Pharmaceutical Regulatory Science Team

The editors of Journal of Applied Pharmaceutical Regulatory Science (JAPRS) are delighted to announce the publication of Volume 1 Issue 2, entitled 'Taking a Stand for Quality by Advancing Pharmaceutical Quality Leadership, Quality Risk Management & Knowledge Management.'  This issue features in detail the proceedings from the inaugural Quality Business Leadership Summit hosted at TU Dublin on 01-May-2024, including compelling keynote addresses from janet woodcock and Lorraine Nolan.   In addition, post-summit, the PRST has advanced the theme of operationalising QRM and KM in unison, as a means for organisations to improve and demonstrate PQS effectiveness. An initial paper on this topic, entitled 'Taking a Stand for Quality - Demonstrating PQS Effectiveness by Operationalising QRM and KM,' written by the editors, is coming soon and will be included in this issue. You can find the current version of JAPRS here: https://lnkd.in/grzEmABD   Thank you to all of the QBL Summit contributors and sponsors for supporting this important initiative in the drive to evolve pharmaceutical quality leadership and PQS effectiveness. Declan McCormack, Anders Vinther, Dr. Colin Hughes, Holger Rathgeber, Kevin O'Donnell, Rick Friedman, Jane Wyatt, Valerie Mulholland, Donncadh Nagle, Paul O'Neill, Pat O'Mahony, Tracy Walshe, Maureen Larkin, Cathal Elliott, Ashley ODonoghue PhD MCIPD, Anne Greene, Martin Lipa, PhD, Janine Jamieson, Anya Hillery TU Dublin Graduate Business School, TU Dublin Enterprise Academy, Accenture, GetReskilled, CAI, Nuala Calnan, PhD, International Pharmaceutical Quality, Redica Systems, QBA

The editors of Journal of Applied Pharmaceutical Regulatory Science (JAPRS) are delighted to announce the publication of Volume 1 Issue 2, entitled 'Taking a Stand for Quality by Advancing Pharmaceutical Quality Leadership, Quality Risk Management & Knowledge Management.'  This issue features in detail the proceedings from the inaugural Quality Business Leadership Summit hosted at TU Dublin on 01-May-2024, including compelling keynote addresses from janet woodcock and Lorraine Nolan.   In addition, post-summit, the PRST has advanced the theme of operationalising QRM and KM in unison, as a means for organisations to improve and demonstrate PQS effectiveness. An initial paper on this topic, entitled 'Taking a Stand for Quality - Demonstrating PQS Effectiveness by Operationalising QRM and KM,' written by the editors, is coming soon and will be included in this issue. You can find the current version of JAPRS here: https://lnkd.in/grzEmABD   Thank you to all of the QBL Summit contributors and sponsors for supporting this important initiative in the drive to evolve pharmaceutical quality leadership and PQS effectiveness. Declan McCormack, Anders Vinther, Dr. Colin Hughes, Holger Rathgeber, Kevin O'Donnell, Rick Friedman, Jane Wyatt, Valerie Mulholland, Donncadh Nagle, Paul O'Neill, Pat O'Mahony, Tracy Walshe, Maureen Larkin, Cathal Elliott, Ashley ODonoghue PhD MCIPD, Anne Greene, Martin Lipa, PhD, Janine Jamieson, Anya Hillery TU Dublin Graduate Business School, TU Dublin Enterprise Academy, Accenture, GetReskilled, CAI, Nuala Calnan, PhD, International Pharmaceutical Quality, Redica Systems, QBA

Best wishes to our PRST colleagues Martin Lipa, PhD and Kevin O'Donnell, who are presenting at the PDA/FDA Joint Regulatory Conference in Washington DC. Another important opportunity to share the work of the PRST and to hear feedback.

It is hard to believe that a week has passed since our Quality Business Leadership Summit (QBL Summit), where we brought together senior global leaders from Academia, Industry and Regulatory organisations. It was a motivational and thought-provoking event where attendees explored the critical role of Quality Business Leadership in moving beyond Quality as a compliance function to a business leadership organisation ensuring uninterrupted supply of high-quality medicines while driving innovation and continual improvement of the Pharmaceutical Quality System. The presentations were inspiring and the dialogue rich, in particular Dr Janet Woodcock’s keynote presentation “Taking a Stand for Pharmaceutical Quality” where she summarized: •Pharmaceutical quality has a long and rather notorious history •The last few decades have seen therapeutic advances yet continuing quality lapses •Quality should be recognized as an essential business capability rather than a compliance function •Quality leaders should have appropriate status in corporate hierarchies •Taking united action by Pharmaceutical Quality Leadership is needed to get to the next level Janet’s presentation complemented the excellent opening Keynote, by Dr Lorraine Nolan, Chief Executive of HPRA, who shared the transformational effort of turning a Concept into Possibility by Working towards a Global Quality Dossier. Now that the dust has settled, we would like to send a big THANK YOU to the sponsors of the summit, without whom the event would not have been possible, namely TU Dublin Graduate Business School, TU Dublin Enterprise Academy, Chemical and BioPharmaceutical Sciences TU Dublin, Accenture, GetReskilled, CAI, Quality Business Administration, International Pharmaceutical Quality, The Quality Risk Management Institute, Redica Systems Furthermore, we are delighted to share all the speaker presentations on PRST website (https://lnkd.in/gtgu5fTx). Here also is a link to Rick Friedman’s recent paper which he referenced during his presentation (https://lnkd.in/gndAunRW). Importantly, we have also finalized Quality Business Leadership Manifesto, a document outlining the shared vision of the opportunity before us. You can find this at the QBL Summit link above. In addition we intend to publish the proceedings including panel discussions, survey results and an executive summary of the Summit in partnership with IPQ (https://ipq.org/), in a special edition of the Journal of Applied Pharmaceutical Regulatory Sciences (JAPRS) (https://lnkd.in/gqKNHXiP) by summer. Stay tuned for further details. #QualityBusinessLeadershipSummit

