Industry/Regulator Dialogue on Knowledge Management is Intensifying in Wake of ICH’s Q12 Initiative

The focus has been intensifying at industry/regulator forums on how to evolve knowledge management programs, on the one hand, and the quality regulatory paradigm, on the other, to better support the goal of continuous improvement across the product lifecycle. 

How pharma companies are managing their knowledge internally and how that knowledge is flowing through and influencing the regulatory processes are getting heightened attention as ICH explores how Q12 can help liberate the power of the quality-by-design (QbD), quality risk management (QRM), and quality system (QS) principles laid out in ICH Q8-10.

Emerging into stronger relief is the foundational role KM plays in facilitating product development, marketing clearance and post-marketing process control and improvement. Also becoming clearer is that the current regulatory processes are less than optimal in their ability to encourage and reward firms for advancing down the KM pathway. 

The Q12 initiative, in turn, is providing the catalyst for a more intense dialogue between industry and regulators on what KM programs and regulatory processes should look like to be most effective.

The nexus of issues around the intersection of knowledge management and the quality regulatory process were in focus at a session of the ISPE/FDA/PQRI Quality Manufacturing Conference, held in Bethesda, Maryland in June.

The session began with a presentation by Pfizer Right First Time Program Office Director Mariah Deguara-Pagan, in which she explored the interrelationships between KM, QbD, QRM and control strategy, and Pfizer’s effort to strengthen these relationships. Based in manufacturing, the RFT Program Office partners with product development teams in leveraging KM techniques to refine Pfizer’s QbD, QRM and control strategy efforts.

Deguara-Pagan was followed to the podium by Center for Biologics Evaluation and Research (CBER) Special Advisor to the Associate Director for Review Management Ingrid Markovic. As part of her responsibilities at FDA for advancing and communicating science and risk-based quality regulatory policies in the biologics review arena, Markovic is one of four members of the FDA team serving on the Q12 Expert Working Group (EWG).

At the conference session, she explained how knowledge management fits in to the Q12 effort to improve the lifecycle regulatory process – providing insights on how a robust KM program should function, and how knowledge should be communicated between industry and regulators.

The third presenter was Paige Kane, who was speaking on behalf of the Dublin Institute of Technology and the regulatory research program she is involved with there. Kane is working with Merck on its KM program, having helped manage Pfizer’s until April. At the ISPE/FDA/PQRI session, she addressed the relationship between KM and data integrity, explaining how a “holistic” effort is needed that encompasses the knowledge flow between people, processes and IT systems.

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