RQA Quality Practices for Real World Non-Interventional Studies (RW-NIS) Special Interest Group

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MI PASS Meeting

On the 28th March 2022, the group devoted a whole meeting to sharing best practices regarding Non-Interventional Post Authorisation Safety Studies (NI PASS). Speakers provided a summary of the recent MHRA RQA joint meeting on NI PASS Inspections and on experiences of their NI PASS being inspected by the MHRA.

Audio (and the slides) from the session can be found below.

GSK’s experience on MHRA Inspection of NI PASS  (slides)

Joint RQA – MHRA roundtable Non-interventional Post Authorisation Safety Studies  (slides)