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#339: Pharmaceutical Quality Knowledge Management Platform Supporting Global Regulatory Assessment: Regulatory and Industry Perspectives for Translating Vision to Implementation
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
209ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-639-L04-P; CME 1.00; RN 1.00

ICH is advancing a global technology platform for multi-region collaborative review for CMC Post Approval submissions and inspections. Industry and regulators will discuss the platform’s governance, security, financing, and operations and outlook.

Learning Objectives

Explain the drivers, purpose, and plan for a global regulator-industry collaboration platform for PQKM; Describe the platform operating framework including governance and operation implications for regulators and industry participants; Discuss the initiative’s lessons learned and expectations by industry and regulators.

Chair

David C. Isom

Speaker

Industry Perspective
David Sidney Ross, MBA, MSc, PMP, RAC

EMA Perspective
Hilmar Hamann, PhD

Health Canada Perspective
Marcin Boruk, MBA, MSc


Speakers
MB

Marcin Boruk

acting Director, Business Facilitation and Modernization Directorate, Health Can, Health Canada, Canada
Marcin Boruk has been with Health Canada since 2005 and has worked in the areas review, legislation and business transformation. Currently he is an acting Director in the Business Facilitation and Modernization Directorate, Health Canada supporting the branch in projects related to... Read More →
avatar for Hilmar Hamann

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands
Dr Hilmar Hamann is currently the Head of Information Management at the European Medicines Agency (EMA) where he focuses on improving technological capabilities within the EU Regulatory Medicines Agencies Network to support efficient, all-digital, and data-driven operations. Previously... Read More →
avatar for David Isom

David Isom

Senior Director, Global Regulatory Policy and Intelligence, Global Product Devel, Pfizer Inc, United States
David Isom is Senior Director, Global Regulatory Policy and Intelligence at Pfizer. He leads policy and advocacy for digital modernization of the regulatory ecosystem. Before joining GRPI (2016), David led Pfizer information management, digital, and data services for clinical and... Read More →
avatar for David Ross

David Ross

Senior Director, Regulatory Data and Submissions, AstraZeneca, United States
David Ross (Senior Director, Regulatory Data and Submissions, AZ) has undergraduate degrees in Chemical Engineering, and Biochemistry with an MBA and Engineering Management graduate degrees. He led global complex Business Transformation projects in the Pharmaceutical and Biologics... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session |   03: Data-Tech, Session

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