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Tuesday, June 27 • 10:30am - 11:30am
#228: A Regulatory Pharmaceutical Quality Knowledge Management System to Improve the Availability of Quality Medicines

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-23-575-L04-P; CME 1.00; RN 1.00

The current session will outline high-level lessons learned from the ICMRA collaborative pilots focusing on CMC-related post-approval changes and hybrid inspections, in addition to updates on current ICMRA-ICH-IPRP and PIC/S collaborations.

Learning Objectives

Discuss the different working groups, ongoing activities, and identify suitable contacts responsible for progressing ongoing harmonization efforts to support the development of a global regulatory PQ KMS; Evaluate provisional lessons learned following the collaborative pilots focusing on CMC-related PAC and hybrid inspections.

Chair

Theresa Mullin, PhD

Speaker

ICMRA Work Advancing Development of a Global Regulatory PQ KMS
Lorraine Nolan, PhD

ICMRA Collaboration Pilots: Collective Vision and Achievements to Date Paving the Way Forward 
Stelios Tsinontides, PhD, MA

ICMRA PAC Pilot: Share Process and Learnings from Simultaneous PACMP Submission/Collaborative Review to 6 Health Authorities
Lisa Little-Tranter, MS

Panelist: ICMRA Collaboration Pilot Regulatory Participant
Brendan Cuddy

Panelist: ICMRA Joint Reflection Paper Collaboration
Gabriela Zenhaeusern, DrSc, PhD

Panelist: ICMRA Joint Reflection Paper Collaboration—PIC/S Perspective
Paul Gustafson

Industry Perspective
Robert Iser, MS


Speakers
avatar for Theresa Mullin

Theresa Mullin

Associate Center Director - Strategic Initiatives, 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 →
avatar for Lorraine Nolan

Lorraine Nolan

Chief Executive, Health Products Regulatory Authority , Ireland
Dr Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming... Read More →
avatar for Stelios Tsinontides

Stelios Tsinontides

Office Director, OPMA, OPQ, CDER, FDA, United States
Dr. Stelios Tsinontides is the Office Director of the Office of Pharmaceutical Manufacturing Assessment (OPMA). OPMA evaluates facilities, process design, and control strategies to assess capabilities of manufacturers to produce quality pharmaceutical and biotechnology products at... Read More →
avatar for Lisa Little-Tranter

Lisa Little-Tranter

Senior Director, CMC Global Biologics, Merck & Co., Inc., United States
Lisa Little-Tranter currently serves as Senior Director - Chemistry, Manufacturing & Controls supporting biologics at Merck. Lisa joined Merck in May 2020 and has over 30 years of pharmaceutical industry experience in manufacturing, quality and regulatory roles. Lisa currently provides... Read More →
avatar for Brendan Cuddy

Brendan Cuddy

Lead Scientific Officer, European Medicines Agency, Netherlands
Brendan Cuddy joined the European Medicines Agency in October 2002. He was Head of the Manufacturing and Quality Compliance Service at the Agency from 2014 – 2020. Brendan is currently the Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP... Read More →
avatar for Gabriela Zenhaeusern

Gabriela Zenhaeusern

Deputy Head Stakeholder Engagement, Swissmedic, Switzerland
Gabriela Zenhäusern, a pharmacist with a PhD in biomedical research, joined the Stakeholder Engagement Division at Swissmedic, Switzerland in 2019. In her current position, she is responsible for the coordination of international collaboration, acts as Vice-Chair of the Assembly... Read More →
avatar for Robert Iser

Robert Iser

Lead, Quality Policy and Advocacy, Pharma Technical Quality and Compliance, Genentech, A Member of the Roche Group, United States
Bob joined Genentech in 2022 as the Lead for Quality Policy and Advocacy, where he champions CGMP Compliance and Sustainability, advocates for Genentech, positions in the area of Quality & Compliance in strategic committees and industry working groups involving and interacting with... Read More →

Tuesday June 27, 2023 10:30am - 11:30am EDT
Room 151 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session |   10: RegCMC-Product Quality, Session