NIBRT Hosts Successful 2nd Annual Quality Business Leadership (QBL) Summit
NIBRT proudly hosted the 2nd Annual Quality Business Leadership (QBL) Summit on Friday, May 11th. The event brought together 85 quality, regulatory, and industry experts to discuss the QBL manifesto and its application across the pharmaceutical industry.
The summit featured keynote addresses from several distinguished speakers, including:
- Janet Woodcock, former Commissioner of the FDA. Dr. Woodcock has had a remarkable career at the FDA, where she served as the Principal Deputy Commissioner and Acting Commissioner. She has been instrumental in modernizing drug manufacturing and regulation, and her leadership has significantly advanced public health initiatives.
- Alice Redmond, Chief Strategy Officer at CAI. With over 30 years of experience in the pharmaceutical and biotechnology industries, Dr. Redmond is a renowned expert in regulatory compliance, commissioning, qualification, and validation. Her background includes leading global regulatory and technical operations at Novartis and contributing to the lifecycle management of pharma facilities.
The summit built upon the inaugural event held in 2024, further advancing the QBL approach to pharma and biopharma management. Attendees engaged in insightful discussions and collaborative sessions, exploring innovative strategies to enhance quality and regulatory practices within the industry.
The QBL manifesto champions the following principles:
- Patient-Centric Focus: Prioritizing patient safety and well-being in every decision.
- Leadership by Ownership and Partnership: Fostering a shared mindset of quality excellence across all organizational levels.
- Regulatory Collaboration: Advocating for a streamlined, global regulatory framework that encourages continuous improvement and innovation.
- Streamlining for Efficiency: Simplifying quality management systems and processes for enhanced effectiveness and agility.
- Financial Advantage Through Quality: Achieving sustainable financial success while upholding the highest quality standards.
The sessions during the day included:
- "Quality Business Leadership in Action"
- "Quality Owned by All through Partnership with Operations"
- "From Cost of Quality to Value of Quality - Starting the QBL Movement"
The event was expertly coordinated by the PRST team at TUD Dublin (Anne Greene TUD, Anders Vinther QBA, Marty Lipa TUD, Kevin O'Donnell HPRA, Ghada Haddad PRST, Tim Kilroy BMS, Liz Tolan Abbvie, and Brian Brunner Accenture), ensuring an impactful experience for all participants. The summit was generously sponsored by Accenture, Innerspace, and Redica Systems, whose support was instrumental in making the event a success.
NIBRT is committed to fostering excellence in bioprocessing and continues to support industry advancements such as quality business leadership. The success of this year's summit underscores the importance of collaboration and knowledge sharing in driving the industry forward. For more information about NIBRT and the QBL Summit, please visit NIBRT's website and the PRST website.
