Name: #228: Advancing a Global Regulatory Approach to Pharmaceutical Quality Knowledge Management
Start: 2025-06-17T10:30:00-0400
End: 2025-06-17T11:30:00-0400

Tuesday June 17, 2025 10:30am - 11:30am EDT

143ABC

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-575-L04-P; CME 1.00; RN 1.00

The International Coalition of Medicines Regulatory Authorities (ICMRA) Pharmaceutical Quality Knowledge Management System (PQKMS) project is enabling greater regulatory and manufacturing agility to address issues impacting supply and availability of medicines. This session from ICMRA regulators will provide an update on the latest progress made within the project.

Learning Objectives

Describe the latest developments in the ICMRA Pharmaceutical Quality Knowledge Management (PQKM) project, including workstreams within ICMRA, ICH, IPRP and PIC/S to support a PQKM capability; Discuss the long-term potential for the PQKM project to enable a global pathway for submission and assessment of CMC post-approval changes, thereby supporting greater regulatory harmonisation and reliance.

Chair

Michael McDonald, PhD

Speaker

Supporting regulatory convergence and reliance through Pharmaceutical Quality Knowledge Management
Theresa Mullin, PhD

PQKM collaborative assessment pilot programme - Regulator's perspective and udpates
Sean Barry, PhD

PQKM pilot programmes – Industry perspective
Susanne Ausborn, PhD

Panelist
Evdokia Korakianiti, PhD, MSc

Speakers

Susanne Ausborn

Global Head International Regulatory Policy, Roche, Switzerland

Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →

Sean Barry

Senior Pharmaceutical Assessor, Health Products Regulatory Authority (HPRA), Ireland

Sean is a Senior Biologicals Assessor at the Irish health authority, HPRA, where he reviews CMC data for new product applications, scientific advices, clinical trials, and variations for mAbs, recombinant proteins, vaccines, and cell & gene therapies. Sean is chair of the Biologicals... Read More →

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands

Evdokia joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which includes Quality, GxP Compliance, Referrals and PhV. She is the EMA lead of the EU Network's strategic priority to facilitate the uptake of advanced manufacturing approaches. She... Read More →

Stephen Mahoney

Head of Quality Policy and Advocacy, Gilead Sciences, United States

Stephen Mahoney is an Executive Director in Global Quality and Compliance at Genentech, Inc. In this role, he advises senior leaders on critical regulatory and manufacturing matters. Previously, Stephen served as a Compliance Officer in the FDA's Center for Drug Evaluation and Research... Read More →

Michael McDonald

Programme Manager, Office of the Chief Executive, Health Products Regulatory Authority, Ireland

Theresa Mullin

Associate Center Director - CDER, FDA, United States

Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

10: RegCMC-Product Quality, Session | 08: RD-Quality-Compliance, Session

Level Advanced
Keyword Regulator Perspectives
Level Advanced
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives
Tags Session

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