior to publication, which is now available for sponsor testing.

The search functionality allows sponsors to access TGA held adverse event data relevant to their products.

Members are invited to provide feedback on critical issues with the new functionality, including any data discrepancies, as well as comments on the draft guidance.

Please read todays full alert for more information and details, including how to access the new AEMS search function. 

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