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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.

Chair

Christine M. V. Moore, PhD

Speaker

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


Speakers
avatar for Christine Moore

Christine Moore

Executive Director, Merck & Co., Inc
Christine Moore is Global Head and Executive Director, CMC Policy at Merck. Christine joined Merck after more than a decade in various positions in the US FDA. Prior to working at FDA, Christine spent 10 years in small and large molecule process development. Throughout her career... Read More →
MO

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
  10: RegCMC-Product Quality, Forum