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Tuesday, June 26 • 4:15pm - 5:30pm
#291: ICH Q12: A Paradigm Changing Guidance for Post-Approval Changes?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-618-L04-P; CME 1.25; IACET 1.25; RN 1.25

ICH Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” has the potential to be a paradigm changing document for post-approval changes. The guideline provides new tools to streamline and harmonize processes for post approval changes, through introduction of “established conditions”, “post approval change management plans (PACMPs)”, and product lifecycle management (PLCM) documents. Speakers in this session will introduce the concepts included in the ICH Q12 draft document and provide forward looking thoughts on the potential utilization. Following, a panel of international regulators will discuss the implementation plans and challenges .

Learning Objectives

Describe the elements for regulatory flexibility under ICH Q12 (e.g., established conditions, PACMPs) and their future potential for regulatory flexibility.


Christine M. V. Moore, PhD


ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Mary Oates, PhD

Pathways for Decreasing Regulatory Burden Through ICH Q12
Christine M. V. Moore, PhD

avatar for Christine Moore

Christine Moore

Global Head and Executive Director, GRACS CMC - Policy, Merck Research Laboratories
Christine Moore is the Global Head and Executive Director of CMC Policy at Merck. She joined Merck in 2016 after 11 years in various positions at FDA, including Acting Office Director of the ONDQA and OPF. Throughout here career, Christine has been at the forefront of development... Read More →

Mary Oates

Vice President, Innovative Operations and Network Excellence, Pfizer Inc
Mary Oates is the Vice President of Innovative Operations and Network Excellence for Pfizer Global Supply. She is active in a variety of industry initiatives and holds a PhD in Analytical Chemistry.

Tuesday June 26, 2018 4:15pm - 5:30pm
Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA