18: Happy Birthday QRM!

The Risk Revolution Crew is back with an exciting celebratory podcast. Join Nuala, Val, and Lori as they reflect on 20 years of QRM with Prof Kevin O’Donnell. This week’s guest needs almost no introduction to our listeners as he was the rapporteur for the ICH Q9(R1) update, chairs the PIC/s expert circle on QRM and is the Market Compliance Manager with the Irish Regulatory Agency the HPRA. Prof O’Donnell shares his reflections on the QRM journey and what is to come.

Listeners should note that Prof O’Donnell’s views are his own and do not necessarily reflect those of the agencies and organizations referenced above.

Show Notes

ICH Q9(R1) and the supporting training materials can be accessed here:

https://www.ich.org/page/quality-guidelines

The EMA recommendations draw on lessons learned from the presence of nitrosamines in sartan medicines

https://www.ema.europa.eu/en/news/european-regulators-make-recommendations-drawing-lessons-learnt-presence-nitrosamines-sartan-medicines

Technical Report No. TR 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages

https://www.pda.org/bookstore/product-detail/7852-technical-report-no-68