Abstract
At the June 2023 PRST meeting on the ICH Q9 revision, HPRA Market Compliance Manager and Senior GMP Inspector Kevin O’Donnell, who has been serving as rapporteur for ICH Q9 (R1), addressed the changes introduced in the revision, the practicalities of implementation, and his “personal thoughts” on the implementation process. Click here for ICH Q9(R1) with the changes highlighted by O’Donnell, and here for the slides accompanying O’Donnell’s remarks. Formatting
changes and other minor edits have been made for clarity by IPQ. Expressions of thanks to the meeting organizers/attendees and disclaimers that the presentation represents the speaker’s views and not necessarily those of their organization are not included.
Recommended Citation
O'Donnell, Kevin
(2023)
"HPRA’S KEVIN O’DONNELL ON THE ICH Q9 REVISION AND CONSIDERATIONS FOR ITS IMPLEMENTATION,"
Level 3:
Vol. 19:
Iss.
1, Article 5.
doi:https://doi.org/10.21427/raxf-fe44
Available at:
https://arrow.tudublin.ie/level3/vol19/iss1/5
DOI
https://doi.org/10.21427/raxf-fe44
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