We are very excited to announce the ‘birth’ of the Journal of Applied Pharmaceutical Regulatory Science! The Journal of Applied Pharmaceutical Regulatory Science (JAPRS) has been almost 20 years in the making and is being launched to address a gap in the academic journal ecosystem, to publish peer-reviewed research papers and other articles on the topic of Applied Pharmaceutical Regulatory Science. Its origins stem from 2005, when the Pharmaceutical Regulatory Science Team (PRST) (https://prst.ie) was founded at the Dublin Institute of Technology (DIT; now Technological University Dublin), in response to a call for a paradigm shift in quality from the international regulatory community. Since then the PRST has actively engaged with global industry and regulators to address the challenges and opportunities of implementing science and risk based manufacturing and decision-making approaches. The PRST’s body of work and influence has grown over the last 20 years, emerging from the doctoral research undertaken by its researchers, including Kevin O’Donnell, Nuala Calnan, PhD, Joe Brady, PhD, Ian Jones, Kelly Waldron, PhD, MBA, Paige Kane, PhD, CPIP, Ghada Haddad, PhD, Martin Lipa, PhD, Emabelle Ramnarine, Lori Richter, Valerie Mulholland, Donncadh Nagle, Ann Ryan (Flavin), Melanie Byrne Adams, and Amin Ziaie. Driven by the desire to have a positive impact on the persistent global problem of drug shortages, the PRST has sought avenues to publish its work in open access publications. It is our hope that JAPRS will serve as a vehicle to aggregate the research of the PRST and other relevant global Applied Pharmaceutical Regulatory Science work, affording maximum opportunity for reach and impact for all key stakeholders. The first issue features the work of One Voice of Quality (https://prst.ie/1vq/). As they say, it takes a village, and this journal would not have come about without important behind-the-scenes support. Many thanks to Anne Murphy, Aisling Coyne, Alison Stichal and in particular our talented copy editor, Nicole Lipa. Thank you as well to the many partners and collaborators of the PRST, across academia, industry and regulatory agencies. You can find the Volume 1, Issue 1 here 👉 https://lnkd.in/eZw3DKXF . Stay tuned for more issues to follow, and we welcome your submissions in the future.

Check out this "must read" article by PRST colleague Valerie Mulholland on risk-based decision-making (RBDM). While the concept of "RBDM" may seem commonplace - perhaps even obvious - in reality there is an opportunity for the industry to develop an appreciation and in time a competency - in the art and science of risk-based decision-making. Val's article offers some not-to-be-missed insights into RBDM based on fundamentals and practices across many high-risk / high-reliability industries. It holds valuable advice for anyone looking to up their game in effective decision making at large (hint: check out the 21 attributes of effective RBDM in Fig. 6), while also helping those in the pharma industry effectively adopt key concepts in quality risk management / ICH Q9(R1).

Congrats to Amin Ziaie for the inaugural publication of his PhD research study. The publication, 'Shining a Light on the Long Shadow of Subjectivity in Quality Risk Management,' is an introductory article which explores key concepts from ICH Q9(R1) and sets the stage for some impactful and formative work to follow to help the industry address subjectivity inherent in quality risk management (QRM). Check it out at the link below, and watch for future updates on this topic. Thanks also to Kevin O'Donnell & Paul Pluta for organizing this special series of papers focused on ICH Q9(R1), and to co-authors Anne Greene & Martin Lipa, PhD. https://lnkd.in/gnaJNrnp

Pleased to have the work of PRST colleagues Anne Greene, Martin Lipa, PhD and Kevin O'Donnell highlighted in the recent Pharmaceutical Technology eBook, as well as a thought-provoking article led by Rick Friedman. More papers covering a variety of important topics on recent ICH Q9(R1) QRM guidance are on the way - including on risk-based decision making, addressing uncertainty and subjectivity, and much more. Stay tuned for updates!

The Pharmaceutical Regulatory Science Team (PRST), in partnership with International Pharmaceutical Quality (IPQ), are delighted to announce a special edition of the TU Dublin online journal Level 3, which captures the presentations and dialogue exchanged at the 01 June 2023 seminar ICH Q9(R1): The Next Frontier. You can access the special edition with the complete proceedings at this link (https://lnkd.in/eZegwzKQ). Stay tuned to our website (https://prst.ie/) for an exciting early summer 2024 follow on event we are planning! Many thanks to all of our authors and contributors to the special edition, including, International Pharmaceutical Quality, Chemical and BioPharmaceutical Sciences TU Dublin, TU Dublin Graduate Business School, TU Dublin Enterprise Academy, Anne Greene, Martin Lipa, PhD, Bill Paulson, Ed Hoffman, Emabelle Ramnarine, Gregg Claycamp, Kevin O'Donnell, Anders Vinther, Alice Redmond, Aidan Harrington, Ana Margarida Ventura, Patrick T.O'Sullivan, Michael Schousboe, Valerie Mulholland, Emily Grayek, Baruch Fischhoff, Steph Friedrichsen, Nuala Calnan, PhD, Adrienne Fleming, Shingo Sakurai, Osamu Hiruta, Rhoko Naruse, Anne Murphy and Brendan P. Devlin, as well as our additional speakers and panelists from the June seminar, including Rick Friedman, Thomas Friedli, Peter Twomey, Grainne Power, David Twohig and Jean Louis Robert, who's presentations are available at the PRST events page (https://prst.ie/events/)

Check out the helpful new resource available from our good friends at International Pharmaceutical Quality.