A “Quality Business Leadership Summit” (QBL), held in Dublin, Ireland in May 2024, brought industry, regulator and academic experts together to explore how to speed up pharma’s progress from a compliance to a quality investment value modus operandi that better drives innovation, financial performance, and supply chain resilience.
At the summit, hosted by the Pharmaceutical Regulatory Science Team (PRST) at the Technological University (TU) Dublin, prominent leaders in the quality regulatory dialogue from the US and Europe took stock of where the pharmaceutical industry is on this journey, where the constraints and hurdles now lie, and what needs to be done to make this “fundamental shift” a reality.
Emerging into relief was the need for industry, with regulator blessing, to take the lead in embedding quality culture into the highest levels of business decision-making – so that investment in quality management and systems is evaluated in terms of its ability to create value and produce resource savings rather than as a line-item budgetary cost to be minimized.
The summit was designed around “Six Traits of Quality Business Leadership,” with speakers and panel discussions addressing the traits in turn:
● lead the path to one global quality regulatory framework
● visibly demonstrate responsibility for quality
● advocate that quality is owned by all through developing senior management partnerships
● engage employees to continuously improve quality
● make risk-informed decisions that benefit patients, and
● promote quality as a value-driven financial advantage
Anders Vinther, chair of the summit and CEO of Quality Business Administration, noted in his opening remarks that the pharmaceutical industry has yet to fully achieve the vision – laid out in 2002 by former FDA Acting Commissioner Janet Woodcock in launching the “Pharmaceutical cGMPs for the 21st Century” initiative – of “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive regulatory oversight.”
Woodcock has continued her engagement with the issues of pharmaceutical quality since her retirement from FDA in 2024, including collaborating with Vinther in raising awareness of the need to further empower quality leadership.
At the summit they both stressed that quality leaders need to acquire the necessary communication skills to engage with company executives and secure the investments necessary to drive a robust quality culture – and that when properly integrated, quality can provide a financial advantage rather than being seen solely as a regulatory obligation.
[Editor’s Note: For other recent IPQ coverage of the current regulatory dialogue on evolving the quality paradigm in pharmaceutical operations see:
● IPQ September 25, 2023, which draws from a PRST meeting on the ICH Q9 revision in reviewing the heightened focus on integrating knowledge into risk-based decision-making to enable improvements in quality and reduce drug shortages
● IPQ February 20, 2024, which focuses on the challenges of and drivers for this shift from a compliance-oriented mindset to one based on a control strategy embodying the risk management principles of ICH Q9(R1) as the complexities of processes, products, and big data handling continue to expand, and
● IPQ May 31, 2024 on the continued realization of the 2003 ICH “Quality Vision” goal of evolving its quality guideline series to keep pace with and provide support for technological innovation through the development of “a harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science.”]
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